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Administrative Procedures Manual
FERPA GuidelinesSection 301 - Mission Statements
Section 302 – Academic Calendars
Section 303 – Academic Degrees
Section 304 – Transfer of Academic Credit
Section 304.1 – Uniform Course Numbering
Section 304.2 – Standard University of Maine System Grading Designations
Section 304.3 – Standard Definitions of Academic & Administrative Terms
Section 304.4 – Academic Record and Transcripts
Section 304.5 - FERPA Guidelines
Section 305 – Program Inventory
Section 305.1 – Academic Program Approval
Section 305.2 – Substantive Changes to Existing Academic Programs
Section 305.3 – Academic Program Review
Section 305.4 – Academic Program Suspension
Section 305.5 – Academic Program Elimination
Section 305.6 – Brokering Academic Programs
Section 305.7 – Programs for Examination
Section 306 – Student Appeals Policy for Academic Affairs
Section 307 - Admission or Readmission of Students
Section 308 - Accreditation
Section 309 - Organization and Establishment of Major Units
Section 310 - Tenure
Section 311 - Intra-System Student Exchange
Section 312 - University Professor
Section 313 – Student Evaluation of Faculty
Section 314 – Community College Partnership of Maine
Section 601 – Human Subject Research
Section 601.1 – Institutional Review Policy – IRB Review of UMS Cooperative Research
Procedures for Submission of Mission Statements and Strategic Plans
Mission statements and strategic plans will normally be brought to the Board for approval on a five-year cycle However, the Board, in consultation with the Chancellor, may call for review and revision of a mission or strategic plan at any time outside the normal cycle.
Mission statements, strategic plans and/or revisions result from the following process:
1. Campus-wide discussion and deliberation led by the president and/or his/her designees.
2. Discussion with the Chancellor and his/her designees at the System level.
3. Approval of the draft documents and/or revisions at the campus level.
4. Approval of the draft documents and/or revisions by the Chancellor.
5. Approval of the draft documents and/or revisions by the Board of Trustees at a regularly scheduled meeting.
6. Inclusion of the approved mission or strategic plan and/or revisions in all appropriate campus and system publications.
Procedures for Submission of Academic Calendars
At least six months prior to implementation, each institution’s academic calendar shall be forwarded to the Chancellor for review and approval. Academic calendars for the following academic year are submitted by the Chancellor to the Board of Trustees for the Board’s information each January.
Departure from an approved calendar must be reported to the Chancellor for information.
Procedures for Awarding of Academic Degrees:
Degrees in course are awarded by means of a blanket resolution as follows:
Recommended that: the Board of Trustees award degrees in course at the appropriate commencement exercise for the (semester) to those students fully recommended by the appropriate faculties and Presidents of the respective institutions and/or divisions of the University of Maine System, whose names appear in the appropriate commencement programs.
The names of all students receiving degrees in course are appended to the minutes of the Board of Trustees.
Diplomas will be prepared in the following manner:
a. The name of the individual unit at which the degree is awarded will appear in the diploma heading and in the perimeter ring of the University seal which is imprinted in the lower center of the certificate. b. The text will read:
Be it known that on recommendation of the Faculty, with the concurrence of the President and the Chancellor, and in recognition of the successful completion of the requisite course of study, the Trustees of the University of Maine System have conferred upon
the degree of
with all the rights, privileges and honors thereto appertaining. In testimony whereof, this diploma is granted at on the day of in the year .
c. The diploma will be signed by the Chair of the Board of Trustees, the Chancellor of the University of Maine System, and the President of the University.
Procedures for Transfer of Academic Credit
Board of Trustees policy provides the maximum opportunity for transfer within the University of Maine System. To effect successful transfer experiences for UMS students, the following transfer practices are endorsed and followed by University of Maine System institutions.
1. Generally, course grades do not transfer from institution to institution. Semester and cumulative grade point averages reflect only those courses taken at the home institution. Students in external degree programs and/or taking courses at distant sites and centers should inquire about any exceptions which may apply.
2. Grades of C- or better in courses taken within the University of Maine System and accepted for transfer credit will be recorded on the student’s transcript although not computed into the cumulative grade point average.
3. All undergraduate courses successfully completed with a C- or better at one University of Maine System institution will transfer to another.
4. Each student must meet the established requirements of the academic program or college into which s/he is transferring. Transfer credits do not necessarily count toward such requirements.
5. Transfer students must consult the individual institution catalog to determine requirements regarding the number of degree credits that must be taken through the degree-granting institution.
6. Transferring students will be expected to provide official transcripts reflecting all previous postsecondary coursework.
7. Each accepted transfer student will receive a written evaluation of transfer credit. The transfer student should then meet with program faculty/advisors at the receiving institution to review how the transfer credit will be applied.
8. Course credit will be transferred only for coursework delivered by regionally accredited institutions, through AP or CLEP, or through life experience (i.e. prior learning or other learning such as military training, etc.) when validated through the approved campus processes.
9. Course credit from international institutions will be accepted for transfer consistent with established institutional policies.
10. If a student disagrees with a decision made in regard to the transfer of his/her credits from one institution to another, the student may appeal through the regular academic appeals process at the receiving institution.
Procedures for Uniform Course Numbering:
The Basic Structure. The course identifier has two components: (1) an alphabetic-subject-area identifier that has three characters, and (2) a three-digit course number .
The alphabetic-subject-area identifier is determined using logic developed by the Inter-Institutional Cooperation Committee of the Florida Association of Collegiate Registrars and Admissions Officers (see Appendix A).
Course Numbering Guide. The first of the three numbers indicates whether or not a course carriers credit, what type of credit, and the level of the course offering.
X = Non-credit community service courses.
0 = Associate degree, vocational courses, or other courses not normally transferable toward a baccalaureate degree.
1,2 = Associate and/or lower-level baccalaureate degree courses.
3 = Upper-level baccalaureate courses.
4 = Upper-level baccalaureate courses; with appropriate qualification and permission, may be taken for graduate credit.
5 = Graduate-level courses; with appropriate qualifications and permission, may be taken for undergraduate credit.
6 = Doctoral and professional courses.
7,8,9 = Reserve levels for future assignments.
The second and third positions of the numeric segment of the course number are designations within each department. These numbers are assigned sequentially, and consideration should be given to series courses (examples: Calculus = MAT 101, MAT 102).
00 – 89 Developmental designations
90 – 99 Reserved for special studies
90 – Reserved for future assignment
91 – Reserved for future assignment
92 – Reserved for future assignment
93 – Reserved for future assignment
94 – Cooperative education
95 – Internship
96 – Field experience
97 – Independent study
98 – Directed study
99 – Thesis
To illustrate the three alpha and three numeric portions of the course number:
B I O 3 2 2
Identifies departmental designations and course sequence.
Identifies whether or not a course carries credit and what type of credit.
Identified to establish uniqueness and visual and/or phonemic relationship with the name of the discipline.
Should correspond to the initial letter of the discipline to be identified.
The following logic is utilized for establishing prefixes that will avoid duplication and offer a usable three-letter system.
Rule #1. The prefix will contain no more or less than three alpha characters.
Rule #2. To establish the prefix in single-word departmental titles, use:
A. The first three alpha characters of the word (e.g., English, ENG).
B. Where conflicts exist, if the title is a compound word combination, use the first two letters of the first word and the first letter of the second word (e.g., Astrophysics, ASP; Biochemistry, BIC; Floriculture, FLC; Psychotherapy, PST).
C. If the first two options (A and B above) have been exhausted and a conflict still exists, use the first two letters and the last letter of the word to establish the three-letter prefix (e.g., English, ENH).
D. If the first three options have been exhausted and a conflict remains, use the first letter of the first syllable, the first letter of second syllable, and the last letter of the word (e.g., Engineering, EGG).
E. If another option is necessary, use the first letter in each of the first three syllables.
Rule #3. In dual-word titles, use:
A. The first two alpha characters in the first word and the first alpha character in the second word (e.g., Animal Husbandry, ANH).
B. If a duplication exists, use the first character of the first word and the first two characters of the second word (e.g., Animal Husbandry, AHU).
C. If a conflict still exists, use the first character of the first word and the first and last characters of the second word (e.g., Animal Husbandry, AHY).
D. If a need exists for another combination, use the first and last characters of the first word and the first character of the second word (e.g., Animal Husbandry, ALH).
E. If a further extension is necessary and one of the words in the title is a compound-word combination, the compound may be treated as separate words to develop a suitable designation.
Rule #4. In triple-word titles, use:
A. The first alpha character in each word (e.g., East Asian Studies, EAS).
B. If another combination is necessary, use the alpha combination which most clearly designates the discipline without duplicating another prefix.
Rule #5. In multi-word titles, use:
A. The first alpha character of the first three words (e.g., Aviation Maintenance Management Studies, AMM).
B. The first alpha character of the three most prominent or root words (e.g., Classical Civilization and Literature, CCL).
Rule #6. In the case of subject titles which are fields within a discipline (e.g., Agriculture, Education, Engineering, etc.) a common set of root characters is used. All fields with AAgriculture@ in the title begin with AA.@ All with AEducation@ or AEngineering@ begin with AE.@
1. a. EDS = Education Secondary
b. ESS = Education Social Studies
c. ESL = Education Special
d. ESE = Education Science
e. EST = Education Statistics
f. ESU = Education Supervision
2. a. EAD = Engineering Administration
b. EAE = Engineering Aerospace
c. EAG = Engineering Agriculture
d. EBE = Engineering Bioenvironmental
3. a. CHI = Chinese Language
b. CZE = Czech Language
c. The word Alanguage@ is added to distinguish from Chinese History, or Chinese Studies, but not incorporated in the prefix.
Procedures for Standard Grading Designations
Standard grading designations were adopted in September 1999. The following menu of common designations is available to all faculty and will simplify implementation of a single academic record throughout the University of Maine System. A single academic record with standard designations will be easy to interpret by academic advisors, especially for multi-campus distance students or those who attend more than one UMS institution. Faculty prerogatives in assigning grades are not affected by these standard designations, although faculty now have more options than previously.
