Waivers/Alteration of Consent and Waiver of Documentation of Consent
Consent or a waiver of consent is no longer necessary for screening, recruiting, or determining eligibility (45CFR46.116(g)(1) or (2)). An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective participants if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Telephone screens may require a HIPAA Waiver form (see link). See also the HIPAA Guidance under Consent.
If your work meets the federal definition of research involving human subjects, then written informed consent is required according the regulations. However, under limited circumstances, defined below, the IRB can consider your request for a waiver or an alteration of consent (45CFR46.116(f)(3)).
- The research involves no more than minimal risk;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
A Waiver of Documentation of Consent (45CFR46.117 (c)(1)(2) or (3)) is utilized in a protocol when the signature of the participant is likely the only identifiable link to the participant. In those cases, a waiver of documentation of consent may be requested to remove the signature line for the participant on the consent form in an effort to protect confidentiality. The person obtaining consent will need to sign and date the form. Participants or legally authorized representative should still be provided with a copy of the consent form.
The IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subject if any of the following apply:
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- That the research present no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.