Revised Common Rule (45 CFR 46): Final Rule

2017·0.78 MB·English

Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations 7149
DEPARTMENT OF HOMELAND NATIONAL SCIENCE FOUNDATION III. Definitions for Purposes of this Policy
SECURITY (§ll.102)
45 CFR Part 690 IV. Ensuring Compliance with this Policy
6 CFR Part 46 (§ll.103)
V. Exempt Research (§ll.104)
DEPARTMENT OF TRANSPORTATION
VI. Protection of Identifiable Private
DEPARTMENT OF AGRICULTURE
Information and Identifiable
49 CFR Part 11 Biospecimens
7 CFR Part 1c VII. IRB Membership and Modification to
Federal Policy for the Protection of
References to Vulnerability
DEPARTMENT OF ENERGY Human Subjects (§§ll.107(a), ll.111(a)(3), and
ll.111(b))
AGENCY: Department of Homeland
VIII. IRB Functions and Operations
10 CFR Part 745 Security; Department of Agriculture;
(§ll.108)
Department of Energy; National IX. IRB Review of Research (§ll.109)
NATIONAL AERONAUTICS AND Aeronautics and Space Administration; X. Expedited Review Procedures (§ll.110)
SPACE ADMINISTRATION Department of Commerce; Social XI. Criteria for IRB Approval of Research
Security Administration; Agency for (§ll.111)
14 CFR Part 1230 International Development; Department XII. Cooperative Research (§ll.114)
of Housing and Urban Development; XIII. IRB Records (§ll.115)
DEPARTMENT OF COMMERCE Department of Labor; Department of XIV. General Requirements for Informed
Consent (§ll.116)
Defense; Department of Education;
XV. Documentation of Informed Consent
15 CFR Part 27 Department of Veterans Affairs; (§ll.117)
Environmental Protection Agency;
XVI. Applications and Proposals Lacking
SOCIAL SECURITY ADMINISTRATION Department of Health and Human Definite Plans for Involvement of Human
Services; National Science Foundation; Subjects (§ll.118)
and Department of Transportation. XVII. Research Undertaken Without the
20 CFR Part 431
ACTION: Final rule. Intention of Involving Human Subjects
(§ll.119)
AGENCY FOR INTERNATIONAL SUMMARY: The departments and agencies XVIII. Conditions (§ll.124)
DEVELOPMENT listed in this document announce XIX. Regulatory Impact Analyses
revisions to modernize, strengthen, and XX. Environmental Impact
22 CFR Part 225 make more effective the Federal Policy XXI. Paperwork Reduction Analysis
XXII. Tribal Consultation Statement
for the Protection of Human Subjects
Final Regulatory Text
DEPARTMENT OF HOUSING AND that was originally promulgated as a
URBAN DEVELOPMENT Common Rule in 1991. This final rule Executive Summary
is intended to better protect human Purpose of the Regulatory Action
24 CFR Part 60 subjects involved in research, while
facilitating valuable research and Individuals who are the subjects of
DEPARTMENT OF LABOR reducing burden, delay, and ambiguity research may be asked to contribute
for investigators. These revisions are an their time and assume risk to advance
29 CFR Part 21 effort to modernize, simplify, and the research enterprise, which benefits
enhance the current system of oversight. society at large. U.S. federal regulations
DEPARTMENT OF DEFENSE DATES: This rule is effective on January governing the protection of human
19, 2018. The compliance date for this subjects in research have been in
32 CFR Part 219 rule, except for §ll.114(b) existence for more than three decades.
(cooperative research), is January 19, The Department of Health, Education,
2018. The compliance date for and Welfare first published regulations
DEPARTMENT OF EDUCATION
§ll.114(b) (cooperative research) is for the protection of human subjects in
January 20, 2020. 1974, and the Department of Health and
34 CFR Part 97
ADDRESSES: Jerry Menikoff, M.D., J.D., Human Services (HHS) revised them in
OHRP, 1101 Wootton Parkway, Suite the early 1980s. During the 1980s, HHS
DEPARTMENT OF VETERANS
200, Rockville, MD 20852. began a process that eventually led to
AFFAIRS
the adoption of a revised version of the
FORFURTHERINFORMATIONCONTACT: Jerry
regulations by 15 U.S. federal
Menikoff, M.D., J.D., Office for Human
38 CFR Part 16 departments and agencies in 1991. The
Research Protections (OHRP),
purpose of this effort was to promote
Department of Health and Human
ENVIRONMENTAL PROTECTION uniformity, understanding, and
Services, 1101 Wootton Parkway, Suite
AGENCY compliance with human subject
200, Rockville, MD 20852; telephone:
protections as well as to create a
240–453–6900 or 1–866–447–4777;
40 CFR Part 26 uniform body of regulations across
facsimile: 301–402–2071; email:
federal departments and agencies
[email protected].
DEPARTMENT OF HEALTH AND (subpart A of 45 Code of Federal
S6 SUPPLEMENTARYINFORMATION:
ULE HUMAN SERVICES Regulations [CFR] part 46), often
R Preamble referred to as the ‘‘Common Rule’’ or
D with 45 CFR Part 46 Executive Summary ‘‘Protection of Human Subjects
PRO I. The Rationale for Modernizing the Regulations.’’ Those regulations were
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SK3 and Applicability of the Regulations of this final rule.
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7150 Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations
Since the Common Rule was Summary of the Major Changes in the conducting the research on
promulgated, the volume and landscape Final Rule nonidentified information and
of research involving human subjects The final rule differs in important nonidentified biospecimens, having an
have changed considerably. Research ways from the NPRM. Most institutional review board (IRB) waive
with human subjects has grown in scale significantly, several proposals are not the requirement for informed consent,
and become more diverse. Examples of being adopted: or obtaining consent for a specific study.
developments include: an expansion in • The final rule does not adopt the • Establishes new exempt categories
the number and types of clinical trials, proposal to require that research of research based on their risk profile.
as well as observational studies and involving nonidentified biospecimens Under some of the new categories,
cohort studies; a diversification of the be subject to the Common Rule, and that exempt research would be required to
types of social and behavioral research consent would need to be obtained in undergo limited IRB review to ensure
being used in human subjects research; order to conduct such research. that there are adequate privacy
increased use of sophisticated analytic • To the extent some of the NPRM safeguards for identifiable private
proposals relied on standards that had information and identifiable
techniques to study human
not yet been proposed, the final rule biospecimens.
