Institutional Review 
Board (IRB) 
Written Procedures:
 
 
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) 
 
 
May 2018  Contains Nonbinding Recommendations 
 
 
Institutional Review Board (IRB) 
Written Procedures: 
 
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) 
 
 
May 2018 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 2 
IV.  WRITTEN PROCEDURES CHECKLIST .................................................................... 4 
i  Contains Nonbinding Recommendations 
 
 
Institutional Review Board (IRB) Written Procedures: 
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).  To enhance human subject protection and reduce regulatory burden, OHRP and FDA 
have been actively working to harmonize the Agencies regulatory requirements and guidance 
for human subject research.  This guidance document was developed as a part of these efforts.  In 
addition, on December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was 
signed into law.  Title III, section 3023 of the Cures Act requires the Secretary of HHS to 
harmonize differences between the HHS human subject regulations and FDAs human subject 
regulations.  This guidance document is consistent with the goals of section 3023 of the Cures 
Act.  This guidance is intended for institutions and institutional review boards (IRBs) responsible 
for review and oversight of human subject research under the HHS and FDA regulations. 
 
OHRP and FDA believe that when institutions and IRBs develop and follow clear written 
procedures, there is an increased likelihood that the rights and welfare of human subjects will be 
protected.  The purpose of this guidance is to assist staff at institutions and IRBs who are 
responsible for preparing and maintaining written procedures.  The guidance includes a Written 
Procedures Checklist (also referred to in this guidance as the Checklist) that incorporates the 
HHS and FDA regulatory requirements for written procedures for the IRB and recommendations 
on the type of operational details to include to support each of these requirements.  In addition, 
the Checklist includes some additional topics the institution/IRB may consider when developing 
comprehensive procedures. 
 
OHRPs and FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidance describes 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 OHRP and FDA joint 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 OHRP and FDA joint guidance means that 
something is suggested or recommended, but not required. 
 
1  Contains Nonbinding Recommendations 
 
 
Note:  References in this guidance to HHS regulations at 45 CFR part 46, subpart A, are to this 
subpart in effect at the time this guidance is published, and not to subpart A as amended by a 
final rule published January 19, 2017 (82 Fed. Reg. 7149) and not to an interim final rule 
published January 22, 2018 (83Fed.Reg. 2885). 
 
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 46.103(b)(4) and (5) and the FDA regulations at 21 CFR 56.108(a) and (b) 
state that IRBs must follow written procedures for the following functions and operations: 
 
1.  Conducting initial and continuing review of research and reporting findings and 
actions to the investigator and the institution; 
 
2.  Determining which projects require review more often than annually and determining 
which projects need verification from sources other than the investigator that no 
material changes have occurred since previous IRB review; 
 
3.  Ensuring prompt reporting to the IRB of proposed changes in a research activity and 
ensuring that changes in approved research, during the period for which IRB approval 
has already been given, may not be initiated without IRB review and approval except 
where necessary to eliminate apparent immediate hazards to the human subjects; 
 
4.  Ensuring prompt reporting to the IRB, appropriate institutional officials, and the 
department or agency head (i.e., OHRP) for research conducted or supported by HHS, 
and FDA for FDA-regulated research of any: 
 
  Unanticipated problems involving risks to human subjects or others; 
  Instance of serious or continuing noncompliance with the applicable HHS and 
FDA regulations or the requirements or determinations of the IRB; 
  Suspension or termination of IRB approval. 
 
III.  DISCUSSION 
 
OHRP and FDA frequently receive questions about the scope and content of written procedures.  
We recognize that written procedures may vary among institutions and IRBs because of 
differences in the way organizations are structured, the type of research studies reviewed by the 
IRB, institutional policy or administrative practices, the number of IRBs at the institution, 
affiliation with an institution, and local and state laws and regulations.  To provide guidance on 
the appropriate content of written procedures, while considering these variations, this guidance 
provides a Written Procedures Checklist to assist institutions and IRBs in preparing and 
maintaining detailed written procedures.  The Checklist is designed to prompt a thorough 
evaluation of written procedures that help to ensure the protection of human research subjects.   
 
