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IRB   

Consent for Research

Consent Forms

Templates

Resources

 

Instructions and Guidance

For general instructions on how to use the templates, go to Instructions for using Consent Templates.

Information pertaining to the research proposal should be added to the templates using complete sentences in non-technical language.

 

Consent Template

The following consent templates contain the basic elements of informed consent and are recommended for use to streamline IRB review and assure that regulatory requirements are met. For more information about the requirements for informed consent, see the OSU HRPP policies, Informed Consent Process and the Elements of Informed Consent and Documentation of the Informed Consent Process.

 

Parental Permission Template

The permission of a parent(s) or guardian must be obtained and documented for his/her child to participate in research, unless these requirements are waived by the IRB. For more information about the requirements for parental permission, see the OSU HRPP policy Assent and Parental Permission.

 

Assent Template

For research involving children, the assent of a child to participate in research is required whenever the child is capable of providing assent, based on the age, maturity, condition, and psychological/emotional state of the child. Documentation of assent is generally required, based on the age and literacy level of the child and nature of the research. If verbal assent will be obtained, the IRB must review a written description of the information (i.e., a script) that will be provided to the children during the assent process. 

Assent may also be appropriate for adults with diminished decision-making capacity and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent.

For more information about assent, see the OSU HRPP policy Assent and Parental Permission.

 

Consent Addendum Template

A consent addendum may be used for optional sub-studies presented at the start of subject participation or when new information becomes available during the study. This addendum template must be used in conjunction with the consent template.

 

OSU/WIRB Consent Template

For protocols reviewed by WIRB, the OSU/WIRB consent template should be used. For more information, see the WIRB research page.

 

Waiver of Informed Consent (Appendix M1) and Waiver of Consent Documentation (Appendix M2)

Complete Appendix M1 to request a Waiver or Alteration of the Consent Process.  DHHS regulations permit waivers (or alterations) of the consent process if the research meets certain conditions; however, FDA has no provision for waiver or alteration of consent. For more information about waiving or altering the consent process, see the OSU HRPP policy Informed Consent Process and the Elements of Informed Consent.

Complete Appendix M2 to request a Waiver of Consent Documentation for the proposed research. For more information about waiver of documentation of consent, see the OSU HRPP policy Documentation of the Informed Consent Process.

Additional guidance can be found in the following regulations: 45 CFR 46.116, 45 CFR 46.117 and 21 CFR 56.109.

 

Glossaries

 

OSU HRPP Policies

 

Regulatory Guidance

 

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Last Modified: October 22, 2009