IRB Chair

The IRB Chair (also called IRB Chairperson) is the member of an Institutional Review Board (IRB) designated to preside over convened board meetings, make or assign expedited-review determinations between meetings, and lead the board’s day-to-day conduct of its human-subjects research review responsibilities under the Common Rule (45 CFR 46) and, for FDA-regulated research, 21 CFR Part 56. The Chair is a role held by one member of the board — not a separate compliance office and not the institution’s regulatory signatory.

What makes someone the IRB Chair

Operationally, a person functions as IRB Chair when all of the following are true:

• Designated by the institution to lead a specific, registered IRB. The Chair (and typically a Vice Chair) is named on the IRB’s OHRP registration and roster, alongside the board’s other voting and non-voting members, consultants, and alternates required under 45 CFR 46.107.
• Presides over convened meetings. The Chair calls meetings to order, confirms quorum (a majority of members, including at least one non-scientist member, per 45 CFR 46.108), manages discussion, and calls the vote. A proposed research activity may only be approved by a majority of members present at a convened meeting; it may only be disapproved through this non-expedited, convened-meeting procedure.
• Holds statutory authority to conduct or assign expedited review. Under 45 CFR 46.110 (and the parallel FDA provision at 21 CFR 56.110), review of research that qualifies for expedited review — certain categories of no-more-than-minimal-risk research, and minor changes to already-approved research — may be carried out by the IRB Chairperson personally, or by one or more experienced reviewers the Chairperson designates from among the board’s members. An expedited reviewer (including the Chair acting in that capacity) may exercise all the authorities of the full IRB except one: they may not disapprove the research. A study can only be disapproved through full-board review at a convened meeting.
• Coordinates the board’s overall function. Beyond specific regulatory acts, IRB Chairs are typically responsible for scheduling meetings, ensuring minutes are kept and approved, arranging member training, consulting with investigators on pending or prospective submissions, and keeping the board current on regulatory and policy changes — institutional-policy responsibilities layered on top of the regulatory core above.

Federal regulations do not prescribe a single required procedure for how IRB determinations are documented or signed — whether the Chair personally signs approval correspondence, or whether that is delegated to IRB staff/administration acting under the Chair’s determination, is set by each institution’s own written IRB procedures (required under 45 CFR 46.103(b)(4) / 21 CFR 56.108). What is fixed by regulation is the underlying determination authority itself: the vote of the convened board, or the Chair’s (or Chair-designated reviewer’s) expedited-review decision.

IRB Chair vs. a regular IRB member

Every IRB Chair is an IRB member, but not every IRB member is the Chair. Regular members review protocols, participate in convened-meeting discussion, and vote; only the Chair (or a reviewer the Chair specifically designates for a given expedited submission) can independently carry out expedited review, and only the Chair presides over and calls votes at convened meetings. A Vice Chair typically holds the same authorities as the Chair, but only when formally acting in the Chair’s stead (e.g., the Chair’s absence or recusal for conflict of interest) — it is not a standing, independent second seat with the Chair’s authority in parallel.

IRB Chair vs. Designated Institutional Official (DIO) / Institutional Official

The IRB Chair is frequently confused with the institution’s Designated Institutional Official (DIO) or, in human-subjects research specifically, its Federalwide Assurance (FWA)-signing Institutional Official (IO) — but these are separate roles under separate regulatory schemes, and are not automatically held by the same person:

• IRB Chair — a member of a specific IRB, with authority over that board’s review conduct: presiding at convened meetings and making or assigning expedited-review determinations. Scope is bounded to the review function itself.
• Institutional Official (IO) — the individual authorized to sign the institution’s FWA with HHS’s Office for Human Research Protections (OHRP) and to commit the institution to the FWA’s terms, including designating which IRB(s) the institution relies on. This is an institution-wide compliance-commitment authority, not a board-review role.
• DIO — a separately defined ACGME graduate medical education accreditation role (see the DIO term page for the full distinction); some institutions colloquially extend “DIO” to describe the FWA-signing Institutional Official above, but the two aren’t the same regulatory position.

An institution can, and often does, have all three positions filled by different people. None of the three roles substitutes for another: an IO’s FWA signature does not review or approve individual protocols, and an IRB Chair’s expedited-review determination does not obligate the institution’s overall compliance commitments the way an FWA signature does.

Worked examples

• A university’s Biomedical IRB is reviewing a greater-than-minimal-risk drug trial at its monthly convened meeting. The IRB Chair confirms a quorum of members is present (including the required non-scientist member), presides over the board’s discussion of the protocol’s risk-benefit balance and consent document, and calls the vote; the protocol is approved because a majority of members present vote in favor, consistent with 45 CFR 46.108.
• A study team submits a minor amendment to an already-approved minimal-risk survey study — adding one additional validated questionnaire, which qualifies under one of OHRP’s expedited-review categories. Rather than waiting for the next convened meeting, the IRB Chair reviews the amendment directly (or assigns it to an experienced board member) under the expedited procedure at 45 CFR 46.110, and approves it administratively between meetings; a subsequent report of the expedited approval is provided to the full board, as required for IRBs using expedited review.

Counter-example

An IRB member who reviews assigned protocols, participates in convened-meeting votes, but has no designated authority to preside over meetings or independently carry out expedited review is not the IRB Chair — they are a regular voting or non-voting member. Likewise, the institution’s Institutional Official who signs the FWA, or a hospital’s DIO overseeing its ACGME-accredited residency programs, is not the IRB Chair by virtue of that other role alone; each arises under a distinct regulatory framework with its own designation and scope, as described above.

Related CASRAI content

• IRB (Institutional Review Board) — the board itself, its composition and general regulatory basis.
• Designated Institutional Official (DIO) — the ACGME GME accreditation role, including its own dedicated section distinguishing it from the FWA-signing Institutional Official.
• Federalwide Assurance (FWA) — the institutional compliance commitment the Institutional Official signs, and under which IRBs are designated.
• IRB/REC Approval Process: What Needs Review and What Doesn’t — how expedited, full-board, and exempt determinations fit together end to end.

Outside the United States, ethical review of human-subjects research is often carried out by an Independent Ethics Committee (IEC) or Research Ethics Committee (REC) — bodies that perform a broadly equivalent function to a US IRB under frameworks such as ICH E6 Good Clinical Practice, typically with an analogous chairperson role presiding over convened review.