Individual institutions may use and publish a subset of the standard grading designations listed below, but they may not change the meaning of the grades or add additional grades unless they are formally added to the designations by the Chief Academic Officers. The standard designations are effective with the Fall 2000 semester grading.
|Grade Definition||Grade||Quality Points|
|deferred grade – multi-semester course||DG||None|
|dropout – punitive||L||0.0|
|honors – pass/fail course||H||None|
|incomplete – temporary||I||None|
|incomplete – permanent non-punitive||INC||None|
|incomplete – permanent punitive||*I||0.0|
|low pass (UM School of Law)||LP||None|
|missing grade – permanent punitive||*M||0.0|
|pass/fail course – pass||P||None|
|pass/fail course – fail||*F||None|
|undergraduate thesis – deferred||T||None|
|withdraw failing – punitive||WF||0.0|
|graduate thesis – acceptable||ACC||None|
|graduate thesis – deferred||R||None|
Symbols used to address non-traditional functionality of grading
When the symbols listed below precede any of the grades above, they are used when grades are not treated in the traditional method of grading. They include, but are not limited to, grading for developmental courses, academic “forgiveness” of previous grades, and special circumstances where a student on academic suspension is readmitted. (Example: *A – the grade is used to determine quality points and is computed into the grade point average but no degree hours are earned for the course).*Grade counts in GPA; no credits are earned.~Grade does not count in GPA; credits are earned.#Grade does not count in GPA; no credits are earned.
Procedures for Standard Definitions of Academic & Administrative Terms
Although each university in the University of Maine System (UMS) develops specific implementation practices and procedures for many academic and administrative actions, a standard definition of terms exists to facilitate cross-institutional enrollments, transfer within the UMS and production of UMS student transcripts. Each university will include the definitions in catalogs and other appropriate institutional publications.
1. Academic Terms
A. Academic Dismissal – When a degree student is not making satisfactory progress toward a degree, an appropriate official/committee at each university takes dismissal action against the student and (s)he is not allowed to take any courses as a matriculated student at that institution.
1) The student is not normally allowed to apply for readmission.
2) The action is posted to the official academic record.
3) A hold is placed on the student’s record to preclude enrollment as a matriculated student at that institution.
B. Academic Probation/Warning – The degree student whose grade point average indicates that (s)he will have difficulty achieving the required minimum GPA to graduate will be notified of this possibility.
1) Academic probation/warning may have an impact on financial aid awards.
2) Posting probation/warning on transcripts varies with each institution.
C. Academic Suspension – When a degree student is not making satisfactory academic progress toward a degree, an appropriate official/committee at each university may take suspension action against the student.
1) The student shall not take courses as a matriculated student at that institution for the next academic semester nor thereafter until the conditions established for termination of that suspension have been met.
2) The action is posted to the official academic record.
3) A hold is placed on the student record to preclude enrollment as a matriculated student at that institution until the conditions of the suspension have been met.
4) The student may enroll as a non-degree student at any UMS institution.
D. Repeat Grades – With one exception, institutions allow students to repeat courses that result in only one grade being computed into the GPA and the earned hours accruing only once. The method used to recompute the GPA varies with each institution.
E. Satisfactory Academic Progress – In keeping with Title IV Federal Financial Aid Regulations continued eligibility for financial aid depends on a student making satisfactory academic progress (SAP) toward completion of degree requirements. The guidelines require the policy to include both qualitative (GPA) and quantitative (attempted versus earned hours) measures. The maximum time for receipt of aid may not exceed 150% of the published length of the program as measured in academic semesters. The practices at each university are being reviewed to determine the possibility of developing a single educational progress scale that incorporates both the federal and university requirements.
1) Financial Aid Probation – If a student fails to meet the minimum requirements, (s)he will be placed on financial aid probation. The student may receive financial aid for the probationary term(s) but must complete the designated number of credits with the corresponding GPA by the end of the probationary period.
2) Financial Aid Suspension – Suspension results from failure to meet the minimum GPA and to attain the required minimum earned credits at the end of the probationary semester. Financial aid is not available.
F. Transfer Credit Evaluations Within the UMS – Board of Trustees policy is to provide the maximum opportunity for transfer within the System. When a student is accepted for transfer, all undergraduate degree credits obtained at any institution of the University of Maine System will be transferable to any other institution but may not be automatically applied to the specific academic degree program to which the student has transferred.
2. Administrative Terms
Students in violation of the Student Conduct Code may be subject to disciplinary action by the University pursuant to the Code.
A. Administrative Suspension – The suspension may be separation from the University for a specific period of time or until other conditions have been met.
1) The student shall not be admitted as a matriculated student by the same or another institution for the next academic semester nor thereafter until the conditions established for termination of that suspension have been met.
2) The student may enroll as a non-degree student at another UMS institution.
3) The action is not posted to the academic record.
4) An administrative hold is placed on the student record to preclude enrollment at all UMS institutions.
B. Administrative Dismissal – The UMS Student Conduct Code contains sanctions for students that include dismissal from the University.
1) The student is not entitled to apply for readmission.
2) An administrative hold is placed on the student record to preclude enrollment at all UMS institutions.
3) The action is not posted to the student record.
3. Hold Types
Several hold actions are posted to student records to preclude student enrollments and other appropriate university services. A cross-institutional hold facility with the Student Information System applies to the areas listed below.
A. Academic – as a result of academic suspension or dismissal
B. Administrative – as a result of an administrative suspension or dismissal
C. Financial – as a result of a student who is in arrears to the UMS
1) Student receivables = >$100
2) Student loans >$0
4. Hold Actions
Hold actions taken against the student are dependent on the hold type.
A. Cross-Campus Holds
1. Registration as a matriculated student. Registration is not allowed at any UMS institution as a result of any or all of the hold types listed below.
a. Administrative suspension
b. Administrative dismissal
2. Registration as a non-degree student. Registration is not allowed at any institution as a result of the hold type listed below.
a. Administrative dismissal
3.Transcript requests – Student transcript requests will not be honored by any university as a result of the hold type listed below.
4.Diploma – Attendance at the commencement exercises is allowed but no diploma is released to the student as a result of the hold type listed below.
B. Campus-Based Holds
1. If a student is academically suspended or dismissed from a UMS institution, the student may not register as a matriculated student until such time as that institution readmits the student. The institution shall place a campus-based hold to prevent registration as a matriculated student. This hold will only affect the student’s status at the UMS institution which took one of the following actions against the student.
a. Academic suspension
b. Academic dismissal
NOTE: Italicized items indicated that varying policies/procedures exist.
See: Policy Manual Section 304: Transfer of Academic Credit
Policy Manual Section 307: Admission or Readmission of Students
Academic Affairs Administrative Procedures Manual Section 304: Transfer of Academic Credit
Academic Affairs Administrative Procedures Manual Section 307: Admission or Readmission of Students
Administrative Practice Letter 18
Student Loan Fund Procedures Manual, Section D, Subsection 2.1
Procedures for the Academic Record and Transcripts
In March 1998 the Chief Academic Officers of the University of Maine System voted to adopt a single academic record. The academic record will be the source for all transcripts and will contain:
1. all courses taken within the University of Maine System
2. the view of the academic record will be from the home campus
3. transfer credit will be posted as evaluated by the home campus
4. the imprinted signatures of all seven registrars
5. the imprinted seal of the University of Maine System
6. a common key that defines the grading system and other appropriate University of Maine System academic record features
Students will be able to obtain a transcript from any University of Maine System institution.
See: Academic Affairs Administrative Procedures Manual Section 304.2: Standard University of Maine System Grading Designations
Procedures for Submission of Program Inventory
Board of Trustees policy states that the Academic Program Inventory is the definitive list of all academic degree programs offered by the institutions or units of the University of Maine System. An academic program is defined as a course of study identified by a specific degree title and a specific subject matter area with a prescribed set of requirements which a student must complete.
The Academic Program Inventory is maintained by the Office of the Vice Chancellor for Academic Affairs. Each summer the institutions are requested to update their portions of the Inventory. The completed document is submitted to the Board of Trustees for the Board’s information each September.
See: Policy Manual Section 305: Program Inventory
Section 305.1 Academic Program Approval
Last Revised: 2/25/2010
Academic Program Approval
The approval process requires the following steps, some of which can occur in parallel:
Part A: Intent to Plan
1. The initiating university will follow all appropriate university processes in preparing the Intent to Plan.
2. When approved by the university President, the Intent to Plan will be submitted to the Vice Chancellor for Academic Affairs who will acknowledge receipt of the document.
3. The Vice Chancellor will distribute via email the Intent to Plan, along with the names and contact information of four potential reviewers, to the President and the Chief Academic Officer of each university for their information.
4. The Intent to Plan will be discussed by the Chief Academic Officers first via email. If a consensus to accept the Intent to Plan can be reached via email, then the Plan is moved to step 5. If no consensus can be reached via email, the proposing CAO will be notified and the Plan may be considered at the next regular CAO business meeting. To provide adequate time for individuals to prepare and distribute written statements in support of or in opposition to the Plan, only Plans submitted 7 days prior will be considered at the next scheduled meeting of the Chief Academic Officers. Items not submitted within the time frame established will not receive consideration until the next CAO meeting.
In review of the Intent to Plan, the CAOs will take into consideration the following:
a. Appropriateness of the program to the mission and goals of the submitting university;
b. Need for the program and rationale for any duplication;
c. Availability of adequate resources to support the program; and
d. Statewide need and corresponding interest, mode of delivery, and the potential catchment areas from which students would be drawn.
After review of the Intent to Plan, the University of Maine System Chief Academic Officers will decide upon one of four actions:
b. Acceptance with qualifications;
c. Returned with suggestions for revision; or
d. Rejection with rationale to substantiate decision.
5. The recommendation of the CAOs will be conveyed to the Vice Chancellor who in turn will make his/her recommendation concerning an Intent to Plan to the Chancellor. The minutes of the Chief Academic Officers will be the record of action on an Intent to Plan. If the Intent to Plan is approved by the Chancellor, the Vice Chancellor will notify the Chief Academic Officer of the originating university in writing that the development of a full proposal may proceed, with copies of the action to all other universities. The Board of Trustees will be informed when Intent to Plan Statements have been approved by the Chancellor.