2  Contains Nonbinding Recommendations 
 
 
HHS and FDA regulations1 allow flexibility in both format and content of written procedures, 
which gives IRBs the ability to establish procedures best suited to their own operations.  Written 
procedures may be maintained electronically or may be paper-based and formatted in a style that 
conforms to the needs of the institution.  Institutions/IRBs may choose to create written 
procedures that focus solely on the regulatory responsibilities of the IRB, or they may choose to 
also incorporate institutional policies and procedures that are a function of the institutions 
Human Research Protections Program (HRPP).  Detailed administrative procedures for the IRB 
support staff (e.g., how and where to track study approvals for calculating continuing review) 
may be included, or may be managed through other locally written policies and procedures (e.g., 
work instructions, standard operating procedures (SOPs), or a staff operations manual).  
Institutions and IRBs should use the flexibility afforded by the regulations to adopt written 
procedures that are suitable for their organizations. 
 
OHRP and FDA have observed that some IRBs develop written procedures for the IRB that 
simply restate the regulations at 45 CFR 46.103(b)(4) and (5), and at 21 CFR 56.108(a) and (b).  
In general, this approach does not provide sufficient detail about the IRBs operations to ensure 
that the IRBs operations meet the applicable regulatory requirements.  Developing meaningful 
content for written procedures involves a comprehensive and critical assessment of the IRBs 
responsibilities, functions, and operations, and the institutions organizational structure.  Written 
procedures should be sufficiently detailed to help IRB members and institutional administrative 
staff understand how to carry out their duties in a consistent and effective way that ensures that 
the rights and welfare of subjects are protected and that the IRB operates in compliance with the 
regulations.  When preparing written procedures, institutions/IRBs should generally identify who 
carries out specific duties by reference to position title (e.g., IRB chairperson) rather than by 
name to avoid the need to update written procedures if duties change, or there are changes in IRB 
membership. 
 
Both OHRP and FDA have issued many guidance documents2 that cover numerous topics that 
may serve as useful resources to staff at institutions and IRBs who prepare written procedures.  
For example, guidance on IRB continuing review of research3 offers recommendations about the 
type of information to include in written procedures specific to continuing review, which should 
be incorporated into the written procedures for the IRB.  We recommend that institutions/IRBs 
review all relevant OHRP and FDA guidance documents when preparing written procedures. 
 
Institutions/IRBs may decide to make their written procedures available to ensure that others 
(e.g., investigators, sponsors) are aware of the IRBs requirements, and to facilitate compliance.  
Some institutions/IRBs post their written procedures on a website to provide broad access.  
Written procedures should be reviewed on a regular basis and updated as necessary to ensure 
they reflect the institutions/IRBs current processes. 
 
                                                 
1See 45 CFR 46.103(b)(4) and (5), 21 CFR 56.108(a) and (b). 
2See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html, 
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm, 
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm. 
3See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html, 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf. 
3  Contains Nonbinding Recommendations 
 
 
IV.  WRITTEN PROCEDURES CHECKLIST 
 
Sections I-IV of the Written Procedures Checklist identify each HHS and FDA regulatory 
requirement for written procedures for the IRB set forth in 45 CFR 46.103(b)(4) and (5) and 21 
CFR 56.108(a) and (b) (REGULATORY REQUIREMENT) along with suggestions 
(RECOMMENDATIONS) about operational details to include in support of each regulatory 
requirement.  Section V of the Written Procedures Checklist identifies some additional topics the 
institution/IRB may consider when developing comprehensive procedures. 
 