biospecimens; and the growing use of
either does not adopt those proposals or • Creates a requirement for U.S.-
electronic health data and other digital
includes revisions to eliminate such based institutions engaged in
records to enable very large datasets to
reliance. cooperative research to use a single IRB
be rapidly analyzed and combined in • The final rule does not expand the for that portion of the research that takes
novel ways. Yet these developments
policy to cover clinical trials that are not place within the United States, with
have not been accompanied by major
federally funded. certain exceptions. This requirement
change in the human subjects research • The final rule does not adopt the becomes effective 3 years after
oversight system, which has remained proposed new concept of ‘‘excluded’’ publication of the final rule.
largely unaltered over the past two activities. Generally, activities proposed • Removes the requirement to
decades. to be excluded are now either described
conduct continuing review of ongoing
On July 26, 2011, the Office of the as not satisfying the definition of what research for studies that undergo
Secretary of HHS, in coordination with constitutes research under the expedited review and for studies that
the Executive Office of the President’s regulations or are classified as exempt. have completed study interventions and
• The proposed revisions to the
Office of Science and Technology Policy are merely analyzing study data or
exemption categories have been
(OSTP), published an advance notice of involve only observational follow up in
modified to better align with the long-
proposed rulemaking (ANPRM) to conjunction with standard clinical care.
standing ordering in the final rule. The
request comment on how current final rule does not include the proposed Other minor changes have been to
regulations for protecting those who requirement that exemption improve the rule and for purposes of
participate in research might be determinations need to be made in clarity and accuracy.
modernized and revised to be more
specified ways.
Estimated Costs and Benefits
effective.1 • The final rule does not include the
On September 8, 2015, HHS and 15 proposed standardized privacy Table 1 summarizes the quantified
other federal departments and agencies safeguards for identifiable private and nonquantified benefits and costs of
published a Notice of Proposed information and identifiable all changes to the Common Rule. Over
Rulemaking (NPRM) proposing biospecimens. Aspects of proposals that the 2017–2026 period, present value
revisions to the regulations for relied on those safeguards have been benefits of $1,904 million and
protection of human subjects in modified or are not being adopted. annualized benefits of $223 million are
• The final rule does not adopt the estimated using a 3 percent discount
research.2Like the ANPRM, the NPRM
most restrictive proposed criteria for rate; present value benefits of $1,494
sought comment on how to better
obtaining a waiver of the consent million and annualized benefits of $213
protect research subjects while
requirements relating to research with million are estimated using a 7 percent
facilitating valuable research and
identifiable biospecimens. discount rate. Present value costs of
reducing burden, delay, and ambiguity
The final rule makes the following $528 million and annualized costs of
for investigators. Public comments on
significant changes to the Common $62.0 million are estimated using a 3
both the ANPRM and the NPRM have
Rule: percent discount rate; present value
informed the final rule that is now being • Establishes new requirements costs of $474 million and annualized
promulgated.
regarding the information that must be costs of $67.0 million are estimated
The final rule is designed to more given to prospective research subjects as using a 7 percent discount rate.
thoroughly address the broader types of part of the informed consent process. Nonquantified benefits include
research conducted or otherwise • Allows the use of broad consent improved human subjects protections in
supported by all of the Common Rule (i.e., seeking prospective consent to research; enhanced oversight of research
departments and agencies such as unspecified future research) from a reviewed by IRBs not operated by a
behavioral and social science research. subject for storage, maintenance, and Federalwide Assurance (FWA)-holding
It also benefits from continuing efforts secondary research use of identifiable institution; and increased uniformity in
to harmonize human subjects policies private information and identifiable regulatory requirements among
S6 biospecimens. Broad consent will be an Common Rule departments and
E across federal departments and
UL optional alternative that an investigator agencies. Nonquantified costs include
R agencies.
with may choose instead of, for example, the time needed for consultation among
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Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations 7151
Common Rule agencies before federal
guidance is issued.
TABLE 1—ACCOUNTING TABLE OF BENEFITS AND COSTS OF ALL CHANGES
Present value of 10 years by Annualized value over 10
discount rate years by discount rate
(millions of 2015 dollars) (millions of 2015 dollars)
3 percent 7 percent 3 percent 7 percent
Benefits:
Quantified Benefits ................................................................................... 1,904 1,493 223 213
Nonquantified Benefits:
Improved human subjects protections in research; enhanced oversight in research reviewed by IRBs not operated by an FWA-holding insti-
tution; and increased uniformity in regulatory requirements among Common Rule departments and agencies.
Costs:
Quantified Costs ....................................................................................... 528 474 62.0 67.0
Nonquantified Benefits:
Time for consultation among Common Rule agencies before federal guidance is issued.
I. The Rationale for Modernizing the combining research and medical data. the 1979 Belmont Report3that underlie
Common Rule Biospecimen repositories and large the Common Rule—respect for persons,
databases have made it easier to do beneficence, and justice—are applied in
A. The Changing Nature of Research
research on existing (stored) practice to the myriad new contexts in
This final rule recognizes that in the biospecimens and data. Clinical which U.S. research is conducted in the
past two decades a paradigm shift has research networks connected through 21st century. The changes that are being
occurred in how research is conducted. electronic health records have implemented in the final rule continue
Evolving technologies—including developed methods for extracting to be shaped by those principles (a
imaging, mobile technologies, and the clinical data for research purposes and detailed background discussion of
growth in computing power—have are working toward integration of which was provided in the NPRM).
changed the scale and nature of research data into electronic health Finally, it is important to note that, to
information collected in many records in a meaningful way. The the extent appropriate, the intent is to
disciplines. Computer scientists, scientific community recognizes the eventually amend the other subparts of
engineers, and social scientists are value of data sharing and open-source the HHS human subjects protection
developing techniques to integrate resources and understands that pooling regulations in 45 CFR part 46 (subparts
different types of data so they can be intellectual resources and capitalizing B, C, D, and E), and consider the need
combined, mined, analyzed, and shared. on efficient uses of data and technology for updates to FDA regulations and
The advent of sophisticated computer represent the best ways to advance other relevant federal departmental or
software programs, the Internet, and knowledge. agency regulations with overlapping
mobile technology has created new scope.