6. Once an Intent to Plan has been approved, a status report must be filed in the Vice Chancellor’s Office at the end of a six-month period in order to keep the plan active if a program proposal has not yet been submitted. An approved Intent to Plan which is not followed by the submission of a program proposal within one year from the time of initial acceptance will be automatically voided unless a specific request for an extension of time has been received and approved by the Vice Chancellor for Academic Affairs.
Part B: Program Proposal
7. Approval of an Intent to Plan is to be followed by the submission of a Program Proposal by the originating university through the appropriate university process. The development of the Program Proposal in most instances will be developed in parallel with the Intent to Plan in order to speed the approval process, and it is urged that the university administration share an early draft of the program proposal with other Chief Academic Officers and the Vice Chancellor for Academic Affairs. The Program Proposal must address the following areas:
a. Program objectives and content
b. Evidence of program need
c. Program resources and total financial considerations
d. Program evaluation
When approved by the university President, the program proposal will be submitted electronically to the Vice Chancellor for Academic Affairs who will acknowledge receipt of the document and distribute via e-mail copies to the Chief Academic Officers.
8. The Vice Chancellor will select, contact, and compensate two external reviewers from those suggested to provide an independent assessment of the proposal. The external reviewers will report in writing their findings and recommendations to the Vice Chancellor for Academic Affairs, who in turn will share these with the originating university for proposal revision, as deemed necessary.
Following revisions, the completed proposal, with the approval of the university President, will be submitted to the Vice Chancellor for Academic Affairs 30 days before the Board meeting at which the proposal is to be considered. The Vice Chancellor for Academic Affairs will distribute it to the Chief Academic Officers for information only.
The Vice Chancellor has three action options:
a. forward the proposal with a recommendation for approval to the Chancellor;
b. return the proposal to the originating university with specific critiques and suggestions for revision; or
c. return the proposal to the initiating university with specific written rationale for its rejection.
9. The Chancellor will recommend program proposals to the Board of Trustees for its review and approval. Notice of final approval of program proposals will be transmitted to all universities.
To meet urgently needed workforce development demand in a university’s immediate catchment area, the Vice Chancellor of Academic Affairs may make exceptions to the above policy. Universities may seek permission from the VCAA to offer credit bearing certificates and associate degrees for a specified and limited time period.
1. Proposal is sent to VCAA electronically
2. VCAA shares proposal electronically with all CAOs
3. Consultation between the CAOs and VCAA is held to:
a. Review soundness of the proposal
b. Determine if collaboration is needed, desired, and/or valuable to the success of the plan
c. Facilitate any such collaboration(s) as deemed needed
4. Chancellor signs-off on the proposal on behalf of the BOT
When a university plans to make substantive changes to a previously-approved academic program, the program should be brought to a regular business meeting of the Chief Academic Officers for review and discussion.
Substantive changes to an existing academic program (degree, certificate, or other form of academic recognition) include:
- a significant departure in terms of either the content or method of delivery from those that were offered when the academic program was most recently evaluated, such as distance learning or correspondence courses;
- changes in the geographic area in which a degree program is being offered, either physically or through distance learning technologies
The Vice Chancellor for Academic and Student Affairs will make a decision, based on the recommendation of the Chief Academic Officers, whether to approve or reject the proposed changes to academic programs.
Academic program review must be institution-based and reflect an institution’s mission and capacity. Program review should focus on student outcomes and should support a systematic and broad-based approach to the assessment of student learning focused on educational improvement through understanding how and what students are learning in their academic program.
Regular program assessment will improve the program review process. Specific identification of program goals and student learning objectives is a critical first step.
1. All academic degree programs are to be reviewed within an established time frame. The schedule of academic program reviews is to be revised biennially in concert with the review and revision of the university operational plan of which it becomes a part. Academic program review schedules are to be submitted to the Vice Chancellor for Academic Affairs and any deviations from these review schedules must be approved by the Vice Chancellor for Academic Affairs.
Program review should be undertaken within five years for new programs and at least every seven years for continuing programs, unless a shorter interval is deemed necessary for specified conditions resulting from a review. The schedule should allow for flexibility and can change to coordinate with the timing of reviews by specialized accrediting bodies. University-level processes should be developed for programs less than degree-level.
2. Academic program review should ensure broad institutional and community representation in the process, including but not limited to appropriate faculty and program alumni. Structures and mechanisms that blend academic affairs and student affairs in a constructive fashion should be encouraged.
3. The program review process on each university should include:
a. a self-study by the unit being reviewed.
The self-study should include:
• rationale for the program
• five-year summary of program enrollment (number of majors and number of graduates)
• course section enrollments
• number of full-time faculty equivalents
• an assessment of progress made in relation to the recommendations of previous program reviews.
The self-study should address the quality of the faculty and the methods used to ensure that quality (such as post-tenure review practices). The quality and appropriateness of the curriculum should be examined, with attention to such matters as student outcomes assessment and pluralistic perspectives. In addition, the self-study should discuss the relation of the program to the university mission.
b. a report by external reviewers based on a review of the self-study, additional materials as required, and a site visit.
c. a final report by the university, endorsed by the President.
The final report should include:
• a statement on how the program enhances the mission of the university
• a statement on the value of the program to the state and the nation
• a set of recommendations, with rationale, for future action,
• budget implications based on the self-study and the external review, and
• actions taken as a result of previous reviews.
Attention should be given to whether or not a program having had few graduates over a period of years as well as low course section enrollments should be continued. Professional accreditation processes may substitute for appropriate components of this section. The University of Maine System encourages program review and accreditation assessments be held at the same time where possible and appropriate.
4. Program reviews carried out during the previous two years shall become a part of the biennial review and revision of the university operational plan and the recommendations emanating from the review should be taken into consideration in the development of the biennial budget request.
5. Each year, each Chief Academic Officer will submit a report to the Vice Chancellor that summarizes program review activity at the universities. This report should include information on reviews in progress, reviews completed in the past year, an executive summary of the results of completed reviews and actions taken as a result of those reviews.
The Vice Chancellor will review the documents submitted and, based on this review, will recommend that the Chancellor accept the reviews and the recommendations in the final report and initiate any appropriate action(s), or recommend that the Chancellor discuss the review documents with the university President and examine possible future actions.
Institutions and the System should fully vet program reviews and provide adequate responses to programs.
Program review documents will be kept on file in the Chancellor’s Office where they can be reviewed by members of the Board of Trustees.
An academic program may be suspended for many reasons, including change in campus mission, low enrollments, and lack of resources. A campus may choose to suspend a program in order to gain time before restructuring the program or eliminating it. The following procedure should be followed in the case of suspending an academic program.
An academic program can be assessed for possible program suspension:
1) as a result of the program review process, or
2) at any time at the initiative of the campus offering the program, or
3) at any time at the initiative of the Chancellor.
A program should not remain in the suspended state for longer than three years. By the end of the third year, a decision should be made to restructure and re-institute the program or to eliminate it. In the case of a decision to eliminate, the formal program elimination process will be initiated.
Academic degree program suspension process shall including the following:
1. The initiation of the Program Suspension Procedure, including notification in writing by the President to the Vice Chancellor for Academic Affairs and to the Associated Faculties of the University of Maine System of the intent to develop a Program Suspension Proposal.
2. The development of a Program Suspension Proposal, which shall normally include the following:
a. A five-year summary of program enrollments (number of majors and number of graduates) and number of faculty equivalents (FTEs) associated with the program.
b. The specific rationale for the suspension of the program.
c. The relationship of the program suspension to the institutional mission and to other programs at the institution. Where faculty positions are involved, UMS will follow the AFUM agreement and will consult with the appropriate faculty governance body.
d. A plan for the assignment of faculty during the suspension period.
e. The impact of the program suspension on students, including plans for assisting students to complete an appropriate degree program.
f. A timetable for the program suspension, with date for consideration of the program for reinstatement or elimination.
g. The input obtained from meeting and discussion with the appropriate faculty committees and with the Associated Faculties of the University of Maine System prior to completion of the proposal.
3. Campus submission of the Program Suspension Proposal to the Vice Chancellor for Academic Affairs. The Vice Chancellor will make copies of the Program Suspension Proposal available to the Presidents and Chief Academic Officers of each campus for their information.
4. The Vice Chancellor for Academic Affairs’ recommendation, after consultation with the Chief Academic Officers, to the Chancellor for approval of the Suspension Proposal.
5. The Chancellor’s informing the Board of Trustees of the Suspension at the next regular Board meeting.
6. If a university desires to reinstate a suspended academic program, the President will notify the Chancellor in writing of the university’s intention and request approval to reinstate the suspended program. This letter must explain the reasoning for the reinstatement; detailing the importance of the program to the mission of the university and the State of Maine. The letter must also show how the university will maintain student enrollments, ensure financial stability, and keep the program viable in the future.
An academic program can be assessed for possible program elimination
(1) as the result of the program review process as indicated,
(2) at any time at the initiative of the campus offering the program, or
(3) at any time upon the recommendation of the Chancellor based on enrollments and the centrality of the program to the campus mission. In those situations in which the Chancellor believes there is sufficient reason for a campus to consider invoking the program elimination process, he/she will make such a recommendation, accompanied by the rationale for the recommendation, to the campus President. Following receipt of such a recommendation, the campus will either initiate the program elimination process or provide justification for not eliminating the program.
Academic degree program elimination shall include the following:
1. The initiation of the Program Elimination Procedure including notification in writing by the President to the Vice Chancellor for Academic Affairs and to the Associated Faculties of the University of Maine System for the programs to which unit members are assigned, of the intent to develop a Program Elimination Proposal.
2. The development of a Program Elimination Proposal which shall include the following:
a. A five-year summary of program enrollments (number of majors and number of graduates), course section enrollments, number of full-time faculty equivalents associated with the program, and budgets.
b. The specific rationale for the elimination of the program including an indication of the campus process used to reach the recommendation.
c. The relationship of the program elimination to the campus mission and to other programs on the campus.
d. A plan for the retrenchment or reassignment of faculty.
e. The impact of the program elimination on students.
f. A timetable for the program elimination.
g. The input obtained from meeting and discussion with the Associated Faculties of the University of Maine System prior to completion of the proposal.
3. Campus submittal of the Program Elimination Proposal to the Vice Chancellor for Academic Affairs. The Vice Chancellor will make copies of the Program Elimination Proposal available to the President and Chief Academic Officer of each campus for their information.
