0130 SS 2017 Extension

INSTITUTIONAL REVIEW BOARDS –
Recordkeeping Requirements
OMB Control Number 0910-0130
Supporting Statement

Terms of Clearance: None.

A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations
governing Institutional Review Boards (IRBs). As promulgated under 21 CFR Part 56, the
regulations explain the provisions and requirements regarding the composition, operation, and
responsibilities of IRBs, including recordkeeping requirements. While the agency maintains a
related information collection request in support of regulations regarding specific IRB
documents and the protection of human subjects (see also OMB Control No. 0910-0755), this
information collection covers the general requirements under 21 CFR Part 56; Subpart D. Under
the regulations, respondents must create and maintain records and make those records available
for FDA inspection when requested. The recordkeeping should describe the structure and
membership of the IRB; methods that the IRB will use in performing its functions; and other
documentation relating to research protocols, informed consent, progress reports, and reports of
injuries to subjects submitted by investigators to the IRB. Also included in the recordkeeping are
minutes of meetings showing attendance, votes and decisions made by the IRB; the number of
votes on each decision for, against, and abstaining; the basis for requiring changes in or
disapproving research; records of continuing review activities; copies of all correspondence
between investigators and the IRB; statement of significant new findings provided to subjects of
the research; and a list of IRB members by name, showing each member's earned degrees,
representative capacity, and experience in sufficient detail to describe each member's
contributions to the IRB's deliberations, and any employment relationship between each member
and the IRB's institution. Finally, the information collection is applicable to any other
information collection described in 21 CFR Part 56 Subpart D: Records and Reports.
2. Purpose and Use of the Information Collection
The information is used by FDA in conducting audit inspections of IRBs to determine whether
IRBs and clinical investigators are providing adequate protections to human subjects
participating in clinical research. The IRB must maintain documentation of its activities as
required under 21 CFR 56.115 to fulfill its responsibility to protect the rights and welfare of
human research subjects. The records are maintained by IRBs to document that these
responsibilities have been fulfilled and must be made available to FDA when requested.

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3. Use of Improved Information Technology and Burden Reductions
The regulations impose no technological burdens nor require standardized formats for
respondents, and we encourage the use of automated technology.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
A substantial majority of IRB reviews are conducted at large institutions such as universities,
medical schools, and research and teaching hospitals. The recordkeeping requires what FDA
believes is the minimal documentation necessary to ensure both the effective operation of IRBs
and implementation of human subject protection. To assist respondents, FDA has developed an
“Institutional Review Board Frequently Asked Questions Information Sheet,” available on its
website at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm.
Information is available regarding the agency’s bioresearch monitoring program as well, which
respondents may also find helpful.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with existing laws and regulations under 21
CFR Part 56; Subpart D: Records and Reports.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5(d)(2)
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of November 1, 2016 (81 FR 75826), we published a 60 day notice
requesting comments on this proposed collection of information. No comments were received
regarding the information collection.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The documentation obtained during IRB inspections rarely contains any sensitive or confidential
information that has not been submitted to FDA (e.g., copies of research protocols which may be
considered confidential and contain trade secret information). The material is kept confidential

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in accordance with 18 U.S.C. 1905, 21 U.S.C. 331(j), and 21 U.S.C. 520(c), as well as sections
301(j) and 520(c) of the Federal Food, Drug and Cosmetic Act.
11. Justification for Sensitive Questions
The documentation maintained and collected does not contain questions pertaining to sexual
behavior, attitude, religious beliefs, or any other matters that are commonly considered private or
sensitive in nature. Such data are more commonly contained in behavioral research, which FDA
does not regulate. The identity of study subjects is rarely collected. Such sensitive information
is treated as confidential and not released to third parties unless required by law or requested by
Congress.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Respondents to the collection are sponsors, members, or other individuals subject to the
requirements of 21 CFR Part 56; Subpart D; specifically, 21 CFR 56.115. We estimate the
annual burden for the collection of information as follows:
Table 1 – Estimated Annual Recordkeeping Burden1
21 CFR 56 –
Institutional
Review Boards
Subpart D; 56.115
– IRB Records
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No. of
Recordkeepers

No. of Records
per Recordkeeper

2,520

14.6

Total
Annual
Records
36,792

Average
Burden per
Recordkeeping
100

Total
Hours
3,679,200

There are no capital or operating and maintenance costs associated with the information collection.

Based on our review, we estimate there are approximately 2,520 IRBs that meet an average of
14.6 times annually. We further estimate approximately 100 hours of burden per meeting would
be required to fulfill the regulatory requirements regarding recordkeeping.
12b. Annualized Estimated Cost Burden Estimate
Using 2016 wage data from the Bureau of Labor Statistics, we estimate $85 per hour
(mean salary of upper plus middle management, and clerical support, plus overhead and
personnel benefits) for preparing and submitting the information requested. When multiplied by
the total number of burden hours discussed above (3,679,200), we estimate $312,732,000 as the
total cost burden to respondents for the collection of information.
13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers/Capital
Costs
There are no capital costs, or operating and maintenance costs, associated with the collection of
information.

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14. Annualized Cost to the Federal Government
Periodically FDA investigators conduct bioresearch monitoring inspections of IRBs. Funding is
allocated from existing bioresearch monitoring allocations and therefore we estimate no cost to
the Federal government for the collection of information.
15. Explanation for Program Changes or Adjustments
The information collection reflects an adjustment in the agency’s estimate. We have increased
the number of responses by 292 with a corresponding increase in burden hours by 29,200. We
attribute the adjustment to an increase in the number of respondents based on our review of
available data.
16. Plans for Tabulation and Publication and Project Time Schedule
The records maintained under this regulation are not expected to be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration Date is appropriate.
18. Exceptions to the Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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