The Food and Drug Administration (FDA) has regulations that govern human subject protection aspects of research on products regulated by the Agency. In addition, other federal agencies and departments and some States have regulations that govern human subject protection. Each IRB/institution should be familiar with the laws and regulations that apply to research reviewed by the IRB. This checklist was developed to help IRBs/institutions evaluate procedures for the protection of human subjects of research.

Successful IRBs make use of written procedures that, in one way or another, cover a common core of topics. This checklist is an effort to present these topics in a systematic way. Written procedures for some of the items are not specifically required by FDA regulations (e.g., policy regarding place and time of meeting) but are appropriate to consider when comprehensive procedures are being developed.

Once an IRB/institution establishes its structure and procedures, those procedures should be followed. FDA inspections assess compliance with both the regulatory requirements and the IRB/institution's own written procedures. Since the written procedures should reflect the current processes, the written procedures should be reviewed on a regular basis and updated as necessary to remain current. FDA believes that when good procedures are developed, written, and followed, the rights and welfare of the subjects of research are more likely to be adequately protected.

Tips on checklist use:

Three "response" columns are provided -- "Yes," "No," and N/A." A "Yes" means that the institution has a written policy/procedure and that it is current. A "No" may mean that a policy/procedure is lacking or needs to be updated. The "N/A" column indicates that a topic is not applicable or a procedure is not needed by the IRB.

The columns may be completed by checking the appropriate box. Instead of a check-mark, some IRBs record the date of issuance or revision date. Others have found it useful to record the policy/procedure number on the form. Any "No" responses indicate a need to write/revise policies and/or procedures.

FOOTNOTED items are referenced in the FDA regulations. ASTERISKED items are those for which WRITTEN PROCEDURES are specifically required by the FDA regulations.

