Minutes of Institutional 
Review Board (IRB) 
Meetings
 
 
Guidance for 
Institutions and IRBs 
 
 
 
 
U.S. Department of Health and Human Services 
Office for Human Research Protections (OHRP) 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH) 
Office of Regulatory Affairs (ORA) 
 
 
September 2017 
 
   
Minutes of  
Institutional Review 
Board (IRB) Meetings 
 
Guidance for 
Institutions and IRBs 
 
Additional copies are available from: 
 
Division of Policy and Assurances 
Office for Human Research Protections 
1101 Wootton Parkway, Suite 200 
Rockville, MD  20852 
(Tel) 240-453-6900 or 866-447-4777 
(Fax) 301-402-2071 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html 
 
or 
 
Office of Good Clinical Practice 
Office of Special Medical Programs, Office of Medical Products and Tobacco 
Food and Drug Administration 
10903 New Hampshire Avenue 
WO32-5103 
Silver Spring, MD  20993 
(Tel) 301-796-8340 
(Fax) 301-847-8640 
https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices
/ucm219433.htm 
 
U.S. Department of Health and Human Services 
Office for Human Research Protections (OHRP) 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH) 
Office of Regulatory Affairs (ORA) 
 
 
September 2017 
  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  DISCUSSION .................................................................................................................... 2 
A.  Attendance at the IRB Meeting ....................................................................................... 3 
B.  Actions Taken by the IRB ................................................................................................ 5 
C.  The Vote on IRB Actions ................................................................................................ 10 
D.  Requiring Changes or Disapproving Research ............................................................ 11 
E.  Controverted Issues and Their Resolution ................................................................... 12 
IV.  ADDITIONAL CONSIDERATIONS ........................................................................... 12 
i  Contains Nonbinding Recommendations 
Minutes of Institutional Review Board (IRB) Meetings 
Guidance for Institutions and IRBs 
 
This guidance represents the Office for Human Research Protections (OHRPs) and the Food 
and Drug Administrations (FDAs) current thinking on this topic.  This guidance does not create 
or confer any rights for or on any person and does not operate to bind OHRP, FDA, or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable 
statutes and regulations.  If you want to discuss an alternative approach, contact the appropriate 
OHRP or FDA staff responsible for implementing this guidance.  If you cannot identify the 
appropriate OHRP or FDA staff, call the appropriate number listed on the second title page of 
this guidance. 
 
I.  INTRODUCTION 
 
This guidance has been prepared jointly by the Department of Health and Human Services 
(HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration 
(FDA), and is consistent with the goals of section 3023 of the 21st Century Cures Act (Cures 
Act) (Pub. L. 114-255).  This guidance is intended for institutions and institutional review boards 
(IRBs) responsible for oversight of human subject research under HHS and FDA regulations. 
 
This guidance is intended to assist institutions and IRBs responsible for preparing and 
maintaining minutes of IRB meetings (also referred to in this guidance as minutes).  This 
guidance document describes requirements for minutes and provides recommendations for 
meeting the regulatory requirements for minutes. 
 
OHRPs and FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe OHRPs and FDAs current thinking on 
a topic and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word must in joint OHRP and FDA guidance means that 
something is required under the HHS regulations at 45 CFR part 46 or the FDA regulations at 21 
CFR parts 50 and 56.  The use of the word should in joint OHRP and FDA guidance means that 
something is recommended or suggested, but not required. 
 
Note:  References in this guidance to HHS regulations at 45 CFR part 46 are to this part in effect 
at the time this guidance is published, and not to the part as amended by a final rule published 
January 19, 2017, that has not yet gone into effect (82 Fed. Reg. 7149). 
 
II.  BACKGROUND 
 
IRBs must comply with HHS and FDA regulations in 45 CFR part 46 and 21 CFR parts 50 and 
56, respectively, when reviewing research subject to those regulations.  Both the HHS 
regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically 
require that an institution, or when appropriate, an IRB, prepare and maintain adequate 
documentation of IRB activities, including minutes in sufficient detail to show: 
 
1  Contains Nonbinding Recommendations 
 
1.  Attendance at the meetings; 
 
2.  Actions taken by the IRB; 
 
3.  The vote on these actions, including the number of members voting for, against, and 
abstaining; 
 
4.  The basis for requiring changes in or disapproving research; and 
 
5.  A written summary of the discussion of controverted issues and their resolution. 
 
These five items must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 
56.115(a)(2)). 
 