At the same time, the level of public
areas of research activity, particularly
engagement in the research enterprise B. Public Comments, Expert Advice,
within the social and behavioral
has changed. More people want to play Stakeholder Dialogue
sciences. In biomedical science, the
an active role in research, particularly
Human Genome Project laid the The revisions to the Common Rule are
related to health.
foundation for precision medicine and based on a variety of sources of public,
promoted an environment of data As technology evolves, so does the stakeholder, and expert comments and
sharing and innovation in analytics and nature of the risks and benefits of advice, including comments received on
technology, and drew attention to the participating in certain types of the 2011 ANPRM and the 2015 NPRM.
need for policies that support a research. Many studies do not involve They also benefit from guidance
changing research landscape. New interaction with research subjects, but provided by a 2014 National Research
technologies, including genomic instead involve secondary analysis of Council consensus report, Proposed
sequencing, have quickly led to data or biospecimens. Risks related to Revisions to the Common Rule for the
exponential growth in the data to which these types of research studies are Protection of Human Subjects in the
investigators have access. The sheer largely informational, not physical; that Behavioral and Social Sciences,4and
is, harms could result primarily from
volume of data that can be generated in
research, the ease with which it can be the inappropriate disclosure of 3National Commission for the Protection of
information and not from the research Human Subjects of Biomedical and Behavioral
shared, and the ways in which it can be
interventions themselves. Nonetheless, Research. Belmont Report. Washington, DC: U.S.
used to identify individuals were Department of Health and Human Services. 1979.
those harms can be significant.
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SK3 conducted in clinical care settings, thus of how the fundamental principles of Continued
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7152 Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations
the National Academies of Science, Medicare Access and Children’s Health and proposals giving investigators too
Engineering, and Medicine 2016 report Insurance Program Reauthorization Act much leeway to determine if their
Optimizing the Nation’s Investment in of 2015 (Pub. L. 114–10) was passed. research is exempt or falls outside the
Academic Research: A New Regulatory That law requires HHS to issue a scope of the rule.
Framework for the 21st Century.5 clarification or modification of the Several commenters expressed
Since the publication of the 2011 Common Rule with regard to how the concerns that they were unable to
ANPRM, HHS has continued to solicit regulatory requirements should be adequately or meaningfully comment on
public comment on a variety of policy applied to activities involving clinical particular provisions proposed in the
issues related to human subjects data registries. In addition, in December NPRM because an underlying
protections, including consent, the use 2016 the 21st Century Cures Act (Pub. document, tool, or list had not been
of a single IRB for multi-institutional L. 114–255) was enacted. developed or shared with the public at
studies, and sharing of genomic data. Finally, as a result of conducting a the time the NPRM was published,
Although these policies were more variety of public discussions associated specifically: (1) the proposed broad
specific than the issues raised in the with the President’s Precision Medicine consent templates; (2) the proposed
ANPRM, the responses received from Initiative,91011many perspectives were standards for privacy protection; (3) the
public comments provide insight for heard, with much alignment around the proposed list of eligible expedited
refining the proposals initially put central tenet that participants should be procedures; and (4) the proposed
forward in the ANPRM. Of particular active partners in such research and not exemption decision tool. Several
relevance are the National Institutes of merely passive subjects of research commenters suggested that these items
Health’s (NIH’s) recently issued policy studies. should be removed from the final rule
on the use of a single IRB for multi- and developed independently, urging
1. Summary of Public Comments on
institutional research,6the Office for government personnel to work
Human Research Protection’s (OHRP’s) Structural, Conceptual, and Policy collaboratively with representatives
draft guidance on the required content Implications of the Proposed Rule from the research community and
of consent language for research The NPRM received more than 2,100 funding agencies in the development of
conducted within the standard of care,7 public comments, the majority of which such documents, tools, and lists.
and NIH’s policy to promote sharing of were from people writing in their Some commenters suggested issuing a
large-scale human genomic data individual capacity. The remaining new NPRM that would be more
generated from studies funded or comments were submitted by complete and would include details on
conducted by NIH.8 institutions, professional organizations the privacy protection standards,
Other developments include the and societies, and membership exemption decision tool, and broad
enactment of the Newborn Screening organizations. The proposals receiving consent templates. Another commenter
Saves Lives Reauthorization Act of 2014 the most comments were those related recommended that only the fully
(Pub. L. 113–240) in December 2014. to biospecimens (expanded definition of developed, less controversial provisions
The law made a number of changes human subject, broad consent, and of the NPRM should be adopted into a
relevant to the HHS regulations for tightened criteria for waiver of consent). final rule. Another commenter urged the
protecting research subjects, including Here we summarize comments on the Common Rule departments and
asserting that research with newborn overall structural, conceptual, and agencies to reissue the NPRM to solicit
dried blood spots (DBS) that is federally policy implications of the proposed comment on several of these documents,
funded pursuant to the Public Health rule. Comments regarding the specific tools, and lists, arguing that it would be
Service Act is to be considered research provisions of the rule appear throughout unlawful for a final rule to be issued
with human subjects, and that the this preamble. until such an action were taken. This
provisions allowing IRBs to waive The NPRM asked for public comment commenter noted that for members of
consent would not apply. By statute, the on whether the proposed changes will the public to reasonably participate in
changes made by this law applied only achieve the objectives of: (1) decreasing rulemaking, agencies must provide
until changes to the Common Rule are administrative burden, delay, and enough factual detail and rationale to
promulgated. Thus, the changes made ambiguity for investigators, institutions, allow interested parties to comment
by this statute will no longer apply after and institutional review boards (IRBs); meaningfully on the rule. This
the effective date of this rule, January and (2) strengthening, modernizing, and commenter also argued that the NPRM
19, 2018. In addition, in April 2015, the making the regulations more effective in did not satisfy the requirement set forth
protecting research subjects. In in the Administrative Procedure Act
protection-of-human-subjects-in-the-behavioral- response, many public commenters that the notice provided to the public in
and-social-sciences. rulemaking include either the terms or
expressed concern about the overall
5National Academies of Sciences, Engineering, substance of the proposed rule or a
and Medicine. Optimizing the Nation’s Investment complexity and length of the NPRM, the
description of the subjects and issues
in Academic Research: A New Regulatory unavailability of key deliverables,
Framework for the 21st Century. Washington, DC: proposals being internally inconsistent, involved. In sum, the commenter argued
The National Academies Press; 2016. Retrieved that the NPRM sought comments on
from https://www.nap.edu/read/21824/chapter/1. numerous provisions without providing
6National Institutes of Health. Final NIH Policy 9The White House, Office of the Press Secretary.
on the Use of a Single Institutional Review Board Fact Sheets: President Obama’s Precision Medicine the ‘‘terms or substance’’ of the specific
for Multi-Site Research. June 21, 2016. Notice Initiative. January 30, 2015. Retrieved from https:// proposals.
