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SECTION II
MATERIALS REQUIRED FOR SUBMISSION TO THE IRB
Applications to conduct research activities, which involve
human subjects, must be filed with Human Subjects Office and must be approved
prior to commencement of the activity. Materials required for submission include:
A. An
IRB application, complete with the following signatures:
1. Signature of the researcher, who ensures accuracy of
the information contained within the submitted materials, and, upon approval,
assures compliance
with all aspects of Section V titled "Responsibility of Researchers".
2.
If applicable, the signature of the supervisor of the student principal
researcher, who assumes complete responsibility for the student's research
including:
- Ensuring accuracy of the information contained within
the submitted materials.
- Assuring compliance with all aspects of Section
V entitled "Responsibility
of Researchers".
B. Answers to the Application questions. Clearly
discuss, in lay language, the research protocol. Do not cut and
paste from a grant proposal. The following must be included:
1. Complete answers to all questions.
2. All advertisements
(i.e., newspaper, radio, flyers, etc.) to be used.
3. Inclusion/exclusion
criteria for subject entry including notification to the IRB if an researcher
proposes to include themselves,
or members of their family as subjects in the proposed research.
4.
If access to research subjects is gained through cooperating institutions
not under the control of the University, the
institution(s) must
be identified on the IRB form and evidence provided that
the authorized official of
that institution has approve the research application.
C.
When funding is being sought from an external agency (NIH, NSF, pharmaceutical
company, etc.), the number assigned by the Office for Sponsored Programs, or
the proposal number assigned by the funding agency should be inserted on the
cover page of the application.
D. Consent and assent form(s) or consent scripts/letters. Section
VIII provides detailed information about the informed consent
process and contains guidelines for writing consent forms.
E. If a proposed project involves a component of research
that falls under the jurisdiction of the Animal Care and Use and/or the Biosafety
Offices, approval must be obtained from the appropriate Compliance Office(s)
prior to review by the Human Subjects Office/IRB.
F. Supplemental Materials:
1. If access to research subjects
is gained through other institutions, those institutions must be identified
on the IRB form and an authorization letter
or IRB approval must be provided prior.
2. All advertisements related
to recruitment (i.e., newspaper, radio, flyers, etc.) to be used.
3. A debriefing
form if appropriate. This is required for all studies that recruit from
the psychology RP Pool.
4. All the instruments to be used for the research,
e.g. questionnaires, interview or focus group protocols, scales, medical
history forms,
demographic forms,
phone screens, MRI screens, etc.
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