III.  DISCUSSION 
 
IRBs have been cited in OHRP Determination Letters1 and FDA Warning Letters2 for failing to 
prepare and maintain adequate minutes.  For this reason, OHRP and FDA believe providing 
recommendations on the type and amount of information to include in minutes will help IRBs 
meet the regulatory requirements for minutes. 
 
Examples of noncompliance related to minutes include: 
 
  Minutes are missing. 
 
  Minutes reflect an inaccurate account of meeting attendance. 
 
  Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the 
number of members voting for, against, and abstaining. 
 
  Minutes are incomplete and only describe voting actions as passed unanimously. 
 
  Minutes do not clearly indicate, or contain discrepancies about, what the IRB approved. 
 
  Minutes fail to include a summary of the discussion of controverted issues. 
 
Minutes are intended to provide a summary of what occurred during a convened meeting and 
provide information to persons not present at the meeting (e.g., investigators, institutional 
officials, regulators, IRB members who could not attend) about what the IRB reviewed and the 
actions taken by the IRB. 
                                                 
1 OHRP Determination Letters are posted at https://www.hhs.gov/ohrp/compliance-and-reporting/determination-
letters/index.html and can be viewed by the date issued.  
2 FDA Warning Letters are posted at https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm 
and can be viewed via multiple browsing options (e.g., by date, by company, by subject).   
2  Contains Nonbinding Recommendations 
 
When reviewing proposed research, the IRB must document the information required by 45 CFR 
46.115(a)(2) and 21 CFR 56.115(a)(2) in the minutes.  However, there are other findings and 
determinations the IRB must make to fulfill other regulatory requirements (e.g., the IRB must 
review research involving children as subjects that is covered by 45 CFR part 46, subpart D 
and/or 21 CFR part 50, subpart D, and approve such research only if it satisfies the conditions of 
all applicable sections of those subparts).  While we recommend that IRBs document these 
additional findings and determinations in the minutes, these can be documented elsewhere in the 
IRB records to avoid redundancy (e.g., IRB reviewer form/checklist, database entries, other 
forms of physical or electronic records).  Documentation should include relevant summary 
information when such information contributes to an understanding of the IRBs findings and 
determinations (e.g., a brief rationale for the IRBs pediatric risk determination). 
 
The regulations for meeting minutes at 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2) provide 
institutions and IRBs with flexibility in choosing how to prepare minutes.  Institutions and IRBs 
should adopt written procedures for preparation and maintenance of minutes that best suit their 
particular organization and allow the IRB to efficiently accomplish its tasks. 
 
A.  Attendance at the IRB Meeting 
 
Minutes of IRB meetings must be in sufficient detail to show attendance at the convened 
meetings of the IRB (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  In addition, except when an 
expedited review procedure is used, the IRB must review proposed research at convened 
meetings at which a majority of the members of the IRB are present, including at least one 
member whose primary concerns are in nonscientific areas (nonscientist).  In order for the 
research to be approved, it must receive the approval of a majority of those members present at 
the meeting (45 CFR 46.108(b); 21 CFR 56.108(c)). 
 
1.  Members, Alternates, Consultants, and Guests 
 
The minutes must be in sufficient detail to show attendance at the convened meeting (45 CFR 
46.115(a)(2); 21 CFR 56.115(a)(2)).  For ease of review, OHRP and FDA recommend that 
attendance information be listed at the beginning of the minutes and include the full name and 
representative capacity (e.g., scientist, nonscientist, unaffiliated) of each IRB member present at 
the convened meeting.  Some IRBs may choose to append a current IRB membership roster to 
the minutes to avoid having to repeat certain information (e.g., representative capacity for each 
IRB member).  However, the minutes must clearly document which IRB members were present 
at any given convened meeting (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
IRB members may participate in a convened meeting of the IRB via telephone or video 
conferencing when those members have received in advance of the meeting a copy of the 
documents for research proposals that are to be reviewed at the meeting.  The minutes should 
make clear which members, if any, participated in the convened meeting via an alternative 
mechanism, such as telephone or video conferencing. 
 