Number: NOT–OD–16–094. Retrieved from https:// www.whitehouse.gov/the-press-office/2015/01/30/ Some commenters encouraged
grants.nih.gov/grants/guide/notice-files/NOT-OD- fact-sheet-president-obama-s-precision-medicine- dropping the proposal to require
S6 16-094.html. initiative.
E consent for research use of
UL 7HHS. Draft Guidance on Disclosing Reasonably 10Collins FS, Varmus H. A New Initiative on
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SK3 03policy2.html. 20150917-2.pdf. consultation. A few commenters
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Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations 7153
suggested that Common Rule 2. Response to Public Comments on of HHS to publish a list of activities that
departments and agencies fund pilot Structural, Conceptual, and Policy are minimal risk (as was proposed in the
studies to better understand how such a Implications of the Proposed Rule NPRM in the definition of minimal
system might work. Additional The final rule differs in numerous, risk). The final rule retains the
commenters focused on the importance major ways from what was proposed in requirement at §ll.110(a) that the
of public education about the research the NPRM. Most significantly, the Secretary of HHS will establish and
enterprise regardless of the policy provisions relating to making publish for public comment a list of
choices pursued in a final rule. nonidentified biospecimens subject to categories of research that may be
Commenters, including state health the Common Rule are not being reviewed by an IRB through the
departments and other health entities implemented. That change alone expedited review procedure, consistent
involved in newborn screening addresses many of the public comments with the pre-2018 rule.
activities, raised concerns that several of on the NPRM. Eliminating that proposal Some of the ‘‘new ideas’’ for altering
the NPRM proposals represented is intended to address concerns about the system for protecting research
unfunded mandates, specifically the the complexity of and lack of subjects that were presented by
expansion of the definition of human justification for the proposed changes in commenters—for example, addressing
subject to include all biospecimens the rule, as well as concerns about compensation for research-related
regardless of identifiability, expansion embarking on significant changes injuries or the meaning of equivalent
of the policy to apply to all clinical without evidence that they would protections when research is conducted
trials that meet certain conditions, and improve the system. Responses to in foreign countries—were either very
mandatory single IRB review of public comments on specific provisions innovative or not yet widely discussed.
appear throughout this preamble. Below This made it difficult to adopt them at
cooperative research. Several
we summarize our responses to this point without further study and
institutions and disease advocacy
comments that addressed major additional notice and opportunity for
groups noted that statewide newborn
structural or organizational issues or public comment. Therefore, the fact that
screening programs are often modestly
perceived insufficiencies in the NPRM one or another of these ideas was not
funded, and the NPRM proposals would
proposals and their presentation. incorporated into the final rule should
impose processes that could cost
Concerns about the overall not be viewed as a rejection of their
millions of dollars each year.
complexity of the proposed changes possible merits, or an indication that
In addition, commenters raised have been addressed in several ways. they might not be explored in some
concerns that HHS and other Common For example, concerns about creating a future revision of the Common Rule or
Rule departments and agencies are not new category of ‘‘excluded’’ activities in guidance.
authorized under 42 U.S.C. 289 to have been addressed by not adopting
a. Process Issues
regulate humanities and social science that concept in the final rule. Instead,
research. the goal of clarifying what is covered by We carefully considered concerns
Public comments also discussed the rule has been accomplished by voiced by commenters about the process
several ideas for consideration in a final modifying the definition of what that led to this final rule, and other legal
rule that were not otherwise proposed constitutes research, and by adding or concerns about the adequacy of that
in the NPRM, including: modifying exemptions that were already process. We concluded that the
• Develop or strengthen sanctions in the pre-2018 rule.12And, even where approach proposed in the NPRM and
existing concepts are modified, we have the approach adopted in this final rule
and penalties for investigators or
attempted to make those modifications are consistent with the Federal
institutions that re-identify subjects
in ways that minimize the extent of the Government’s obligations under the
without proper authorization or review,
change (such as largely preserving much Administrative Procedure Act.
rather than focusing solely on obtaining
of the core structure of the previous Regarding the concerns expressed that
consent as the way to protect subjects.
exemption categories). the Common Rule departments and
To this end, several commenters
To reduce public concerns about the agencies are not authorized to regulate
suggested that a separate section be
aspects of the proposal that were not yet humanities and social science research,
added to the Common Rule focused on
developed, we chose not to implement this challenge had been asserted
investigator responsibilities.
most of those provisions. For example, previously against the 1981 HHS
• Develop an IRB efficiency rating given the changes made to the proposals protection of human subjects
system. regarding broad consent, the final rule regulations,13as well as the 1991
• Deem research about IRB operations does not reference or include the Common Rule,14and in each case the
as an excluded, exempt, or expeditable concept of broad consent templates. The regulatory agencies concluded that the
activity to foster research into IRB requirement that the Secretary of HHS regulation of humanities and social
operations. develop a list of proposed privacy science research is justified. We
• Include provisions about safeguards has been eliminated, as has continue to assert the authority to
the proposed exemption decision tool. regulate humanities and social science
compensation for research-related
In addition, we have dropped the research that falls within the scope of
injuries.
regulatory requirement for the Secretary the final rule.
• More fully review and address how
the rule should or should not apply to 12For purposes of this preamble, the terms ‘‘pre- 13Federal Regulations Amending Basic HHS
ES6 prisoners, children, and pregnant 2018 requirements’’ or ‘‘pre-2018 rule’’ refer to the Policy for the Protection of Human Research
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RO funded studies in developing countries originally published on June 18, 1991 and documents/19810126.pdf.
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7154 Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations
C. Signatories to the Common Rule subpart A. (See Pub. L. 103–296 §106(b), entities; effective and compliance dates;
108 Stat. 1464, 1476.) and severability.
This section provides information
The Department of Labor (DOL),
about where each Common Rule A. IRBs Not Operated by an Institution
which was not a signatory to the pre-
department or agency’s statutory Holding a Federalwide Assurance
2018 rule, is now a signatory to this
authority for enacting and revising (§ll.101(a)(1))
rulemaking and is codifying the final
human subjects research protection
rule in DOL regulations for human 1. Background and Pre-2018
regulation lies, and provides additional
subjects research that DOL conducts or Requirements
information about new signatories to the
supports.
Common Rule.
