Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, 40325-40331 [2016-14513]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40325-40331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Final NIH Policy on the Use of a Single Institutional Review 
Board for Multi-Site Research

AGENCY: National Institutes of Health.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is issuing this policy 
on the use of a single Institutional Review Board (IRB) for multi-site 
research to establish the expectation that a single IRB (sIRB) of 
record will be used in the ethical review of non-exempt human subjects 
research protocols funded by the NIH that are carried out at more than 
one site in the United States. The goal of this policy is to enhance 
and streamline the IRB review process in the context of multi-site 
research so that research can proceed as effectively and expeditiously 
as possible. Eliminating duplicative IRB review is expected to reduce 
unnecessary administrative burdens and systemic inefficiencies without 
diminishing human subjects protections. The shift in workload away from 
conducting redundant reviews is also expected to allow IRBs to 
concentrate more time and attention on the review of single site 
protocols, thereby enhancing research oversight.

DATES: This policy will take effect May 25, 2017.

FOR FURTHER INFORMATION CONTACT: Office of Science Policy, National 
Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 
20892,

[[Page 40326]]

301-496-9838, SingleIRBpolicy@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The NIH published for public comment a 
proposed draft sIRB policy in a notice in the NIH Guide for Grants and 
Contracts on December 3, 2014, (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html) and in the Federal Register on January 
6, 2015, (80 FR 511) (https://federalregister.gov/a/2014-30964). The 
NIH received 167 comments from a range of stakeholders, including 
individual researchers, academic institutions, IRBs, patient advocacy 
groups, scientific societies, healthcare organizations, Tribal Nation 
representatives, and the general public. A compilation of the public 
comments is available at https://osp.od.nih.gov/sites/default/files/resources/sIRB%2007-21-2015.pdf. The NIH appreciated the public 
interest in the draft policy and the time and effort stakeholders made 
to provide comments. The NIH carefully considered those comments in the 
development of the final policy.

