Institutional Review Board
The function of the Institutional Review Board (IRB) is to review projects and activities that involve human subjects. The Board determines for each activity, as planned and conducted, whether subjects will be placed at risk and, if risk is involved, whether:
- The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks;
- The rights and welfare of any subjects will be adequately protected;
- Legally effective informed consent will be obtained by adequate and appropriate methods; and
- The conduct of the activity will be reviewed at timely intervals.
Procedures for IRB Review
- Two copies of all research documents involving human subjects (research documents in this context may be research proposals, thesis proposals, class projects, survey, etc.) will be forwarded to the Chairperson of the IRB along with a copy of the IRB Review Form that has been signed by the investigator, the instructor or advisor if the investigator is a student, department chairperson or director, and dean or area administrator.
- The chairperson of the IRB will conduct a preliminary
review of the research document and determine: (a) if the proposed research
is exempt from Office of Protection from Research Risks (OPRR) regulations,
(b) if an expedited review is appropriate, or (c) if full IRB review is
- When it is determined that the proposed research is exempt from OPRR regulations, the IRB Approval Form will be returned to the investigator with appropriate notification that the investigation is so exempted.
- When an expedited review is deemed appropriate, such a review will be conducted by the IRB chairperson and/or selected members of the IRB. The full IRB will be informed of the expedited review action.
- When a full review is deemed appropriate, the IRB
chairperson will request eight (8) additional copies of the research document
from the investigator.
- The chairperson will distribute these copies to the IRB with
an appropriate cover memorandum and approval form.
- The IRB members will review the document for compliance with federal regulations and report their findings by indicating whether or not the potential risks are outweighed by the benefits of the research. As a part of its review the IRB will indicate the frequency with which the project requires review if more than annually.
- During the annual (or specified) review, the IRB will determine that no changes have been made in the research activity without prior IRB approval. Further, the IRB will review any unanticipated problems involving risks to subjects or others and report said risks to OPRR.
- The IRB will return completed Approval Forms directly to the Chairperson.
- Following receipt of the Approval Forms from the IRB, the Chairperson will notify the investigator of the action of the Board.
- The chairperson will distribute these copies to the IRB with an appropriate cover memorandum and approval form.
- No changes in research activities can be made subsequent to IRB approval without written approval from the IRB Chairperson. The procedure described above for initial review will be followed for proposed research changes.