Informed Consent/Assent/Information Sheet
The IRB is charged with
the responsibility to protect the rights and welfare of the human participants of research.
This responsibility is based on the ethical principles of the Belmont Report and the
federal guidelines as outlined in the Common Rule, 45 CFR 46.
The most important way in which an IRB can fulfill its responsibilities is to ensure
that the informed consent, the vehicle for the protection of human participants, satisfies
adequate standards. A template (a mold or pattern used as a guide) can assist the
investigator in the submission of the protocols to the IRB. In addition it insures that
the process for obtaining informed consent from the research participant meets all of the
requirements outlined by the IRB and are in compliance with the Common Rule for the
Protection of Research Subjects.
Templates which have been developed (medical, behavioral and
pediatric), to provide a starting point for investigators and research staff when developing
study specific consents. Remember that the templates are guides. The accompanying
instructions indicate which elements are required and which sections can be modified to
fit individual protocols.
The following templates are in Microsoft Word format:
Behavioral Template (Revised 05/08)
Behavioral Assent Template (Revised 05/08)
Medical Template (Revised 05/08)
Parental Permission Template
(Revised 05/08)
Parental School Permission Template (Revised 05/08)
Parental School Information Sheet (Revised 05/08)
Humanitarian Use Device Template (Created 07/06)
Assent Template
(Revised 05/08)
Information Sheet
(Revised 05/08)
Short Form Consent's are available in
Arabic,
Bengali, Chinese,
Hindi, French,
German, Italian,
Polish, Russian,
Spanish and Swahili.
(Please see the HIC standard operating procedure on Informed Consents Involving Non-English Speaking Participants for guidance if necessary.)
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