Document ID: FDA-2013-N-0403-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Protection of Human Subjects; Informed Consent; and Institutional Review Boards
Posted Date: 2019-12-19T05:00Z

[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69747-69749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Protection of Human 
Subjects; Informed Consent; and Institutional Review Boards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
21, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0130. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Protection of Human Subjects; Informed Consent; and Institutional 
Review Boards--21 CFR Parts 50 and 56

OMB Control Numbers 0910-0755 and 0910-0130--Revision

    This information collection supports Agency regulations pertaining 
to the protection of human subjects, informed consent, and 
responsibilities of Institutional Review Boards (IRBs) as set forth in 
parts 50 and 56 (21 CFR parts 50 and 56). Parts 50 and 56 apply to all 
clinical investigations regulated by FDA under sections 505(i) and 
520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 355(i) and 360j(g), respectively), as well as clinical 
investigations that support applications for research or marketing 
permits for products regulated by FDA. The regulations in parts 50 and 
56 are intended to protect the rights and safety of subjects involved 
in such investigations. The regulations also contain the standards for 
composition, operation, and responsibilities of IRBs that review 
clinical investigations regulated by FDA.

21 CFR Part 50--Protection of Human Subjects

    Provisions in 21 CFR part 50 provide for the protection of human 
subjects involved in FDA-regulated clinical investigations. With few 
exceptions, 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.
    Basic elements of informed consent are set forth in Sec.  50.25 and 
include, among other things, 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 Sec.  50.25 are required in the informed consent as 
appropriate. Exceptions to these requirements are governed by Sec.  
50.23, which requires both investigator and physician to certify in 
writing that necessary elements for exception from general requirements 
have been satisfied; and Sec.  50.24, which covers exception from 
informed consent requirements for emergency research. In accordance 
with Sec.  50.27, informed consent must be documented, except as 
provided in Sec.  56.109(c), which provides for an IRB to waive 
documentation of informed consent in certain circumstances. Informed 
consent must be documented using a written consent form approved by the 
IRB and signed and dated by the subject or the subject's legally 
authorized representative at the time of consent. For each clinical 
investigation reviewed by an IRB, we believe there will typically be 
one associated written consent form developed by an investigator. In 
some cases, investigators will seek IRB approval of changes in the 
research and/or consent form after initial IRB approval. For some 
multi-institutional clinical investigations, the IRB of each 
institution involved may separately conduct initial and continuing 
review of the research, including review of the written consent form to 
determine

[[Page 69748]]

whether it is in accordance with Sec.  50.25. However, in cases where a 
multi-institutional clinical investigation uses a single IRB review 
process, there may only be one IRB conducting such reviews.
    Finally, additional safeguards are required for children, as 
prescribed in subpart D (21 CFR parts 50.50 through 50.56) of the 
regulations.

21 CFR Part 56--Institutional Review Boards

    The general standards for the composition, operation, and 
responsibilities of an IRB are set forth in 21 CFR part 56. IRBs serve 
in an oversight capacity by reviewing, among other things, informed 
consent documents and protocols for FDA-regulated studies, to make 
findings required to approve research and document IRB actions. Part 56 
also regulates the administrative activities of IRBs reviewing FDA-
regulated research including, among other things, identification of 
types of IRB records that must be prepared and maintained. Required 
recordkeeping includes documentation pertaining to written procedures, 
proposals reviewed, committee membership, meeting minutes, actions 
taken by the IRB, 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.

Consolidation of Information Collection Requests

    On our own initiative, we are revising the information collection 
under OMB control number 0910-0130 to include information collection 
under OMB control number 0910-0755 pertaining to the protection of 
human subjects, including informed consent and certain IRB 
requirements. Because of the related nature of the information 
collections and the applicable regulations in parts 50 and 56, we 
believe taking this action will improve our operational efficiency.
    Description of Respondents: Respondents to the information 
collection are IRBs that review and approve clinical investigations 
regulated by the FDA and clinical investigators of such research who 
obtain informed consent of human subjects prior to research 
participation.
    In the Federal Register of August 14, 2019 (84 FR 40421), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. Upon our own 
review, however, we have reorganized and added detail to the notice to 
describe more clearly the information collection and associated burden. 
We continue to invite comment.
    We estimate the annual burden for the collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
        21 CFR section            Number of     disclosures per    Total annual   Average burden    Total hours
                                 respondents       respondent       disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
56.113; suspension or                   2,520                  1           2,520           * 0.5           1,260
 termination of research.....
56.120(a); IRB response to                  7                  1               7              10              70
 lesser administration
 actions for noncompliance...
56.123; reinstatement of an                 1                  1               1               5               5
 IRB or an institution.......
                              ----------------------------------------------------------------------------------
    Total....................  ..............  .................  ..............  ..............           1,335
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (30 minutes).

    Based on a review of data, there are currently 2,520 IRBs 
overseeing FDA-regulated clinical research. After reorganizing the 
table summarizing estimated annual reporting burden to list only one 
requirement per row as discussed in the 60-day notice (84 FR 40421), we 
recognized that some of those regulatory provisions are more 
appropriately characterized as having associated recordkeeping or 
third-party disclosure burdens. Therefore, we have revised Tables 1, 2, 
and 3 accordingly in this notice. We request comments on this estimate.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
50.24; exceptions from informed                8               3              24               1              24
 consent for emergency research.
50.27; documentation of informed           2,520              40         100,800           * 0.5          50,400
 consent........................
56.115; IRB records                        2,520            14.6          36,792              40       1,471,680
 (documentation of IRB
 activities)....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,626,759
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (30 minutes).

    As discussed above, we have reorganized the table to characterize 
our estimate of burden associated with 50.24 and 50.27 as recordkeeping 
burdens. 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 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

[[Page 69749]]

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 invite comment on 
burden associated with these information collection requirements.

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

    As discussed above, we have reorganized the table to 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 Sec.  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.

    Dated: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27351 Filed 12-18-19; 8:45 am]
 BILLING CODE 4164-01-P