4. Program Elimination Proposals submitted to the University of Maine System Chief Academic Officers, who will review all proposals and decide upon one of the following three actions:
a. Program Elimination Proposal accepted.
b. Program Elimination Proposal returned with request for additional information.
c. Program Elimination Proposal rejected with rationale to substantiate decision.
5. The Chief Academic Officers’ recommendation to the Vice Chancellor for Academic Affairs, who will in turn make his/her recommendation concerning the Program Elimination Proposal to the Chancellor.
6. The Chancellor’s recommendation of the Program Elimination Proposal to the Board of Trustees for its review and final approval, to come before the Board twice a year at the January and July Board meetings.
See: Policy Manual Section 305.1: Program Approval, Review and Elimination
Administrative Procedures for Brokering of Academic Programs:
A brokered program is a collaboration between two universities where one University (the “provider” institution) allows another university (the “receiver” institution) to offer a curriculum resulting in a degree. The receiver generally admits the students and offers the curriculum based on guidelines set by the provider institution.
A. Letter of Intent. A Letter of Intent signed by the President of the provider institution and the President of the receiver Institution is to be submitted to the Vice Chancellor for Academic Affairs for approval. The Letter of Intent is to include:
1. The name of the proposed brokered program
2. The providing and receiving institutions
3. Rationale (need)
4. Tentative cost and revenue projections
5. Anticipated starting date
Upon receipt of the Letter of Intent the Vice Chancellor for Academic Affairs will forward a copy for review and comment to each campus president and chief academic officer. Within thirty (30) days thereafter the Vice Chancellor for Academic Affairs will:
1. Approve the Letter of Intent, with or without qualifications, authorize the development of a written agreement and notify the Chancellor and the involved campus presidents and chief academic officers of the decision, or;
2. Reject the Letter of Intent and notify the involved presidents and chief academic officers and the Chancellor.
B. Written Agreement.
1. Upon approval of the Letter of Intent by the participating campuses a written agreement between the campuses involved is to be developed.
2. The written agreement signed by the respective campus presidents is to be forwarded to the Vice Chancellor for Academic Affairs. The Vice Chancellor will forward a copy of the agreement for review and comment to each campus president and chief academic officer. Within thirty (30) days thereafter, the Vice Chancellor for Academic Affairs will:
a. Approve the written agreement and notify the Chancellor and each campus president and chief academic officer, or;
b. Reject the written agreement and notify each campus president and chief academic officer and forward a copy to the Chancellor.
3. The agreement should specify:
a. the name and description of the program;
b. any variance in the curriculum from the degree-granting, provider institution, and the plan for offering and supporting the curriculum at the receiving institution;
c. arrangements under which faculty at the receiving campus are approved for delivery of the program;
d. who will be responsible for making admissions decisions and advising students admitted into the program;
e. the cohort size and the length of time the program will be available;
f. a plan for how records for students in the program will be managed;
g. that students enrolled in the brokered program will be subject to the rules, regulations and procedures of the receiving campus;
h. program budget;
i. a plan for review and evaluation of the program, and;
j. a plan for resolution of disagreements.
k. who shall award the degree
To ensure timely and ongoing attention to programmatic vitality, all academic programs within the UMS will be examined annually for the (a) number of graduates being produced, (b) the number of undergraduate majors, and (c) the number of faculty available to the program. The Programs for Examination process is intended as a proactive mechanism by which to foster broader collaborative discussions among faculty and academic administrators regarding program size in the context of mission, quality, and sustainability.
1. Programs for Examination Thresholds – Programs not meeting the thresholds listed below must be examined by the Chief Academic Officer (CAO) and other appropriate academic administrators, in collaboration with the faculty, the Chief Academic Officers Council (CAOC), and the UMS Vice Chancellor for Academic Affairs (VCAA):
- number of graduates per year:
- Undergraduate: average five graduates per year over three years
- Master’s: average of three graduates per year over three years
- Doctorate: average of two graduates per year over three years
- number of undergraduate majors: 15 (as determined by the number of active majors at the end of each academic year)
- number of tenure-track or just-cause eligible faculty: 3 (as determined by the headcount of faculty at the end of each academic year)
2. Programs for Examination Academic Year Timeline –
a. By August 1 of each year – UMS IR office will provide a dashboard summary of graduates, majors and faculty by campus for each program in the UMS program inventory, and will have identified for the CAOs those programs not meeting the above thresholds;
b. In November of each year – each CAO will notify the VCAA of the following items for discussion with the CAOC:
i. reason(s) of why any program need not be examined further because of meeting critical university needs, regardless of the Programs for Examination criteria;
ii. programs not meeting the Programs for Examination criteria for which more examination is needed; for those programs for which questions remain, the CAO will communicate to the appropriate academic unit(s) the need for further information, analysis, discussion, etc.;
iii. progress on actions to address concerns for programs identified in the previous year of the Programs for Examination process;
c. In March of each year –
i.For discussion with the CAOC, the VCAA will have provided a written summary of those programs identified by the Programs for Examination process, but determined to meeting critical university needs.
ii.the CAOC will engage in a discussion of action plan outlines developed by each CAO to address low numbers of graduates, majors and/or faculty for any remaining program(s) identified by the Programs for Examination process.
3. Other Considerations: Simple measures of numbers of graduates, majors and faculty are clearly only a subset of variables that provide insight into a program’s role and function. Thus, for programs not meeting the thresholds, other considerations for subsequent discussions include: SCH production, provision of service courses, centrality to institutional mission or strategic plan, societal or workforce need, relevance and access to underrepresented groups, program uniqueness, K-12 or community college pathways, research impact, accreditation, ratio of part-time to full-time instructors, certification pass rates or other assessment outcomes, instructional cost, etc.
The Student Appeals Policy for Academic Affairs guarantees to each student an objective review of an academic grievance.
Each institution has an established written policy on student appeals for academic affairs, and these policies have been reviewed and approved for implementation by the Chancellor.
Any proposed revisions to campus policies should be submitted to the Chancellor for review and approval. The following criteria were applied by the Chancellor in approving the original documents and will also be applied in approving any proposed revisions:
Each institutional policy shall provide for:
1. Purpose of appeals document (general statement of policy).
2. Procedures to be followed in an appeal of a decision on academic affairs:
a. Types of issues which may be appealed.
b. Steps to be taken by the student to appeal a decision on academic affairs.
c. Procedures to be followed by the institution to resolve the issue.
3. Provision for periodic re-evaluation of the policy.
In addition, the campus should indicate how students and faculty were involved in formulating any revisions to the policy, and endorsements by appropriate student and faculty organizations should be noted.
Procedures for Admission or Readmission of Students:
A student seeking re-admission to the same institution after academic suspension or dismissal shall, complete an application for re-admission with Admissions or other appropriate office, including on the application the reasons why the student feels he or she will be successful if allowed to enter as a matriculated student.
The student’s transcript will show academic status; and the application form of each university will include the question:
Have you ever been dismissed from, or suspended by, any institution in the University of Maine System or any other college or university for any reason? (Yes or No)
If yes, please explain.
See: Policy Manual Section 307: Admission or Readmission of Students
Procedures for Accreditation:
No procedures necessary.
Procedures for Organization and Establishment of Major Units
Proposals for major university reorganization, the establishment of a new unit, or the merger of two or more units should include a rationale that describes how the proposed change or addition will enhance the university’s ability to carry out its mission, a projected five-year budget, and a proposed review process.
Proposals for elimination of a unit should provide a rationale and budget and personnel implications.
Proposals should be submitted by the university President to the Chancellor for review and submittal to the Board of Trustees.
The establishment and maintenance of research and public service centers, institutes, laboratories, and bureaus will follow the Policy for Establishing and Maintaining Centers.
See: Policy Manual Section 309: Organization and Establishment of Major Units
Procedures for Awarding Tenure
The decision to grant or not to grant tenure rests solely with the Board of Trustees. Nothing in these guidelines, or in the criteria developed under these guidelines, or in the approval of the criteria, shall limit or restrict that discretionary authority of the Board.
1. Each new appointee should receive a letter of appointment that includes, as a minimum, such data as:
a. academic rank and/or title of position;
b. general duties to be performed;
c. beginning and ending dates of appointment;
d. type of appointment – probationary, temporary;
e. indication of amount, if any, or prior service to be counted toward probationary period;
2. The specific assignment of prior credit will be part of the letter received at the time of initial appointment. The time credited as probationary years with regard to service at other institutions of higher education, whether units of the University of Maine System or not, shall not exceed three years.
3. A probationary appointment shall not exceed six consecutive academic years in a full-time position on a single campus. A leave of absence, sabbatical, or teacher improvement assignment shall not constitute a break in continuous service, nor shall it be included in the six-year period without prior written agreement between the faculty member and the President at the time of the request.
4. Individuals on probationary appointments shall normally complete the full term, i.e., the sixth year, before the Board awards tenure.
5. At the time of initial appointment, exceptionally qualified individuals may be awarded tenure at the rank of full professor, with the approval of the appointment by the Trustees. In other cases, as the institutions deem appropriate, full professors may receive an initial appointment without tenure but, with Trustee approval at the time of their appointment, may be given the opportunity to apply for tenure during the second year of their appointment.
6. Tenure shall not be awarded ordinarily below the associate professor level or its equivalent.
7. Each institution shall develop its criteria for promotion and tenure, and, once developed, a statement of such criteria shall be forwarded to the Chancellor and the Trustees for review and approval and thereafter be made available by the campus administration to all faculty members in the institution. These criteria shall include reference to teaching, public service, research, and scholarship activities as are appropriate to the University System and institution missions. Criteria may vary among units or departments, but shall be in accord with the overall campus criteria.
8. Student input is a desirable and meaningful part of faculty evaluation, and the contribution students make to the evaluative process is essential to the improvement of instruction. Student evaluations are to be secured on a regular, systematic, and equitable basis and made part of the official record.
9. Evidence should be obtained from outside the institution and from outside the University of Maine System, as appropriate, regarding the scholarship and research of candidates for tenure.
10. Tenured faculty, as well as nontenured faculty, shall be reviewed on an annual basis. Each institution shall develop its own criteria for faculty evaluation, and, once developed, a statement of such criteria shall be forwarded to the Chancellor and the Trustees for review and approval and thereafter be made available by the campus administration to all faculty members in the institution.
