512 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 

the use of a single IRB could lead to increased 

liability and diminished accountability for 

participating sites, and decreased consideration of 

local context. See http://www.gpo.gov/fdsys/pkg/

FR–2011–07–26/html/2011–18792.htm 

12On March 5, 2009, OHRP published an ANPRM 

requesting public comments on whether OHRP 

should pursue rulemaking to hold institutional 

review boards and institutions or organizations 

operating them directly accountable for compliance 

with the provisions of 45 CFR part 46 that relate 

to IRB responsibilities. In the ANPRM, OHRP 

identified: Responsibilities that may be unique to 

IRBs and the institutions operating them; 

responsibilities that may be unique to institutions 

engaged in human subjects research; and, 

responsibilities that may be fulfilled by either IRBs/ 

IORGs or institutions engaged in human subjects 

research. See http://www.gpo.gov/fdsys/pkg/FR– 

2009–03–05/pdf/E9–4628.pdf. 

13For example, FDA-regulated research involving 

a device is required to have local IRB review under 

21 U.S.C. 360j(g)(3)(A)). 

14When a final policy is issued, NIH will also 

provide more specific procedural guidance to 

facilitate implementation. 

Request for Comments 

NIH encourages the public to provide 

comments on any aspect of the draft 

policy outlined below. Comments 

should be submitted electronically by 

January 29, 2015, to the Office of 

Clinical Research and Bioethics Policy, 

Office of Science Policy, NIH, via email 

at SingleIRBpolicy@mail.nih.gov; mail 

to 6705 Rockledge Drive, Suite 750, 

Bethesda, MD 20892; or fax at 301–496– 

9839. Submitted comments are 

considered public information; private 

or confidential information should not 

be submitted. Comments may be posted 

along with the submitter’s name and 

affiliation on the OCRBP Web site after 

the public comment period closes. 

Draft NIH Policy on the Use of a Single 

Institutional Review Board for MultiSite Research 

Purpose. The purpose of this Policy is 

to increase the use of single Institutional 

Review Boards (IRB) for multi-site 

studies funded by the National 

Institutes of Health (NIH). Its goal is to 

enhance and streamline the process of 

IRB review and reduce inefficiencies so 

that research can proceed efficiently 

without compromising ethical 

principles and protections. 

Scope. NIH generally expects all 

domestic sites of multi-site NIH-funded 

studies to use a single IRB of record. 

The Policy applies to all domestic sites 

participating in NIH conducted or 

supported multi-site studies, whether 

supported through grants, contracts, or 

the NIH intramural program. While 

foreign sites in multi-site studies will 

not be expected to follow this Policy, 

they may elect to do so. 

Responsibilities. All sites 

participating in a multi-site study will 

be expected to rely on a single IRB to 

carry out the functions that are required 

for institutional compliance with IRB 

review set forth in the HHS regulations 

for the Protection of Human Subjects. 

The single IRB will be the IRB of record 

for the other participating sites. The 

single IRB will be accountable for 

compliance with regulatory 

requirements for IRBs specified under 

the HHS regulations at 45 CFR part 46, 

such as providing initial and continuing 

review of the research.12 All 

participating sites will be responsible 

for meeting other regulatory obligations, 

such as obtaining informed consent, 

overseeing the implementation of 

approved protocols, and, reporting 

unanticipated problems and adverse 

events to the single IRB of record. 

Agreements between the single IRB of 

record and other participating sites will 

be needed in accordance with 45 CFR 

part 46. IRB Authorization Agreements 

will document the delegation of 

responsibilities of IRB review to the 

designated IRB of record and that IRB 

site’s acceptance of the responsibilities. 

