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.æ |
_____ | _____ | _____ | 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 |
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* -- description of the process ensuring that27 | ||||
_____ | _____ | _____ |
or |
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_____ | ______ | _____ |
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_____ | _____ | _____ | -- role of any subcommittees of the IRB | |
_____ | _____ | _____ | * -- emergency use notification and reporting procedures28 | |
* -- expedited review procedure29 | ||||
_____ | _____ | _____ |
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_____ | _____ | _____ |
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_____ | _____ | _____ | 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. |
____________________
æ21 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)
ºº21 CFR 56.107(b) Only requires every nondiscriminatory effort
ºæ21 CFR 56.107(a)
º21 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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