YES NO N/A DOES THE INSTITUTION HAVE WRITTEN POLICIES OR PROCEDURES THAT DESCRIBE:
_____ _____ _____ I. THE INSTITUTIONAL AUTHORITY UNDER WHICH THE IRB IS ESTABLISHED AND EMPOWERED.ć
_____ _____ _____ II. THE DEFINITION OF THE PURPOSE OF THE IRB, i.e., THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH."
_____ _____ _____ III. THE PRINCIPLES WHICH GOVERN THE IRB IN ASSURING THAT THE RIGHTS AND WELFARE OF SUBJECTS ARE PROTECTED.
IV. THE AUTHORITY OF THE IRB.
_____ _____ _____ A. The scope of authority is defined, i.e., what types of studies must be reviewed.
_____ _____ _____ B. Authority to disapprove, modify or approve studies based upon consideration of human subject protection aspects.4
_____ _____ _____ * C. Authority to require progress reports from the investigators and oversee the conduct of the study.5
_____ _____ _____ * D. Authority to suspend or terminate approval of a study.6
_____ _____ _____ * E. Authority to place restrictions on a study.7
V. THE IRB'S RELATIONSHIP TO
_____ _____ _____ A. The top administration of the institution.
_____ _____ _____ B. The other committees and department chairpersons within the institution.
_____ _____ _____ C. The research investigators.
_____ _____ _____ D. Other institutions.
_____ _____ _____ E. Regulatory agencies.
VI. THE MEMBERSHIP OF THE IRB.
_____ _____ _____ A. Number of members.8
_____ _____ _____ B. Qualification of members.9
C. Diversity of members10(for example, representation from the community, and minority groups), including representation by:
_____ _____ _____ --both men and women11
_____ _____ _____ -- multiple professions12
_____ _____ _____ -- scientific and non-scientific member(s)13
_____ _____ _____ -- not otherwise affiliated member(s)14
_____ _____ _____ D. Alternate members (if used).
VII. MANAGEMENT OF THE IRB.
A. The Chairperson
_____ _____ _____ -- selection and appointment
_____ _____ _____ -- length of term/service
_____ ______ _____ -- duties
______ _____ _____ -- removal
B. The IRB Members.
______ _____ _____ -- selection and appointment
_____ _____ _____ -- length of term/service and description of staggered
rotation or overlapping of terms, if used
_____ _____ _____ -- duties
_____ _____ _____ -- attendance requirements
_____ _____ _____ --removal
C. Training of IRB Chair and members
_____ _____ _____ -- orientation
_____ _____ _____ -- continuing education
_____ _____ _____ -- reference materials (IRB library)
_____ _____ _____ D. Compensation of IRB members.
_____ _____ _____ E. Liability coverage for IRB members.
_____ _____ _____ F. Use of consultants.15
_____ _____ _____ G. Secretarial/administrative support staff (duties).
_____ _____ _____ H. Resources (for example, meeting area, filing space, reproduction equipment, computers).
I. Conflict of interest policy
_____ _____ _____ -- no selection of IRB members by investigators
_____ _____ _____ -- prohibition of participation in IRB deliberations
and voting by investigators.16
VIII. FUNCTIONS OF THE IRB.
_____ _____ _____ * A. Conducting initial and continuing review.17
_____ _____ _____ * B. Reporting, in writing, findings and actions of the IRB to the investigator and the institution.18
_____ _____ _____ * C. Determining which studies require review more often than annually.19
______ ______ _____ * D. Determining which studies need verification from sources other than the investigators that no material changes have occurred since previous IRB review.20
_____ _____ _____ E. Ensuring prompt reporting to the IRB of changes in research activities. 21
_____ _____ _____ * F. Ensuring that changes in approved research are not initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards. 22
G. Ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of:
_____ _____ _____ * -- unanticipated problems involving risks to subjects or others23
_____ _____ _____ * -- serious or continuing noncompliance with 21 CFR parts 50 and 56 or the requirements of the IRB24
_____ _____ _____ * -- suspension or termination of IRB approval.25
_____ _____ _____ H. Determining which device studies pose significant or non-significant risk.
IX. OPERATIONS OF THE IRB.
_____ _____ _____ * A. Scheduling of meetings. 26
_____ _____ _____ B. Pre-meeting distribution to members, of, for example, place and time of meeting, agenda, and study material to be reviewed.
C. The review process
* -- description of the process ensuring that27
_____ _____ _____ 1) all members receive complete study documentation for review (see XI.B);
or _____ ______ _____ 2) one or more "primary reviewers"/"secondary reviewers" receives the complete study documentation for review, reports to IRB and leads discussion; if other members review summary information only, these members must have access to complete study documentation
_____ _____ _____ -- role of any subcommittees of the IRB
_____ _____ _____ * -- emergency use notification and reporting
procedures28 * -- expedited review procedure29
_____ _____ _____ -- for approval of studies that are both minimal risk and on the FDA approved list (see Appendix A)
_____ _____ _____ -- for approval of modifications to ongoing studies involving no more than minimal risk
_____ _____ _____ D. Criteria for IRB approval contain all requirements of 21 CFR 56.111.
E. Voting requirements30
