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Last Updated: 05/03/21

Informed Consent

“Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.” 45 CFR 46.116(a)(1)

Informed consent protects research participants who contribute samples and information to make research possible. Informed consent is generally required for research with human biological samples and data conducted or supported by federal funds, unless that research meets certain criteria described in the federal regulations protecting human research subjects (the revised Common Rule or “2018 Requirements”) at 45 CFR 46.104(d)(4). Under certain circumstances described in these regulations, secondary research uses of existing biospecimens and identifiable private information may be exempt from research participant protection requirements, including review by Institutional Review Boards (IRBs), and informed consent. One such circumstance is when the biospecimens and/or individually identifiable information are publicly available (45 CFR 46.104(d)(4)(i)). Another circumstance is if information about biospecimens is recorded without direct or indirect identifiers, and the investigator neither contacts nor re-identifies participants (45 CFR 46.104(d)(4)(ii)).

Additionally, IRBs may waive consent for minimal risk research on existing specimens if specified criteria in the federal regulations at 45 CFR 46.116(f) have been met. Consent cannot be waived for research involving identifiable specimens or information, however, if the research could practicably be carried out using de-identified information or biospecimens.

For certain research involving high throughput sequencing technologies, there is emerging consensus that informed consent from participants should be obtained due to the elevated risk of re-identification. The revised Common Rule requires that for research involving biospecimens, the informed consent document must tell participants whether the research will (if known) or might include whole genome sequencing (45 CFR 46.116(c)(9)).

In 2018, the Health and Human Services (HHS) Office for Human Research Protections (OHRP) Secretary’s Advisory Committee on Human Research Protections (SACHRP) released Updated FAQs on Informed Consent for Use of Biospecimens and Data, which offers recommendations relating to informed consent under the revised common rule.

There is an emerging consensus that informed consent should also be obtained for research collection of identifiable specimens during routine medical care. Consent for taking, storing and using biospecimens and associated data in research, including anticipated or potential known future research uses, should be sought when patients undergo surgery or biopsy. The consent process should include an explanation of the scientific rationale for research with the excised biospecimens and collected data.

The revised Common Rule authorizes the use of a broad consent model for collecting research tissue from patients for long-term storage and future approved research uses that are not precisely known or specified at the time of collection.

The National Cancer Institute has developed consent and patient information templates that aim to describe in clear and concise language what it means to participate in research involving biospecimens, including potential privacy risks, and the concept of a research biorepository.

The following resources may be helpful:

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