Before this final rule, IRBs not
The Consumer Product Safety
The regulations are codified in each operated by an institution holding an
Commission (CPSC), subject to
department or agency’s title or chapter FWA were not directly subject to
Commission vote, intends to adopt this
of the CFR. The Common Rule was oversight for compliance with the
rule through a separate rulemaking.
based on HHS’s regulations, 45 CFR part Common Rule. In situations in which an
46, subpart A, and includes identical The legal authority for the institution relied on an IRB not operated
language in the separate regulations of departments and agencies that are by the institution, OHRP’s practice was
each department and agency. signatories to this action is as follows: to hold the institution engaged in
Although they did not previously Department of Homeland Security, 5 human subjects research accountable for
issue the Common Rule in regulations, U.S.C. 301; Pub. L. 107–296, sec. 102, compliance violations, even in
four departments and agencies have 306(c); Pub. L. 108–458, sec. 8306. circumstances in which the regulatory
historically complied with all subparts Department of Agriculture, 5 U.S.C. 301; violation was directly related to the
of the HHS protection of human subjects 42 U.S.C. 300v–1(b). Department of responsibilities of the IRB.
regulations at 45 CFR part 46. These are Energy, 5 U.S.C. 301; 42 U.S.C. 7254; 42
An institution might rely on an IRB
the Central Intelligence Agency (CIA), U.S.C. 300v–1(b). National Aeronautics
not operated by that institution to
the Office of the Director of National and Space Administration, 5 U.S.C. 301;
review cooperative research, that is,
Intelligence (ODNI), the Department of 42 U.S.C. 300v–1(b). Department of
research conducted at more than one
Homeland Security (DHS), and the Commerce, 5 U.S.C. 301; 42 U.S.C.
institution. However, for some, such
Social Security Administration (SSA). 300v–1(b). Social Security
reliance has been considered
Pursuant to Executive Order 12333 of Administration, 5 U.S.C. 301; 42 U.S.C.
problematic due to lack of direct
December 4, 1981, as amended, 289(a). Agency for International
elements of the Intelligence Community Development, 5 U.S.C. 301; 42 U.S.C. regulatory accountability for these IRBs.
must comply with the guidelines issued 300v–1(b), unless otherwise noted. Previously, the choice to have
by HHS regarding research on human Department of Housing and Urban cooperative research reviewed by a
subjects found in 45 CFR part 46. This Development, 5 U.S.C. 301; 42 U.S.C. single IRB was voluntary and, for
final rule does not supersede the 300v–1(b) and 3535(d). Department of federally funded research, most
Executive Order. The CIA will continue Labor, 5 U.S.C. 301; 29 U.S.C. 551. institutions have been reluctant to
to adhere to the HHS regulations at 45 Department of Defense, 5 U.S.C. 301. replace review by their own IRB with
CFR part 46, pursuant to the Executive Department of Education, 5 U.S.C. 301; review by a single IRB not operated by
Order. 20 U.S.C. 1221e–3, 3474; 42 U.S.C. that institution.
300v–1(b). Department of Veterans
Through this rulemaking, DHS is 2. NPRM Proposal To Cover IRBs not
Affairs, 5 U.S.C. 301; 38 U.S.C. 501,
codifying the final rule into its own Operated by an Institution Holding an
7331, 7334; 42 U.S.C. 300v–1(b).
agency regulations. DHS, which was FWA
Environmental Protection Agency, 5
created after issuance of the pre-2018
rule, has been required by statute (Pub. U.S.C. 301; 7 U.S.C. 136a(a) and For the reasons outlined above, and
L. 108–458, title VIII, section 8306) to 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. based on comments to OHRP’s 2011
comply with 45 CFR part 46, or with 201, Pub. L. 109–54, 119 Stat. 531; and ANPRM, the NPRM proposed adding a
equivalent regulations promulgated by 42 U.S.C. 300v–1(b). Department of new provision at §ll.101(a) that
the Secretary of Homeland Security or Health and Human Services, 5 U.S.C. would explicitly give Common Rule
his designee. Through this rulemaking, 301; 42 U.S.C. 289(a); 42 U.S.C. 300v– departments and agencies the authority
DHS is issuing equivalent regulations, 1(b). National Science Foundation, 5 to enforce compliance directly against
consistent with statute, and will comply U.S.C. 301; 42 U.S.C. 300v–1(b). IRBs that are not operated by an FWA-
with the DHS regulations as the Department of Transportation, 5 U.S.C. holding institution (sometimes referred
requirements will be equivalent to 301; 42 U.S.C. 300v–1(b). to as ‘‘independent IRBs’’). Under the
compliance with HHS regulations at 45 II. To what does this policy apply? pre-2018 rule, even if an institution
CFR part 46, subpart A. engaged in research relied on an IRB
Scope and Applicability of the operated by another FWA-holding
Through this rulemaking, SSA is
Regulations institution, OHRP’s practice has been to
codifying the final rule into its own
enforce compliance through the engaged
agency regulations. SSA was separated This section of the preamble describes
institution and not the reviewing IRB.
from HHS in 1995 and, pursuant to the changes made in the final rule with
transition rules provided in Section 106 regard to its scope and applicability. Relatedly, another NPRM proposal
of title 1 of Pub. L. 103–296, has been Specifically, it addresses which entities would require single IRB review of
S6
E required to apply regulations that are subject to the rule; coverage of multi-institution studies (see Section XII
UL
R applied to SSA before the separation, clinical trials; department and agency of this preamble). This proposal would
with absent action by the Commissioner. discretion in applying the rule; the place responsibility for meeting the
D
RO With this rulemaking, SSA will follow relevance of state and local laws; relevant regulatory requirements on the
P
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K3 HHS regulations at 45 CFR part 46, harmonizing guidance across the federal engaged in the research.
S
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Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations 7155
3. Public Comments that is not federally conducted or receive federal support to conduct
supported has not been subject to the research subject to the regulatory
Approximately 50 comments
Common Rule’s requirements unless the requirements than they do with
addressed this proposal, largely in
U.S. institution receiving federal institutions that receive such support
support, because it would encourage
funding for research voluntarily for only exempt human subjects
institutions to rely on IRBs not operated
extended the Common Rule to all research.
by an FWA-holding institution when
research conducted at that institution, The NPRM proposed that a clinical
necessary and would place
regardless of funding source. trial be defined as a research study in
responsibility on the IRB and its
The Institute of Medicine,15the which one or more human subjects are
decisions rather than on the institution
National Bioethics Advisory prospectively assigned to one or more
relying on the IRB’s determination.