3  Contains Nonbinding Recommendations 
An IRB may choose to appoint alternate members who may substitute for primary members for 
an entire meeting (e.g., when the primary member is not able to attend the meeting), or at any 
time during a meeting (e.g., when the primary member is not able to attend the whole meeting, or 
when the primary member has a conflicting interest and is recused from review of a particular 
study).  When an alternate member replaces a primary member at a convened meeting, the 
minutes must include the name of the alternate member in attendance (45 CFR 46.115(a)(2); 21 
CFR 56.115(a)(2)).  When an alternate member substitutes for a primary member due to a 
conflicting interest, the minutes should identify the name of the primary member for whom the 
alternate member is substituting, and state that this is the reason for the substitution. 
 
IRBs may invite consultants to assist in the review of a particular study when expertise is 
required beyond or in addition to that available on the IRB (45 CFR 46.107(f); 21 CFR 
56.107(f)).  If the IRB uses a consultant and the consultant is present at the convened meeting, 
the minutes must include the name of the consultant (45 CFR 46.115(a)(2); 21 CFR 
56.115(a)(2)), and should include a brief description of the consultants expertise.  In accordance 
with 45 CFR 46.107(f) and 21 CFR 56.107(f), the consultant may not vote with the IRB on the 
study. 
 
If the IRB permits non-members and guests to attend a convened meeting (e.g., IRB support 
staff, the investigator whose study is being reviewed, study coordinator), then the minutes must 
record the name(s) of all such attendees (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
The institution and the IRB may establish written procedures covering the use of alternate 
members, the use of consultants, and attendance of non-members and guests at a convened 
meeting.  Such written procedures may help to ensure that those who attend an IRB meeting 
understand their role, and to promote respect for the IRBs advice and counsel in safeguarding 
the rights and welfare of human subjects. 
 
2.  Quorum 
 
A quorum is the minimum number and type of IRB members that must be present at a convened 
meeting.  In order to review proposed research at a convened meeting, a majority of the members 
of the IRB must be present, including at least one member whose primary concerns are in 
nonscientific areas (45 CFR 46.108(b); 21 CFR 56.108(c)).  If a majority of the IRB membership 
is not present, or if a nonscientist is not present, then quorum has not been met. 
 
The attendance information in the minutes assists in determining whether enough IRB members 
were present to constitute a quorum, whether the nonscientist was present, and whether proposed 
research received enough votes (i.e., a majority of those present) to be approved. 
 
IRBs often calculate majority by using the half-plus-one technique.  This technique works well 
for IRBs with an even number of IRB members.  For example, if the total IRB membership is 10, 
then the majority is 6 (half of 10 is 5, plus 1 equals 6).  However, if the IRB has an odd number 
of members, then the majority should be calculated by taking half of the total number of IRB 
4  Contains Nonbinding Recommendations 
members, and rounding up to the next whole number.  For example, if the IRB membership is 
15, then majority is 8 (half of 15 is 7.5, and rounding up to the next whole number is 8).3 
 
A quorum must be maintained throughout the meeting.  If quorum is lost during a meeting, then 
the IRB may not vote on proposed research (45 CFR 46.108(b); 21 CFR 56.108(c)).  Because 
IRB members may occasionally enter or leave the room at various times during a convened 
meeting (e.g., arrive late, depart early, or leave the meeting temporarily), we recommend that the 
minutes provide sufficient information to indicate that a quorum is maintained. 
B.  Actions Taken by the IRB 
 
The minutes of IRB meetings must be in sufficient detail to show the actions taken by the IRB at 
the convened meeting (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  OHRP and FDA interpret 
actions taken by the IRB (also called IRB actions) to refer to any vote taken by the IRB 
related to a proposed research activity.  Accordingly, to be in sufficient detail to show actions 
taken by the IRB, the minutes must provide sufficient information to identify the research 
activities being reviewed and voted on by the IRB at that meeting (e.g., initial review of protocol 
title/protocol number).  The minutes should serve as a central repository for IRB actions on 
proposed research activities. 
 
