HRRC Structure and Process
- GVSU is guided by the ethical principles regarding all research involving humans as set forth 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 (often referred to as the "Belmont Report"). The report may be found on-line through the HRRC homepage.
- All institutional and non-institutional performance sites for this institution, domestic or foreign, will be obligated by this institution to conform to ethical principles which are at least equivalent to those of this institution, as cited in the previous paragraph or as may be determined by the Department of Health and Human Services (DHHS) Secretary.
Before any human subject is involved in research in relationship to this institution, an Institutional Review Board (IRB; known locally as the Human Research Review Committee or HRRC)) will give proper consideration 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
- the informed consent process to be employed
Jurisdiction of the IRB
45 CFR 46.109, 46.112, 46.113; 21 CFR 56.109, 56.112, 56.113
- The HRRC has the authority to approve, require modifications in (to secure approval), or disapprove ALL research (funded and not funded) involving human subjects conducted at GVSU as well as research conducted elsewhere by GVSU faculty and staff except research where the only involvement of human subjects is in one or more exempt categories (see Exempt Research Checklist).
- Research that has been approved by the HRRC is subject to review and disapproval by institutional officials, but those officials may NOT approve research that has been disapproved by the HRRC.
The HRRC has the authority to suspend or terminate previously approved research that is not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects.
45 CFR 46.108(b), 21 CFR 56.108(c)
- Except when an expedited review procedure is used, proposed research must be reviewed at convened meetings at which a majority of the members of the HRRC 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 the majority of the members present at the meeting.
Page last modified August 17, 2010