| To jump to a topic, click your choice below: | ||
|---|---|---|
| Signature/Waiver | Remote Verification | Electronic Signatures |
| HIPAA-compliant, Remote | Assent | Participant Copy |
Comparison of Regulatory Agency Consent Requirements
Signature/Waiver/Waiver of Signature (Documentation)
| Instance | HHS Common Rule 45 CFR 46.117 | HIPAA 45 CFR 164.508 | FDA 21 CFR 56.109 |
|---|---|---|---|
| Signature | Written informed consent form approved by the IRB and signed (including electronic) by the subject or subject’s LAR.* | Written authorization signed and dated by the individual or personal representative. | Written consent form approved by the IRB and signed and dated by the subject or the subject’s LAR at the time of consent. |
| Waiver | X | X | X |
| Waiver of Documentation | X | No specific provision | No specific provision |
| Person Obtaining Consent | Not a regulation, but it is a part of the ICH Good Clinical Practice (GCP) guidelines |
*Legally Authorized Representative
Remote Verification of Identification
| HHS Common Rule 45 CFR 46.117 | HIPAA 45 CFR 164.508 | FDA 21 CFR 56.109 |
|---|---|---|
| Advises researchers to use a Risk-Based Approach to decide when verification is warranted. Social behavioral, minimal risk research will NOT typically warrant such verification. | HIPAA recommends user authentication to verify identity. | FDA requires verification of identity under Part 11 Electronic Records/Signatures. |
SHORT FORM (consistent with both HHS and FDA regulations).
Electronic Signatures
| HHS Common Rule 45 CFR 46.117 | HIPAA 45 CFR 164.508 | FDA 21 CFR 56.109 |
|---|---|---|
| Permitted if legally valid within jurisdiction | Allowed provided legally valid, secure, & no risk to the integrity of PHI | Permitted provided compliant with FDA Part-11 |
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Note: Investigators are generally expected to use consent documents containing the “IRB Approval” stamp unless circumstances do not accommodate use of a version containing the stamp (e.g., use of an electronic system). Regulations do not mandate consent stamps, and IRB policy permits exceptions where uploading a stamped version may not be feasible.
HIPAA-compliant Remote Communication Non-Public Facing End-to-End Encryption
| Video Communication Products with HIPAA Compliance Provisions | Compliant Non-public-facing Remote Communication Platforms |
|---|---|
| HIPAA and Telehealth | What is a "non-public-facing" remote communication product? |
Assent Documentation
| Office of Human Research Protection (OHRP) Guidance | UK IRB Policy on Children in Research | FDA 21 CFR 56.109 Guidance |
|---|---|---|
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The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child’s age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent. If young children are involved who are yet unable to read, documentation should use a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted. |
When the IRB determines that assent is required, the regulation permits the IRB to also determine whether and how assent must be documented. Unless the requirement is waived by the IRB, signatures are generally required on the assent for subjects aged 12-17. |
When the IRB determines that assent is required, it must also determine whether and how assent must be documented (21 CFR 50.55(g)). Considerations such as the child’s age, maturity, and degree of literacy for determining the capability of children to provide assent should be considered when determining whether assent should be in writing or oral. |
Note: The title of each column is a link to guidance for that agency/institution.
Signed/Unsigned Copy for Participant
| Agency | Language Excerpt |
|---|---|
| FDA: Does not require. Recommends a copy of the signed document. | In addition, the person signing the consent form must receive a copy of the consent form (21 CFR 50.27(a)). Although FDA regulations do not require the subject’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided. |
| FDA ICH GCP* Requires, but UK ORI does not comply with ICH Good Clinical Practice (GCP) Guidelines | The subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form. |
| OHRP Common Rule: Does not specify copy be signed | Written copy shall be given to the person signing the informed consent form. |
| FDA/OHRP E-consent guidance (States FDA recommends) | The copy provided to the subject can be paper or electronic and may be provided on an electronic storage device or via email. |
| UK Consent SOP: Does require | The subject or LAR signing on the subject’s behalf receives a copy of the signed form. |
| UK HIPAA Authorization Guidance: Does require | The subject must be given a copy of the signed authorization. |
| AAHRPP: Standard-ii3/element-ii.3.f Only requires if compliant with ICH GCP |
A copy of the consent document will be given to the person signing the consent document.
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*International Conference on Harmonization Good Clinical Practice Guidelines – UK only complies with ICH GCP to the extent that it is consistent with FDA regulations.