Informed Consent/Assent and Information Sheet Templates
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 01/09)
- Behavioral Assent Template (Revised 05/08)
- Medical Template (Revised 01/09)
- Parental Permission Template (Revised 02/09)
- Parental School Permission Template (Revised 02/09)
- Parental School Information Sheet (Revised 01/09)
- Humanitarian Use Device Template (Created 07/06)
- Assent Template (Revised 05/08)
- Information Sheet (Revised 05/08)
Short Form Consents are available in Arabic, Bengali, Chinese, French, German, Hindi, Italian, Polish, Russian, Spanish, and Swahili
Englist translation of Short Form Consents
(Please see the HIC standard operating procedure on Informed Consents Involving Non-English Speaking Participants for guidance if necessary)