_____ _____ _____ - quorum required to transact business
______ _____ _____ - diversity requirements of quorum (for example requiring at least one physician member when reviewing studies of FDA regulated articles)
_____ _____ _____ - percent needed to approve or disapprove a study
_____ _____ _____ - full voting rights of all reviewing members
_____ _____ _____ - no proxy votes (written or telephone)
_____ _____ _____ - prohibition against conflict-of-interest voting
_____ _____ _____ F. Further review/approval of IRB actions by others within the institution. (Override of disapprovals is prohibited.)31
G. Communication from the IRB.
_____ _____ _____ * - to the investigator for additional information32
_____ _____ _____ * - to the investigator conveying IRB decision33
_____ _____ _____ * - to institution administration conveying IRB decision34
_____ ______ _____ - to sponsor of research conveying IRB decision H. Appeal of IRB decisions.
_____ _____ _____ - criteria for appeal
_____ _____ _____ - to whom appeal is addressed
_____ _____ _____ - how appeal is resolved (Override of IRB disapprovals by external body/official is prohibited.)35
X. IRB RECORD REQUIREMENTS.
_____ _____ _____ A. IRB membership roster showing qualifications36
_____ _____ _____ * B. Written procedures and guidelines. 37 C. Minutes of meetings. 38
_____ _____ _____ - members present (any consultants/ guests/others shown separately)
_____ _____ _____ - summary of discussion on debated issues - record of IRB decisions
_____ _____ _____ - record of voting (showing votes for, against and abstentions)
_____ _____ _____ D. Retention of protocols reviewed and approved consent documents39
_____ _____ _____ E. Communications to and from the IRB.40
_____ _____ _____ * F. 1) Adverse reactions reports, and41
_____ _____ _____ 2) documentation that the IRB reviews such reports.
_____ ______ _____ H. Records of continuing review.42
I. Record retention requirements. (at least 3 years after completion for FDA studies)43
_____ _____ _____ J. Budget and accounting records.
_____ _____ _____ K. Emergency use reports.44
______ _____ _____ L. Statements of significant new findings provided to subjects.45
XI. INFORMATION THE INVESTIGATOR PROVIDES TO THE IRB.
_____ _____ _____ A. Professional qualifications to do the research (including a description of necessary support services and facilities).
B. Study protocol which includes/addresses46
_____ _____ _____ - title of the study.
_____ _____ _____ - purpose of the study (including the expected benefits obtained by doing the study).
_____ _____ _____ - sponsor of the study.
_____ _____ _____ - results of previous related research.
_____ _____ _____ - subject inclusion/exclusion criteria.
_____ _____ _____ - justification for use of any special/vulnerable subject populations (for example, the decisionally impaired, children)
_____ _____ _____ - study design (including as needed, a discussion of the appropriateness of research methods).
_____ _____ _____ - description of procedures to be performed.
_____ _____ _____ - provisions for managing adverse reactions.
_____ _____ _____ - the circumstances surrounding consent procedure, including setting, subject autonomy concerns, language difficulties, vulnerable populations.
_____ _____ _____ - the procedures for documentation of informed consent, including any procedures for obtaining assent from minors, using witnesses, translators and document storage.
_____ _____ _____ - compensation to subjects for their participation.
_____ _____ _____ - any compensation for injured research subjects.
_____ _____ _____ - provisions for protection of subject's privacy.
_____ _____ _____ - extra costs to subjects for their participation in the study.
_____ _____ _____ - extra costs to third party payers because of subject's participation.
_____ _____ _____ C. Investigator's Brochure (when one exists)47
_____ _____ _____ D. The case report form (when one exists)
E. The proposed informed consent document48.
_____ _____ _____ - containing all requirements of 21 CFR 50.25(a)
_____ _____ _____ - containing requirements of 21 CFR 50.25(b) that are appropriate to the study.
_____ _____ _____ - meeting all requirements of 21 CFR 50.20
_____ _____ _____ - translated consent documents, as necessary, considering likely subject population(s)
_____ _____ _____ * F. Requests for changes in study after initiation.49
_____ _____ _____ * G. Reports of unexpected adverse events.50
_____ _____ _____ * H. Progress reports.51
_____ _____ _____ I. Final report.
_____ _____ _____ J. Institutional forms/reports
XII. EXEMPTION FROM PROSPECTIVE IRB REVIEW52
_____ _____ _____ * A. Notify IRB within 5 working days53
_____ _____ _____ B. Emergency use54
_____ _____ _____ C. Review protocol and consent when subsequent use is anticipated.55
XIII. EMERGENCY RESEARCH CONSENT EXCEPTION56
_____ _____ _____ A. The IRB may find that the 50.24 requirements are met57
_____ _____ _____ B. The IRB shall promptly notify in writing the investigator and the sponsor when it determines it cannot approve a 50.24 study58
_____ _____ _____ C. The IRB shall provide in writing to the sponsor a copy of the information that has been publically disclosed under 50.24(a)(7)(ii) and (a)(7)(iii)59
_____ _____ _____ D. In order to approve an emergency research consent waiver study, the IRB must find and document:
_____ _____ _____ (1) subjects are in a life-threatening situation, available treatments unproven or unsatisfactory and collection of scientific evidence is necessary 60
(2) Obtaining informed consent is not feasible because:61