Overview of the Public Comments

    In general, most of the comments that were submitted on the draft 
policy were supportive of NIH's goal of enhancing and streamlining IRB 
review in multi-site research. Commenters, especially individual 
researchers, scientific and professional societies, and patient 
advocacy organizations, generally agreed that the use of a single IRB 
for multi-site studies involving the same protocol would help 
streamline IRB review and would not undermine and might even enhance 
protections for research participants. Most of the comments also 
favored the approach the NIH proposed to promote the use of single IRBs 
by making reliance on an sIRB an expectation for all non-exempt multi-
site studies carried out at U.S. sites. At the same time, a number of 
commenters, mainly academic institutions and organizations representing 
them, did not agree with the scope of the proposed policy or that it 
should become a term and condition of funding, and suggested the NIH 
incentivize, not mandate, reliance on an sIRB.
    Comments from researchers that supported the draft policy described 
unnecessary delays and additional costs caused by duplicative IRB 
reviews. They noted that IRB submission requirements at each site 
differ and take time to navigate and manage. They also indicated that 
review of the same protocol by multiple IRBs can sometimes lead to 
protocol and consent document changes that can introduce 
inconsistencies in the execution of the protocol across sites, lead to 
enrollment imbalances, and skew the analysis of the aggregated data. 
More often, however, multiple IRB reviews result in changes to consent 
documents that are merely stylistic and not substantive, or changes 
that focus on institutional interests (e.g., liability management) 
rather than human research protections. Commenters raised the concern 
that the current practice of requiring multiple IRB reviews may 
actually contribute to some researchers' reluctance to participate in 
rigorous, multi-site research and may incentivize smaller and simpler 
study designs.
    Scientific and professional societies generally favored the 
proposed policy. These stakeholders stated that the policy would 
decrease administrative burdens on clinical research staff, speed up 
participant recruitment, and streamline the research process and that 
these changes would result in enhancements to the efficiency of 
research and acceleration of research progress. They also suggested 
that the benefits of such a policy include enhanced adverse event 
monitoring and improvements to the quality and consistency of IRB 
reviews.
    Most of the comments from patient advocacy groups and participant 
representatives were supportive of the proposed policy. These 
stakeholders pointed out that greater use of single IRBs will lead to 
enhanced protections through increased accountability and improved 
efficiency.
    In general, comments from academic institutions, IRBs, and 
organizations that represent them cited concerns about the proposed 
policy, even though many also expressed support for its goal and agreed 
it could have a positive impact in reducing research review and 
initiation time to the study. These stakeholders suggested that the 
scope of the proposed policy is too broad and that the NIH should not 
make the policy a term and condition of award. They said that decisions 
about whether to use a single IRB should be voluntary and that the NIH 
should offer incentives to promote change. For example, they suggested 
that the NIH encourage investigators and institutions to use single 
IRBs in grant applications by providing additional funding to those 
grants that agree to use a single IRB. Some suggested that before 
issuing a broad policy, the NIH should pilot and evaluate a narrower 
use of single IRBs and provide appropriate resources to support the 
participating awardees. Others suggested that the NIH should fund 
research on existing central IRB models to evaluate potential benefits 
and costs before mandating single IRB review. A few commenters raised 
concerns about the timing of the policy in relation to the revisions of 
the Common Rule, stating their preference that the NIH not adopt a 
single IRB policy until Common Rule revisions have been finalized. 
However, other commenters praised the NIH for addressing the single IRB 
issue in the absence of an updated Common Rule. Finally, a few 
commenters discussed how the policy could be harmonized with other 
federal policies. One commenter recommended that the Office for Human 
Research Protections (OHRP) in the Department of Health and Human 
Services (HHS) provide guidance to support the policy's stance on 
duplicative IRB review.
    Stakeholders from academic institutions were concerned that the 
membership of any given sIRB would not be able to achieve the level of 
local support for a particular research study or its acceptability in 
terms of all the participating sites' institutional commitments and 
regulations, applicable laws, and standards of professional conduct and 
practice. Some commenters contended that only a local IRB is able to 
understand the specific protections required for a vulnerable 
population that comprises their research participant base. Some 
suggested that site-specific practices for recruitment and retention, 
especially for vulnerable populations, would pose challenges for an 
sIRB. A number of commenters stated that their institutional IRBs are 
in the best position to know and understand competencies of and 
potential conflicts of interest of specific investigators. Others 
stressed the importance of the relationship between an investigator and 
the local IRB and noted that IRB members can serve as mentors to 
investigators whose protocols they oversee.
    Some commenters asserted that the proposed policy does not 
recognize the time and effort needed to identify and establish a single 
IRB of record, including negotiating and executing authorization 
agreements and standard operating procedures, conducting study 
initiation meetings, creating account activities, and modifying 
information technology (IT) systems. They suggested that the policy 
would result in the formation of hundreds of different ``single IRBs of 
record'' with which institutions and investigators will need to 
interact. Some questioned whether an sIRB would be equipped to ensure 
local compliance at a relying institution and expressed the concern 
that a compliance problem for an sIRB would lead to

