Broad consent is a specific, defined pathway created by the 2018 revisions to the U.S. Common Rule, codified at 45 CFR §46.116(d). It lets a researcher ask a subject, at the point of collection, for prospective permission to store identifiable private information or identifiable biospecimens and use them for future, not-yet-specified secondary research — instead of returning to that subject (or an IRB waiver process) every time a new study wants to use the material. It is a defined regulatory construct with enumerated required elements, not a synonym for a vague “we might use your data for other things” statement.
This guide covers what §46.116(d) actually requires, how broad consent differs from ordinary study-specific consent and from an IRB waiver of consent, the limited-IRB-review step that has to happen before broad-consent data is actually used, and where broad consent does and doesn’t apply. For the core definition alone, see the dictionary entry on broad consent; this guide goes deeper into implementation and the surrounding regulatory mechanics.
Why the Common Rule added a broad consent option
Before the 2018 revisions, the Common Rule’s default consent model assumed a specific study with a describable purpose. That model fits a single clinical trial poorly enough already, but it fits biobanks, longitudinal cohorts, and large observational registries even worse: the entire value of that kind of resource is that it can support research questions nobody has formulated yet, sometimes years or decades after collection. Institutions had two workarounds — re-consenting subjects for every new secondary use, which is often impractical at scale, or asking an IRB to waive consent for each new secondary study under §46.116(f), which requires the IRB to make a fresh minimal-risk determination each time.
Broad consent gives institutions a third option: obtain one prospective consent, at first contact, that is broad enough in scope to cover a general category of future secondary research, but specific enough that it still counts as informed consent rather than an open-ended blank check.
What §46.116(d) actually requires
Broad consent under §46.116(d) is a substitute for the standard consent process described in §46.116(b)–(c) — it is not a lighter-touch version of it. It has to include a defined set of elements, several incorporated from the standard basic-elements list plus additions specific to broad consent:
- A general description of the types of research that may be conducted, specific enough that a reasonable person would understand the scope of what they’re agreeing to — not just “future research.”
- A description of the types of identifiable private information or identifiable biospecimens that might be used, and whether they might be shared with other institutions or investigators.
- How long the information or specimens will be stored and used, which may be described as indefinite.
- A statement that the subject will not routinely be informed of the details of individual future studies conducted under the broad consent, unless the specific details would affect the subject’s willingness to continue.
- A statement about whether clinically relevant research results, including individual genetic findings, will or will not be disclosed, and if so, under what conditions.
- Contact information for questions about the subject’s rights and about the storage and use of their information or specimens.
Because broad consent stands in for the full consent process, several of the general basic elements at §46.116(b) still apply by reference (purpose, voluntariness, right to withdraw, and so on) — broad consent adds the elements above on top of, not instead of, that baseline. Institutions drafting a broad consent document should treat it as a distinct document type with its own review checklist, not a lightly edited version of a standard study consent form.
Broad consent vs. an IRB waiver of consent
Broad consent and a waiver of informed consent under §46.116(f) solve a similar practical problem — using existing data or specimens for research without going back to the individual subject — but they are legally distinct pathways with an important interaction rule: if a subject was asked to provide broad consent and declined, an IRB cannot use the §46.116(f) waiver pathway to bring that subject’s data or specimens into a secondary study anyway. A refusal of broad consent is not a gap a waiver is meant to fill; treating it as one would defeat the purpose of having asked in the first place. Once a subject has properly given (or refused) broad consent, that decision governs future secondary use of their identifiable information or biospecimens, and an IRB weighing a waiver for a specific downstream study needs to know which one occurred before proceeding.
Where the two pathways remain genuinely separate: a waiver under §46.116(f) is a case-by-case IRB determination made for a specific study, typically because re-consent is impracticable and the research is minimal risk; broad consent is a single, prospective, subject-facing consent obtained once, up front, that then governs a general category of later studies without a fresh waiver determination for each one — subject to the limited-IRB-review check below.
Limited IRB review: the gate between broad consent and actual use
Obtaining broad consent does not, by itself, authorize any specific secondary study to proceed. Before identifiable information or biospecimens covered by broad consent are actually used in a given secondary research project, that use has to pass through limited IRB review — a narrower review focused on confirming the study falls within the scope of what was described in the broad consent document, that adequate privacy and confidentiality protections are in place, and (where the exemption categories apply) that any other applicable exemption conditions are met. This is the review contemplated at the related exempt-research categories in 45 CFR §46.104(d)(7)–(8), which cover storage/maintenance of identifiable information or biospecimens for future secondary use, and secondary research use under broad consent obtained per §46.116/§46.117, respectively — both conditioned on limited IRB review rather than a purely administrative sign-off.
In practice this means an institution running a broad-consent program needs a documented process for two separate reviews: the review that approves the original broad-consent collection instrument, and the ongoing limited IRB review of each individual secondary use against that instrument’s stated scope. Skipping the second step because the first one happened is a common implementation error.