11. The tenure guidelines provide the policy framework for the process to be followed at each institution. Where exceptions are sought, it is necessary that the campus present its request in detail, including the rationale for the exception, to the Chancellor and the Board of Trustees.
12. Tenure may be transferable among the institutions of the University of Maine System at the discretion of the Board of Trustees, consistent with the tenure policies of the institution to which transfer is sought.
13. Senior administrators shall not be awarded tenure as part of their administration contracts. However, the Trustees will consider, on an exceptional basis, a nomination to tenure for an academic dean, when presented under these conditions:
1. the nominee will have been accepted by an appropriate academic department and accorded faculty rank, at the time of appointment as academic dean;
2. the nomination will have been duly evaluated through the campus tenure processes.
14. A chief academic officer or other university employee in a position at the level of vice president may be considered for tenure to be effective upon assuming a full-time faculty appointment after completion of service in the administrative position. The employee must have been accepted by an appropriate academic department and accorded faculty rank at the time of appointment to the administrative position. Evaluation for tenure will occur under the university’s tenure process at the time of initial appointment, or, with approval of the President, during the final year of service in the administrative position. The final decision regarding the award of tenure is made by the Board of Trustees. If tenure is granted, it will not be effective until the date the employee assumes the full-time faculty position and the term in the administrative position ends.
See Policy Manual Section 310: Tenure
Procedures for Intra-System Student Exchange:
No procedures necessary.
Procedures for University Professor:
Appointment as a University Professor shall be recommended by the President, nominated by the Chancellor and approved by the Board of Trustees. Each unit shall establish procedures for the selection of nominees.
See Policy Manual Section 312: University Professor
Procedures for Student Evaluation of Faculty:
Each university shall establish procedures for student evaluations of faculty. These procedures shall be in accordance with Board policy mandating such evaluations and, where applicable, in accordance with the current collective bargaining agreement.
See Policy Manual Section 313: Student Evaluation of Faculty
Definitions and Procedures for Identifying and Tracking Students in the Community College Partnership of Maine (CCPM)
Community College Partnership of Maine (CCPM) – The Partnership is a collaborative effort on the part of the University of Maine System and the Maine Technical College System to deliver community college courses and services statewide. The two Systems will collaborate to expand access to associate of arts foundation courses, increase availability of courses statewide, offer ready transfer between the technical colleges and universities, and provide educational access to all Maine’s citizens.
CollegeStart: Providing Community College Access Statewide to Maine People is the System’s effort to expand access to high quality programs and services for Maine citizens through affordable participation rates. CollegeStart serves as the vehicle for supporting and enhancing the CCPM.
CollegeStart students are those who are enrolled in developmental, 100- and 200-level courses offered on-site, through ITV, or asynchronously at:
•UMS Off-campus Centers and Sites
•University College of Bangor
The students may be degree or non-degree students.
•Degree students may be enrolled in associate degree programs already offered by the UMS institutions.
•Degree students will be eligible to apply for financial aid.
•Degree students may opt to receive a Certificate in Liberal Arts – Level I that will be awarded after successful completion of courses in six liberal arts areas.
Certificate in Liberal Arts – Level I is a certificate awarded to UMS enrolling students at CollegeStart locations who register for and successfully complete six courses, that is, one designated 100- or 200-(introductory) level course in each of the six required liberal arts skill/discipline areas. Fifty percent (50%) of courses for the certificate may be taken outside the University of Maine System. The designated courses will transfer directly into the general education core at all UMS institutions, as well as into the associate of arts in general studies degree programs at the Technical Colleges.
The participating institutions that will award the certificates are:
University of Maine at Augusta
University of Maine at Fort Kent
University of Maine at Machias
University of Maine at Presque Isle
University of Southern Maine
Effective with Fall 2000 the following definitions and procedures will be in effect:
1. ISIS fields identified with each student
a. ‘CERTIFICATE’ – multiple instance field
b. ‘DATE ADMITTED’ – multiple instance field
c. ‘DATE RECEIVED’ – multiple instance field
2. ISIS fields identified with each course section
a. ‘CCI’ will become a non-maintainable attribute field for sections where ‘SITE,’ ‘location type,’ and ‘delivery mode’ are equal to the appropriate values.
b. ‘SITE’ – A System table is maintained by the Office of Financial Planning & Budget. When the System table is updated, it spawns the changes to campus tables thus campus tables are copies of the System table. An attribute is attached to each SITE that flags CollegeStart courses (i.e., yes/no).
‘LOCATION TYPE’ – Within the SITE table, all location types identified as part of CollegeStart have identifiers unique from those of regular institutional offerings. They include UMS off-campus centers, ITV sites and some branch campuses.
c. ‘DELIVERY MODE’ – All delivery types identified as part of CollegeStart have identifiers unique from those of regular institutional modes of instructional delivery. They include such modes as World Wide Web, interactive television, and asynchronous courses.
3. System reporting.
The Office of Financial Planning & Budget will develop a program that will, through combinations of new fields, enable unique reporting of CollegeStart students.
4. ad hoc reporting.
To assist university reporting of CollegeStart students, UNET developed Natural programs that look at combinations of fields to display and track CollegeStart students. The programs can be found in PRODISIS.
Procedures for Human Subject Research
Research with human subjects at Universities within the University of Maine System (UMaine System) shall be guided by three general ethical principles: respect for persons, beneficence, and justice. These principles and the rules that may be derived from them shall form the analytical framework for determining whether and how research with human subjects may be conducted. Researchers must respect and protect the rights and privacy and welfare of individuals recruited for and participating in research. More precisely, all human subject research must comply with the US Department of Health and Human Services (DHHS) “Common Rule” 45 CFR 46; 21 CFR 50; the Belmont Report; The Nuremburg Code; and the Declaration of Helsinki.
B. Research Activities that May Be Exempt from Further Review
1. Student Classroom Projects – Certain projects, conducted in the context of an assigned class activity, may be deemed to constitute a Student Classroom Project. The responsible faculty member will submit a request for exemption, which will be evaluated. A determination of exemption from further review will be officially communicated to the responsible faculty member.
2. Exempt – The Common Rule outlines certain types of research that are exempt from Institutional Review Board (IRB) oversight: 45 CFR 46.101(b); 21 CFR 50 and 56 [US Food and Drug Administration (FDA research)]. Only the IRB can determine if a proposed project qualifies as exempt. Principal Investigators (PI) whose research is exempt are not required to have any further interaction with the IRB unless adverse events occur, or there is a substantial change to the protocol.
Exempt Categories [45 CFR 46.101(b)]:
a. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
1) Research on regular and special educational instructional strategies, or
2) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
1) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
2) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
c. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under section B.2.b of this document or 45 CFR 46.101 (b)(2), if
1) The human subjects are elected or appointed public officials or candidates for public office, or
2) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
d. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
e. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads , and which are designed to study, evaluate, or otherwise examine:
1) Public benefit or service programs;
2) Procedures for obtaining benefits or services under those programs;
3) Possible changes in or alternatives to those programs or procedures; or
4) Possible changes in methods or levels of payment for benefits or services under those programs.
f. Taste and food quality evaluation and consumer acceptance studies,
1) If wholesome foods without additives are consumed, or
2) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA, or approved by the US EPA, or the Food Safety and Inspection Service of the US Department of Agriculture.
Adverse Event, Serious: Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
1. Serious Adverse Events include those that:
a. Are fatal or life threatening;
b. Result in significant or persistent disability;
c. Require or prolong hospitalization;
d. Result in a congenital anomaly/birth defect; or
e. Represent other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators.
2. Unexpected Serious Adverse Events are those that have not been described in the:
a. Package insert for a given drug or investigator’s brochure (for FDA investigational agents);
b. Approved protocol; or
c. Informed consent document. [21 CFR 312.32(a)]
Adverse Research Event- Adverse research events include a wide spectrum of events. Adverse events include, but are not limited to:
1. Physical or psychological harm or injuries,
2. Threats to privacy or safety,
3. Unusual attrition of human subjects.
4. Breaches of confidentiality or emotional harms such as the emotional distress that could be triggered by questions about traumatic life events or a subject’s complaints about the experimental procedures or the conduct of the investigators.
Certificate of Confidentiality: A discretionary document issued by the National Institutes of Health (NIH), which helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical, and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Further information is available at http://grants1.nih.gov/grants/policy/coc/.
Coercion: To bring about participation in research by force or threat, actual or perceived, or through any other imbalance of power.
Common Rule: The federal regulation that is the primary source of human subjects’ protections. This is the common reference for 45 CFR 46, PROTECTION OF HUMAN SUBJECTS.
Generalizable Knowledge: Currently, US DHHS Office of Human Research Protection (OHRP) does not have a formal position on what does and does not constitute “generalizable knowledge” beyond the language of the Common Rule. There is no official federal written policy statement or published guidance on the topic. Federal officials take the position that each institution is responsible for developing its own rationally based standards and definitions. Each individual institution is responsible for adopting a reasonable, well grounded definition of “generalizable knowledge” and research. Dissemination is not the fundamental defining characteristic of research, nor is a statistically-based model an acceptable indicator of research under current OHRP policies. In keeping with the positions articulated by OHRP senior staff, the UMaine System adopts the following definition of generalizable knowledge:
Generalizable knowledge is information which has the potential to be expanded from the isolated circumstances in which it is acquired to any broader context.
Thus, a case study, designed to illuminate the course of a single individual’s experience generally will not be considered to be developing or contributing to generalizable knowledge. A series of case studies, intended to lead to improvements in the management of a particular circumstance or condition, generally will be considered generalizable knowledge.
Human Subject: “A living individual(s) about whom an investigator (whether professional or student) conducting research obtains:
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.” [45 CFR 46.102(f)]
Identifiable Private Information: Includes (but is not limited to):
1. Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. [45 CFR 46.102(f)]
2. Information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). [45 CFR 46.102(f)]
3. Private information that is individually identifiable. [45 CFR 46.102(f)]
4. Information of a nature that the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(f)]
5. Information that was collected specifically for the proposed project through intervention or interaction with living individuals and is of a nature that the investigator can readily ascertain the identity of the individuals.
