Section 601 Human Subject Research

Effective: 1/29/90
Last Revised: 5/18/09
Responsible Office: Academic Affairs

Policy Statement:

A.  Research is defined in the Code of Federal Regulations 45 CFR 46.

102(d) as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The Universities within the University of Maine System are encouraged to engage in research activities whenever possible and appropriate.  In all such instances, it is the responsibility of the Investigator1 to ensure that research activities are conducted in compliance with this policy and all other policies and procedures related to human subject research.  Each campus is responsible for determining when and whether purely internal data collection requires IRB review.  Some examples are:

1.  student surveys of dining preferences;

2.  evaluations of student satisfaction for accreditation reports;

3.  exit surveys for graduates or employees;

4.  surveys to determine residence hall programming needs.

Such projects are generally not considered human subject research, but a campus may opt to have IRB notification or IRB review, or may allow persons conducting such activities to forego IRB contact.  A campus that opts to forego contact or review must establish a clear set of guidelines and conditions to determine what projects qualify for this treatment.

B.  Any data collection activities involving human subjects2 shall be conducted in accordance with relevant laws, regulations, and guiding principles.  “Human subjects” are defined as living individuals 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 even in the absence of an intervention or interaction with the individual 3.  In particular, all such research must comply with the “Common Rule” 45 CFR 46; 21 CFR50; the Belmont Report, The Nuremburg Code; and the Declaration of Helsinki regardless of funds, funding source, or governing federal agency.

C.  Each campus conducting federally funded non-exempt human subject research is required to have a Federal Wide Assurance on file with the US Department of HHS Office of Human Research Protection.  In addition, each campus is required to either (1) institute a practice of human subject research review using a duly constituted Institutional Review Board (IRB)4; or (2) ensure that all human subject research be reviewed by an appropriate off-campus IRB, whether a commercial IRB or an IRB located at another campus within the System.

D. Each campus that elects to implement its own IRB shall provide adequate administrative support for the IRB.  The scope of this administrative support will vary according to the demand for IRB review on the particular campus.

E. In accordance with best practices articulated in US Department of HHS Office of Human Research Protection Guidances and Determination Letters, and to avoid the appearance of a conflict of interest, (1) the IRB  must be administratively housed separately from the Office of Sponsored Projects or Office of Research and Sponsored Programs, or equivalent entity; and (2) no Investigator is permitted to determine the exemption status of that Investigator’s own human subject research activities.

Related Documents:

Administrative Procedures for Human Subject Research

1 An Investigator may be a faculty member or a staff member or a student.  Student researchers require supervision of a faculty member who acts as lead Principal Investigator.

2 Data collected by interaction with or intervention upon human subjects may occur in medical, physical, or social and behavioral science contexts.

3 45 CFR 46.102(f)

4 Established in accordance with 45 CFR 46.107.