Examples
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.
Counter-examples
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.
Editorial commentary
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.
Required elements under 45 CFR 46.116(d)
The 2018 Common Rule revisions created broad consent as a new, formal regulatory option (it did not exist as a regulatory category before). Beyond the standard 46.116(b) disclosure elements it incorporates by reference, 46.116(d) adds: a general description of the types of research that may be conducted, specific enough for a reasonable person to understand the scope; a description of the identifiable information or biospecimens that might be used and whether they might be shared with third parties; the period of storage and use, which may be indefinite; a statement that subjects will not be told study-specific details unless separately specified; a statement on whether clinically relevant findings will be disclosed, and under what conditions; and contact information for questions about the subject’s rights and about storage/use of their data or specimens.
Broad consent vs. “blanket consent”
“Blanket consent” has no definition in the Common Rule, FDA human-subjects regulations, or ICH GCP — it is an informal term from bioethics and biobanking literature, generally used for essentially unrestricted future-use consent that lacks broad consent’s built-in scope limits and ongoing IRB oversight. Treat the two as distinct: broad consent is a specific regulatory pathway with defined required elements and IRB accountability; blanket consent is a looser, non-regulatory description sometimes used (often critically) to describe consent language broader than what 46.116(d) actually permits.
What happens on refusal
Under 46.116(e)–(f), if a subject was specifically asked to provide broad consent and refused, an IRB cannot fall back on the general 46.116(f) waiver-of-consent pathway to bring that subject’s existing data or biospecimens into a secondary study anyway — refusal of broad consent forecloses that route for that individual’s material, distinct from the separate waiver test used when broad consent was never sought at all.
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)
Related: Informed consent · Dynamic consent · Common Rule (45 CFR 46) · Waiver of Informed Consent (45 CFR 46.116(f)).
Also known as
Common Rule broad consent · u00a746.116(d) broad consent
Machine-readable encodings
Use in your systems
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