Institutional Review Board (IRB): A research review committee whose primary purpose is to review all research involving human subjects and to provide oversight of human subjects’ protections.
Interaction: A communication or interpersonal contact between investigator and subject for research purposes.
Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Key Research Personnel: Persons who have direct contact with subjects, contribute to the research in a substantive way, have contact with subjects’ identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects’ personal information.
Minimal Risk: “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily living or during the performance of routine physical or psychological examinations or tests”. [45 CFR 46.102(i)]
Minor: An individual under the age of 18 years.
Minor Changes: Minor changes have no substantive effect upon an approved protocol or reduce the protocol risk already approved by the IRB. Examples of minor changes are:
1. Changes in research personnel that do not alter the competence of the research team to conduct the research, or
2. Minimal changes in remuneration.
Principal Investigator (PI): Any UMS faculty, staff member, student, or individual so designated in a protocol who is the primary person responsible for all aspects of the research project and assumes all responsibilities for the results.
Prisoner: Any individual, regardless of age, involuntarily confined or detained in a penal institution or a parolee detained in a treatment center as a condition of parole. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. This definition also includes data from non-publicly available databases and secondary sources.
Protected Population: (Also referred to as protected subject group). These groups of potential research subjects have specific regulatory compliance requirements and receive special protections under the Common Rule and/or other federal regulations. These groups include (but not restricted to):
1. Children/Minors (under the age of 18)
2. Prisoners (now includes non-publicly available secondary data)
3. Pregnant women
4. Fetuses and products of labor and delivery
5. People with diminished capacity to give consent
6. Mentally or physically challenged individuals
Protocol: Any type of research project that is submitted for IRB review (also known as a research project, proposal, submission, etc.).
Protocol Violation, Major: A major protocol violation occurs when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Major protocol violations include violations that:
1. Cause or pose a significant risk of substantive harm to research participants;
2. Damage the scientific integrity of the data collected;
3. Show evidence of willful or knowing misconduct on the part of the investigator; or
4. Demonstrate a serious or continued noncompliance with federal, state or local research policy, laws, or regulations.
Protocol Violation, Minor: A minor protocol violation occurs when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Minor protocol violations include violations that:
1. Have no substantive effect on the risks to research participants;
2. Do not impact the value of the data collected (meaning the violation does not confound the scientific analysis of the results); and
3. Do not result from willful or knowing misconduct on the part of the investigator(s).
Research: The UMaine System takes as its starting point the federal definition of research set forth in the Common Rule, [45 CFR 46.102(d)]:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes (e.g., some demonstration and service programs may include research activities). Please note that risk assessment plays no role in the determination of whether a proposed activity constitutes research. See also the definition of generalizable knowledge, above.
Research Misconduct (42 CFR §93.103): means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
1. Fabrication is making up data or results and recording or reporting them as if they were real.
2. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
3. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
4. Research misconduct does not include honest error or differences of opinion.
Sensitive Information: According to the NIH Certificate of Confidentiality Kiosk, sensitive information is that which, if disclosed, may reasonably pose a risk to the subject’s psychological, social, medical, legal, or economic well-being or quality of life. Categories of sensitive information include (but are not limited to):
1. Sexual attitudes, preferences, or practices
2. Use of alcohol, drugs, or other addictive products
3. Information pertaining to illegal conduct
4. Information that if released might be damaging to an individual’s financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination
5. Health and medical information contained in a medical record, chart, or insurance file (this category may also require a HIPAA review)
6. Information pertaining to an individual’s psychological well-being or mental health (this category may also require a HIPAA review)
7. Genetic information or tissue samples (this category may also require a HIPAA review)
Signatory/Institutional Official: The signatory/institutional official (IO) is the highest institutional official who has the legal authority to represent the inidivudal campus’ Assurance filed with the OHRP, and is responsible for the provisions of this policy.
Specimen: Specimen is used to refer to biological specimens (e.g., blood or tissue samples), as well as to other types of data “specimens” that could be stored for use in future research (e.g., audio tapes, video tapes, etc.).
Substantive Changes Affecting Risk: Substantive changes are changes that may increase the research population’s risk or are of questionable risk. Examples of substantive changes that are considered to increase the risk to the study/individual include, but are not limited to:
1. Increasing the length of time a study participant is exposed to experimental aspects of the study.
2. Changing the originally targeted population to include a more at-risk population (e.g., previous exclusion for those with renal failure are now allowed to enroll, or adding children or pregnant women to the study).
3. Adding an element that may breach the confidentiality of the subject such as tissue banking or genetic testing.
Undue Influence: Inappropriate remuneration or any other form of compulsion offered to an individual that may unfairly compel that individual to participate as a human research subject.
Unanticipated Problem: Any event that is not expected given the nature of the research procedures and the subject population being studied, and places subjects or others at greater risk or harm/discomfort related to the research than was previously known or recognized. An event which was previously unforeseeable based on the information provided to the IRB.
D. Assurance of Compliance
Any University within the UMaine System that conducts federally funded non-exempt human subject research must have a legally binding agreement with US DHHS. This Federal Wide Assurance is administered by US DHHS’s OHRP and governs all human subject research receiving, or eligible to receive federal (US DHHS) funds. This agreement is guided by the ethical principles of the Belmont Report and requires, at a minimum, compliance with 45 CFR 46 (The Common Rule).
E. IRB Membership
Responsibility for the protection of human subjects of research at the institutions of the UMaine System is largely vested in the individual institutional IRB. The IRB is responsible not only for reviewing, regulating, and monitoring human subject research but also for educating the University community in the protection of human subjects.
1. Each IRB shall have no fewer than five voting members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
2. A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, e.g., full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in IRB membership shall be reported to US DHHS’s OHRP.
3. Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. No IRB may have a
member participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available to the IRB; such individuals may not vote with the IRB.
4. Members are appointed for one to three-year terms and may be reappointed toadditional terms.
5. All IRB members are formally confirmed by the President (or designee) of the University; any designation must be specific and in writing.
6. The Chair of the IRB should be a tenured faculty member with experience inconducting human subject research. Appointment is confirmed officially by the President or designee and is for two years; may be reappointed to additional terms. A Vice Chair can be appointed, if desired, using the same confirmation procedure.
F. IRB Functions and Operations
In order to fulfill the requirements of this policy each UMaine System campus IRB shall:
1. Follow written procedures in the same detail as described in 45 CFR 46.103(b)(4), and to the extent required by 45 CFR 46.103(b)(5).
2. Except when an expedited review procedure is used (see section H.), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting
G. IRB Review of Research
1. An IRB shall review protocol applications and has the authority to approve, require modifications, or disapprove.
2. Ensures that legally effective informed consent of human research subjects will be obtained in a manner and method that meets the requirements of federal, state, and local rules and laws and in accordance with section N.
3. An IRB shall require documentation of informed consent or may waive documentation in accordance with section O.
4. An IRB shall notify investigators and the University in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
5. An IRB shall monitor the research it has approved by any means it deems appropriate, including observation of the consent process and the research activities and appointment of a third party to undertake such observations.
6. An IRB shall conduct continuing review of approved research activities at intervals appropriate to the degree of risk, but not less than once per year.
H. Expedited Review Procedures
1. The Secretary of the US DHHS has established, and published a list of categories of research that may be reviewed by the IRB through an expedited review procedure. A copy of the list is available from the OHRP, or any successor office, and included here:
a. Research activities that (i) present no more than minimal risk to human subjects, and (ii) involve only procedures listed in one or more of the categories detailed below (section H.3), may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
b. The categories in this list apply regardless of the age of subjects,except as noted.
c. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
d. The expedited review procedure may not be used for classified research involving human subjects.
e. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–expedited or convened–utilized by the IRB.
f. Research categories 3.a. through 3.g. below pertain to both initial and continuing IRB review.
3. Research Categories
a. Clinical studies of drugs and medical devices only when condition 1) or
2) is met.
1) Research on drugs for which an investigational new drug
application (21 CFR part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
2) Research on medical devices for which (i) an investigational device exemption application (21 CFR part 812) is not required; or (ii) the medical device is cleared/approved for marketing, and the medical device is being used in accordance with its cleared/approved labeling.
b. Collection of blood samples by finger stick, heel stick, ear stick, or
venipuncture as follows:
1) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
2) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
c. Prospective collection of biological specimens for research purposes by
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
d. Collection of data through noninvasive procedures (not involving
general anesthesia or sedation) routinely employed in clinical practice,
excluding procedures involving x-rays or microwaves. Where medical
devices are employed, they must be cleared/approved for marketing.
Studies intended to evaluate the safety and effectiveness of the
medical device are not generally eligible for expedited review,
including studies of cleared medical devices for new indications.
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
e. Research involving materials (data, documents, records, or specimens)
that have been collected, or will be collected solely for nonresearch
purposes (such as medical treatment or diagnosis). (NOTE: Some
research in this category may be exempt from the DHHS regulations
for the protection of human subjects. [45 CFR 46.101(b)(4)]. This
listing refers only to research that is not exempt.)
f. Collection of data from voice, video, digital, or image recordings made
for research purposes.
g. Research on individual or group characteristics or behavior (including,
but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history,
focus group, program evaluation, human factors evaluation, or quality
assurance methodologies. (NOTE: Some research in this category may
be exempt from the DHHS regulations for the protection of human
subjects. [45 CFR 46.101(b)(2) and (b)(3)]. This listing refers only to
research that is not exempt.)
h. Continuing review of research previously approved by the convened
IRB as follows:
1) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
2) where no subjects have been enrolled and no additional risks have been identified; or
3) where the remaining research activities are limited to data analysis.
i. Continuing review of research, not conducted under an investigational
new drug application or investigational device exemption where
research categories 3.b. through 3.h. do not apply, but the IRB has
determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been
4. An IRB may use the expedited review procedure to review either or both
of the following:
a. some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk;
b. minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).
5. Each IRB using an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.
6. The department or agency heads may restrict, suspend, terminate, or choose not to authorize an institution’s or IRB’s use of the expedited review procedure.