1.  Approve, Require Modifications to Secure Approval, Disapprove 
 
OHRP and FDA regulations require that an IRB review and have the authority to approve, 
require modifications in (to secure approval), or disapprove all proposed research activities 
covered by the regulations (45 CFR 46.109(a); 21 CFR 56.109(a)).  Any IRB action to approve, 
require modifications in (to secure approval), or disapprove proposed research activities that 
occurs at a convened meeting must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 
56.115(a)(2)).  Additionally, the IRB or institution may develop a range of other allowable 
actions the IRB may take when reviewing proposed research activities (e.g., approve with 
conditions4, defer a decision until additional information can be obtained).  The IRBs written 
procedures should describe the range of possible actions the IRB can take. 
 
The minutes must be in sufficient detail to show the actions taken by the IRB at the convened 
meeting (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  In order to approve research covered by 
the regulations in 45 CFR part 46 and/or 21 CFR part 56, the IRB must determine that all of the 
criteria for IRB approval of research are satisfied (45 CFR 46.111; 21 CFR 56.111).  We 
recommend that the minutes, or other IRB record (e.g., correspondence with the investigator), 
identify the effective date of approval and the approval period (continuing review interval) for 
any research approved by the IRB.  IRBs must determine which projects require review more 
often than annually (45 CFR 46.103(b)(4)(ii); 21 CFR 56.108(a)(2)).  Both OHRP and FDA have 
                                                 
3 Note that the regulations do not prohibit IRBs from having more stringent requirements for quorum. 
4 OHRPs Guidance on IRB Approval of Research with Conditions can be found at 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-irb-approval-of-research-with-conditions-
2010/index.html; FDAs Guidance on IRB Continuing Review after Clinical Investigation Approval can be found at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf. 
5  Contains Nonbinding Recommendations 
issued guidance on continuing review of research to assist the IRB in determining the effective 
date of the initial approval and the subsequent date of continuing review.5 
 
If the IRB takes an action to require modifications in the proposed research to secure approval, 
or disapproves the proposed research, the minutes must be in sufficient detail to show the action 
taken by the IRB, and the basis for requiring changes in, or for disapproving the proposed 
research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
2.  Suspension or Termination of IRB Approval 
 
Both OHRP and FDA regulations authorize an IRB to suspend or terminate approval of research 
that is not being conducted in accordance with the IRBs requirements or that has been 
associated with unexpected serious harm to subjects (45 CFR 46.113; 21 CFR 56.113).  Any IRB 
action to suspend or terminate IRB approval that occurs at a convened meeting must be 
documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  Any suspension or 
termination of approval must include a statement of the reasons for the IRBs action (45 CFR 
46.113; 21 CFR 56.113).  Any decision to suspend or terminate the study that occurs outside of a 
convened IRB meeting (e.g., as determined by the IRB Chair or Institutional Official for subject 
safety reasons) should be reported to the convened IRB and the discussion summarized in the 
minutes.  Any subsequent action taken by the convened IRB (e.g., to lift the suspension or to 
terminate the study) must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 
56.115(a)(2)). 
 
3.  Other IRB Regulatory Determinations and Review Responsibilities 
 
As previously mentioned, in addition to the findings and determinations the IRB must make and 
document in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)), there are other findings 
and determinations the IRB must make to fulfill other regulatory requirements.  While we 
recommend that IRBs document these additional findings and determinations in the minutes, 
these can be documented elsewhere in the IRB records to avoid redundancy (e.g., IRB reviewer 
form/checklist, database entries, other forms of physical or electronic records).  Again, we 
recommend that documentation include relevant summary information when such information 
contributes to an understanding of the IRBs findings and determinations. 
 
  Criteria for IRB Approval of Research 
 
In order to approve research, the IRB must determine that all of the criteria for IRB 
approval of research are satisfied (45 CFR 46.111; 21 CFR 56.111).  The process the IRB 
follows for considering the approval criteria should be addressed in the IRBs written 
procedures.  The IRBs consideration of these criteria applies to both initial review and 
continuing review of research and provides the framework for the IRBs evaluation of 
                                                 
5 OHRPs Guidance on Continuing Review can be found at https://www.hhs.gov/ohrp/regulations-and-
policy/guidance/guidance-on-continuing-review-2010/index.html; FDAs Guidance on IRB Continuing Review 
after Clinical Investigation Approval can be found at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf. 
6  Contains Nonbinding Recommendations 
research.  The minutes must document actions taken by the IRB (45 CFR 46.115(a)(2); 
21 CFR 56.115(a)(2)). 
 
