81 FR 56667 - Proposed Collection; 60-Day Comment Request; Materials To Support NIH Serving as an Institutional Review Board (IRB) of Record or a Single IRB for Outside Institutions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 162 (August 22, 2016)

To provide the opportunity for public comment on proposed data collection projects, the Office of Human Subjects Research Protections (OHSRP), Office of the Director, National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56667-56668]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Materials To Support 
NIH Serving as an Institutional Review Board (IRB) of Record or a 
Single IRB for Outside Institutions

SUMMARY: To provide the opportunity for public comment on proposed data 
collection projects, the Office of Human Subjects Research Protections 
(OHSRP), Office of the Director, National Institutes of Health (NIH), 
will publish periodic summaries of proposed projects to be submitted to 
the Office of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received with 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Dr. Julia 
Slutsman, Health Science Policy Analyst, Office of Human Subjects 
Research Protections (OHSRP), IRP, OD, NIH, Building 10, Room 1C154, 10 
Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 
402-3444 or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: In compliance with the requirement of 
Section 350(c)(2)(A) of the Paperwork Reduction Act of 1995, written 
comments and/or suggestions from the public and affected agencies are 
invited on one or more of the following points: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    PROPOSED COLLECTION: Materials to support the NIH Serving As an 
Institutional Review Board (IRB) of Record or a Single IRB for Outside 
Institutions, 0925--New, Office of Human Subjects Research Protections 
(OHSRP), Office of the Director, National Institutes of Health (NIH).
    Need and Use of Information Collection: The NIH Human Research 
Protections Program (HRPP) is preparing to implement the recent ``NIH 
Policy on the Use of a Single Institutional Review Board (sIRB) of 
Record for Multi-Site Research,'' which requires the use of a single 
IRB of record for human subject protections review of certain multisite 
studies. Additionally, the NIH and HHS have recently established the 
Public Health Emergency Research Review Board (PHERRB) mechanism, for 
human subject protections review of certain--typically multi-site--
public health emergency research studies. Any of the 12 NIH intramural 
IRBs can be designated to serve as the PHERRB for review of a public 
health emergency research protocol. Finally, proposed changes to 
federal human subject protections regulations, if finalized, will 
require the use of single IRB review for the majority of HHS funded, 
multi-site studies.
    To meet all of these needs, and support efficient single IRB 
review, researchers at outside institutions will need to provide 
information to the NIH HRPP, which includes the NIH intramural IRBs, 
using materials developed by the NIH Office of Human Subject 
Protections. The required materials which include: The Application for 
PHERRB Review (APR); the Initial Review Local Context Worksheet 
(IRLCW); and the Continuing Review Local Context Worksheet (CRLCW). 
This information collection is intended to provide the NIH HRPP and the 
NIH IRBs with information necessary for the NIH to maintain regulatory 
compliance in its conduct of human subject protections review when an 
NIH IRB serves an IRB of record for multi-site research and to provide 
high quality and timely human subject protections reviews.
    When an NIH IRB serves as the PHERRB, investigators seeking PHERRB 
human subject protections review will need to submit their request 
using the ``Application for PHERRB Review (APR).'' This application 
will be used to collect information to allow the NIH to evaluate public 
health emergency research protocol submissions' suitability for review 
by the PHERRB. The form will collect the investigator's name, work 
address, phone, fax and email, the curriculum vitae of the principal 
investigator and all co-investigators on the research study, and a 
detailed description of the proposed research study including the 
funding source for the study. The APR will facilitate the timely review 
of public health emergency protocols for human subjects protections 
review by the PHERRB for protocols meeting PHERRB review eligibility 
criteria.
    As part of meeting regulatory requirements for IRB review of 
protocols and ensuring the welfare and safety of human subjects, IRBs 
need to consider local context considerations, that is the sum of state 
and local laws related to the conduct of human subjects research, 
relevant institutional policies and resources, research team 
qualifications and contextual considerations particular to the site 
where research is taking place. When an NIH IRB serves as the IRB of 
record for institutions participating in a multisite study, it is 
necessary for IRBS to have a systematic way of collecting information 
about local context.
    To facilitate local context information collection, the NIH has 
developed two forms: The Initial Review Local Context Worksheet (IRLCW) 
and the Continuing Review Local Context Worksheet (CRLCW). The IRLCW 
will be submitted by investigators at each institution participating in 
a multi-site study for which an NIH IRB is the IRB of record at the 
time of submission of the research protocol. The CRLCW will be 
submitted at the time of continuing review of the protocol. These forms 
asks principal investigators to PIs to provide their name and the name 
of the institution with which they are affiliated, as well as names of 
regulatory points of contact and information about institutional 
policies and state and local laws on issues related to informed 
consent, legally authorized representative designation procedures and 
other relevant laws. This data collection is authorized pursuant to 
sections 301, 307, 465, and 478A of the Public Health Service Act [42 
U.S.C. 241, 242l, 286

[[Page 56668]]

and 286d]. OHSRP has as part of its mission a commitment to provide 
high quality human subject protections review to all research reviewed 
by NIH IRBs.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annual burden 
hours are 790.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Estimated
                                                                                             Estimated       number of     Average time      Estimated
            Data collection activity                       Type of respondents               number of     responses per   per response    total annual
                                                                                            respondents     respondent      (in hours)     burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
APR............................................  Principal Investigator (M.D. or Ph.D.).              20               1               2              40
IRLCW..........................................  Principal Investigator (M.D. or Ph.D.               250               1               2             500
                                                  degree) or Research Coordinator (RN,
                                                  BA, MA degree) or Regulatory Staff (BA
                                                  degree).
CRLCW..........................................  Principal Investigator (M.D. or Ph.D.               250               1               1             250
                                                  degree) or Research Coordinator (RN,
                                                  BA, MA degree) or Regulatory Staff (BA
                                                  degree).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             520             520  ..............             790
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: August 13, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-19829 Filed 8-19-16; 8:45 am]
 BILLING CODE 4140-01-P