Broad consent

A regulatory consent option introduced by the 2018 revised Common Rule at §46.116(d) by which a subject consents prospectively to the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens for future unspecified studies, subject to the elements enumerated in that paragraph.

ByCASRAI Editorial Board

· Last updated 21 May 2026

Worked examples

Is an instance

A biobank programme obtains broad consent at enrolment, then later releases coded specimens to an investigator whose study the IRB determines falls within the scope of the original broad-consent description.

Is an instance

A hospital implements broad consent at clinic registration covering future research with leftover clinical specimens for up to twenty years of storage.

Looks similar, but isn't

Not an instance

A consent form that simply states 'your samples may be used for future research' without the enumerated regulatory elements does not meet the broad-consent standard.

Not an instance

Broad consent does not authorise the return of individual research results to participants unless explicitly addressed.

Broad consent is a defined regulatory construct, not a synonym for vague or open-ended consent. It must include a general description of types of research that may be conducted, the types of information or biospecimens that might be used, the types of institutions that might conduct the research, the period of storage and use, and a statement that subjects will not be informed of details of specific studies or commercial profits. Once obtained, broad consent permits an IRB to waive consent for individual secondary studies that fit within its scope; if broad consent is sought and refused, the data or specimens may not be used for secondary research under the broad-consent pathway.

References

Common Rule 45 CFR §46.116(d) Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens
SACHRP recommendations on broad consent (US Secretary's Advisory Committee on Human Research Protections)

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Broad consent"
      vocab-term-identifier="https://casrai.org/dictionary/term/broad-consent" />

Schema.org DefinedTerm (JSON-LD)

json

{
  "@context": "https://schema.org",
  "@type": "DefinedTerm",
  "name": "Broad consent",
  "identifier": "https://casrai.org/dictionary/term/broad-consent",
  "description": "A regulatory consent option introduced by the 2018 revised Common Rule at §46.116(d) by which a subject consents prospectively to the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens for future unspecified studies, subject to the elements enumerated in that paragraph.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-and-regulatory/",
  "url": "https://casrai.org/dictionary/term/broad-consent",
  "sameAs": [
    "Common Rule broad consent",
    "u00a746.116(d) broad consent"
  ],
  "license": "https://creativecommons.org/licenses/by/4.0/"
}