IRB Approval and Expiration of Recruitment Materials

Recruitment materials — flyers, print or broadcast advertisements, social-media ad copy and images, posted study listings, phone or email scripts, and screening questionnaires used to identify and approach prospective research participants — are not incidental marketing collateral. Under longstanding FDA/OHRP guidance, direct advertising for research subjects is treated as the start of the informed-consent and subject-selection process itself, and must be reviewed and approved by the IRB before use, the same as the protocol and consent form. That approval is not open-ended: it runs on the study’s current IRB approval period and expires when that period does, independent of whether the protocol itself remains open.

Why this is tracked separately from protocol continuing review

The general renewal cycle for a study — continuing review under 45 CFR 46.109(e) and, for FDA-regulated research, 21 CFR 56.109(f) — asks whether the study as a whole should continue to be approved. Recruitment-material approval is a narrower, document-level question nested inside that broader determination: does this specific flyer, ad, script, or screening instrument still accurately reflect the currently-approved eligibility criteria, study description, and contact information, and is it still within its own authorized window of use? A study can pass continuing review and remain fully approved while a specific recruitment document has, in practice, fallen out of date — because it was never resubmitted, because eligibility criteria changed since it was last approved, or because the approval period printed on it has simply run out. When that happens, the protocol continuing to be open does not authorize continued use of the outdated material. Using an expired, unapproved, or superseded recruitment or screening document to approach or screen prospective participants is treated as noncompliance in its own right, separate from any lapse in the protocol’s overall approval status.

What triggers a new recruitment-material approval

Recruitment and screening materials typically need fresh IRB review and approval — not just a rubber-stamp renewal — whenever any of the following occurs: the study’s approval period is renewed at continuing review and the materials were not resubmitted alongside that renewal; the eligibility or exclusion criteria change, since a screening script or flyer that still describes the old criteria would misrepresent who is eligible; the underlying protocol or consent form is amended in a way that affects what the material claims about the study (compensation, procedures, risks, duration); or the recruitment channel itself changes (for example, adding a new social-media platform or a paid ad placement that was not part of the originally-approved plan). Many IRBs address this with a visible approval-and-expiration date stamped directly on the material — a printed date range on the flyer or ad copy itself — specifically so the expiration is checkable without cross-referencing the protocol file.

What screening materials add to the picture

Screening instruments — the phone script, online pre-screener, or intake questionnaire used to determine whether a caller or respondent meets eligibility criteria before consent is obtained — sit in the same review-and-expiration category as advertising, because they are also part of the subject-selection process the IRB is required to evaluate: is the eligibility determination applied consistently and fairly, does the script avoid implying enrollment is guaranteed, and does it collect only the information needed to make the eligibility call. A screening script drafted or revised after initial approval, but never itself submitted for IRB review, is not an approved recruitment document regardless of how closely it tracks the approved protocol’s stated criteria.

What lapses when recruitment-material approval expires

Concretely, an expired recruitment or screening material means: the flyer, ad, or posted listing must come down or stop running; the phone/email script cannot be used to screen new callers or respondents; and no new participant can be identified or approached using that material until an updated version, reflecting current protocol terms and covering the current approval period, has been submitted and approved. This is narrower than a full protocol approval lapse — which halts essentially all study activity, including enrollment, intervention, and (absent an IRB finding that continued participation is in current subjects’ best interest) data collection — but it functions the same way at the document level: what the IRB has not currently approved cannot be used to bring people into, or screen people for, a study.

Related CASRAI content

• Continuing Review (IRB) — the periodic re-review of the study as a whole; recruitment-material approval is a narrower, document-level tracking obligation nested inside that broader cycle.
• IRB (Institutional Review Board) — the body that reviews and approves recruitment and screening materials alongside the protocol and consent form.
• ICF (Informed Consent Form) — the consent document recruitment materials must accurately foreshadow, particularly on risks, compensation, and voluntariness.
• Protocol Deviation — using an expired or unapproved recruitment/screening document is typically logged and reported through the same noncompliance/deviation pathway.
• 21 CFR Part 56 — FDA’s IRB regulation governing review of advertising for FDA-regulated research.
• Common Rule (45 CFR 46) — the federal framework establishing the continuing-review cycle this document-level tracking sits inside.
• IRB/REC Approval Process: What Needs Review and What Doesn’t — how initial review, amendments, and continuing review fit together end to end.
• Clinical Trial Patient Recruitment: Methods, Screening, and Enrollment — recruitment and screening methods in practice, including the compliance touchpoints covered here.