Commission,16and others have stated interventions (which may include
Commenters stated that this change
that human subjects would be best placebo or other control) to evaluate the
could increase IRB accountability and
protected by applying consistent ethical effects of the interventions on
protect institutions relying on IRBs that
standards and a uniform system of biomedical or behavioral health-related
they do not operate. However, a few
regulatory oversight to all human outcomes. By the term ‘‘behavioral
commenters supported the proposal
subjects research conducted in the health-related outcomes,’’ the NPRM
only if the mandate for a single IRB of
United States. Common Rule recognized that clinical trials may occur
record in multi-institutional research
departments and agencies do not have outside of the biomedical context, and
was not implemented. That is, they
statutory authority to directly apply the further stated that the studies addressed
supported the concept of holding IRBs
Common Rule to all human subjects in the proposed definition of clinical
not operated by the institution engaged
research conducted in the United States. trial are more likely to present more
in research accountable for compliance,
However, departments and agencies can than minimal risk to subjects, and,
but did not support it if it was intended
require U.S. institutions that receive therefore, require the highest level of
solely to facilitate mandatory single IRB
some federal funding from a Common oversight.
review for cooperative research, because
Rule department or agency for research
they opposed that mandate. One 3. Public Comments
with human subjects to extend
organization that advocates for human
regulatory protections to all research Approximately 70 comments
subjects protections opposed the
studies conducted at the institution as a discussed the proposal to extend the
proposal because it did not believe that
condition of funding. The 2011 ANPRM Common Rule to cover certain clinical
any research should be reviewed by an
sought comment on this approach. trials. Opinion was mixed, with a slim
independent IRB, and feared this
majority opposing the proposed change.
practice would become more frequent 2. NPRM Proposal
Universities and medical centers
with this change. Several academic
The NPRM proposed changes in the providing comments largely opposed
institutions opposed the proposal, as
regulatory language to extend the rule to the proposed measure, while
did a large trade organization, stating all clinical trials, irrespective of funding professional associations and advocacy
that this extension of the rule was not source, that met three conditions: (1) groups largely supported the proposal.
necessary. The clinical trials are conducted at an We note that some of those who
4. Response to Comments and institution that receives support from a opposed the clinical trial extension did
Explanation of the Final Rule: Authority federal department or agency for human so because they felt that the proposal
To Enforce Compliance Directly Against subjects research that was not proposed did not go far enough to include
IRBs Not Operated by an FWA-Holding to be excluded under the NPRM and additional types of research.
Institution was not exempt; (2) the clinical trials Those supporting the proposed
are not subject to FDA regulation; and change indicated that it had the
New language at §ll.101(a) is
(3) the clinical trials are conducted at an potential to ensure greater consistency
adopted that gives Common Rule
institution located within the United of rules and protections for research
departments and agencies the authority
States. subjects, thereby aiding efficiency and
to enforce compliance directly against
The purpose of the proposed clinical speeding the review process of study
IRBs that are not operated by an assured
trials extension was to ensure that protocols. However, even those
institution. This authority will allow
clinical trials involving significant risks commenters who supported the
Common Rule departments and
that would otherwise not be covered be proposal indicated that such an
agencies to avoid involving other
subject to federal oversight. It was for extension must fulfill the intent of a
engaged institutions in enforcement
that reason that the proposed extension risk-based, streamlined approach to
activities related to the responsibilities
excluded clinical trials subject to FDA human subject protection, considering
of the designated IRB. It is anticipated
oversight. The proposed extension also the effects of this extension on certain
that this change will reassure
was based on whether an institution minimal risk research activities, such as
institutions using an IRB that they do
received funding specifically for other student research, and social, behavioral,
not operate because compliance actions
human subjects research that had to and educational research.
could be taken directly against the IRB comply with the substantive Those expressing opposition to this
responsible for the regulatory requirements of the Common Rule. The expansion of coverage noted concerns
noncompliance, rather than against the Common Rule departments and that: (1) Because the research
institutions that relied on that review. agencies have a more substantial institutions likely to engage in clinical
S6 B. Coverage of Clinical Trials relationship with institutions that trials already require IRB review of such
E research, the expansion would only
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RO The Common Rule has historically Protecting Research Participants. Washington, DC: this type of research without a
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SK3 Rule department or agency. Research Human Participants. Bethesda, MD; 2001. extension to nonfederally funded
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7156 Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations
clinical trials would encompass many accruing to subjects or the research determination would be made that a
minimal-risk social and behavioral enterprise. particular activity involves more than
research activities and currently minimal risk. Thus, there would be a
4. Response to Comments and
unregulated institutional activities that very real possibility that such a rule
Explanation of the Final Rule: Coverage
involve randomization (such as would lead to an administrative burden
of Certain Clinical Trials
nonfederally funded quality on substantially more activities than the
improvement or quality assurance The final rule does not adopt the rule itself would be targeting (such as
activities); and (3) because an NPRM proposal. Although we continue many minimal risk quality improvement
institution’s funding status may change, to maintain the position that increased activities).
implementation of this proposal would harmonization of appropriate standards We also considered the alternative of
be complicated. Several commenters for ethical oversight of human subjects maintaining the pre-2018 standard of
expressed concern about the lack of research is an important and desirable allowing institutions to voluntarily
detail in the NPRM regarding the endpoint, we agree with the concerns extend their FWAs to nonfederally
planned implementation of the expressed by commenters suggesting funded research. We concluded that this
proposed requirement. that our proposal for extending the alternative would not further the
Several commenters also expressed Common Rule to currently unregulated expressed goal of increasing the
concern that the unfunded clinical trials clinical trials would benefit from further application of consistent protections to
encompassed by this proposal would be deliberation. Some commenters asserted clinical trials, regardless of the source of
that, in our attempt to close the support, because the extension of the
subject to the single IRB mandate
perceived ‘‘gap’’ in oversight, the NPRM FWA would be optional. We therefore
without a corresponding provision of
created a structure that would be both plan to implement the proposed
federal funds to implement that
confusing and complicated for nonregulatory change to the assurance
requirement.
institutions to implement. We received mechanism to eliminate the voluntary
Some commenters suggested that the
multiple comments objecting to the extension of the FWA to nonfederally
proposed change in the NPRM will not
administrative complexity involved in funded research.
