Non-Exempt Studies: Informed Consent Templates

Expedited and Full Board Studies

Expedited studies are research projects that meet one of the categories under 46.110 and involve minimal risk.

Full board studies are those the IRB determines does not fall under exempt or expedited categories and need to be reviewed at a convened meeting of the IRB in which a quorum of members are present. Often, these studies involve more than minimal risk, but this is not always true. 

Required Elements of an Informed Consent

Non-exempt studies must follow the HHS regulations 45 CFR 46.116 and 45 CFR 46.117 unless a waiver/alteration has been noted and strongly justified within the protocol application.

The application and consent must reflect the VA State Law and W&M Data Storage Guidance of maintaining study documentation for 5 years following study completion. Signed consent forms need to be maintained for a minimum of 5 years after active data collection has ended. 

Key elements:

1. Disclosing to potential research subjects information needed to make an informed decision;
2. Facilitating the understanding of what has been disclosed;
3. Promoting the voluntariness of the decision about whether or not to participate in the research;
4. Document using a written document that provides key information regarding the research, i.e. ICF
5. The ICF should be updated when necessary (e.g. new risks, potential benefits, etc.)
6. Collection of identifiable information (e.g. audio/video recordings, PHI, etc.) should be made clear to the participant. If it is optional, the participant should be made aware that they can opt out of the collection of such information.
7. If using a wearable device or other technology to collected, please make sure to follow the guidance outlined in "Management and Retention of Data" informational page. 
   NIH Guidance and Sample Language

Informed Consent Form Templates

Click on each header below to view templates that can be used. 

Once consent forms are approved, they will be "stamped." The stamped versions must be used when consenting participants.

Note: The linked "templates" provide a skeleton of what should be included in your consent forms. Please adjust as you see fit.

Types of consent

Adult Informed Consent Informed Consent for 18+ Participants Generally required for research with human participants Document is signed by participant and/or LAR and researcher/personnel administering the consent. If any collection of identifiable information is optional (i.e. audio recordings), provide a separate section in the form that allows the participant to agree or not agree to the collection of this information. Can be obtained electronically via AdobeSign or DocuSign. Collection of electronic consent must be stated clearly in your protocol submission. Anonymity for the participants cannot be guaranteed if you are collecting a signature from a consent!

Implied Consent (no signature required) IMPLIED CONSENT TEMPlATE Expedited or a full board studies require a waiver of documentation of informed consent, and the study must meet the requirements stipulated by the HHS to waive consent Common in most Internet-based research Only for use with participants 18 years or older. A question verifying age must be included before the participant begins with the study. Online surveys and consents must be administered through an approved W&M platform (such as Qualtrics). If the "stamp" cannot be put into the survey platform, please ensure the following sentence is included on the consent: THIS PROJECT WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD AT WILLIAM & MARY ON [INSERT DATE] AND EXPIRES ON [INSERT DATE]. Participants are still given all the information that would've been presented in a "signed consent"

Consent of Minors and Parents/Guardian Permission Child Assent Template Parent/Guardian Permission Template Consent from minors (called "Child Assent") requires permission from a parent/guardian or legally authorized representative (LAR). Parent/guardian permission should be obtained for all studies involving minors. The parent/guardian should sign the permission form prior to the child assention. Child Assent forms should be written to match the reading and comprehension level of your participant population. Assent is required for children between the ages of 7-17. Children younger than 7 should still be informed about the study and asked their permission. Signatures are not required for young children; however, the protocol submission should clearly document how consent will be obtained and how proof of consent will be recorded if no signatures are collected.

Oral/Verbal Consent If you think this option is appropriate for your participants, please include this as part of the study plan in the protocol when describing your consent procedures and include the rationale for use of an oral/verbal consent method. Within the protocol application, the researcher should attach:  The script to be used by the researcher to obtain consent (See guidance) An information sheet about the study using the "Implied Consent Template"  The process should meticulously documented including who was present and date/time the consent was collected Witness should be present when oral consent is obtained and a signature of the witness should be collected A waiver of documentation of informed consent must be obtained; the study must meet the requirements stipulated by the HHS to waive consent

Waiver or Alteration of Informed Consent

Per HHS regulations 45 CFR part 46, the investigator must obtain informed consent from the participant or their legally-authorized representative (LAR). Unless the research is....

1. Exempt under 45 CFR 46.101(b)
2. Informed consent can be waived (45 CFR 46.116(c) or (d), or
3. Meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) in emergency settings

Non-exempt research involving deception or incomplete disclosure must meet the requirements for "alteration of consent," and the Consent Waiver" section must be completed within protocol application.

Waiver of Documentation of Consent

Non-exempt research that is not collecting signatures from participants must apply for a waiver of documentation of consent.

The study team must provide a subject with the required consent information, but the study team is not required to obtain the subject’s signature on the informed consent document.

A waiver of documentation is permissible when:

• The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.  For example, for research on sensitive topics, such as domestic violence or illegal activities;
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that involves surveys/interviews conducted via telephone or online.
• Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.
  (University of Michigan)