Documentation: broad consent still has to be recorded correctly
Broad consent is governed by the informed-consent process rules at §46.116(d); documenting that consent was obtained is governed separately at §46.117. The distinction matters operationally: a signed form is not itself the consent, it is the record of it, and §46.117(c) allows an IRB to waive the signed-document requirement under specific conditions even while the underlying broad-consent process still has to occur. Institutions should not conflate “we have a signed broad consent form on file” with “the consent process met every §46.116(d) element” — the form needs to actually reflect all the required elements, not just carry a signature.
Where broad consent does not apply
Broad consent under §46.116(d) is a Common Rule provision. It does not automatically extend to FDA-regulated clinical investigations governed separately by 21 CFR Part 50. FDA’s own 2018 harmonization rulemaking added a parallel minimal-risk waiver/alteration provision at 21 CFR §50.22, but that is a narrower, study-specific waiver mechanism, not an equivalent to §46.116(d)’s prospective broad consent for future unspecified secondary use. Institutions running FDA-regulated trials alongside biobank or registry activity should not assume a broad consent obtained under the Common Rule automatically covers FDA-regulated use of the same specimens or data — that determination should go through institutional regulatory affairs or the HRPP, not be assumed by analogy.
Broad consent is not “blanket consent”
“Blanket consent” is a term used in bioethics and biobanking literature for essentially unrestricted future-use consent with no defined categories and no ongoing case-by-case oversight. It has no definition anywhere in the Common Rule, FDA’s human-subjects regulations, or ICH E6 — it is not a regulatory pathway at all. Broad consent, by contrast, is a defined regulatory construct with the enumerated elements above and a continuing limited-IRB-review checkpoint for each secondary use. The practical difference is oversight: broad consent keeps an IRB in the loop for every downstream study; blanket consent, as the term is used in the literature, generally does not. See Blanket Consent vs. Broad Consent for a fuller side-by-side.
Broad consent (U.S. Common Rule) vs. GDPR’s “broad consent” (Recital 33)
Researchers working across U.S. and EU sites sometimes assume these are the same thing because both use the phrase “broad consent” to solve a similar underlying problem — consent for research whose exact future scope can’t be fully specified in advance. They are not the same legal instrument:
- 45 CFR §46.116(d) is an operative regulatory provision with a specific enumerated list of required elements (above) and a defined limited-IRB-review gate before use.
- GDPR Recital 33 is preambular/interpretive text, not an operative Article — it does not itself create a lawful basis for processing. The operative provisions are Article 6(1)(a) (consent as a lawful basis), Article 9(2)(a) or 9(2)(j) (processing of special-category data), and Article 89(1) (research safeguards). How much latitude “broad consent” actually gets in practice under GDPR varies by EU member state, because Article 9(2)(j)/Article 89 research derogations are implemented nationally.
An institution operating under both regimes needs two separate compliance analyses, not one consent form that assumes the two frameworks line up element-for-element.
Common implementation pitfalls
- Treating broad consent as a formality rather than a distinct document. A generic “future research” clause bolted onto a standard consent form, without the §46.116(d) elements, does not meet the standard and does not authorize the broad-consent pathway.
- Skipping limited IRB review for individual secondary uses because the original broad consent was already IRB-approved. The original approval covers the consent instrument; each secondary use still needs its own scope-and-privacy check.
- Using a §46.116(f) waiver to work around a refusal. Not permitted — see above.
- Assuming broad consent travels with data shared to another institution without checking whether the original document’s scope, storage duration, and sharing disclosures actually cover that recipient and use.
- Applying it to FDA-regulated research without confirming applicability, given the separate consent framework at 21 CFR Part 50.
Frequently asked questions
Is broad consent mandatory under the Common Rule?
No. Broad consent is an optional pathway institutions may offer as an alternative to study-specific consent or to an IRB waiver process for secondary research. An institution or investigator can choose not to use it and instead rely on study-specific consent or a case-by-case waiver determination.
Can a subject withdraw broad consent after giving it?
The general Common Rule right to withdraw applies to broad consent as it does to other consent, subject to the practical limits on data already incorporated into completed research. Institutions should specify their own withdrawal mechanics for broad-consent programs in the consent document itself, since §46.116(d) does not prescribe one universal withdrawal procedure.
Does broad consent expire?
The storage and use duration is one of the required §46.116(d) elements, and it may be stated as indefinite — there is no regulatory expiration built into the pathway itself. Whatever duration is disclosed in the specific consent document is what governs.
Who decides whether a new secondary study fits within the scope of an existing broad consent?
The IRB, through limited IRB review, not the investigator’s own judgment. That review is what confirms the proposed use falls within the general description the subject actually agreed to.
Does broad consent apply to clinical trials regulated by FDA?
Not automatically. Broad consent under §46.116(d) is a Common Rule (45 CFR 46) provision. FDA-regulated clinical investigations are governed separately under 21 CFR Part 50, which has its own consent and waiver/alteration framework. Confirm applicability with institutional regulatory affairs before assuming coverage across both.
Related CASRAI resources
- Broad consent — the core operational definition
- Waiver of Informed Consent (45 CFR 46.116(f))
- The Components of Informed Consent: The Required Elements Under 45 CFR 46.116
- Blanket Consent vs. Broad Consent
- GDPR Recital 33 (Broad Consent for Scientific Research)
- Common Rule (45 CFR 46)
- Informed consent
- Dynamic consent
