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.
Attention PI’s of Investigator Initiated Studies and PIs with Sponsors: Clinical Trial research studies are required by law to be registered on the clinicaltrials.gov website [U.S. Public Law 110-85 (FDAAA)] and a statement must appear in the informed consent document stating that it is registered. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page http://prsinfo.clinicaltrials.gov/fdaaa.html
The following templates are in Microsoft Word format:
- Check the reading level of the consent:
- [Medical] Adolescent Assent Template (11/2012)
- [Behavioral] Adolescent Assent Template (11/2012)
- [Behavioral] Research Informed Consent Template (08/2011)
- [Medical] Research Informed Consent Template (08/2011)
- Humanitarian Use Device Informed Consent Template (08/2011)
- Parental Permission/Research Informed Consent Template (08/2011)
- [School] Shorter Parental Permission/Research Informed Consent or Information Sheet Template (11/2012)
- [School] Parental Permission/Research Informed Consent Template (11/2012)
- Information Sheet (10/2012)
- Required Elements of Informed Consent
- Oral Assent Template- There is no template for oral assent because of the varying developmental levels of the children or adults where its use would be appropriate. The IRB suggests that you use the question and answer format on the Adolescent Assent Template and rewrite the content of each section at an age-appropriate level. Remove initial lines on the bottom of each page and the signature lines on the back page. For oral assent of children, the child does not sign to assent. The person obtaining the oral assent fills in the line stating "Oral Assent (children age 7-12) obtained by" on the Parental Permission Form signature page.
(Please see the IRB standard operating procedure on Informed Consents Involving Non-English Speaking Participants for guidance if necessary)