  Informed Consent 
 
In order to approve a study, the IRB must determine that informed consent will be sought 
from each prospective subject or the subjects legally authorized representative (LAR) in 
accordance with the regulations (45 CFR 46.111(a)(4); 21 CFR 56.111(a)(4)).  The IRB 
must also determine that informed consent will be appropriately documented in 
accordance with the regulations (45 CFR 46.111(a)(5); 21 CFR 56.111(a)(5)).  The 
minutes should indicate that, as part of its review and approval of a study, the IRB 
reviewed the informed consent form(s) and determined that the form(s) meet the 
applicable regulatory requirements.6 
 
The IRB may require changes to the informed consent form(s).  The minutes of IRB 
meetings must be in sufficient detail to show the basis for requiring changes in (to secure 
approval) or disapproving research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  The 
IRB may summarize any changes to the informed consent form(s) required by the IRB in 
the minutes, or other IRB record (e.g., an annotated informed consent form that includes 
IRB-required changes that gets appended to the minutes). 
 
Both OHRP and FDA regulations permit an IRB to waive the requirement that the subject 
or the subjects LAR sign a written consent form if the IRB determines that certain 
criteria are met (45 CFR 46.117(c); 21 CFR 56.109(c) and (d)).  We recommend that any 
such waiver of documentation of informed consent be documented in the minutes or 
other IRB record. 
 
In addition, for HHS-conducted or -supported research, the regulations at 45 CFR 
46.116(c) and (d) permit an IRB to approve a consent procedure that does not include, or 
which alters, some or all of the elements of informed consent, or waive the requirement 
to obtain informed consent provided the IRB finds and documents that certain criteria are 
met.7  When an IRB approves a waiver or alteration of consent for research reviewed by 
the convened IRB, these findings must be documented (45 CFR 46.116(c) and (d)).  
OHRP recommends that IRB decisions for waiver or alteration of consent be documented 
in the minutes or other IRB record. 
 
                                                 
6 See 45 CFR 46.116, 45 CFR 46.117, 21 CFR 50.20, 21 CFR 50.25 and 21 CFR 50.27. 
7 On December 13, 2016, the President signed the 21st Century Cures Act (P.L. 114-255) into law.  Title III, section 
3024 of the 21st Century Cures Act amended sections 520(g)(3) and 505(i)(4) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) to provide FDA with the authority to permit an exception from informed consent when 
the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate 
safeguards to protect the rights, safety, and welfare of the human subjects.  FDA intends to promulgate regulations 
to permit this exception and to specify appropriate human subject protection safeguards.  FDA issued guidance in 
July 2017 for sponsors, investigators, and IRBs on enforcement of FDA regulations governing informed consent 
requirements for clinical investigations that involve no more than minimal risk to human subjects  see 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm566474.htm. 
7  Contains Nonbinding Recommendations 
  Studies Involving Children 
 
Each IRB that reviews studies involving children as subjects covered by 45 CFR part 46 
subpart D and/or 21 CFR part 50 subpart D may approve only those studies that satisfy 
the conditions of all applicable sections of those subparts (45 CFR 46.403; 21 CFR 
50.50). 
 
In its review of proposed research involving children, the IRB must find that the research 
meets the conditions of 45 CFR 46.404 and/or 21 CFR 50.51 (research/clinical 
investigations not involving greater than minimal risk); 45 CFR 46.405 and/or 21 CFR 
50.52 (research/clinical investigations involving greater than minimal risk but presenting 
the prospect of direct benefit to individual subjects); or 45 CFR 46.406 and/or 21 CFR 
50.53 (research/clinical investigations involving greater than minimal risk and no 
prospect of direct benefit to individual subjects, but likely to yield generalizable 
knowledge about the subjects' disorder or condition).  If the IRB determines that the 
proposed research cannot be approved under these categories, then additional regulatory 
requirements under 45 CFR 46.407 and/or 21 CFR 50.54 (research/clinical investigations 
not otherwise approvable that present an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of children) must be met.  Both OHRP 
and FDA have issued guidance to assist IRBs with handling clinical investigations that 
include children as subjects and that have been referred under 45 CFR 46.407 or 21 CFR 
50.54.8 
 