The agreement will set forth the specific 

responsibilities of each participating 

site. Participating sites will then rely on 

the IRB of record to satisfy the 

regulatory requirements relevant to the 

IRB review. The awardee or lead site for 

an NIH-funded, multi-site study will be 

responsible for maintaining 

authorization agreements and should be 

prepared to provide copies of the 

authorization agreements and other 

necessary documentation to the NIH 

funding Institute or Center upon 

request. As necessary, mechanisms 

should be established to enable the 

single IRB of record to consider local 

context issues during its deliberations. 

A duplicate IRB review at a 

participating site would be counter to 

the intent and goal of the Policy, but the 

Policy does not prohibit any 

participating site from carrying out its 

own IRB review. If this approach is 

taken, the participating site should 

expect to bear the cost of the additional 

review. 

Identification of the IRB that will 

serve as the single IRB of record will be 

the responsibility of the extramural 

applicant or offerer, or the intramural 

principal investigator. The funding NIH 

Institute or Center has final decisional 

authority for approving the selected 

single IRB. Use of the designated single 

IRB will be a term and condition of 

award. If the agreed-upon single IRB is 

a fee-based IRB, these costs will be 

included in the Notice of Award as a 

direct cost. 

Compliance with this Policy will be a 

term and condition in the Notice of 

Award and a contract requirement in 

the Contract Award. 

Exceptions. Exceptions to the 

expectation to use a single IRB may be 

made with appropriate justification. 

Exceptions will be allowed only if the 

designated single IRB is unable to meet 

the needs of specific populations or 

where local IRB review is required by 

federal, tribal, or state laws or 

regulations.13

Effective Date. The Policy applies to 

all new grant applications (Type 1 and 

2) and contract proposals with receipt 

dates after [date to be determined]. It 

will also apply to intramural multi-site 

studies submitted for initial review after 

that date.14

Dated: December 24, 2014. 

Lawrence Tabak, 

Principal Deputy Director, 

[FR Doc. 2014–30964 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Special Emphasis Panel, 

January 29, 2015 10:30 a.m. to January 

30, 2015, 04:00 p.m., National Cancer 

Institute Shady Grove, 9609 Medical 

Center Drive, Rockville, MD 20850 

which was published in the Federal 

Register on November 26, 2014, 

79FR70537. 

The meeting notice is amended to 

change the date and start time to be held 

on January 29, 2015 at 10:00 a.m. The 

meeting is closed to the public. 

Dated: December 30, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30883 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 513 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: January 27–28, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3G50, 5601 Fisher Lane, Rockville, MD 20582 

(Telephone Conference Call). 

Contact Person: B. Duane Price, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DHHS/NIH/NIAID, 5601 Fisher 

Lane, Rockville, MD 20582, 240–669–5074, 

pricebd@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Clinical Trial 

Implementation Cooperative Agreement 

(U01) and Clinical Trial Planning Grant 

(R34). 

Date: February 2, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3G50, 5601 Fisher Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: B. Duane Price, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DHHS/NIH/NIAID, 6700B 

Rockledge Drive, MSC 7616, Room 3139, 

Bethesda, MD 20892, (301) 451–2592, 

pricebd@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: December 30, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30881 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders C. 

Date: February 26–27, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Alexandria, 1900 

Diagonal Road, Alexandria, Virginia 22314. 

Contact Person: William C. Benzing, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

NINDS/NIH/DHHS/Neuroscience Center, 

6001 Executive Boulevard, Suite 3208, MSC 

9529, Bethesda, MD 20892–9529, 301–496– 

0660, benzingw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: December 30, 2014. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30876 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Quantitative Imaging for Evaluation of 

Response to Cancer Therapies-Renewal. 

Date: January 30, 2015. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

1E030, Rockville, MD 20850, (Telephone 

Conference Call). 

Contact Person: Gerald G. Lovinger, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, 9609 Medical Center Drive, 

Room 7W266, Bethesda, MD 20892–9750, 

240–276–6385, lovingeg@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http://

deainfo.nci.nih.gov/advisory/sep/sep.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: December 30, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30880 Filed 1–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 


tkelley on DSK3SPTVN1PROD with NOTICES