I. Criteria for IRB Approval of Research
The IRB approves research only when it has determined that all of the following requirements are satisfied:
1. Risks to subjects are minimized. Procedures used are consistent with sound research design and do not unnecessarily expose subjects to risk. Whenever appropriate, the research uses procedures already being performed on the subjects for other purposes, such as diagnosis or treatment.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result. The IRB considers only those risks and benefits that may result from the research. The IRB does not consider possible long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
3. The selection of subjects is equitable, taking into account the purpose of the research and the setting in which the research will be conducted.
4. Informed consent is sought from each prospective subject or the subject’s legally authorized representative. The IRB conforms to federal regulations of informed consent procedures and may impose additional requirements.
5. Informed consent is appropriately documented, in accordance with, and to the extent required by, federal regulations. The IRB may also impose documentation requirements in addition to those required by federal regulations.
6. When appropriate, the research protocol makes adequate provision for monitoring the data collected to insure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included in the protocol to protect the rights and welfare of these subjects.
J. Review by Institution
Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
K. Suspension or Termination of IRB Approval of Research
The IRB has authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. When the IRB exercises this authority, it promptly communicates its action and the reasons for the action in writing to the Principal Investigator, Chief Academic Officer or other appropriate campus official, and the extramural sponsor of the research, if any.
L. Cooperative Research
Cooperative research projects are those projects covered by this policy, or the Common Rule, involving more than one institution, whether within UMaine System campuses or other institutions outside the System. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. A campus participating in a cooperative project may enter into a joint review arrangement with another campus IRB, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
M. IRB Records
1. An IRB shall prepare and maintain adequate documentation of its activities, including the following:
a. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
b. Minutes of IRB meetings shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; votes on actions including the number of members voting for, against, and abstaining; basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
c. Records of continuing review activities.
d. Copies of all correspondence between the IRB and the investigator.
e. A list of all IRB members in the same detail as described in section E.
f. Written procedures for the IRB in the same detail as described in §46.103(b)(4)and §46.103(b)(5).
g. Statements of significant new findings provided to subjects, as required by §46.103(b)(5).
2. The records required by this policy shall be retained for a least 3 years; and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspections and copying by authorized representatives of US DHHS OHRP at reasonable times and in a reasonable manner.
N. General Requirements for Informed Consent
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
1. Basic elements of informed consent. Except as provided in paragraph 3. or 4. of this section, in seeking informed consent the following information shall be provided to each subject:
a. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
b. A description of any reasonably foreseeable risks or discomforts to the subject;
c. A description of any benefits to the subject or to others which may reasonably be expected from the research;
d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
e. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
f. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
g. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
h. A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
2. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
a. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
b. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
c. Any additional costs to the subject that may result from participation in the research;
d. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
e. A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject; and
f. The approximate number of subjects involved in the study.
3. An IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
a. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
b. The research could not practicably be carried out without the waiver or alteration.
4. An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
a. The research involves no more than minimal risk to the subjects; and
b. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
c. The research could not practicably be carried out without the waiver or alteration; and
d. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
5. The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.
6. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
O. Documentation of Informed Consent
1. Except as provided in paragraph 3. of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.
2. Except as provided in paragraph 3. of this section, the consent form may be either of the following:
a. A written consent document that embodies the elements of informed consent required by section N. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
b. A short written consent document stating that the elements of informed consent required by section N have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
3. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
a. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
P. Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects
Certain types of research proposals may not have fully defined plans set forth in the application or proposal. Such proposals may include institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an application for award can be filed, nor before an award may be made. However, except for research exempted or waived under this policy, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB.
Q. Research Undertaken without the Intention of Involving Human Subjects
In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB.
R. Use of Federal Funds
Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.
S. Early Termination of Research Support: Evaluation of Applications and
1. The IRB, senior administrator responsible for the IRB, or the UMS may terminate or suspend an approved project if an investigator has failed to comply with the terms of this policy.
2. The IRB, senior administrator responsible for the IRB, or the UMaine System may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or
suspension under paragraph 1. of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have in their judgment materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).
With respect to any research project or any class of research projects, the senior administrator responsible for the IRB or the UMaine System may impose additional conditions necessary for the protection of human subjects.
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
This subpart applies to all research involving pregnant women, human fetuses, neonates,and neonates of uncertain viability or nonviability.
1. The exemptions noted in section B. of Administrative Procedures for Human Subject Research are applicable to this subpart.
2. This policy does not alter any present or future state or local laws or regulations that may otherwise be applicable and which may provide additional protections for human subjects. This subpart is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.
3 This policy does not alter any present or future foreign laws or regulations that may otherwise be applicable and which may provide additional protections for human subjects.
1. Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she test positive on a pregnancy test or exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative, or until delivery.
2. Fetus means the product of conception from implantation until delivery.
3. Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
4. Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.
5. Neonate means a newborn.
6. Viable, as it pertains to a neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
7. Nonviable neonate means a neonate after delivery that, although living, is not viable.
B. Research Involving Pregnant Women or Fetuses
Pregnant women or fetuses may be involved in research if all of the following conditions are met:
1. Where scientifically appropriate, preclinical studies (including studies on pregnant animals) and clinical studies (including studies on nonpregnant women) have been conducted and provide data for assessing potential risks to pregnant women and fetuses.
2. The risk to the fetus is caused solely by interventions or procedures that have the prospect of direct benefit for the woman or the fetus; or, if there is no prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.
3. Any risk is the least possible for achieving the objectives of the research.
4. If the research has the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of
important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions.
5. If the research has the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father must be obtained in accord with the informed consent provisions, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
6. Each individual providing consent must be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate.
7. For children who are pregnant, assent and permission are obtained in accord with the informed consent provisions for children.
8. No inducements, monetary or otherwise, can be offered to terminate a pregnancy.
9. Individuals engaged in the research can have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.
10. Individuals engage in the research can have no part in determining the viability of a neonate.
C. Research Involving Neonates
1. A neonate, after delivery, that has been determined to be viable may be included in research by and in accord with the requirements described in sections Administrative Procedures for Human Subject Research and Additional Protections for Children Involved as Subjects in Research.
2. Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
a. Where scientifically appropriate, preclinical and clinical studies have beenconducted and provide data for assessing potential risks to neonates.
b. Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
c. Individuals engaged in the research will have no part in determining the viability of a neonate.
d. Requirements outlined in 3. and 4. below have been met as applicable.
3. Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research unless the following additional conditions have been met:
a. IRB determines that:
1) The research has the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
2) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means, and there will be no added risk to the neonate resulting from the research.
b. The legally effective informed consent of either parent of the neonate or, if
neither parent is able to consent because of unavailability, incompetence, or
temporary incapacity, the legally effective informed consent of either parent’s
legally authorized representative is obtained in accord with the section on
Administrative Procedures for Human Subject Research, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
4. After delivery, nonviable neonates may not be involved in research unless all of the following conditions are met:
a. Vital functions of the neonate will not be artificially maintained.
b. The research will not terminate the heartbeat or respiration of the neonate.
c. There will be no added risk to the neonate resulting from the research.
d. The purpose of the research is the development of important biomedicalknowledge that cannot be obtained by other means.
e. The legally effective informed consent of both parents of the neonate is obtained. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice, except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice.
D. Research Involving After Delivery, the Placenta, Dead Fetus, or Fetal Material
1. Research involving after delivery, the placenta, dead fetus, macerated fetal material; or cells, tissues, or organs excised from a dead fetus, must be conducted in accord with applicable federal, state, or local laws and regulations regarding such activities.
2. If information associated with 1. of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are considered research subjects.
Research Involving Prisoners
Under appropriate circumstances, the UMaine System permits research involving prisoners as subjects. Any researcher proposing to conduct such research must have his or her research reviewed by an IRB that has, as a regularly serving member, an appropriate prisoner representative. Note that the prisoner representative may not be a consultant to or guest of the IRB reviewing the research, but must instead be a duly appointed member of the IRB, listed on the official roster of IRB members filed with OHRP
1. The regulations in this section are applicable to all biomedical and behavioral research involving prisoners conducted by any member of the UMaine System.
2. All research involving prisoners as subjects must comply with any state or local laws limiting such research.
3. The requirements of this section are in addition to those imposed under the other sections of the UMaine System Policy on Human Subject Research.
Inasmuch as prisoners may be under constraints because of their incarceration, which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is the purpose of this section to provide additional safeguards for the protection of prisoners involved in activities to which this section is applicable.
As used in this section:
1. Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. The UMaine System extends the term “prisoner” to include persons on pre-trial supervised release, on community supervision or on probation, or who is in any court-ordered deferred prosecution or diversion program.
2. Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
D. Composition of IRB where Prisoners are Involved
In addition to satisfying the requirements in section E. of the Administrative Procedures for Human Subject Research, an IRB carrying out responsibilities under this section shall also meet the following specific requirements:
1. A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB.
2. At least one member of the IRB shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one IRB only one Board need satisfy this requirement.
A prisoner representative with appropriate background may include an attorney with experience in criminal defense or prisoners’ rights, a member of a prisoners’ rights advocacy organization, a chaplain or a counselor or other similar professional who deals, or has dealt with, prisoners.
E. Additional Duties of the IRB where Prisoners are involved
1. In addition to all other responsibilities prescribed for IRB under this part, the IRB shall review research covered by this subpart and approve such research only if it finds that:
a. The research under review represents one of the categories of research permissible under 306(a)(2);
b. Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
c. The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
d. Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
e. The information is presented in language which is understandable to the subject population;
f. Adequate assurance exists that parole boards, community release supervisors, and/or probation officers will not take into account a prisoner’s participation in the research in making decisions regarding parole, community supervision, or probation, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole, community supervision, or probation; and
g. Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact.
2. The IRB shall carry out such other duties as may be assigned by the Secretary of the US DHHS.
3. The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the IRB under this section have been fulfilled.
F. Permitted Research Involving Prisoners
1. Biomedical or behavioral research not conducted or supported by DHHS may involve prisoners as subjects only if all of the conditions outlined above for general human subject research, and the special conditions for research with prisoners, are met.
2. Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if:
a. The institution responsible for the conduct of the research has certified to the Secretary that the IRB has approved the research under 45 CFR 46.305; and
b. In the judgment of the Secretary, the proposed research involves solely the following:
1) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
2) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
3) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis, which is much more prevalent in prisons than elsewhere; and research on social and psychological problems, such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the FEDERAL REGISTER, of his intent to approve such research; or
4) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the FEDERAL REGISTER, of the intent to approve such research.