In addition to the findings and determinations described above, the IRB must also 
determine that requirements for permission by parents or guardians and for assent by 
children are met (45 CFR 46.408; 21 CFR 50.55).  If the proposed research involves 
children who are wards of the State or other agency, institution or entity, then the IRB 
must ensure that additional requirements are met (45 CFR 46.409; 21 CFR 50.56). 
 
OHRP and FDA recommend that the IRBs findings and determinations for studies 
involving children be documented in the minutes. 
 
  Emergency Research 
 
If the IRB reviews a proposal for research involving an exception from informed consent 
requirements for emergency research, the IRB must find and document that the proposed 
research satisfies the criteria found in OHRPs Secretarial Waiver9 and/or FDAs 
regulations at 21 CFR 50.24. 
                                                 
8 OHRPs guidance on Children as Research Subjects and the HHS 407 Process can be found at 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-407-review-process/index.html; FDAs 
guidance on the Process for Handling Referrals to FDA Under 21 CFR 50.54, Additional Safeguards for Children in 
Clinical Investigations can be found at 
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127605.pdf. 
9 Information about OHRPs Informed Consent Requirements in Emergency Research can be found at 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/emergency-research-informed-consent-
requirements/index.html. 
8  Contains Nonbinding Recommendations 
 
FDA has issued guidance on the exception from informed consent requirements for 
emergency research.10  As outlined in FDAs guidance, FDA anticipates that an 
emergency research study in which informed consent is not obtained for all subjects is, 
by its very nature, controversial.  Therefore, IRBs must summarize their discussions and 
decisions about the required elements for these studies in the minutes (45 CFR 
46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
  FDA-Regulated Medical Device Studies 
 
Unless FDA has already made a risk determination for a device study (e.g., significant 
risk (SR), or nonsignificant risk (NSR)), or the study is exempt in accordance with 21 
CFR 812.2(c), sponsors are responsible for making the initial risk determination and 
presenting it to the IRB.  In that case, the IRB must then make its own SR/NSR 
determination about the study, and either agree or disagree with the sponsors 
determination by reviewing relevant information provided by the sponsor at a convened 
meeting (21 CFR 56.108(a)(1); 21 CFR 812.66).  FDA considers this determination to be 
part of the IRBs responsibilities for conducting its initial review of a study.  FDA 
recommends that the IRB document each SR/NSR determination, along with the reason 
for the determination, in the minutes. 
 
  Studies Involving Pregnant Women, Human Fetuses, and Neonates 
 
The regulations for research conducted or supported by HHS require specific findings for 
research involving pregnant women, human fetuses, and neonates as subjects (45 CFR 
part 46, subpart B).  OHRP recommends that when such research is approved by the 
convened IRB, all required findings should be documented in the minutes or other IRB 
record. 
 
IRBs should be aware that FDA regulations do not require specific findings for research 
involving pregnant women, human fetuses, and neonates as subjects.  If an IRB reviews 
an FDA-regulated study that is not HHS-conducted or -supported research, and the study 
is expected to involve pregnant women, fetuses, or neonates as subjects, IRBs may find 
45 CFR part 46, subpart B to be helpful. 
 
  Studies Involving Prisoners 
 
The regulations for research conducted or supported by HHS require specific findings for 
research involving prisoners as subjects (45 CFR part 46, subpart C).  OHRP 
recommends that when such research is approved by the convened IRB, all required 
findings should be documented in the minutes or other IRB record. 
 
                                                 
10 FDAs guidance on the Exception from Informed Consent Requirements for Emergency Research can be found at 
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm249673.pdf. 
9  Contains Nonbinding Recommendations 
IRBs should be aware that FDA regulations do not require specific findings for research 
involving prisoners as subjects.  If an IRB reviews an FDA-regulated study that is not 
HHS-conducted or -supported research, and the study is expected to involve prisoners as 
subjects, IRBs may find 45 CFR part 46, subpart C, and OHRPs guidance on prisoners 
in research11 to be helpful. 
 
