Human Subjects Institutional Review Board (HSIRB)
Research subject consent/assent document approval stamp policy
All consent and assent documents must have the official HSIRB approval stamp and signature
before they are presented to subjects.
Steps for obtaining
and/or using a consent document:
develop the final version of the consent documents to be used in the
research project and submit them to the HSIRB exactly as they are
to be presented to the subject.
- The HSIRB reviews
the consent documents as a part of the proposal review process.
- If any changes
are required in the consent documents, the HSIRB will notify the investigators,
who will make the needed changes and return them to the HSIRB for
final approval prior to initiation of the research.
When approved by the HSIRB, the consent documents will receive the following approval
- The stamped and signed consent documents will be returned to the investigators
with written notice of HSIRB approval of the research project. A copy
of the documents will be maintained in the HSIRB files. The investigators
will copy the consent documents that bear the original stamp for distribution
to potential research subjects.
- After recruitment,
research subjects should receive a copy of the consent document. Only
consent documents bearing the HSIRB approval stamp may be used to
Questions? Email the research compliance