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compliance actions against the sites relying on that sIRB. Several 
commenters who supported the use of sIRBs recommended that rather than 
having participating sites identify a single IRB for each protocol, the 
NIH should establish a central IRB to review all multi-site research 
studies, akin to the National Cancer Institute's Central Institutional 
Review Board (CIRB). They suggested that this approach would create an 
even ``playing field'' for every institution, big or small, regardless 
of whether their own IRB has the resources to act as a single IRB of 
record.
    Many commenters, regardless of whether or not they supported the 
proposed policy, noted that over the past several decades, the IRB's 
role has been expanded to include functions that go beyond ethical 
review of proposed research. For example, IRBs are often responsible 
for reviewing compliance with institutional policies, such as conflict 
of interest and investigator training. Commenters in favor of the 
proposed policy thought that greater use of sIRBs would help to return 
sIRB review to its primary mission of ensuring appropriate protections 
for human subjects rather than protecting the institution from legal 
liability or damage to its reputation. They also suggested that when 
institutions rely on a single IRB of record for multi-site research 
studies, IRB responsibilities are clearer, which helps institutions to 
develop policies and to provide resources beyond IRB review (e.g., 
human research protections experts) to facilitate compliance with the 
institutional human research protections program. Some commenters 
opposed to the proposed Policy suggested that the ancillary 
responsibilities of IRBs are so intertwined with the research oversight 
responsibilities that using a sIRB would disrupt the existing system of 
``checks and balances'' at institutions. They also argued that the 
opportunity for the IRB to recommend protocol changes for reasons 
unrelated to ethical review (e.g., scientific improvements, changes to 
study design) would be lost.
    Many commenters, regardless of whether they supported or opposed 
the proposed policy, made a number of specific practical suggestions 
about implementation. These are summarized below.
    Applicability. Most commenters supported a broad application of the 
policy to all studies involving the same protocol carried out at 
multiple sites in the U.S. These stakeholders stated that use of a 
single IRB of record for all types of studies and populations and study 
arrangements would encourage standardization of clinical research 
protocols and more effective implementation of protocols and protocol 
amendments. In contrast, a number of commenters suggested that the NIH 
should narrow the application of the policy or phase it in over time. 
Ideas about how the applicability of the policy should be narrowed were 
wide-ranging. Some stakeholders suggested that the level of risk should 
be a consideration in whether the policy should apply, with some 
pointing to minimal risk research and others to research involving more 
than minimal risk as being more appropriate for single IRB review. 
Others suggested that the policy should apply only to multi-site 
studies that involve a large number of sites (e.g., greater than 10); 
only to research involving clinical trials; only to studies carried out 
within established cooperative groups; or only to lengthy studies 
requiring an extended period of IRB oversight, e.g., three years or 
more. Some commenters suggested that the applicability of the policy 
remain broad, but that it be phased in over time.
    Exceptions. The draft policy proposed exceptions only if the 
designated single IRB of record is unable to meet the needs of specific 
populations or where local IRB review is required by federal, tribal, 
or state laws or regulations. Most commenters agreed that there was a 
need to allow for exceptions to the ues of a single IRB. There were a 
number of comments calling for additional exceptions to those proposed 
in the policy. Commenters who generally supported the proposed policy 
stated that exceptions should be very limited. Some were concerned that 
a determination that the sIRB would be unable to meet the needs of 
specific populations was an overly subjective criterion or that 
institutions would routinely request exceptions asserting that the 
needs of specific populations could only be met by local IRBs. Tribal 
Nation commenters pointed to the importance of firsthand knowledge of 
local tribal customs, cultural values, and tribal sensitivities and 
supported exceptions to address those needs and also as a way of 
respecting tribal sovereignty. Other commenters said that the policy 
should allow for situational exceptions, depending on the types and 
complexity of studies and study teams, types and numbers of involved 
institutions, resources available for the sIRB (including IT 
resources), available resources for investigators, accreditation status 
of the human research protection program, or when study sites have 
concerns regarding the constitution of the designated reviewing IRB, 
that IRBs' experience reviewing a particular type of research was 
inadequate, or if relying on the single IRB would affect the 
institutional IRB's accreditation status.
    Assuring Consideration of Local Context. Commenters were divided 
about the extent to which individual sites' local contexts would 
present a challenge for an sIRB. Some commenters suggested that in 
today's highly interconnected world, local contexts would not be unique 
or different enough to affect the review of research protocols. Others 
suggested that local context does vary, not only from state to state 
and community to community, but even among institutions serving the 
same community.
    Commenters identified a number of capabilities that the sIRB would 
need to have in order to be effective, and one comment identified four 
such capabilities:
     Knowledge of state law and local standards relevant to 
human subject research, e.g., age of majority and assent laws, 
mandatory reporting, data security, and awareness of differences in 
laws that would affect research conducted at sites in multiple states.
     Systems and procedures for collecting information from 
participating sites in order to ascertain whether the research could 
feasibly be carried out at the site. The sIRB would need to consider 
the number of competing studies underway, limits to participant pools, 
and whether the site had the capabilities and resources to execute 
research studies. Resources for consideration would include space, 
equipment, drug/device storage, handling, and dispensing, data storage 
capacities, and personnel, needed to support the research. 
Institutional capabilities would include policies on issues such as 
confidentiality, contraception, compensation for injury, or contacts 
who can answer research subjects' questions.
     Mechanisms in place to assess the experience and 
qualifications of site investigators and study staff, including whether 
they are in good standing with state board and other licensing 
authorities and have a good record of compliance with all laws and 
regulations. Other factors to be considered in this assessment would 
include financial conflicts of interest, research workload, and 
training in research ethics and the responsible conduct of research.
     Mechanisms for obtaining supplemental information when 
research would involve sensitive topics or when research would require 
the participation of discrete and insular communities. In some cases, 
the sIRB