  Reporting of Expedited Review Activities 
 
Each IRB that uses an expedited review procedure must adopt a method for keeping all 
members advised of research proposals which have been approved under the expedited 
review procedure (45 CFR 46.110(c); 21 CFR 56.110(c)).  There are various methods 
IRBs can use to keep the IRB members apprised of expedited actions.  One method that 
may be used is to present a report of expedited actions during a convened meeting.  If this 
method is used and the IRB reviews a report summarizing expedited review actions at a 
convened meeting, the minutes should describe what was presented to the IRB, indicate 
that the IRB members had an opportunity to ask questions or raise concerns, and 
summarize questions or concerns, if any, raised by the IRB members.  The report of 
expedited actions may also be appended to the minutes for reference. 
 
  Unanticipated Problems, Serious or Continuing Noncompliance, Suspension or 
Termination of IRB Approval 
 
If at a convened meeting, the IRB reviews an issue that requires prompt reporting to the 
IRB under 45 CFR 46.103(b)(5) or 21 CFR 56.108(b) (e.g., an unanticipated problem 
involving risk to human subjects or others), the minutes should summarize the report and 
must document the IRBs action, if any, resulting from that review (45 CFR 46.115(a)(2); 
21 CFR 56.115(a)(2)).  Any review of such information and any decisions made outside 
of a convened meeting (e.g., as determined by the IRB Chair or Institutional Official for 
subject safety reasons) should be reported to the convened IRB and the discussion 
summarized in the minutes.  Any subsequent action taken by the convened IRB (e.g., to 
lift suspension or to terminate the study) must be documented in the minutes (45 CFR 
46.115(a)(2); 21 CFR 56.115(a)(2)). 
C.  The Vote on IRB Actions 
 
The minutes of IRB meetings must be in sufficient detail to show the vote on IRB actions as 
determined during the convened meeting, including the number of members voting for, against, 
and abstaining (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  Individual voting records by name 
are not required.  The following are examples of acceptable formats for documenting the votes 
on actions taken by the IRB in the minutes.  Each example assumes that 15 members are 
attending the meeting: 
                                                 
11 OHRPs guidance on Prisoner Involvement in Research can be found at https://www.hhs.gov/ohrp/regulations-
and-policy/guidance/prisoner-research-ohrp-guidance-2003/index.html, and the Prisoner Research FAQs can be 
found at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html. 
 
10  Contains Nonbinding Recommendations 
 
  Total Voting = 15; Vote:  For = 14, Opposed = 0, Abstained = 1. 
 
OR 
 
  Total Voting = 14 [1 member was recused and did not vote]; Vote:  For = 12,  
Against = 1, Abstained = 1. 
 
The minutes should identify any member who has a conflicting interest in a research study, and 
as such, is excluded (recused) from participation in the IRBs review of that particular research 
including the reason for the recusal.  As shown in the examples above, the minutes of the 
meeting must reflect a vote count (i.e., for, against, and abstaining) that is consistent with the 
number of non-conflicted IRB members present (45 CFR 46.107(e); 21 CFR 56.107(e); 45 CFR 
46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
Members who are recused from voting on a specific study because of conflicting interests may 
not be counted toward the quorum.  That is, their recusal may not be recorded as an abstention. 
 
IRB members who participate in a convened meeting via telephone or video conferencing may 
vote and be counted towards the quorum.  The IRB must ensure that the votes of such members 
are recorded in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
IRB members may not vote on proposed research outside of the convened meeting (e.g., via 
email prior to the convened meeting).  IRB members who cannot attend a convened meeting may 
not send someone (e.g., from their department or office) to vote in their place.  Opinions of 
absent members that are transmitted prior to the convened meeting by mail, telephone, telefax, or 
email may be considered by the attending IRB members but must not be counted as votes or 
towards the quorum for convened meetings (45 CFR 46.108(b); 21 CFR 56.108(c)). 
D.  Requiring Changes or Disapproving Research 
 
