Policy Manual - Human Subject Research
RESEARCH AND PUBLIC SERVICE
Section 601 Human Subject Research
Effective: 1/29/90
Last Revised:
Responsible Office: Academic Affairs
Policy Statement:
A. Research with human subjects within the University of Maine 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. They are articulated in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
B. Each campus of the University of Maine System shall maintain and support an institutional Review Board for the Protection of Human Subjects, whose function it is to determine whether and how research with human subjects may be conducted, and to educate the community with regard to the protection of human subjects.
C. Colleges and other large organizational units that are a part of an individual campus organization in which research with human subjects is regularly conducted may maintain and support a unit review committee, whose function it is to provide merit review and guidance for the protection of human subjects to investigators from that unit, and to determine whether specific research projects are exempt from requirements for further review.
D. No research with human subjects shall be conducted until a unit review committee has reviewed the research protocol and determined that the project is exempt from further review, or the Protection of Human Subjects Review Board has approved the research protocol. Before such approval is granted, proper consideration shall be given to the risks to the subjects, the anticipated benefits to the subjects and others, the importance of the knowledge that may reasonably be expected to result, and the informed consent process to be employed.
E. All institutions of the University of Maine System shall acknowledge and accept responsibility for protecting the rights and welfare of human subjects of research. University of Maine System Policies and Procedures for the Protection of Human Subjects of Research apply to all activities which include research with human subjects and:
1. are sponsored by the campuses of the University System; or
2. are conducted by or under the direction of any employee, student, or agent of the University of Maine System in connection with his or her individual institutional responsibilities; or
3. are conducted by or under the direction of any employee, student, or agent of the University of Maine System using any property or facility of the University of Maine System; or
4. involve the use of the University of Maine System's non-public information.
F. The University of Maine System shall encourage and promote constructive communication among research administrators, department chairs, deans and directors, research investigators, research staff, human subjects, and University of Maine System officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
G. The University of Maine System shall comply with all federal, state and local regulations pertaining to the protection of human subjects.
Definitions:
"Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some programs of "evaluation" or "instruction" may include research activities.
"Human Subject" means a living individual about whom an investigator conducting research obtains either
(a) data through intervention or interaction with the individual; or
(b) identifiable private information.
"Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
"Interaction" includes communication or interpersonal contact between investigator and subject.
"Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also includes information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). If the private information is not individually identifiable (i.e., if the identity of the subject is not known and cannot readily be ascertained by the investigator or associated with the information), the research does not constitute research involving human subjects.
"Minimal risk" means that 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 life or during the performance of routine physical or psychological examinations or tests.
Related Documents:
Administrative Procedures for Human Subject Research