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might need community-related information and demographic data 
including, but not limited to, race/ethnicity, religious affiliation, 
and language.
    Selection of the IRB of Record. A number of commenters called on 
the NIH to establish criteria or a minimum set of requirements to 
assist in the selection of the sIRB, as well as a need for criteria for 
an sIRB to use in its evaluation of participating sites. One commenter 
suggested that the NIH policy should require the applicant, offeror, or 
intramural investigator to justify their proposed sIRB. Since the NIH 
funding Institute or Center (IC) must approve the sIRB, one commenter 
suggested that the NIH describe the criteria to be used in making a 
determination that the proposed sIRB is acceptable.
    Some commenters offered specific suggestions for sIRB evaluation 
criteria. Suggestions for evaluation criteria included the following:
     Evidence of a commitment to the highest ethical standards 
and ability to meet rigorous standards for quality and protection of 
research participants, e.g., through accreditation or assessment of 
policies, procedures, and practices;
     Ability to meet regulatory requirements;
     Well-established track record of compliance and performing 
high quality reviews, e.g., no regulatory errors or failures to address 
Common Rule regulatory requirements or Food and Drug Administration 
regulations;
     Appropriate expertise and experience to review the 
proposed research and the capacity to review the study protocol and 
participating sites;
     Recognition of the importance of building trust across all 
sites;
     Capacity to develop and maintain the respect and trust of 
the research participants and the communities in which the research is 
performed;
     Willingness and ability to serve as a Privacy Board to 
fulfill the requirements of the Health Insurance Portability and 
Accountability Act (HIPAA) Privacy Rule for use or disclosure of 
protected health information for research;
     Adherence to communication standards and a commitment to 
transparency through sharing information about the review process, 
e.g., meeting minutes, approval status;
     Adequate institutional infrastructure and support, and 
evidence of quality and robustness of the institution's human research 
protection program;
     Sufficient staff to handle communications between all 
sites for initial review, continuing review, adverse events, 
amendments, etc.;
     Available interoperable information technology resources 
to facilitate communication and exchange of information between the 
participating institutions;
     Sufficient resources to negotiate and track authorization 
agreements;
     Ability to account for the IRB costs for review and 
management and how those costs will be met;
     Adequate processes in place and administrative support to 
handle additional review responsibilities;
     Statement of support from the nominated IRB and, if 
applicable, its governing institution, and the participating 
investigators.
    Defining IRB and Institutional Responsibilities. Many commenters 
pointed out the importance of defining the sIRB's role and scope of 
responsibility in relation to the responsibilities of the participating 
research sites. These commenters noted that responsibilities of IRBs 
defined by the 45 CFR 46 often constitute only one part of 
institutions' overall human research protections program. Commenters 
called on the NIH to establish a common approach to the division of 
responsibilities by providing model authorization agreements or even a 
uniform agreement that should be used in all cases. In addition to 
helping ensure a well-functioning review process, clear roles and 
responsibilities would, some suggested, also help mitigate concerns 
about added liability that an sIRB might assume.
    A range of views were expressed relating to responsibilities that 
would be assumed by the sIRB and those that would remain with 
participating sites. Some commenters suggested that in addition to 
fulfilling the requirements set out in 45 CFR 46, i.e., conducting 
initial and continuing reviews of protocols, amendments, unanticipated 
problems, protocol deviations, and required regulatory IRB reporting, 
sIRBs should adopt some of the responsibilities that are frequently 
delegated to local IRBs, in particular, acting as a privacy board for 
all sites. One commenter noted that systems would be required to ensure 
that duplicative reviews are not conducted by the sIRB and local IRBs, 
and several commenters expressed concerns about the difficulty of 
coordinating required sIRB reviews with additional reviews that are not 
required by regulation, such as reviews for conflict of interest, 
investigator qualifications, and scientific merit. Some of these 
commenters questioned how sIRB reviews required by the HHS regulations 
should be coordinated with other required reviews that may have been 
delegated to the local IRB. These commenters noted that many 
institutions have established systems and standard operating procedures 
for coordinating local IRB review with other required reviews, such as 
institutional biosafety reviews, radiation safety reviews, pharmacy 
reviews, reviews required by state or local laws, post-approval 
monitoring and for-cause auditing purposes, and research billing. One 
commenter suggested that sIRBs should not be responsible for adverse 
event reporting. Another commenter suggested that sIRBs should be 
responsible for maintaining databases of relevant state laws. In 
addition, a small number of commenters indicated that the regulations 
of other Common Rule agencies, FDA in particular, may create 
contradictory requirements, and called for clarification and a more 
unified approach.
    Several commenters stated that coordinating these additional 
reviews with sIRB reviews would limit the gains in efficiency realized 
from reliance on an sIRB. One commenter recommended that the NIH 
develop a template IRB authorization agreement and guidelines to define 
the institutional obligations that are distinct from the IRB review 
responsibilities. Another commenter recommended that the NIH publish 
guidance delineating the specific regulatory requirements for which the 
sIRB would be responsible, shared responsibilities, and 
responsibilities that an sIRB could negotiate with IRBs at 
participating sites.
    Resources and Funding. Several commenters described the proposed 
policy as an unfunded mandate, or stated that it would result in a 
shifting of expenses from one institution to another. Many commenters 
expressed the concern that if costs associated with using a single IRB 
are taken from a participating institution's indirect costs, there 
would be insufficient funds for the local Human Research Protection 
Program (HRPP) that still has institutional oversight responsibilities, 
even if the IRB of record is external. Most commenters with experience 
using a single IRB of record for multi-site research studies 
recommended that indirect costs remain unchanged for relying 
institutions in order to ensure that the human research protections 
infrastructure are available for institutional responsibilities, e.g., 
post-approval compliance monitoring, conflict of interest reviews. Many 
commenters noted funding sIRBs through indirect costs would divert 
funds required to conduct research and