Although the IRB must follow written procedures for functions and operations specifically 
described at 45 CFR 46.103(b)(4) and (5), and/or 21 CFR 56.108(a) and (b), there are other IRB 
activities that require findings and determinations for which the underlying regulations do not 
explicitly require the IRB to follow a written procedure.  The Checklist includes footnotes that 
identify these underlying regulations, as well as other relevant regulations that we recommend 
institutions and IRBs consider when preparing written procedures. 
 
For example, an IRB that reviews studies involving children must follow the regulatory 
requirements for additional safeguards for children at 45 CFR part 46, subpart D, and/or 21 CFR 
part 50, subpart D, and approve only those studies that satisfy the conditions of all applicable 
sections of those subparts.  Although the subpart D regulations do not explicitly require an IRB 
to follow a written procedure for review of studies involving children, OHRP and FDA 
recommend that written procedures for the IRB address the review of such studies (see 
recommendation #10 in the Checklist under the regulatory requirement regarding written 
procedures for conducting initial and continuing review). 
 
As previously stated, institutions and IRBs have flexibility in how they choose to format their 
written procedures and how much detail to include.  For example, topics listed in the Checklist 
may not be applicable to all institutions/IRBs.  On the other hand, the institution/IRB may 
determine that additional topics not found in the Checklist should be included (e.g., written 
procedures related to how the IRB interacts with an Institutional Biosafety Committee or a 
Radioactive Drug Research Committee).  In addition, institutions/IRBs may choose to combine 
items in the Checklist as needed to avoid redundancy, or use a different order than that presented 
in the Checklist. 
 
OHRP and FDA remind institutions and IRBs that the Checklist is intended to facilitate an 
improved understanding of regulatory requirements in 45 CFR 46.103(b)(4) and (5) and 21 CFR 
56.108(a) and (b) for written procedures for the IRB, to provide recommendations on the 
operational details to include in support of these regulatory requirements, and to provide some 
additional topics the institution/IRB may consider when developing comprehensive procedures.  
The Checklist is intended to be a tool to assist in determining what information should be 
covered in written procedures rather than a tool for assessing compliance. 
 
4  Contains Nonbinding Recommendations 
 
 
WRITTEN PROCEDURES CHECKLIST 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
I.  IRB Initial and Continuing Review of Research; Reporting IRB Findings and Actions 
 
REGULATORY REQUIREMENT  Each IRB must follow written procedures for conducting initial and continuing review of 
research and for reporting IRB findings and actions to the investigator and the institution [45 CFR 46.103(b)(4)(i), 21 CFR 
56.108(a)(1)] 
 
RECOMMENDATIONS  Operational details should include information about: 
 
1.  Conducting review at a meeting of the convened IRB,4 including:         
  Documents submitted to the IRB for review (e.g., protocol, 
informed consent form, recruitment materials). 
  Reviewer system utilized by the convened IRB (e.g., primary 
reviewer(s)). 
  Documents routinely distributed to all IRB members and those 
that may be distributed to specific IRB members (e.g., primary 
reviewer(s)). 
  Range of possible actions the convened IRB can take. 
  Format of a convened meeting (e.g., in person, 
videoconferencing, other mechanism). 
  Defining and maintaining quorum and the process followed if 
quorum is lost.5 
  Managing IRB members/alternates with conflicting interests. 
 
2.  Conducting review via expedited review procedures,6 including:         
  Documents submitted to the IRB for review. 
  Reviewer system utilized for expedited review (e.g., IRB 
chairperson or other experienced reviewer(s) designated by the 
chairperson from among the members of the IRB). 
  Range of possible actions the designated expedited reviewer can 
take. 
  Method used for keeping all IRB members advised of research 
proposals approved via expedited review. 
 
