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)
National Institutes of Health
Federal Register Volume 81, Issue 162 (August 22, 2016)
| Page Range | 56667-56668 | |
| FR Document | 2016-19829 |
[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] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices 56667
7200, Bethesda, MD 20892, 301–496–9659, agency, including whether the multi-site research and to provide high
reillymp@nhlbi.nih.gov. information will have practical utility; quality and timely human subject
(Catalogue of Federal Domestic Assistance (2) The accuracy of the agency’s protections reviews.
Program Nos. 93.233, National Center for estimate of the burden of the proposed When an NIH IRB serves as the
Sleep Disorders Research; 93.837, Heart and collection of information, including the PHERRB, investigators seeking PHERRB
Vascular Diseases Research; 93.838, Lung human subject protections review will
Diseases Research; 93.839, Blood Diseases
validity of the methodology and
and Resources Research, National Institutes assumptions used; (3) Ways to enhance need to submit their request using the
of Health, HHS) the quality, utility, and clarity of the ‘‘Application for PHERRB Review
information to be collected; and (4) (APR).’’ This application will be used to
Dated: August 16, 2016. collect information to allow the NIH to
Ways to minimize the burden of the
Michelle Trout, collection of information on those who evaluate public health emergency
Program Analyst, Office of Federal Advisory are to respond, including the use of research protocol submissions’
Committee Policy. appropriate automated, electronic, suitability for review by the PHERRB.
[FR Doc. 2016–19882 Filed 8–19–16; 8:45 am] mechanical, or other technological The form will collect the investigator’s
BILLING CODE 4140–01–P collection techniques or other forms of name, work address, phone, fax and
information technology. email, the curriculum vitae of the
PROPOSED COLLECTION: Materials principal investigator and all co-
DEPARTMENT OF HEALTH AND to support the NIH Serving As an investigators on the research study, and
HUMAN SERVICES Institutional Review Board (IRB) of a detailed description of the proposed
Record or a Single IRB for Outside research study including the funding
National Institutes of Health Institutions, 0925—New, Office of source for the study. The APR will
Proposed Collection; 60-Day Comment Human Subjects Research Protections facilitate the timely review of public
Request; Materials To Support NIH (OHSRP), Office of the Director, health emergency protocols for human
Serving as an Institutional Review National Institutes of Health (NIH). subjects protections review by the
Need and Use of Information PHERRB for protocols meeting PHERRB
Board (IRB) of Record or a Single IRB
Collection: The NIH Human Research review eligibility criteria.
for Outside Institutions
Protections Program (HRPP) is preparing As part of meeting regulatory
SUMMARY: To provide the opportunity to implement the recent ‘‘NIH Policy on requirements for IRB review of protocols
for public comment on proposed data the Use of a Single Institutional Review and ensuring the welfare and safety of
collection projects, the Office of Human Board (sIRB) of Record for Multi-Site human subjects, IRBs need to consider
Subjects Research Protections (OHSRP), Research,’’ which requires the use of a local context considerations, that is the
Office of the Director, National single IRB of record for human subject sum of state and local laws related to
Institutes of Health (NIH), will publish protections review of certain multisite the conduct of human subjects research,
periodic summaries of proposed studies. Additionally, the NIH and HHS relevant institutional policies and
projects to be submitted to the Office of have recently established the Public resources, research team qualifications
Management and Budget (OMB) for Health Emergency Research Review and contextual considerations particular
review and approval. Board (PHERRB) mechanism, for human to the site where research is taking
DATES: Comments regarding this subject protections review of certain— place. When an NIH IRB serves as the
information collection are best assured typically multi-site—public health IRB of record for institutions
of having their full effect if received emergency research studies. Any of the participating in a multisite study, it is
with 60 days of the date of this 12 NIH intramural IRBs can be necessary for IRBS to have a systematic
publication. designated to serve as the PHERRB for way of collecting information about
review of a public health emergency local context.