_____ _____ _____ - medical condition precludes consent62
_____ _____ _____ - no time to get consent from legally authorized representative63
_____ _____ _____ - prospective identity of likely subjects not reasonable64
(3) Prospect of direct benefits to study subjects because:65
_____ _____ _____ - life-threatining situation that necessisates treatment
_____ _____ _____ - data support potential for direct benefit to individual subjects
_____ _____ _____ - risk/benefit of both standard and proposed treatments reasonable
_____ _____ _____ (4) waiver needed to carry out study
_____ _____ _____ (5) plan defines therapeutic window, during which investigator will seek consent rather than starting without consent. Summary of efforts will be given to IRB at time of continuing review.
_____ _____ _____ (6) IRB reviews and approves consent procedures and document. IRB reviews and approves family member objection procedures
(7) Additional protections, including at least:
_____ _____ _____ - consultation with community representatives
_____ _____ _____ - public disclosure of plans, risks and expected benefits
_____ _____ _____ - public disclosure of study results
_____ _____ _____ - assure an independent Data Monitoring Committee established
_____ _____ _____ - objection of family member summarized for continuing review
_____ _____ _____ (8) Ensure procedures in place to inform at earliest feasible opportunity of subject's inclusion in the study, participation may be discontinued. Procedures to inform family the subject was in the study if subject dies.
_____ _____ _____ (9) Separate IND or IDE required, even for marketed products.
_____ _____ _____ (10) IRB disapproval must be documented in writing and sent to the clinical investigator and the sponsor of the clinical investigation. Sponsor must promptly disclose to FDA, other investigators and other IRBs.
ć21 CFR 56.109(a)
"21 CFR 56.101(a)
421 CFR 56.109(a)
521 CFR 56.108(a)(1) and 56.109(f)
621 CFR 56.108(b)(3) and 56.113
721 CFR 56.108(a)(1), 56.109(a) and 56.113
821 CFR 56.107(a)
921 CFR 56.107(a)
1021 CFR 56.107(a)
şş21 CFR 56.107(b) Only requires every nondiscriminatory effort şć21 CFR 56.107(a)
ş"21 CFR 56.107(c)
1421 CFR 56.107(d)
1521 CFR 56.107(f) Consultant use not required by FDA regulation. 1621 CFR 56.107(e)
1721 CFR 56.108(a)(1) and 56.109(a - f)
1821 CFR 56.108(a)(1) and 56.109(e)
1921 CFR 56.108(a)(2) and 56.109(f)
2021 CFR 56.108(a)(2)
2121 CFR 56.108(a)(3)
2221 CFR 56.108(a)(4) and 56.115(a)(1)
2321 CFR 56.108(b)(1) and 56.115(a)(1)
2421 CFR 56.108(b)(2)
2521 CFR 56.108(b)(3) and 56.113
2621 CFR 56.108(a)(1)
2721 CFR 56.108(a)(1)
2821 CFR 56.104(c), 56.108(a)(1) and 108(b)(1)
2921 CFR 56.108(a)(1) and 56.110(a - c) not required if IRB does not use expedited procedures
3021 CFR 56.108(c) and 56.107(e - f)
3121 CFR 56.112
3221 CFR 56.108(a)(1), 56.109(a) and 56.115(a)(4)
3321 CFR 56.108(a)(1) and 56.109(e)
3421 CFR 56.108(a)(1) and 56.109(e)
3521 CFR 56.112
3621 CFR 56.115(a)(5)
3721 CFR 56.108(a - b) and 56.115(a)(6)
3821 CFR 56.115(a)(2)
3921 CFR 56.115(a)(1)
4021 CFR 56.115(a)(4)
4121 CFR 56.108(a) and 56.115(a)(1 and 4)
4221 CFR 56.115(a)(3)
4321 CFR 56.115(b)
4421 CFR 56.115(a)(4) and 56.104(c)
4521 CFR 56.115(a)(7)
4621 CFR 56.103(a) and 56.115(a)(1)
4721 CFR 56.111 (a)(2), 56.115(a)(1) and 21 CFR 312.55
4821 CFR 56.111(a)(4 - 5) and 56.111(a)(1)
4921 CFR 56.108(a)(4) and 56.115(a)(3 - 4)
5021 CFR 56.108(b)(1), 56.115(a)(3 - 4), 56.115(b)(1) and 56.113
5121 CFR 56.108(a)(1) and 56.115(a)(1, 3 and 4)
52Not required when the scope of studies reviewed by the IRB does not
include serious and life-threatening diseases or conditions.
5321 CFR 56.104(c) and 56.108(a)(3)
5421 CFR 56.102(d) and 56.108(a)(3)
5521 CFR 56.104(c) and 56.108(a)(3) The IRB may determine that a rapid means of approval is preferable to a preapproved protocol and consent. Also see information sheet: "Emergency Use of a Drug or Biologic."
5621 CFR 50.24 The IRB/institituion may determine that research in emergent settings will not be conducted or supported. When that is the case, written procedures for this section need not be prepared.
5721 CFR 56.109(c)(2)
5821 CFR 56.109(e) The written statement shall include a statement of the reasons for the IRB's determination.
5921 CFR 56.109(g)
6021 CFR 50.24(a)(1)
6121 CFR 50.24(a)(2)
6221 CFR 50.24(a)(2)(i)
6321 CFR 50.24(a)(2)(ii)
6421 CFR 50.24(a)(2)(iii)
6521 CFR 50.24(a)(3)
6621 CFR 50.24(a)(3)(i)
6721 CFR 50.24(a)(3)(ii)
6821 CFR 50.24(a)(3)(iii)
6921 CFR 50.24(a)(4)
7021 CFR 50.24(a)(5)
7121 CFR 50.24(a)(6) Family member objection procedures at 50.24 (a)(7)(v)
7221 CFR 50.24(a)(7)
7321 CFR 50.24(a)(7)(i)
7421 CFR 50.24(a)(7)(ii)
7521 CFR 50.24(a)(7)(iii)
7621 CFR 50.24(a)(7)(iv)
7721 CFR 50.24(a)(7)(v)
7821 CFR 50.24(b)
7921 CFR 50.24(d) The study may not begin until FDA approves the separate IND/IDE.
8021 CFR 50.24(e)

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