3.  Determining that the criteria for IRB approval of research are met.7         
 
 
                                                 
4See 45 CFR 46.108(b), 21 CFR 56.108(c). 
5See 45 CFR 46.108(b), 21 CFR 56.108(c). 
6See 45 CFR 46.110, 21 CFR 56.110. 
7See 45 CFR 46.111, 21 CFR 56.111. 
5  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
4.  Reviewing the informed consent form and the informed consent         
process,8 including: 
  Consideration of the required and additional elements of 
informed consent. 
  Translation of the informed consent form for non-English 
speaking subjects, when applicable. 
  For HHS-conducted or -supported research, consideration of a 
waiver or alteration of the consent procedure.9 
  For both HHS-conducted or -supported research and FDA-
regulated research, consideration of a waiver of documentation 
of consent. 
 
5.  Considering whether the study involves subjects that are likely to be         
vulnerable to coercion or undue influence, and, if so, whether 
additional safeguards have been included to protect the rights and 
welfare of these subjects.10 
 
6.  Reviewing studies requesting an exception from informed consent         
requirements for emergency research.11 
 
7.  For FDA-regulated research, assessing whether the investigator and/or         
sponsor determined that an investigational new drug application 
(IND) or investigational device exemption (IDE) is required for the 
proposed study, if applicable, and the basis for this determination.12 
 
8.  For FDA-regulated medical device research, making and         
documenting the significant/nonsignificant risk (SR/NSR) 
determination.13 
 
9.  For HHS-conducted or -supported research, determining the         
applicability of additional protections for pregnant women, human 
fetuses and neonates, and for prisoners.14 
 
10.  Reviewing research involving children as subjects in accordance         
with applicable regulations.15 
 
                                                 
8See 45 CFR 46.111(a)(4) and (5), 21 CFR 56.111(a)(4) and (5), 45 CFR 46.116, 21 CFR 50.20, 21 CFR 50.25, 45 CFR 46.117, 21 CFR 50.27. 
9On 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. 
10See 45 CFR 46.111(b), 21 CFR 56.111(b). 
11See OPRR Letter for Informed Consent Requirements in Emergency Research at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/emergency-research-
informed-consent-requirements/index.html for HHS-conducted or -supported research, and 21 CFR 50.24 for FDA-regulated studies. 
12See 21 CFR 312.2, 812.2. 
13See 21 CFR 812.66. 
14See 45 CFR part 46 subparts B and C. 
15See 45 CFR part 46 subpart D, 21 CFR part 50 subpart D, 45 CFR 46.111(b), 21 CFR 56.111(c). 
6  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
11.  Reviewing the qualifications of the investigator(s) and study staff,         
and the adequacy of the site where the research will be conducted, 
including any institutional requirements for sponsor-investigator 
studies, if applicable. 
 
12.  Determining and documenting the effective date of initial approval,         
and calculating the date for subsequent continuing review. 
 
13.  Communicating the IRBs findings and actions to both the         
investigator and the institution,16 including: 
  Which institutional office(s)/official(s) are notified. 
  Communicating to the investigator any modifications or 
clarifications required by the IRB as a condition of approval. 
  Reviewing and acting on the investigators response to any 
required modifications or clarifications required by the IRB as a 
condition of approval. 
  Communicating the reason(s) for a decision to disapprove, and 
the process followed to allow the investigator to respond. 
 
14.  For FDA-regulated research, reviewing a request for expanded         
access or treatment use.17 
 
15.  For FDA-regulated research, reviewing the emergency use of a test         
article.18 
 
16.  For FDA-regulated research, reviewing a request for the use of a         
Humanitarian Use Device (HUD).19 
 
II.  Frequency of IRB Review; Verification Regarding Material Changes 
 
REGULATORY REQUIREMENT  Each IRB must follow written procedures for determining which projects require review 
more often than annually and determining which projects need verification from sources other than the investigator that no material 
changes have occurred since previous IRB review [45 CFR 46.103(b)(4)(ii), 21 CFR 56.108(a)(2)] 
 
RECOMMENDATIONS  Operational details should include information about: 
 
 
                                                 
