0130 parts 50 56 REV SSA 2020 to consolidate 0755

UNITED STATES FOOD & DRUG ADMINISTRATION
Protection of Human Subjects and Institutional Review Boards
OMB Control Number 0910-0130 – Revision
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations governing requirements for informed consent and institutional review boards (IRBs)
that are intended to protect the rights and safety of human subjects involved in FDA-regulated
clinical investigations (21 CFR parts 50 and 56). The regulations in 21 CFR parts 50 and 56
apply to all clinical investigations regulated by FDA under sections 505(i) or 520(g) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i) or 360j(g)), as well as clinical
investigations that support applications for research or marketing permits for products regulated
by FDA, including food and color additives, drugs for human use, medical devices for human
use, biological products for human use, and electronic products.
Under 21 CFR part 50, except under certain conditions, no investigator may involve a human
being as a subject in FDA-regulated research unless the investigator has obtained the legally
effective informed consent of the subject or the subject's legally authorized representative. The
elements of informed consent are provided in the regulations, along with related requirements for
documentation and IRB approval of informed consent. Specifically, basic elements of the
informed consent are set forth in § 50.25 and include a statement of the purpose and duration of a
subject’s participation in the research; a description of the procedures to be followed;
identification of any experimental procedures; a description of risks, benefits, and appropriate
alternative procedures or treatments; a description of extent to which confidentiality of records
identifying the subject will be maintained; certain contact information; and a statement that
participation is voluntary and may be discontinued at any time. Additional elements set forth in
§ 50.25 are required as appropriate. Exceptions to these requirements are governed by § 50.23,
which requires both investigator and physician to certify in writing that the necessary elements
for exception from general requirements have been satisfied; and § 50.24, which covers
exception from informed consent requirements for emergency research. In accordance with
§ 50.27, informed consent must be documented, unless an IRB waives documentation as
provided in § 56.109(c). Additional safeguards are required for children, as prescribed in subpart
D (21 CFR parts 50.50 through 50.56) of the regulations.
Regulations in 21 CFR part 56 govern the composition, operation, and responsibilities of IRBs,
including review and approval prior to the initiation of FDA-regulated clinical investigations and
continuing review of such research. The regulations in 21 CFR part 56 also cover IRB
administrative activities, including identification of types of IRB records that must be prepared
and maintained. Required recordkeeping includes documentation requirements pertaining to
written procedures, proposals reviewed, committee membership, meeting minutes, actions taken
by the IRB, and correspondence, as well as other functional and operational aspects of the IRB.

Finally, the regulations describe administrative actions for non-compliance, including both
disqualification of IRBs or IRB parent institutions, as well as reinstatement and alternative and
additional actions.
We are revising the information collection by consolidating related elements currently approved
under OMB Control No. 0910-0755. We believe that consolidating the information collection is
appropriate and will improve our efficiency in support of administering laws and regulations for
the protection and welfare of human subjects. In this ICR, we specifically account for burden we
attribute to the requirements found in 21 CFR parts 50 and 56, consistent with OMB terms of
clearance applicable to ICR Control No. 0910-0755:
Burden associated with 21 CFR § 50.25 (Elements of Informed Consent) and 21 CFR § 50.27
(Documentation of Informed Consent) is limited to the burden of development and approval by
an institutional review board (IRB) of a site-specific informed consent document, and the
documentation of informed consent. OMB does not grant approval for the content of individual
consent forms that are reviewed and approved by IRBs and subsequently presented to research
participants.
We therefore request OMB approval of the information collection provisions found in 21 CFR
parts 50 and 56 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information collection is used to protect the rights and safety of human subjects involved in
FDA-regulated research. We also use the information collection to support conducting audit
inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate
protections to human subjects participating in clinical research we regulate.
Certain limited provisions in part 50, subpart B (informed consent of human subjects) and 21
CFR part 56 (IRBs) are currently approved under OMB control number 0910-0755. Those
sections are:
50.24
50.25
50.27
56.109(d)
56.109(e)
56.109(g)
56.113
56.120(a)
56.123

Exception from Informed Consent Requirements for Emergency
Research
Elements of Informed Consent
Documentation of Informed Consent
Written statement about research when documentation of informed
consent is waived
IRB Written Notification to Approve or Disapprove Research
IRB written statements to the sponsor about required public
disclosures related to emergency research under 50.24
Suspension or Termination of IRB Approval of Research
IRB Response to Lesser Administrative Actions for Noncompliance
Reinstatement of an IRB or Institution

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As discussed above, we are now consolidating the provisions into this information collection.
The IRB must maintain documentation of its activities as required under 21 CFR 56.115. The
records are maintained by IRBs to document that the IRB’s responsibilities to protect the rights
and welfare of human subjects in compliance with FDA regulations have been fulfilled and must
be made accessible for inspection and copying to FDA at reasonable times and in a reasonable
manner.
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, although we maintain ICRs that
cover other information collection burden for sponsors of and investigators conducting FDAregulated studies involving human subjects. For example, our regulations in 21 CFR part 312
include investigator recordkeeping requirements for studies conducted under an investigational
new drug application (IND) (21 CFR § 312.62). (Information collection provisions in part 312
are currently approved under OMB Control No. 0910-0014.) Similarly, recordkeeping
requirements for investigators conducting studies under an investigational device exemption
(IDE) in 21 CFR § 812.140 are currently approved under OMB Control Number 0910-0078.
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. Likewise, a substantial majority of clinical
investigators conducting FDA-regulated research conduct those studies at large institutions such
as universities, medical schools, and research and teaching hospitals. To assist respondents,
FDA has developed and widely distributes a series of guidance documents to assist IRBs, clinical
investigators and others concerned with the protection of research subjects to conform to the
requirements in FDA regulations. For example, 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. FDA has issued other guidance to assist respondents to the information
collection including Minutes of Institutional Review Board (IRB) Meetings, available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/minutesinstitutional-review-board-irb-meetings; and Institutional Review Board (IRB) Written
Procedures, available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/institutional-review-board-irb-written-procedures/.