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serve as a disincentive to conducting multisite research. The majority 
of commenters stated a preference for including the additional costs 
associated with a single IRB review in the study budget as direct cost, 
although one commenter stated a preference that sIRB review be included 
as an indirect cost in order to maximize the amount of funding 
available for research.
    Several commenters stated that the costs and resources needed to 
establish sIRBs were not addressed by the proposed policy. 
Infrastructure needs noted by these commenters included additional 
staff and/or staff time to perform sIRB-related activities, costs to 
create or adapt electronic managements systems that are interoperable 
with outside institutions, and the time and cost of developing 
communication tools to link investigators to IRBs outside their 
institution. Other commenters familiar with the operations and use of 
sIRBs noted that while initial financial support from the NIH may be 
required to establish or expand the capacity of some IRBs to serve as 
the IRB of record, most sIRBs should be able to become self-supporting 
eventually.
    Commenters had questions about whether plans for single IRB review 
would be required in grant applications and how plans would be 
reviewed.
    Need for Implementation Guidance. A number of commenters pointed 
out how important it would be for the NIH to provide practical guidance 
to facilitate the implementation of the policy, with some commenters 
stating that, in the absence of such guidance, burden and costs would 
only shift between institutions rather than adding efficiency to the 
IRB process. A few commenters noted that this guidance could be 
developed using the experiences of IRBs that have already implemented 
centralized IRB review processes.
    In addition to general requests for implementation guidance, a 
number of commenters made specific guidance suggestions. These 
suggestions included the need for guidance covering:
     The specific criteria to use for evaluation of IRBs of 
record when selecting a single IRB for a multisite study;
     The process for determining roles and responsibilities of 
the sIRB versus IRBs of participating research sites and a standard 
authorization agreement template that specifies these roles and 
responsibilities. One commenter recommended that this guidance clearly 
define who is responsible for ensuring investigator compliance, while 
another recommended that this guidance cover review of modifications to 
approved research, addition of research sites, and other post- approval 
monitoring issues including the relationship between the IRB and a data 
monitoring committee (such as a data and safety monitoring board). A 
number of commenters asked the NIH to provide guidance about liability 
as part of this guidance;
     Processes for local IRBs working with an sIRB, including 
what types of reviews will be performed by the local IRB (radiation 
safety review, pharmacy review, conflicts of interest) and best 
practices for maintaining oversight of research reviewed and approved 
by a non-institutional IRB. Additionally, one commenter requested that 
NIH encourage and provide guidance for institutional review of the 
impact the sIRB will have on the institution's HRPP business goals, 
policies, accreditation status, tracking and management processes;
     Consent forms, including the process of consent approval 
by the sIRB and participating sites, and whether and how local 
institutions could alter an sIRB informed consent document to fit local 
needs;
     Plans to ensure quality and processes for institutions 
relying on an sIRB to question or appeal sIRB decisions, and to address 
and resolve issues arising from duplicate reviews.
    In addition, commenters requested:
     Guidance and tools to enable sIRBs to consider local 
context issues. Specific guidance was requested on the process by which 
sIRBs would collect local information (e.g., through a standard form or 
through an ad hoc member or consultant with local context knowledge), 
and what types of information should be provided to sIRBs (e.g., how to 
apply state and local laws). One commenter also recommended that the 
NIH develop a set of guidelines for how the sIRB would apply local 
standards, knowledge of institutional policies, institutional capacity 
issues, investigator and study staff qualifications, and local 
community and subject considerations to their reviews;
     An explanation of costs associated with development and 
maintenance of sIRBs and guidance on how the use of an sIRB should be 
proposed at the grant level, including a fee structure to help 
investigators incorporate sIRB review into their budgets;
     A more detailed description of the standards for 
permitting exceptions for sIRB review;
     A description of what resources, if any, NIH would make 
available to assist in training IRBs and researchers regarding single 
IRB review.
    Some of the commenters who requested guidance recommended that any 
NIH guidance on sIRBs be released along with or prior to the issuance 
of the final policy.
    Implementation of the Policy. In developing the final policy set 
out below, the NIH carefully considered the many thoughtful comments we 
received on the Draft NIH Policy on the Use of a Single Institutional 
Review Board (IRB) for Multi-Site Research (NOT-OD-15-026). While we 
found no compelling reason to narrow the essential scope of the final 
policy--it will cover all domestic sites of NIH-funded non-exempt 
multi-site studies as was proposed--we have clarified the policy intent 
and modified several provisions. The final policy is intended to apply 
only to studies where the same research protocol is being conducted at 
more than one site; it does not apply to studies that involve more than 
one site but the sites have different roles in carrying out the 
research. Applicants/offerors will be expected to submit a plan 
identifying the sIRB that will serve as the IRB of record for all study 
sites. It will be the responsibility of the applicant/offeror to assure 
that the sIRB is qualified to serve; the applicant's plan will not be 
evaluated in peer review. The additional costs associated with sIRB 
review may be charged to grants or contracts as direct costs, provided 
that such costs are well-justified and consistently treated as either 
direct or indirect costs according to applicable cost principles in the 
NIH Grants Policy Statement and the FAR 31.202 (Direct Costs) and FAR 
31.203 (Indirect Costs). Exceptions to the policy will be granted, as 
was proposed, if the use of an sIRB is prohibited by federal, state, or 
tribal laws or regulations. We will also grant exceptions where the 
federal, state, or tribal prohibition on the use of an sIRB is 
established by policy, and we will consider granting an exception if a 
request is made and a compelling justification provided for why an 
exception is needed. Such justifications could be for reasons other 
than that the sIRB is unable to meet the needs of a specific 
population, as was proposed in the draft policy. The final policy also 
clarifies that multi-site studies within ongoing, non-competing awards 
will not be expected to comply with the policy until a competing 
renewal application is submitted.
    The NIH recognizes that the policy will begin a paradigm shift in 
IRB review. As such, the final policy will not take effect until May 
25, 2017. In the interim, the NIH will issue guidance and provide 
resources to assist awardees in adapting to the shift.
    Guidance materials will be issued before the policy's effective 
date and