FOR FURTHER INFORMATION CONTACT: To research protocol. Finally, proposed To facilitate local context information
obtain a copy of the data collection changes to federal human subject collection, the NIH has developed two
plans and instruments, submit protections regulations, if finalized, will forms: The Initial Review Local Context
comments in writing, or request more require the use of single IRB review for Worksheet (IRLCW) and the Continuing
information on the proposed project, the majority of HHS funded, multi-site Review Local Context Worksheet
contact: Dr. Julia Slutsman, Health studies. (CRLCW). The IRLCW will be submitted
Science Policy Analyst, Office of To meet all of these needs, and by investigators at each institution
Human Subjects Research Protections support efficient single IRB review, participating in a multi-site study for
(OHSRP), IRP, OD, NIH, Building 10, researchers at outside institutions will which an NIH IRB is the IRB of record
Room 1C154, 10 Center Drive, Bethesda, need to provide information to the NIH at the time of submission of the research
MD 20892, or call non-toll-free number HRPP, which includes the NIH protocol. The CRLCW will be submitted
(301) 402–3444 or Email your request, intramural IRBs, using materials at the time of continuing review of the
including your address to: PHERRB@ developed by the NIH Office of Human protocol. These forms asks principal
mail.nih.gov. Formal requests for Subject Protections. The required investigators to PIs to provide their
additional plans and instruments must materials which include: The name and the name of the institution
be requested in writing. Application for PHERRB Review (APR); with which they are affiliated, as well
SUPPLEMENTARY INFORMATION: In the Initial Review Local Context as names of regulatory points of contact
compliance with the requirement of Worksheet (IRLCW); and the Continuing and information about institutional
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Section 350(c)(2)(A) of the Paperwork Review Local Context Worksheet policies and state and local laws on
Reduction Act of 1995, written (CRLCW). This information collection is issues related to informed consent,
comments and/or suggestions from the intended to provide the NIH HRPP and legally authorized representative
public and affected agencies are invited the NIH IRBs with information designation procedures and other
on one or more of the following points: necessary for the NIH to maintain relevant laws. This data collection is
(1) Whether the proposed collection of regulatory compliance in its conduct of authorized pursuant to sections 301,
information is necessary for the proper human subject protections review when 307, 465, and 478A of the Public Health
performance of the function of the an NIH IRB serves an IRB of record for Service Act [42 U.S.C. 241, 242l, 286
VerDate Sep<11>2014 17:13 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/81_FR_56829/page/1.svg)
![56668 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
and 286d]. OHSRP has as part of its review to all research reviewed by NIH other than their time. The total
mission a commitment to provide high IRBs. estimated annual burden hours are 790.
quality human subject protections OMB approval is requested for 3
years. There are no costs to respondents
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
Estimated Average time Estimated total
Data collection number of
Type of respondents number of per response annual burden
activity responses per
respondents (in hours) hours
respondent
APR ............... Principal Investigator (M.D. or Ph.D.) .................................. 20 1 2 40
IRLCW ........... Principal Investigator (M.D. or Ph.D. degree) or Research 250 1 2 500
Coordinator (RN, BA, MA degree) or Regulatory Staff
(BA degree).
CRLCW .......... Principal Investigator (M.D. or Ph.D. degree) or Research 250 1 1 250
Coordinator (RN, BA, MA degree) or Regulatory Staff
(BA degree).
Total ....... .............................................................................................. 520 520 ........................ 790
Dated: August 13, 2016. Name of Committee: Cardiovascular and DATES: Comments regarding this
Lawrence A. Tabak, Respiratory Sciences Integrated Review information collection are best assured
Deputy Director, National Institutes of Health. Group; Lung Injury, Repair, and Remodeling of having their full effect if received
Study Section. within 60 days of the date of this
[FR Doc. 2016–19829 Filed 8–19–16; 8:45 am]
Date: September 19–20, 2016.