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6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with existing laws and regulations, including
21 CFR parts 50 and 56.
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 August 14, 2019 (84 FR 40421) we published a 60 day notice
requesting comment on this proposed collection of information. We again invited public
comment in our Federal Register notice of December 19, 2019 (84 FR 69748), however no
comments have been received.
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
in accordance with 18 U.S.C. 1905, 21 U.S.C. 331(j), and 21 U.S.C. 360j(c).
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 information collection include clinical investigators and IRBs or other
persons subject to the requirements of 21 CFR parts 50 and 56. Based on a review of data, there
are currently 2,520 IRBs overseeing FDA-regulated clinical research.
We therefore estimate the burden of the information collection as follows:

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Our burden tables are organized to reflect one regulatory provisions per row. We have listed
each provision as either a reporting burden, a recordkeeping burden, or a third-party disclosure
burden in the tables below in a way we feel best reflects the operational aspect of the applicable
provision.
We assume each of the 2,520 IRBs meets an average of 14.6 times annually and that
approximately 40 hours of person-time per meeting are required to meet the IRB recordkeeping
requirements of 21 CFR 56.115. We have reduced the estimate of average burden per response
from 100 hours to 40 hours since last OMB review of the information collection, because we
believe the original estimate of 100 hours has decreased with the use of electronic recordkeeping
and new technologies available to maintain records. We estimate burden associated with
recordkeeping responsibilities under 21 CFR parts 50 and 56 cumulatively, however we have
itemized burden associated with certain of the regulatory provisions for purposes of providing a
more detailed estimate.
We characterize our estimates of burden associated with 21 CFR 50.25, 56.109(d) and 56.109(e)
as disclosure burdens. We estimate that eight IRBs per year will receive a request to review
emergency research under § 50.24, thus requiring written notification under 21 CFR 56.109(g)
from the IRB to the sponsor. We estimate that it will take an IRB approximately 1 hour to
prepare each written statement, for a total of 2 hours per study. The total annual third-party
disclosure burden for IRBs to fulfill this requirement is estimated at 16 hours.

Table 1.--Estimated Annual Reporting Burden1
21 CFR Section
No. of
No. of
Total
Average
Total
Respondents
Disclosures per
Annual
Burden per
Hours
Respondent
Disclosures
Disclosure
56.113; suspension or termination
2,520
1
2,520
0.5
1,260
of research
(30 minutes)
56.120(a); IRB response to lesser
7
1
7
10
70
administration actions for
noncompliance
56.123; reinstatement of an IRB or
1
1
1
5
5
an institution
TOTAL
2,528
1,335
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

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Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section
No. of
No. of
Total
Respondents
Responses per
Annual
Respondent
Responses
50.24; exceptions from informed
8
3
24
consent for emergency research
50.27; documentation of informed
2,520
40
100,800
consent

Average
Burden per
Response
1
0.5
(30
minutes)

Total
Hours
24
50,400

56.115; IRB records (documentation
2,520
14.6
36,792
40 1,471,680
of IRB activities)
TOTAL
137,616
1,626,759
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3.--Estimated Annual Third-Party Disclosure Burden1
21 CFR Section
No. of
No. of
Total
Average
Total
Respondents
Disclosures per
Annual
Burden per
Hours
Respondent
Disclosures
Disclosure
50.25; elements of informed
2,520
40
100,800
0.5
50,400
consent
(30 minutes)
56.109(d); written statement
2,520
2
5,040
0.5
2,520
about minimal risk research when
(30 minutes)
documentation of informed
consent is waived
56.109(e); written notification to
2,520
40
100,800
0.5
50,400
approve or disapprove research
(30 minutes)
56.109(g) IRB written statement
8
2
16
1
16
about public disclosures to
sponsor of emergency research
under 50.24
TOTAL
206,656
103,336
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

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 (1,731,430), we estimate the information
collection costs respondents an average of $ 147,171,550 annually..

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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.
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 both changes and adjustments. We revised the information
collection to include related elements found in other FDA regulations and discuss their
applicability to our burden assessment above. Because of the operational aspects of the
provisions, we feel consolidating the related information collection elements into one ICR will
improve our ability to both administer the regulations and evaluate their attendant burden. In this
request, our estimate reflects a decrease in the average number of annual responses by 1,947,770,
but an increase in the average number of annual hours by 310,008. We feel this shows that most
burden to respondents results from recordkeeping responsibilities described in part 56 (21 CFR
56). We note also that, upon OMB approval of this ICR, we will discontinue OMB control
number 0910-0755, which currently accounts for 104,679 responses and 108,392 hours
associated with recordkeeping requirements in 21 CFR part 56. We have also uploaded cost
figures discussed both previously and with this submission so that they appear at
www.reginfo.gov.
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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