16See 45 CFR 46.103(b)(4)(i), 21 CFR 56.108(a)(1), 45 CFR 46.109(d), 21 CFR 56.109(e). 
17See 21 CFR 312.305(c), 812.36. 
18See 21 CFR 50.23, 56.102(d), 56.104(c). 
19See 21 CFR 814.124. 
7  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
17.  Determining the approval period/continuing review interval of the         
proposed research, including: 
  General criteria used to make these determinations (e.g., the 
nature of the study and risks posed by the study; the degree of 
uncertainty regarding the risks involved; the vulnerability of the 
subject population; the experience of the investigator; the IRBs 
previous experience with the investigator and/or sponsor; the 
projected rate of enrollment; whether the study involves novel 
therapies). 
  Documenting the approval period/continuing review interval 
(e.g., in the IRB meeting minutes or elsewhere in the IRB 
records). 
  Communicating the IRBs determinations regarding the 
approval period/continuing review interval to the investigator. 
 
18.  Determining whether the proposed research requires verification         
from sources other than the investigator, such as the sponsor, or 
other third party, that no material changes have occurred since the 
last IRB review, including the general criteria utilized to make the 
determination (e.g., complex projects; investigators with previous 
compliance issues; continuing review report indicates changes not 
previously reported; randomly selected projects). 
 
III.  Reporting of Proposed Changes to the IRB; Prior IRB Review and Approval of Changes 
 
REGULATORY REQUIREMENT  Each IRB must follow written procedures for ensuring prompt reporting to the IRB of 
proposed changes in a research activity, and ensuring that changes in approved research, during the period for which IRB approval 
has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent 
immediate hazards to the human subjects [45 CFR 46.103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4)] 
 
RECOMMENDATIONS  Operational details should include information about: 
 
19.  Reporting changes in research to the IRB, including:         
  Informing investigators that they may not initiate changes to 
research without prior IRB review and approval except when 
necessary to eliminate apparent immediate hazards to subjects 
(e.g., through training programs, materials for investigators, 
specific directives included in approval letters to investigators). 
  Ensuring that changes in research are being reported to the IRB 
before they are initiated (e.g., random audits of research 
records). 
  Process for notifying the IRB of any changes made to eliminate 
apparent immediate hazards to subjects that did not have prior 
IRB approval. 
 
8  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
20.  Reviewing changes in research, including:         
  What might qualify as a minor change in research. 
  Documents submitted to the IRB for changes in research. 
  Type of review (e.g., full board review vs. expedited review), 
and the range of possible actions the IRB may take. 
  Assessment of whether the IRB-approved informed consent 
form requires revision. 
 
21.  Communicating the IRBs findings and actions for changes in         
research to both the investigator and the institution,20 including: 
  Which institutional office(s)/official(s) are notified. 
  Communicating to the investigator and the institution any 
modifications or clarifications required by the IRB as a 
condition of approval. 
  Reviewing and acting on the investigator's response to any 
required modifications or clarifications required by the IRB as a 
condition of approval. 
  Communicating the reason(s) for a decision to disapprove, and 
the process followed to allow the investigator to respond. 
 
IV.  Reporting of Unanticipated Problems, Serious or Continuing Noncompliance, and Any 
Suspension or Termination of IRB Approval 
 
REGULATORY REQUIREMENT  Each IRB must follow written procedures for ensuring prompt reporting to the IRB, 
appropriate institutional officials, and, as applicable, any department or agency head, OHRP, and/or FDA of any unanticipated 
problems involving risks to human subjects or others, any instance of serious or continuing noncompliance with the applicable HHS 
and/or FDA regulations, or the requirements or determinations of the IRB, and any suspension or termination of IRB approval [45 
CFR 46.103(a) and (b)(5), 21 CFR 56.108(b)] 
 
RECOMMENDATIONS  Operational details should include information about: 
 
22.  Identifying who is responsible for promptly reporting to the IRB,         
appropriate institutional officials, and, as applicable, any department 
or agency head, OHRP, and/or FDA any:21 
  Unanticipated problems involving risks to human subjects or 
others. 
  Serious or continuing noncompliance. 
  Suspension or termination of IRB approval. 
 
