80 FR 59092 - Federal Policy for the Protection of Human Subjects

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

Federal Register Volume 80, Issue 190 (October 1, 2015)

On September 8, 2015, 16 Federal departments and agencies published a proposed rule pertaining to Federal Policy for the Protection of Human Subjects. Due to certain statutory prepublication requirements applicable to HUD rules, HUD was unable to be a signatory to the September 8, 2015, proposed rule. Through this HUD proposed rule, HUD adopts the September 8, 2015, proposal and solicits public comment on the proposal.

[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Proposed Rules]
[Pages 59092-59094]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24831]


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DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

24 CFR Part 60

[Docket No FR-5888-P-01]


Federal Policy for the Protection of Human Subjects

AGENCY: Office of the Assistant Secretary for Policy, Development and 
Research, HUD.

ACTION: Proposed rule.

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SUMMARY: On September 8, 2015, 16 Federal departments and agencies 
published a proposed rule pertaining to Federal Policy for the 
Protection of Human Subjects. Due to certain statutory prepublication 
requirements applicable to HUD rules, HUD was unable to be a signatory 
to the September 8, 2015, proposed rule. Through this HUD proposed 
rule, HUD adopts the September 8, 2015, proposal and solicits public 
comment on the proposal.

DATES: Comment Due Date: No later than 5:00 p.m. on December 7, 2015.

ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2015-0008, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the above

[[Page 59093]]

docket ID number in the ``Enter Keyword or ID'' field and click on 
``Search.'' On the next Web page, click on ``Submit a Comment'' action 
and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Barry L. Steffen, Policy Development 
Division, Office of Policy Development and Research, Department of 
Housing and Urban Development, 451 7th Street SW., Room 8114, 
Washington, DC 20410-8000, telephone 202-402-5926. (This is not a toll-
free number.) Persons with hearing- or speech-impairments may access 
this number through TTY number by calling the Federal Relay Service 
number at 800-877-8339 (this a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal departments and agencies that were signatories to the 
proposed Common Rule, published on September 6, 2015, at 80 FR 53933, 
and HUD (collectively the ``Federal Agencies''), through this proposed 
rule are proposing revisions to modernize, strengthen, and make more 
effective the Federal Policy for the Protection of Human Subjects that 
was promulgated as a Common Rule in 1991. The Federal Agencies seek 
comment on proposals to better protect human subjects involved in 
research, while facilitating valuable research and reducing burden, 
delay, and ambiguity for investigators. The September 8, 2015, proposal 
is an effort to modernize, simplify, and enhance the current system of 
oversight. The Federal Agencies propose these revisions to the 
regulations governing the protection of human subjects because they 
believe these changes would strengthen protections for research 
subjects while facilitating important research.
    Federal regulations governing the protection of human subjects 
recognize that individuals who are the subjects of research may be 
asked to contribute their time and assume risk to advance the research 
enterprise, which benefits society at large. Federal regulations 
governing the protection of human subjects in research have been in 
existence for more than three decades. The Department of Health, 
Education, and Welfare (HEW) first published regulations for the 
protection of human subjects in 1974, and the Department of Health and 
Human Services (HHS) revised them in the early 1980s. During the 1980s, 
HHS began a process that eventually led to the adoption of a revised 
version of the regulations by 15 U.S. Federal departments and agencies 
in 1991. The purpose of this effort was to promote uniformity, 
understanding, and compliance with human subject protections as well as 
to create a uniform body of regulations across Federal departments and 
agencies (subpart A of 45 CFR part 46), often referred to as the 
``Common Rule for the Protection of Human Subjects'' or more succinctly 
the ``Common Rule.''
    Since the Common Rule was promulgated, the volume and landscape of 
research involving human subjects has changed considerably. Research 
with human subjects has grown in scale and become more diverse. 
Examples of developments include: An expansion in the number and type 
of clinical trials, as well as observational studies and cohort 
studies; a diversification of the types of social and behavioral 
research being used in human subjects research; increased use of 
sophisticated analytic techniques for use with human biospecimens; and 
the growing use of electronic health data and other digital records to 
enable very large data sets to be analyzed and combined in novel ways. 
Yet these developments have not been accompanied by major change in the 
oversight system of research involving human subjects, which has 
remained largely unchanged over the last two decades.
    The goals of the September 8, 2015, proposed rule are to address 
overdue changes to the Common Rule; specifically to increase human 
subjects' ability and opportunity to make informed decisions; reduce 
potential for harm and increase justice by increasing the uniformity of 
human subject protections in areas such as information disclosure risk, 
coverage of clinical trials; and facilitate current and evolving types 
of research that offer promising approaches to treating and preventing 
medical and societal problems through reduced ambiguity in 
interpretation of the regulations, increased efficiencies in the 
performance of the review system, and reduced burdens on researchers 
that do not appear to provide commensurate protections to human 
subjects. It is hoped that these changes will also build public trust 
in the research system.
    The full description of the Federal Agencies' proposal is set out 
in the September 8, 2015 rule. By cross-reference to the September 8, 
2015, proposed rule, HUD advises of its adoption of this proposal and 
solicits comment from HUD program participants and the general public 
on the September 8, 2015, proposed Common Rule. HUD's regulation on the 
Protection of Human Subjects is found in 24 CFR part 60. HUD's 
regulation on this subject cross-references to the HHS regulations in 
45 CFR part 46. HUD's regulation at Sec.  60.101, entitled ``Cross-
reference,'' reads as follows: ``The provisions set forth at 45 CFR 
part 46, subpart A, concerning the protection of human research 
subjects, apply to all research conducted, supported, or otherwise 
subject to regulation by HUD.''

II. HUD's Proposed Regulatory Text--No Change Proposed

    HUD's current regulations on the protection of human subjects are, 
by cross-reference, the regulations on the protection of human subjects 
promulgated by HHS, and this proposed rule would apply that approach to 
the September 8, 2015, proposed Common Rule published by 16 U.S. 
Federal departments and agencies.

III. Findings and Certifications

Environmental Impact

    This rule does not direct, provide for assistance or loan and 
mortgage insurance for, or otherwise govern or regulate, real property 
acquisition, disposition, leasing, rehabilitation, alteration, 
demolition or new construction, or establish, revise, or provide for 
standards for construction or construction materials, manufactured 
housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this rule 
is categorically excluded from environmental review under the National 
Environmental Policy Act (42 U.S.C. 4321).

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1531-1538) (UMRA) establishes requirements for federal agencies to 
assess the effects of their regulatory actions on state, local, and 
tribal governments and the private sector. This proposed rule does not 
impose any federal mandates on any state, local, or tribal governments 
or the private sector within the meaning of UMRA.

Executive Order 13132, Federalism

    Executive Order 13132 (entitled ``Federalism'') prohibits an agency 
from publishing any rule that has federalism implications if the rule 
either (1) imposes substantial, direct compliance costs on state and 
local governments, and is not required by statute, or (2) preempts 
state law, unless the agency

[[Page 59094]]

meets the consultation and funding requirements of section 6 of the 
Executive Order. This rule would not have federalism implications and 
would not impose substantial direct compliance costs on state and local 
governments or preempt state law within the meaning of the Executive 
Order.

List of Subjects for 24 CFR Part 60

    Human research subjects, Reporting and recordkeeping requirements.

    Dated: September 9, 2015.
Katherine M. O'Regan,
Assistant Secretary for Policy Development and Research.
[FR Doc. 2015-24831 Filed 9-30-15; 8:45 am]
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