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[printable version]
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.
See also: Guidelines for protection of human subjects
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