                                                 
20See 45 CFR 46.109(d), 21 CFR 56.109(e). 
21See 45 CFR 46.103(a) and (b)(5), 21 CFR 56.108(b). 
9  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
23.  Reviewing information about unanticipated problems involving risks         
to human subjects or others,22 including: 
  What might qualify as an unanticipated problem involving risks 
to human subjects or others, including adverse events that 
should be considered unanticipated problems. 
  Documents submitted to the IRB regarding an unanticipated 
problem (e.g., written summary of the unanticipated problem, 
the outcome, and any steps taken to prevent recurrence). 
  Type of review (e.g., full board review vs. expedited review), 
and the range of possible actions the IRB may take, if any. 
 
24.  Reviewing information about serious or continuing noncompliance         
with the regulations or IRB requirements or determinations,23 
including: 
  What might qualify as serious or continuing noncompliance. 
  Documents submitted to the IRB regarding serious or 
continuing noncompliance (e.g., written summary of the 
noncompliance, the outcome, and any steps taken to prevent 
recurrence). 
  Type of review (e.g., full board review vs. expedited review), 
and the range of possible actions the IRB may take, if any. 
 
25.  Suspending or terminating 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,24 
including: 
  Circumstances in which suspending or terminating IRB 
approval might be appropriate. 
  Consideration of subjects already enrolled (e.g., informing 
subjects about the suspension or termination). 
  Orderly termination of the study, or transfer of the study or 
study subjects, if applicable. 
  Communicating the reason(s) for the IRBs decision to suspend 
or terminate approval of the research. 
 
V.  Additional Topics the Institution/IRB May Consider: 
 
Scope and Authority 
 
26.  The development and scope of the written procedures (e.g., who is         
responsible for preparing and maintaining them, including writing, 
revising, and approving; how often they are reviewed and updated, 
who they apply to; what happens if they are not followed). 
 
                                                 
22See 45 CFR 46.103(b)(5)(i), 21 CFR 56.108(b)(1).  
23See 45 CFR 46.103(b)(5)(i), 21 CFR 56.108(b)(2). 
24See 45 CFR 46.113, 21 CFR 56.113. 
10  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
27.  The institutional authority under which the IRB is established and         
authorized, and the independence afforded the IRB to carry out its 
duties. 
 
28.  The ethical principles that govern the IRB in assuring that the rights         
and welfare of human subjects are protected. 
 
29.  Important regulatory definitions that guide the IRBs review         
processes and procedures (e.g., the definition of research, clinical 
investigation, human subject, minimal risk). 
 
30.  Other relevant federal regulations that may apply to human subject         
research (e.g., Health Insurance Portability and Accountability Act 
regulations, Department of Defense regulations). 
 
31.  Which institutional office(s) or official(s), if any, is responsible for         
further review and approval, or disapproval, of research that is 
approved by the IRB.25 
 
32.  The IRBs relationship to the administration of the institution, the         
other committees and department chairpersons within the institution, 
the research investigators, other institutions, and the regulatory 
agencies. 
 
IRB Membership 
 
33.  The number of members on the IRB.26         
 
34.  Ensuring diversity in IRB membership (e.g., representation of both         
genders, multiple professions, scientific and nonscientific members, 
nonaffiliated members).27 
 
35.  Selecting and appointing the IRB chairperson, the members, and         
alternate members if any, including: 
  The length of term or service, general description of duties, 
attendance requirements, performance evaluation, including 
removal if necessary. 
  The qualifications of the IRB chairperson, members and any 
alternate members.28 
  The criteria used to categorize members and alternate members 
as scientist, nonscientist, and nonaffiliated.29 
 
                                                 
25See 45 CFR 46.112, 21 CFR 56.112. 
26See 45 CFR 46.107(a), 21 CFR 56.107(a). 
27See 45 CFR 46.107, 21 CFR 56.107. 
28See 45 CFR 46.107(a), 21 CFR 56.107(a). 
29See 45 CFR 46.107(c) and (d), 21 CFR 56.107(c) and (d). 
11  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
36.  Defining what constitutes a conflicting interest for the IRB         
chairperson, members, and alternate members, and managing any 
such conflicting interest, including recusal from a meeting to ensure 
that a chairperson, member, or alternate member with a conflicting 
interest does not vote or count towards the quorum.30 
 
37.  Training and education provided to the IRB chairperson, IRB         
members, alternate members, administrative support staff, and 
investigators. 
 