The minutes of IRB meetings must be in sufficient detail to show the basis for requiring changes 
in (to secure approval) or disapproving research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
If the IRB requires that the investigator make specified changes to the research protocol or 
informed consent document(s) and resubmit such documents to the convened IRB for subsequent 
review, the IRBs action, along with the basis for requiring changes must be documented in the 
minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
If the IRB disapproves a research activity, the IRB must include a statement of the reasons for its 
decision in the written notification to the investigator and the institution, and provide the 
investigator an opportunity to respond in person or in writing (45 CFR 46.109(d); 21 CFR 
56.109(e)).  The minutes must document the IRBs action along with the basis for disapproving 
the research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
11  Contains Nonbinding Recommendations 
E.  Controverted Issues and Their Resolution 
 
The minutes of IRB meetings must be in sufficient detail to show a written summary of the 
discussion of controverted issues and their resolution (45 CFR 46.115(a)(2); 21 CFR 
56.115(a)(2)).  Many IRBs struggle with the amount of detail that is necessary to satisfy this 
regulatory requirement. 
 
Controverted issues are those that cause controversy and dispute among the IRB membership 
during a convened meeting.  Controverted issues that arise during the convened meeting usually 
are the result of opposition to some aspect of the proposed research.  During the review of 
proposed research, IRB members may express a difference of opinion, or raise issues, questions 
or concerns that cause debate among the IRB members, or even result in disagreement.  Some 
research, by its very nature, is considered to be controversial (e.g., emergency research where 
informed consent may not be obtained for all subjects or some research involving vulnerable 
populations). 
 
IRB members may resolve controverted issues and concerns with continued discussion and 
deliberation, decide to seek further clarification from the investigator or sponsor of the proposed 
research, or decide to settle the issue by vote.  The minutes must summarize the IRBs discussion 
and resolution of any controverted issues (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). 
 
IV.  ADDITIONAL CONSIDERATIONS 
 
We recommend that institutions and IRBs decide who is responsible for preparing and 
maintaining minutes at their institutions and outline the process in the IRBs written procedures.  
While there is no regulatory requirement for IRBs to approve or accept minutes of IRB meetings, 
if the institution and IRB choose to adopt a process for review and approval/acceptance of 
minutes, this process should be covered in the IRBs written procedures.  Institutions and IRBs 
may consider creating a standard template to assist in the preparation of their minutes. 
 
OHRP and FDA recognize that in addition to documenting the IRBs findings and 
determinations in the minutes, or elsewhere in the IRB records, IRBs may also choose to 
document other activities that occur during the meeting.  For example, some IRBs provide 
continuing education and training to the IRB members at a convened meeting and document such 
training in the minutes.  IRBs may also communicate announcements or other information to the 
IRB members and attendees at the meeting and document this in the minutes (e.g., upcoming 
meeting schedule, staff or membership changes).  This practice is acceptable to OHRP and FDA. 
 
IRBs may choose to record IRB meetings (e.g., video, audio tape) and use the recording as a tool 
to assist in the preparation of written minutes.12  However, retention of complete recordings of 
meetings is not required nor does it relieve an IRB of its obligation to keep written minutes in 
accordance with the requirements of 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2).  We do not 
                                                 
12 Institutions and IRBs should ensure recording is permitted by institutional policy and, if applicable, state law.  All 
members, and any others attending the meeting, should be informed that the meeting is being recorded and how the 
recording(s) will be used. 
12  Contains Nonbinding Recommendations 
expect the minutes to include a verbatim transcription of what each member said during the 
course of the meeting. 
 
IRB records required by the regulations, including meeting minutes, must be retained for at least 
3 years after completion of the research that is the subject of the review and must be accessible 
for inspection and copying by authorized representatives from OHRP and/or FDA at reasonable 
times and in a reasonable manner (45 CFR 46.115(b); 21 CFR 56.115(b)).  Many sets of minutes 
will have records of review of multiple studies.  Relevant portions of the minutes must be 
retained until the regulatory retention period for each study is satisfied.  Institutions and IRBs 
can expect that representatives of OHRP conducting a compliance oversight assessment, or 
representatives of FDA conducting a Bioresearch Monitoring inspection, will review minutes 
and other appropriate IRB records to assess compliance with the regulations. 
13