UNCW Faculty Handbook: Faculty responsibilities: Research: Procedure for review of research proposals involving human subjects

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Procedure for review of research proposals involving human subjects

Proposals for use of human subjects are to be submitted to the IRB Chairperson. Depending on the nature of the research, a proposal may be: (1) exempt from IRB review; (2) appropriate for an expedited review by one member or a subcommittee of the IRB; or (3) subject to review by the full IRB. Only the IRB or its designate, typically the chairperson can determine which type of review is necessary.
If exempt, the documentation form will be signed and returned to the researcher immediately.
If expedited review is required, the chairperson or the chairperson's designate will evaluate the proposal. If the reviewer has questions concerning the proposal he or she will consult with other members of the IRB to determine whether or not full review is required. A research proposal can be approved by the expedited reviewer. However, full review is required for disapproval.
If full review is required, a copy of the research proposal will be distributed to all IRB members prior to a convened meeting. A majority of the IRB members must be present at the meeting for a full review of any proposal to take place. The principle investigator may be invited to answer questions at this meeting. A majority of the members present may approve the research. Members of the IRB who vote to disapprove a proposal shall submit their reasons in writing to the chairperson.
Following expedited review and full review researchers will be notified in writing as soon as possible of the results of the review.
If a proposal is disapproved the researcher will be notified in writing of the reasons for the disapproval and will be given an opportunity to respond in person or in writing.
Proposals covering a wide range of activities, conducted as classroom demonstrations or course requirements, may be submitted to the IRB as one proposal.
Ongoing research must be reviewed each calendar year. Current ongoing research which has previously been approved must be resubmitted for review within one calendar year of its last approval. A new review form should be used for this purpose.