address the real gap in human subjects
applying a regulatory extension We note the concern expressed by
protections—facilities that receive no
triggered by the receipt of Common Rule commenters that a gap in federal
federal funding—and that if broad
department or agency funding for other oversight will remain for nonfederally
concern exists that some subjects are not
nonexempt research, and asserting that funded research, and the comment that
being adequately protected in research
the administrative burden is not offset Congress would be the appropriate body
that is not federally funded, then
by a corresponding increase in the to address any such deficiency through
Congress would be the appropriate body
meaningful protection of human legislation. We recognize that
to address any such deficiency through
subjects. Additionally, it is apparent institutions may choose to establish an
legislation. Further, some commenters
from the public comments received that institutional policy that would require
expressed concern that extending the
our intention to apply the Common Rule IRB review of research that is not
Common Rule to nonfederally funded
to cover the most risky types of funded by a Common Rule department
clinical trials might have an overall
research—clinical trials—was not or agency (and indeed, as commenters
effect of decreasing human subject
accomplished through the NPRM noted, almost all institutions already do
protections by discouraging some
proposal, given the definition of this), and nothing in this final rule
smaller organizations from accepting
‘‘clinical trial’’ included in the NPRM, precludes institutions from providing
any federal funding, thus removing
as that definition encompassed research protections to human subjects in this
federal oversight of their work.
that would pose no more than minimal way. As a result, the final rule continues
One research institution noted that, if risk to subjects. Commenters were to allow institutions the same wide
finalized, the proposed clinical trials further concerned that an unintended degree of flexibility that they currently
extension would be implemented at the consequence might be that the proposed have with regard to making other
same time the ability of institutions to extension would apply to low-risk similar determinations regarding ethical
formally extend the application of the student research and social, behavioral, oversight of research not regulated by
rule to all research conducted at the or educational research, and would the Common Rule.
institution is being eliminated. Some cause currently unregulated Although we are not implementing
states, such as Virginia, have state institutional activities, such as certain the proposed extension of the Common
human subjects regulations that must be quality improvement or quality Rule to ‘‘clinical trials’’ (as defined by
applied to research when federal assurance activities, to fall within this policy), the proposed definition of
regulations are not required. The regulatory oversight. Upon reflection on ‘‘clinical trial’’ is still relevant to the
commenter noted that removing the the perspectives expressed by these final rule provision requiring posting of
option to voluntarily extend the FWA commenters, we are persuaded that the one IRB-approved consent form used to
would have the effect of reducing proposed extension of the Common enroll subjects for a clinical trial
uniform application of the federal Rule is not appropriate to include in a conducted or supported by a federal
standards, as nonfederally funded final rule at this time. We will continue department or agency, at §ll.116(h).
research that does not meet the to carefully consider the related issues. The definition of clinical trial is
proposed definition of a clinical trial As an alternative, we contemplated unaltered from the NPRM proposal and
would by default be subject to state law. explicitly limiting the extension of this appears at §ll.102(b).
A few commenters challenged policy to clinical trials that present
S6 C. Activities Deemed Not To Be
E whether the legal authority provided by greater than minimal risk to subjects in
RUL the Public Health Service Act was order to better align with the intent of Research Appear at §ll.102(l) and
with sufficient to extend the Common Rule to this extension, as described in the Research Exempt From This Policy
ROD nonfederally funded clinical trials. preamble to the NPRM. However, such Appears at §ll.104
P
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Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations 7157
activities as excluded is not included in be required when those additional department or agency is covered by the
the final rule. The final rule reverts to requirements apply to entities outside of Common Rule (§ll.101(c)) and that
the general structure of the pre-2018 the federal department or agency itself. authority continues under the final
rule and integrates some of the This latter requirement was intended to regulations, but with the new limitation
categories proposed for exclusion in the promote harmonization among federal that this judgment must be consistent
NPRM into that structure. Some changes agencies or departments, to the extent with the ethical principles of the
to the categories are also included in the possible, and to ensure transparency Belmont Report. This discretion
final rule. between funding entities and the provides important flexibility given the
In the final rule, some of the proposed regulated community. varying missions and policies of the
exclusions from the requirements of the Finally, at §ll.101(i) the NPRM many departments and agencies.
Common Rule are addressed in the proposed to amend the criteria for a Although some commenters were
definition of research, which includes a department or agency waiving the opposed to ever granting departments or
provision identifying ‘‘activities that are applicability of some or all of the agencies the authority permitted by
deemed not to be research’’ (see Section provisions of the policy, by stating that §ll.101(c), we believe requiring that
III). In addition, some of the proposed the alternative procedures to be these decisions be consistent with the
exclusions are included as exemptions followed must be consistent with the principles of the Belmont Report is an
in the final rule. Under §ll.101(b) of principles of the Belmont Report. The approach that promotes accountability
the pre-2018 rule, six categories of addition of this provision was to make while still giving federal departments
research were considered exempt from explicit the ethical basis underpinning and agencies the necessary flexibility to
this policy unless otherwise required by how waiver decisions have and must be achieve their respective missions.
department or agency heads. In the final considered. The NPRM also proposed The final rule in §ll.101(d) does
rule, exempt research is now described that such waivers be posted on a not adopt the NPRM proposals, and
at §ll.104 and eight categories are publicly accessible federal Web site. instead retains the pre-2018 language.
The NPRM proposed to modify
included (see Section V). 3. Public Comments
§ll.101(d) to say that department or
D. Department or Agency Discretion in Approximately 25 comments related agency heads could require additional
Applying the Policy (§ll.101(c), (d), to the NPRM proposals at §ll.101(c) protections to research activities
(i)) and (i) and none on §ll.101(d). conducted or supported by federal
Comments received on these proposals departments or agencies, but that were
1. Background and Pre-2018
generally expressed opposition to ever not otherwise covered by the Common
Requirements
granting the authority to department or Rule. This language was intended as a
The pre-2018 requirements included agency heads to retain final judgment as clarification to the pre-2018 language.
provisions at §ll.101 that allowed to whether a particular activity is However, we determined that the term
federal department or agency heads to covered by this policy, or to waive ‘‘additional protections’’ could
determine which specific activities or certain requirements, even though these potentially be confusing in that the
classes of activities are covered by the provisions existed in the pre-2018 rule. activities at issue in this provision are
rule and whether certain requirements These commenters were concerned those for which no Common Rule
could be waived. This flexibility was about the potential for Common Rule protections are required; thus the
allowed in recognition of the varying departments and agencies to exclude protections imposed by department or
missions of the federal departments and certain activities for political purposes agency heads might be the only
agencies, the possibility that there may or for expediency, such as certain protections to which these activities are
be superseding or alternative statutes or activities that might involve subject. We also note that departments
regulations governing their activities, surveillance or criminal investigative or agencies conducting or supporting an
and the possibility that a given situation aims. With regard to §ll.101(i), some activity subject to the Common Rule
requires either more stringent oversight commenters stated that reference to the may require additional protections for
(e.g., ‘‘sensitive research’’) or reduced ethical principles of the Belmont Report human subjects.