[[Page 40330]]

posted along with the policy on the following site: https://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review. Among other topics, the guidance 
will address:
     How costs associated with sIRBs may be charged as direct 
versus indirect costs;
     Considerations in the selection of the sIRB;
     The content of the sIRB plan that must be submitted with 
applications and proposals;
     Process for applicants/offerors to submit a request for an 
exception and process for NIH review of the request for exception;
     Roles and responsibilities of the sIRB and participating 
sites;
     Model authorization agreement that lays out the roles and 
responsibilities of each signatory;
     Models for gathering and evaluating information from all 
the reliant sites about community attitudes and the acceptability of 
proposed research;
     A model communication plan that identifies when and which 
documents are to be completed and shared with those involved so each 
may fulfill their responsibilities.
    Finally, while the NIH anticipates that that there will be 
challenges associated with implementation, we expect these to be short-
lived. Once the transition to the new way of operating is made, the 
benefits of widespread use of sIRBs will outweigh any costs and, 
ultimately, reduce burdens to the research process. At the same time, 
the NIH will also closely monitor the implementation of the policy, 
consider its impact on research such as improvements in time to 
initiation of research and reduction of unnecessary burden, and be 
vigilant about any diminution in the protection of human subjects.

Final NIH Policy on the Use of a Single Institutional Review Board for 
Multi-Site Research

Purpose

    The National Institutes of Health (NIH) Policy on the Use of a 
Single Institutional Review Board of Record for Multi-Site Research 
establishes the expectation that all sites participating in multi-site 
studies involving non-exempt human subjects research funded by the 
National Institutes of Health (NIH) will use a single Institutional 
Review Board (sIRB) to conduct the ethical review required by the 
Department of Health and Human Services regulations for the Protection 
of Human Subjects at 45 CFR part 46. This policy, which is consistent 
with 45 CFR part 46.114, is intended to enhance and streamline the 
process of IRB review and reduce inefficiencies so that research can 
proceed as expeditiously as possible without compromising ethical 
principles and protections for human research participants.

Scope and Applicability

    This policy applies to the domestic sites of NIH-funded multi-site 
studies where each site will conduct the same protocol involving non-
exempt human subjects research, whether supported through grants, 
cooperative agreements, contracts, or the NIH Intramural Research 
Program. It does not apply to career development, research training or 
fellowship awards.
    This policy applies to domestic awardees and participating domestic 
sites. Foreign sites participating in NIH-funded, multi-site studies 
will not be expected to follow this policy.
    Consistent with the Roles and Responsibilities section, applicants/
offerors will be expected to include a plan for the use of an sIRB in 
the applications/proposals they submit to the NIH. The NIH's acceptance 
of the submitted plan will be incorporated as a term and condition in 
the Notice of Award or in the Contract Award. This policy also applies 
to the NIH Intramural Research Program.

Definitions

    The Authorization Agreement, which is also called a reliance 
agreement, is the agreement that documents respective authorities, 
roles, responsibilities, and communication between an institution/
organization providing the ethical review and a participating site 
relying on the sIRB.
    A multi-site study uses the same protocol to conduct non-exempt 
human subjects research at more than one site.
    Participating site in a multi-site study is a domestic entity that 
will rely on the sIRB to carry out the site's initial and continuing 
IRB review of human subjects research for the multi-site study.
    sIRB is the single IRB of record that has been selected to carry 
out the IRB review requirements at 45 CFR part 46 for participating 
sites of the multi-site study.

