Consent, Assent, and Parental Permission
Templates and Guidance
Study-specific information should be added to the templates using complete sentences in non-technical language.
For general instructions on how to use the templates, go to Instructions for using Consent Templates.
Consent Guidance
- Informed Consent Guidance – Behavioral and Social Science Research (3/22/19)
- Informed Consent Guidance – Biomedical and Cancer Research (3/22/19)
- Combined Consent & Authorization Guidance (2/9/21)
- Combined Form Submission Instructions (4/25/17)
- Informed Consent Guidance – Exempt Research (1/15/19)
- Electronic Signature for Informed Consent
Consent Templates
The following consent templates contain the basic elements of informed consent and are recommended for use to streamline IRB review and ensure that regulatory requirements are met. For more information about the requirements for informed consent, see HRPP policies, Informed Consent Process and the Elements of Informed Consent and Documentation of the Informed Consent Process.
- Informed Consent Template – Behavioral & Social Science Research (4/19/21)
- Informed Consent Template – Biomedical & Cancer Research (4/19/21)
- Combined Consent & HIPAA Authorization Template (4/19/21)
- Informed Consent Template – Exempt Research (4/19/21)
- Informed Consent Online Template – Exempt Research (4/19/21)
Sample Online Consent Script
For minimal risk research being conducted online (such as using an online survey host, conducting interviews via a video messaging platform, document collection via e-mail) consent may be obtained via participants reading a script and then agreeing to participate by clicking a link to a survey, a check box formatted by the survey host, etc. This is an example of a script to be read by participants to collect consent for participation in online research. The example provided either includes or prompts information for the required elements of consent as well as additional language specific to participant confidentiality when collecting data online. A consent script must be submitted for IRB review in conjunction with a request for a waiver of consent documentation.
- Informed Consent Script Template (4/19/21)
Consent Template Language by Topic
Consent language that has been reviewed and approved by the IRB Policy Committee. This language can be inserted in the designated sections of consent documents, as applicable.
Parental Permission Template
The permission of a parent(s) or guardian must be obtained and documented for children to participate in research, unless these requirements are waived by the IRB. For more information about the requirements for parental permission, see HRPP policy Assent and Parental Permission.
- Parental Permission Template – Behavioral & Social Science Research (4/19/21)
- Parental Permission Template – Biomedical & Cancer Research (4/19/21)
- Combined Parental Permission & HIPAA Authorization Template (4/19/21)
- Submission Instructions
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 child participants during the assent process.
Assent may also be appropriate for adults with decisional impairment and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent.
For more information about assent, see HRPP policy Assent and Parental Permission.
- Assent Template – Behavioral & Social Science Research (12/15/05)
- Assent Template – Biomedical & Cancer Research (12/15/05)
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.
- Consent Addendum Template – Biomedical & Cancer Research (8/05/05)
Short Form Consent Template for Non-English Speaking Participants
Waiver of Informed Consent and Waiver of Consent Documentation
DHHS and FDA regulations permit waivers (or alterations) of the consent process if the research meets certain conditions. For more information about waiving or altering the consent process, see HRPP policy Informed Consent Process and the Elements of Informed Consent.
For more information about waiver of documentation of consent, see HRPP policy Documentation of the Informed Consent Process.
Resources
Glossaries
- Glossary of Lay Terms for use in Preparing Consent Forms (Stanford University)
- Plain Language Medical Dictionary (University of Michigan Library)
The Ohio State University HRPP Policies
- Informed Consent Process and the Elements of Informed Consent
- Documentation of the Informed Consent Process
- Assent and Parental Permission
Regulations and Guidance
- General Requirements for Informed Consent: 45 CFR 46.116 (DHHS)
- Documentation of Informed Consent: 45 CFR 46.117 (DHHS)
- Tips on Informed Consent (OHRP)
- FDA Informed Consent Regulations: 21 CFR 50, Subpart B
- IRB Review of Research: 21 CFR 56.109 (FDA)
- FDA Information Sheets: Guide to Informed Consent