IRB Functions and Operations 
 
38.  Determining whether a study is subject to IRB review (e.g., what         
types of studies must be reviewed, which regulations apply, who 
makes the determination). 
 
39.  Determining which HHS-conducted or -supported research studies         
qualify as exempt from the HHS regulations, including who makes the 
determination. 
 
40.  Implementing cooperative IRB review arrangements, when         
applicable, such as joint review, reliance on the review of another 
qualified IRB, or similar arrangements aimed at avoiding duplication 
of effort.31 
 
41.  Process for reporting the emergency use of an FDA-regulated test         
article to the IRB.32 
42.  The use of consultants by the IRB,33 including a description of the         
process to identify the need for a consultant, to choose a consultant, 
and the consultants participation in the review of research. 
 
43.  Identifying and managing an investigator with a conflicting interest.         
 
44.  Determining the applicability of state and local laws.34         
 
45.  Tracking study approvals and scheduling continuing review to         
prevent lapses in IRB approval, including procedures to follow if 
IRB approval lapses. 
 
46.  Handling subject complaints, problems, concerns and questions         
about rights as a research subject. 
 
47.  Administrative support staff duties.         
 
                                                 
30See 45 CFR 46.107(e), 21 CFR 56.107(e). 
31See 45 CFR 46.114, 21 CFR 56.114. 
32See 21 CFR 50.23, 21 CFR 56.102(d), 21 CFR 56.104(c). 
33See 45 CFR 46.107(f), 21 CFR 56.107(f). 
34See 45 CFR 46.101(f), 21 CFR 56.103(c). 
12  Contains Nonbinding Recommendations 
 
 
ACTIVITY  WRITTEN  NOTES (if any) 
PROCEDURE?   
Check yes if the IRB or 
institution/HRPP has a 
written procedure on this 
topic, no if it does not, and 
N/A if not applicable. 
YES  NO  N/A 
48.  Keeping the IRB informed of study completion and close out to         
ensure record retention in compliance with 45 CFR 46.115(b) and/or 
21 CFR 56.115(b). 
 
49.  Registering the IRB and maintaining IRB registration35 via the HHS         
Internet-based registration system.36 
 
50.  Providing access to information about IRB requirements and written         
procedures (e.g., posting the information on a website accessible to 
the investigators, sponsors, and others). 
 
51.  Contingency plans for transferring oversight of one or more studies         
to another institution or IRB in the event the IRB is unable to 
continue oversight of the study (e.g., the IRB closes, suffers loss due 
to fire, natural disaster). 
 
IRB Records 
 
52.  Maintaining records required to be retained,37 and other records         
(e.g., IRB member training records). 
 
53.  Where records are stored (e.g., on site, off-site archives), and the         
format for record storage (e.g., hard copy, electronic or both). 
 
54.  Preparing and maintaining minutes of IRB meetings.38         
 
55.  Retaining records for at least 3 years after completion of the         
research, and ensuring records are accessible for inspection.39 
 
 
                                                 
35See 45 CFR part 46 subpart E, 21 CFR 56.106. 
36See https://ohrp.cit.nih.gov/efile/IrbStart.aspx .  
37See 45 CFR 46.115, 21 CFR 56.115. 
38See 45 CFR 46.115(a)(2), 21 CFR 56.115(a)(2). 
39See 45 CFR 46.115(b), 21 CFR 56.115(b). 
13