Roles and Responsibilities

    This policy establishes the following roles and responsibilities:
    Applicant/Offeror. In the application/proposal for research 
funding, the applicant/offeror is expected to submit a plan describing 
the use of an sIRB that will be selected to serve as the IRB of record 
for all study sites. The plan should include a statement confirming 
that participating sites will adhere to the sIRB Policy and describe 
how communications between sites and sIRB will be handled. If, in 
delayed-onset research, an sIRB has not yet been identified, 
applications/proposals should include a statement that awardees will 
follow this Policy and communicate plans to use a registered IRB of 
record to the funding NIH Institute/Center prior to initiating a multi-
site study. The applicant/offeror may request direct cost funding for 
the additional costs associated with the establishment and review of 
the multi-site study by the sIRB, with appropriate justification; all 
such costs must be reasonable and consistent with cost principles, as 
described in the NIH Grants Policy Statement and the Federal 
Acquisition Regulation (FAR) 31.302 (Direct Costs) and FAR 31.203 
(Indirect Costs).
    Awardees. Awardees are responsible for ensuring that authorization 
agreements are in place; copies of authorization agreements and other 
necessary documentation should be maintained in order to document 
compliance with this policy, as needed. As appropriate, awardees are 
responsible for ensuring that a mechanism for communication between the 
sIRB and participating sites is established. Awardees may delegate the 
tasks associated with these responsibilities.
    Funding Institute or Center (IC). Funding ICs are responsible for 
management and oversight of the award, including communicating with the 
awardee regarding the implementation of its proposed plan to comply 
with the sIRB Policy. In the event that questions arise about the 
awardee's plan, including the IRB that has been selected to serve as 
the sIRB, the funding IC will work with the awardee to resolve them.
    sIRB. The sIRB is responsible for conducting the ethical review of 
NIH-funded multi-site studies for participating sites. The sIRB will be 
expected to carry out the regulatory requirements as specified under 
the HHS regulations at 45 CFR part 46. In reviewing multi-site research 
protocols, the sIRB may serve as a Privacy Board, as applicable, to 
fulfill the requirements of the HIPAA Privacy Rule for use or 
disclosure of protected health information for research purposes. The 
sIRB will collaborate with the awardee to establish a mechanism for 
communication between the sIRB and the participating sites.
    Participating Site. All sites participating in a multi-site study 
are expected to rely on an sIRB to carry out

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the functions that are required for institutional compliance with IRB 
review set forth in the HHS regulations at 45 CFR 46. Participating 
sites are responsible for meeting other regulatory obligations, such as 
obtaining informed consent, overseeing the implementation of the 
approved protocol, and reporting unanticipated problems and study 
progress to the sIRB. Participating sites must communicate relevant 
information necessary for the sIRB to consider local context issues and 
state/local regulatory requirements during its deliberations. 
Participating sites are expected to rely on the sIRB to satisfy the 
regulatory requirements relevant to the ethical review. Although IRB 
ethical review at a participating site would be counter to the intent 
and goal of this policy, the policy does not prohibit any participating 
site from duplicating the sIRB. However, if this approach is taken, NIH 
funds may not be used to pay for the cost of the duplicate review.

Exceptions

    Exceptions to this policy will be made where review by the proposed 
sIRB would be prohibited by a federal, tribal, or state law, 
regulation, or policy. Requests for exceptions that are not based on a 
legal, regulatory, or policy requirement will be considered if there is 
a compelling justification for the exception. The NIH will determine 
whether to grant an exception following an assessment of the need.

Effective Date

    This policy applies to all competing grant applications (new, 
renewal, revision, or resubmission) with receipt dates on or after May 
25, 2017. Ongoing, non-competing awards will not be expected to comply 
with this policy until the grantee submits a competing renewal 
application. For contracts, the policy applies to all solicitations 
issued on or after May 25, 2017. For the intramural program, the policy 
applies to intramural multi-site studies submitted for initial review 
after May 25, 2017.

    Dated: June 14, 2016.
Lawrence Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-14513 Filed 6-20-16; 8:45 am]
 BILLING CODE 4140-01-P