Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 511 

1 40 FR 11854 (March 13, 1975) 

2 45 CFR part 46.114 and 21 CFR part 56.114 

3See http://www.fda.gov/RegulatoryInformation/

Guidances/ucm127004.htm 

4See http://www.hhs.gov/ohrp/policy/protocol/

cirb20100430.html 

5Flynn KE, et al. Using central IRBs for 

multicenter clinical trials in the United States. PLoS 

ONE. 2013; 8(1):e54999. 

6Wagner TH, et al. Costs and benefits of the 

National Cancer Institute Central Institutional 

Review Board. J Clin Oncol. 2010; 28:662–666. 

7Emanuel EJ et al. Oversight of human 

participants research: identifying problems to 

evaluate reform proposals. Ann Intern Med. 2004; 

141(4): 282–291. 

8Menikoff J. The paradoxical problem with 

multiple-IRB review. N Engl J Med. 2010; 367:1591– 

1593. 

9See http://www.neuronext.org/researchers and 

http://www.nihstrokenet.org/research 

10 Kaufmann P et al. Central institutional review 

board review for an academic trial network. Acad 

Med. 2014; doi: 10.1097/ACM.0000000000000562. 

11An Advance Notice of Proposed Rulemaking 

issued in 2011 sought public comment on proposed 

changes to seven regulatory areas, including 

requiring the use of a single IRB for domestic sites 

in multi-site studies. Most commenters supported 

the idea of requiring the use of a single IRB for 

review of multi-site studies, especially for 

cooperative clinical trials, and agree that such a 

mandate would help speed the initiation of multisite studies. Some commenters were concerned that 

Continued 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Announcement of a Draft NIH Policy on 

the Use of a Single Institutional Review 

Board for Multi-Site Research 

SUMMARY: On December 3, 2014, the 

National Institutes of Health (NIH) 

published a request for public 

comments in the NIH Guide for Grants 

and Contracts on a draft policy to 

promote the use of a single Institutional 

Review Board of record for domestic 

sites of multi-site studies funded by the 

NIH. See Guide notice NOT–OD–15–026 

at http://grants.nih.gov/grants/guide/

notice-files/NOT–OD–15–026.html. NIH 

is publishing this notice in order to 

inform readers of the Federal Register 

about the draft policy and the 

opportunity to comment. 

DATES: The deadline for receiving 

comments on the draft policy is no later 

than 5:00 p.m. on January 29, 2015. 

ADDRESSES: Comments may be 

submitted by any of the following 

methods: 

• Email: SingleIRBpolicy@

mail.nih.gov 

• Fax: 301–496–9839 

• Mail/Hand delivery/Courier: Office 

of Clinical Research and Bioethics 

Policy, Office of Science Policy, 

National Institutes of Health, 6705 

Rockledge Drive, Suite 750, Bethesda, 

MD 20892. 

FOR FURTHER INFORMATION CONTACT: 

Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, National Institutes of Health, 

6705 Rockledge Drive, Suite 750, 

Bethesda, MD 20892, 301–496–9838, 

OCRBP–OSP@od.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The National Institutes of Health 

(NIH) is dedicated to improving the 

health of Americans by conducting and 

funding biomedical research through an 

extensive portfolio of human subjects 

research. While NIH-funded 

investigators must adhere to regulations 

for the protection of human subjects, the 

agency also looks for ways to reduce 

procedural inefficiencies so that human 

subjects research can proceed efficiently 

without compromising ethical 

principles and protections. 

The Department of Health and Human 

Services (HHS) regulations for the 

Protection of Human Subjects at 45 CFR 

part 46 requires Institutional Review 

Board (IRB) review of non-exempt HHS 

conducted or supported human subjects 

research. IRBs are responsible for 

performing an ethical review of studies 

involving human subjects. Research 

protocols and informed consent 

documents must be approved by an IRB 

prior to the commencement of human 

subjects research. In 1975, when the 

HHS regulations for protection of 

human subjects were first published,1

most clinical research was conducted 

primarily at a single institution. Since 

then, the research landscape has 

evolved, and many studies are carried 

out at multiple sites. 

In order to avoid duplication of the 

effort, both the HHS regulations at 45 

CFR part 46 and the IRB regulations of 

the Food and Drug Administration 

(FDA) at 21 CFR part 56 allow 

institutions that participate in multi-site 

studies to use joint review, rely on the 

review of another qualified IRB, or 

establish other arrangements.2 FDA and 

the Office for Human Research 

Protections (OHRP) have also issued 

guidance on this topic.3 4 However, too 

few institutions involved in multi-site 

studies are taking advantage of the 

option.5

Proponents of the single IRB model 

maintain that review of a multi-site 

study by the IRB of each participating 

site involves significant administrative 

burden in terms of IRB staff and 

members’ time to perform duplicative 

reviews. When each participating 

institution’s IRB conducts a review, the 

process can take many months and 

significantly delay the initiation of 

research projects and recruitment of 

human subjects into research studies. 

Use of single IRBs in multi-site studies, 

on the other hand, has been shown to 

decrease approval times for clinical 

protocols and may be more cost 

effective than local IRB review.6

Importantly, there is no evidence that 

multiple IRB reviews enhance 

protections for human subjects. In fact, 

the use of single IRBs may lead to 

enhanced protections for research 

participants by eliminating the problem 

of distributed accountability, 

minimizing institutional conflicts of 

interest, and refocusing IRB time and 

resources toward review of other 

studies.7 8 With regard to assuring that 

local perspectives are addressed, the 

assessment of a study’s risks and 

benefits and the adequacy of the 

informed consent should not generally 

require the perspective of a local IRB. 

Local contextual issues relevant to most 

studies (e.g., investigator competence 

and site suitability) can be addressed 

through mechanisms other than local 

IRB review, such as the involvement of 

ad hoc members or consultants with the 

necessary specialized knowledge or 

expertise or by submission of 

information by the individual site(s). 

Even when certain vulnerable 

populations are targeted for recruitment, 

such alternative approaches may be 

appropriate. 

Several extramural NIH programs 

already support the use of a single IRB 

for multi-sites studies. For example, the 

National Cancer Institute has had a 

Central Institutional Review Board 

(CIRB) in place for the review of NCIsponsored clinical trials since 1999. The 

National Institute of Neurological 

Disorders and Stroke has incorporated 

the use of a single IRB for its Network 

for Excellence in Neuroscience Clinical 

Trials (NeuroNEXT) and Network for 

Stroke Research (NIHStrokeNet).9 10

The draft Policy proposes that NIH 

funded institutions will be expected to 

use a single IRB of record for domestic 

sites of multi-site studies unless there is 

justification for an exception (see 

exceptions below). The draft 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. By 

expecting all domestic multi-site studies 

to use a single IRB, this Policy should 

help achieve greater efficiencies and 

speed the initiation of studies across 

NIH’s entire clinical research portfolio. 

This Policy is also in keeping with one 

of the proposed changes being 

considered to the Common Rule.11


tkelley on DSK3SPTVN1PROD with NOTICES
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