3. Except as provided in paragraph F.2. of this section, biomedical or behavioral research conducted or supported by US DHHS shall not involve prisoners as subjects.
Research Involving Children
Under appropriate circumstances, the UMaine System permits research involving children as subjects. Any IRB reviewing such research must have expertise in the special needs of children as research subjects sufficient to ensure that the rights of children as research subjects are protected. Ideally, any such IRB will have at least one member whose area of expertise includes children. Simply being a parent is insufficient. Being a scholar of children’s issues is sufficient, whether or not the member is a parent.
1. The regulations in this section are applicable to all biomedical and behavioral research involving children conducted by any member of the UMaine System.
2. All research involving children as subjects must comply with any state or local laws limiting such research.
3. The requirements of this section are in addition to those imposed under the other sections of the UMaine System Policy on Human Subject Research.
4. Note that the exemptions described in section B.2. of Administrative Procedures for Human Subjects Research and at 45 CFR 46.101(b)(1) and (b)(3) through (b)(6) are applicable to this section. The exemption at §46.101(b)(2) regarding educational tests is also applicable to this section. However, the exemption at §46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this section, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.
As used in this section:
1. Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
2. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
3. Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
4. Parent means a child’s biological or adoptive parent.
5. Guardian means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.
C. Special IRB Duties
In addition to other responsibilities assigned to IRBs in this section, each IRB shall review research covered by this section and approve only research that satisfies the conditions of all applicable parts of this section.
D. Research not Involving Greater than Minimal Risk (45 CFR 46.404)
Research in which the IRB finds no greater than minimal risk to children to be present may be approved only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth below.
E. Research Involving Greater than Minimal Risk but Presenting the Prospect of Direct Benefit to the Individual Subject (45 CFR 46.405)
If an IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, the proposed research may be approved only if the IRB finds that:
1. The risk is justified by the anticipated benefit to the subjects;
2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
3. Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in H. in this section. [§46.408]
F. Research Involving Greater than Minimal Risk and no Prospect of Direct Benefit to the Individual Subject, but likely to Yield Generalizable Knowledge about the Subject’s Disorder or Condition (45 CFR 46.406)
If an IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, the proposed research may be approved only if the IRB finds that:
1. The risk represents a minor increase over minimal risk;
2. The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
3. The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition that is of vital importance for the understanding or
amelioration of the subjects’ disorder or condition; and
4. Adequate provisions are made for soliciting assent of the children and permission
of their parents or guardians as set forth in H. in this section. [§46.408]
G. Research not Otherwise Approvable that Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of Children (45 CFR 46.407)
If an IRB does not think the proposed research meets the requirements of the three immediately preceding conditions, research may only be approved if:
1. The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
2. The Secretary of US DHHS, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:
a. The research in fact satisfies the conditions in D., E., or F. in this section [§46.404, §46.405, or §46.406], as applicable, or
b. the following:
1) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare
2) the research will be conducted in accordance with sound ethical principles;
3) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in H. in this section.
H. Requirements for Permission by Parents or Guardians and for Assent by Children (45 CFR 46.408)
1. In addition to the determinations required under other applicable sections of this section, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with section N of the Administrative Procedures for Human Subject Research. (45 CFR 46.116)
2. In addition to the determinations required under other applicable parts of this section, the IRB shall determine, in accordance with and to the extent that consent is required by N. in the Administrative Procedures for Human
Subject Research (§46.116), that adequate provisions are made for soliciting
the permission of each child’s parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient forresearch to be conducted under D. and E. in this section [§46.404 or §46.405]. Where research is covered by F. and G. in this section [§46.406 and §46.407] and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
3. In addition to the provisions for waiver contained in N [§46.116] of the
Administrative Procedures for Human Subject Research, if the IRB
determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in A. in this section and paragraph 2. above provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
4. Permission by parents or guardians shall be documented in accordance with and to the extent required by O. [§46.117] of the Administrative Procedures for Human Subject Research.
5. When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
1. Children who are wards of the state or any other agency, institution, or entity can be included in research approved under F. and G. in this section (§46.406 or §46.407) only if such research is:
a. Related to their status as wards; or
b. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
2. If the research is approved under paragraph 1. above, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
The new Policy Statement states that “student researchers require supervision of a faculty member who acts as the lead Principal Investigator.” The term “lead Principal Investigator” implies that the faculty member acts as the student’s sponsor. Each University’s Institutional Review Board (IRB) is empowered, and obligated, to determine exactly how this requirement will be met. Classroom projects in, for example, undergraduate or graduate research methods courses, may be given a blanket exemption from review upon application by the faculty member teaching such a course. More complex projects, or projects dealing with either sensitive populations (e.g. prisoners, pregnant women, children, or persons with diminished decision making capacity) or sensitive topics (e.g. drug or alcohol use, criminal activities or sexual behaviors) should receive a more comprehensive level of review.
Because each University has unique student and faculty compositions and hence unique needs, the precise mechanisms adopted by each University may vary. How each University implements this policy can vary. Any IRB may implement more stringent requirements than those suggested in this guidance document. However, in no instance may a University permit a student researcher, or any other researcher, to conduct research which has not been reviewed by the IRB in the manner deemed appropriate by the IRB.
1.1 The purpose of this policy is to avoid duplicative efforts of Institutional Review Boards (IRB) when a research activity requires review based on the “Common Rule” 45 CFR 46; 21 CFR50 at multiple Universities within the UMS. While intended to encourage reviews in a timely manner, it is not intended to diminish the individual University’s role and responsibilities in accordance with relevant laws, regulations and guiding principles.
2.0 General Description:
2.1 In accordance with section L. Cooperative Research of the Administrative Procedures for the UMS Policy on Human Subject Research [Section 601], this SOP articulates how the Universities within the UMS will enter into a joint review arrangement with each other when participating in a cooperative research project.
3.1 Cooperative Research Project: Cooperative research projects, including external multi site projects, are those projects that involve more than one University within the University of Maine System. In the conduct of cooperative research projects each University is responsible for safeguarding the rights and welfare of human subjects. An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort [45 CFR 46.114]. While relying on any of these arrangements, a University engaged in the research project remains responsible for the rights and welfare of human subjects interacting or intervening with the research activities occurring at their institution and can investigate allegations of noncompliance.
3.2 Lead Principal Investigator: One investigator within the UMS who accepts overall responsibility for a cooperative research project and who is responsible for seeking appropriate IRB review and approval as necessary from the local (University) IRB.
3.3 Lead IRB: The IRB located at the lead principal investigator’s University within the UMS. If the lead principal investigator is a student, this will be the University from which s/he will obtain his/her degree. The lead IRB is the designated IRB responsible for the initial and continuing oversight of a cooperative research project.
3.4 Engaged: In general, an institution is considered engaged in a particular human subjects research project when its employees or agents, such as a principal or primary investigator, for the purposes of the research project such as a project director or principal investigator obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
3.5 The University of Maine System (UMS): Consists of seven Universities (University of Maine, University of Maine at Augusta, University of Maine at Farmington, University of Maine at Fort Kent, University of Maine at Machias, University of Maine at Presque Isle, University of Southern Maine).
3.6 IRB Authorization Agreement: A formal written agreement designating the IRB of record for a research project, such as a cooperative research project, that usually involves federal funding. The IRB of Record will usually be the Lead IRB, unless the institution does not have a Federalwide Assurance. Though cooperative research projects may utilize an IRB Authorization Agreement, it is not limited to such projects. For example, it can be employed by an institution receiving federal funding but without a federally registered IRB to designate an external federally registered IRB.
3.7 Institutional Official: The administrative officer at the University who is authorized to act for the institution and assume overall responsibility for compliance with the federal regulations for the protection of human subjects, and signs the Office for Human Research Protections (OHRP) Federalwide Assurance.
4.1 Execution of SOP: Lead Principal Investigator, UMS IRB Staff, IRB Members, IRB Chair(s), and Institutional Official(s).
5.1 It is the responsibility of the lead principal investigator to seek appropriate IRB review and approval prior to initiation of any cooperative research activity.
5.2 The lead principal investigator should contact his/her local IRB to discuss IRB review and submission requirements prior to submission.
5.3 If the local IRB determines it is not appropriately qualified to act as the lead IRB (see section 6), they will contact a qualified IRB within the UMS to serve as the lead IRB for the project.
5.4 The lead principal investigator will be advised to submit to the lead IRB who will communicate with all UMS engaged sites throughout the procedure.
5.5 The lead IRB will review the project. At the time the submission is received the lead IRB chair/staff will send email notification to all UMS engaged sites IRB chair/staff and all co-investigators at each University. At this time the cooperative institutions may send a written request to the IRB of record if they would like to have an IRB member at their institution consult and provide comment on the project. These comments will be taken into consideration during formal IRB review (by the IRB of record) of the project, and must be received no later than 10 business days after the initial request is made.
5.6 The lead IRB will retain jurisdiction for all project revisions or amendments as well as continuing reviews.
5.7 The lead IRB staff and/or Chair will notify the lead principal investigator, in writing, when a determination has been made or the project has been approved. All co-investigators and relevant IRB staff and Chair(s) at the cooperative sites will be copied on the letter. The letter will explicitly outline the lead principal investigator’s obligations and terms of approval. Relevant minutes of IRB meetings will be made available to cooperative sites upon request
5.8 This policy shall not preclude any local IRB at an engaged site from investigating allegations on noncompliance, adverse events, or potential violations of relevant laws, regulations, and guiding principles in regard to the human subjects interacting or intervening with the research activities at their Institution. The lead IRB, all co-investigators and relevant IRB staff and Chair(s) at the cooperative sites will be notified of any investigations and the lead IRB will conduct an inquiry into the allegations and share its findings with all engaged sites.
6.0 Federally Funded Research:
6.1 If the project is federally funded, the institution of the lead IRB must have a Federalwide Assurance
6.2 If the project is federally funded or when otherwise required, the lead IRB will prepare an IRB Authorization Agreement prior to review of the research project. This IRB Authorization Agreement will formally designate the IRB of record, which will conduct the review for the research project. All engaged sites will be required to have their institution’s Institutional Official or otherwise delegated representative sign the agreement.
See: Policy Manual Section 601: Human Subject Research