BILLING CODE 4140–01–P publication.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant FOR FURTHER INFORMATION CONTACT: To
applications. obtain a copy of the data collection
DEPARTMENT OF HEALTH AND Place: Embassy Suites at the Chevy Chase
HUMAN SERVICES plans and instruments, submit
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
comments in writing, or request more
National Institutes of Health Contact Person: Ghenima Dirami, Ph.D., information on the proposed project,
Scientific Review Officer, Center for contact: Dr. Alyson Ross, Nurse
Center for Scientific Review; Notice of Scientific Review, National Institutes of Researcher, Department of Nursing
Closed Meetings Health, 6701 Rockledge Drive, Room 4122, Research and Translational Science,
Pursuant to section 10(d) of the MSC 7814, Bethesda, MD 20892, 240–498– NIH Clinical Center, Building 10, Room
7546, diramig@csr.nih.gov. 2B07, MSC–1151, Bethesda, Maryland,
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is (Catalogue of Federal Domestic Assistance 20892 or call non-toll-free number (301)
hereby given of the following meetings. Program Nos. 93.306, Comparative Medicine; 451–8338 or Email your request,
The meetings will be closed to the 93.333, Clinical Research, 93.306, 93.333, including your address to: Alyson.ross@
public in accordance with the 93.337, 93.393–93.396, 93.837–93.844, nih.gov. Formal requests for additional
provisions set forth in sections 93.846–93.878, 93.892, 93.893, National plans and instruments must be
Institutes of Health, HHS) requested in writing.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and Dated: August 16, 2016.
SUPPLEMENTARY INFORMATION: In
the discussions could disclose Natasha M. Copeland, compliance with the requirement of
confidential trade secrets or commercial Program Analyst, Office of Federal Advisory Section 3506(c)(2)(A) of the Paperwork
property such as patentable material, Committee Policy. Reduction Act of 1995, written
and personal information concerning [FR Doc. 2016–19885 Filed 8–19–16; 8:45 am] comments and/or suggestions from the
individuals associated with the grant BILLING CODE 4140–01–P public and affected agencies are invited
applications, the disclosure of which
to address one or more of the following
would constitute a clearly unwarranted
points: (1) Whether the proposed
invasion of personal privacy. DEPARTMENT OF HEALTH AND collection of information is necessary
Name of Committee: Center for Scientific HUMAN SERVICES for the proper performance of the
Review Special Emphasis Panel; PAR–15– function of the agency, including
276: Turkey-US Collaborative Program for National Institutes of Health
Affordable Medical Technologies (R01).
whether the information will have
Date: September 16, 2016. Proposed Collection; 60-Day Comment practical utility; (2) The accuracy of the
Time: 11:00 a.m. to 12:30 p.m. Request; A National Survey of Nurse agency’s estimate of the burden of the
Agenda: To review and evaluate grant Coaches (CC) proposed collection of information,
applications. including the validity of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Place: National Institutes of Health, 6701 SUMMARY: To provide opportunity for methodology and assumptions used; (3)
Rockledge Drive, Bethesda, MD 20892 public comment on proposed data Ways to enhance the quality, utility, and
(Telephone Conference Call). collection projects, the National clarity of the information to be
Contact Person: Careen K. Tang-Toth,
Ph.D., Scientific Review Officer, Center for
Institutes of Health Clinical Center (CC) collected; and (4) Ways to minimize the
Scientific Review, National Institutes of will publish periodic summaries of burden of the collection of information
Health, 6701 Rockledge Drive, Room 6214, proposed projects to be submitted to the on those who are to respond, including
MSC 7804, Bethesda, MD 20892, (301) 435– Office of Management and Budget the use of appropriate automated,
3504, tothct@csr.nih.gov. (OMB) for review and approval. electronic, mechanical, or other
VerDate Sep<11>2014 17:13 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/81_FR_56829/page/2.svg)
Document Created: 2018-02-09 11:38:22
Document Modified: 2018-02-09 11:38:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| 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) | |
| FR Citation | 81 FR 56667 |
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