requirements (e.g., a public health was too narrow. That is, one might rely The final rule also does not
emergency). on additional ethical considerations to incorporate the NPRM proposal in
evaluate the applicability of the §ll.101(d) that advance public notice
2. NPRM Proposals
regulations. must be provided when a department or
The NPRM proposed to retain the agency head requires that the Common
4. Response to Public Comments and
Common Rule’s pre-2018 requirement Rule, or part of it, be applied to research
Explanation of the Final Rule:
that federal department or agency heads activities not otherwise subject to the
Department or Agency Discretion About
retain final judgment about the coverage rule. Upon further assessment, we
Applicability of the Policy
of particular research activities under decided that such a requirement could
the Common Rule (§ll.101(c)) and The final rule adopts the NPRM hinder the ability of a department or
proposed an additional requirement that proposals in §ll.101(c). Thus, under agency to move quickly in cases where
federal department or agency heads §ll.101(c), department or agency the department or agency determined
exercise their authority consistent with heads retain final judgment as to that additional protections are
the principles of the Belmont Report. whether a particular activity is covered warranted.
The NPRM also proposed at by the Common Rule, and this judgment Section ll.101(i) of the final rule
§ll.101(d) that a department or should be exercised consistent with the adopts a majority of the NPRM
S6
E agency may require additional ethical principles of the Belmont Report. proposals. As proposed in the NPRM,
UL
R protections for specific types of research We note that under the pre-2018 §ll.101(i) is modified to require that
with it supports or conducts, or that is requirements Common Rule any alternative procedures adopted by
D
RO otherwise subject to regulation by the departments and agencies retained final departments or agency heads are
P
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K3 However, advance public notice would conducted or supported by that NPRM, §ll.101(i) is modified to state
S
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7158 Federal Register/Vol. 82, No. 12/Thursday, January 19, 2017/Rules and Regulations
that, unless otherwise required by E. State and Local Laws That Provide potential to improve outcomes for tribal
statute or executive order, notice of Additional Protections for Human and minority populations.
these alternative procedures must be Subjects (§ll.101(f)) • Research oversight for categories of
forwarded to OHRP (or any successor 1. Background and Pre-2018 research and activities important in
office), or to the equivalent office within Requirements tribal contexts: Commenters noted
the appropriate federal department or concerns about the proposed changes
The pre-2018 rule specified that the
agency. The pre-2018 rule only listed policy does not affect any state or local related to the exclusion of certain
OHRP (or any successor office) as the laws or regulations that may otherwise categories of activities (e.g., oral history,
office to which notices must be sent. be applicable and that provide biography), addition of exempt
This final rule modification is intended additional protections for human categories of research (e.g., educational
to ensure that if a non-HHS department subjects. The NPRM did not propose tests, surveys, interviews), and
or agency allows for alternative any changes to this statement. However, elimination of continuing review
procedures, the appropriate office questions raised by public comments, as requirements for some studies because
within that same department or agency described below, led to some tribal research review often extends the
receives notification. The final rule clarifications to the final rule. scope of examination beyond
retains the pre-2018 requirement for the individual-level protections to enact
1. Public Comments
notice to also be published in the community-level protections important
Federal Register or in such other Several public comments raised for maintaining the integrity of
manner provided for in department or questions and concerns about the ability culturally significant information and
agency procedures. of tribal nations to require additional practices. Changes to excluded and
protections that might be needed for
The final rule also adopts in exempt categories of research and
research involving American Indian/
§ll.101(i) the NPRM proposal to eliminating some continuing review
Alaska Native (AI/AN) populations.
require that the waiver notice include a requirements, especially where no clear
One tribal government noted the
statement that identifies the conditions mechanism for additional tribal
documented mistrust of research by AI/
under which the waiver will be applied oversight and input has been
AN people and communities, and
and a justification as to why the waiver advocated for specific provisions established, are a cause for concern for
is appropriate for the research, acknowledging the authority and role of the AI/AN community.
including how the decision is consistent tribal nations in overseeing research that
2. Response to Public Comments and
with the principles in the Belmont happens on their lands and with their
Explanation of the Final Rule: State and
Report. citizens. Additionally, this entity noted
Local Laws That Provide Additional
Section ll.101(i) of the final rule that tribal nations do not always have Protections
does not include the NPRM proposal their own regulatory bodies for human
that would have required each federal subject research protections, expressing Consistent with the pre-2018 rule, this
department or agency conducting or concern about external groups deciding final rule retains the language in
supporting the research to establish on what constitute risks and benefits for §ll.101(f)) providing that the
the community.
a publicly accessible federal Web site a Common Rule does not affect any state
list of the research for which a waiver Other AI/AN Population concerns of or local laws or regulations that may
has been issued. We decided that the commenters included: otherwise be applicable and that
rule’s requirement to publish the waiver • Tribal (i.e., group) and individual provide additional protections for
notice in the Federal Register, or in consent for secondary research with human subjects. However, the final rule
such other manner as provided in biospecimens: Commenters noted that adds clarifying language providing that
department or agency procedures, group consent can occur and should the referenced state or local laws or
adequately ensures that the waiver inform the proposed changes in the rule. regulations include tribal laws passed
notice will be available to the public They also noted that broad consent for by the official governing body of an AI/
without also requiring that such notices future, unspecified research use of AN tribe. Thus, if the official governing
be listed on a federal Web site. We note biospecimens presents a challenge to body of a tribe passes a tribal law that
that some departments, such as HHS, the ongoing ability of both tribes and provides additional protections for
currently post such notices on their Web individuals to choose to remove their human subjects, the Common Rule does
sites. data from research, or to understand not affect or alter the applicability of
how their information is being used to such tribal law. (Note that a similar
The final rule thus formally codifies
benefit, or put at risk, themselves or change was also made to §ll.116(i)
in §ll.101(c) and (i) the general
others. and (j) to provide the same
practice that the ethical standards • Tribal and individual consent for clarification.) In addition, for purposes
articulated in the Belmont Report are
research with biospecimens or other
of the exception to the single IRB review
the ethical standards that Common Rule
data from people who are no longer
requirement for cooperative research,
departments or agencies will use in alive: AI/AN groups noted the need to
relating to circumstances where review
determining whether an activity is address protections for biospecimens
by more than a single IRB is required by
covered under this policy or whether to initially collected from living humans
law, §ll.114(b)(2)(i) specifies that
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