Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions, 38343-38345 [2013-15160]
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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
responsibilities regarding the
maintenance and availability of
inventory records of assets. Without this
information or ability to access the
information, after an ownership change,
the Government would be unable to
ascertain whether contractor assets were
properly valuated. The cost principles at
FAR 31.205–52 address the allowability
of certain costs resulting from asset
valuations following business
combinations. In order to administer the
cost principles adequately, the
information required by FAR 52.215–19
is necessary.
Comment: The respondent
commented that the agency did not
accurately estimate the public burden
challenging that the agency’s
methodology for calculating it is
insufficient and inadequate and does
not reflect the total burden.
Response: Serious consideration is
given, during the open comment period,
to all comments received and
adjustments are made to the paperwork
burden estimate based on reasonable
considerations provided by the public.
This is evidenced, as the respondent
notes, in FAR Case 2007–006 where an
adjustment was made from the total
preparation hours from three to 60. This
change was made considering
particularly the hours that would be
required for review within the company,
prior to release to the Government.
The burden is prepared taking into
consideration the necessary criteria in
OMB guidance for estimating the
paperwork burden put on the entity
submitting the information. For
example, consideration is given to an
entity reviewing instructions; using
technology to collect, process, and
disclose information; adjusting existing
practices to comply with requirements;
searching data sources; completing and
reviewing the response; and
transmitting or disclosing information.
The estimated burden hours for a
collection are based on an average
between the hours that a simple
disclosure by a very small business
might require and the much higher
numbers that might be required for a
very complex disclosure by a major
corporation. Also, the estimated burden
hours should only include projected
hours for those actions which a
company would not undertake in the
normal course of business.
Upon consideration of the
respondent’s comments and review of
Fiscal Year 2012 (FY12) Federal
Procurement Data System (FPDS)
information an adjustment is being
made to the estimated annual burden.
Based on FPDS information
approximately 1200 novations and non-
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novated mergers and acquisitions were
recorded in FY12 as descriptions for
modifications. However, it is estimated
that 50 percent or 600 of such actions
will require the contractor to meet the
requirements specified at FAR 52.215–
19. The clause is only required to be
inserted in solicitations and contracts
for which it is contemplated that
certified cost or pricing data will be
required or for which any pre-award or
post-award cost determination will be
subject to Subpart 31.2. The estimate of
hours per response is adjusted upwards
to partly allow for the internal
coordination and analysis before
submitting the information to the
Government as stated by the
respondent. However the significant
adjustment suggested was not made
because, apart from a notification to the
ACO, the requirements of the clause are
passive, requiring contractors to
maintain rather than to create records to
meet the specific requirements for
Government submission, and should be
part of the normal course of doing
business. At any point, members of the
public may submit comments for further
consideration, and are encouraged to
provide data to support their request for
an adjustment.
C. Annual Reporting Burden
Respondents: 600.
Responses per Respondent: 1.
Total Responses: 600.
Hours per Response: 5.
Total Burden Hours: 3000.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1275
First Street NE., Washington, DC 20417,
telephone (202) 501–4755. Please cite
OMB Control No. 9000–0115,
Notification of Ownership Changes, in
all correspondence.
Dated: June 21, 2013.
William Clark,
Acting Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2013–15300 Filed 6–25–13; 8:45 am]
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38343
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of a Department of Health and
Human Services Public Meeting and
Request for Comments on Matters
Related to the Protection of Human
Subjects and Research Studying
Standard of Care Interventions
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice of meeting and request
for comments.
AGENCY:
The Department of Health and
Human Services (HHS) is announcing a
public meeting to seek public input and
comment on how certain provisions of
the HHS requirements related to the
protection of human subjects should be
applied to research studying one or
more interventions which are used as
standard of care treatment in the nonresearch context. HHS specifically is
requesting input regarding how an
institutional review board (IRB) should
assess the risks of research involving
randomization to one or more
treatments within the standard of care
for particular interventions, and what
reasonably foreseeable risks of the
research should be disclosed to research
subjects in the informed consent
process. HHS is seeking participation in
the meeting and written comments from
all interested parties, including, but not
limited to, IRB members, IRB staff,
institutional officials, research
institutions, investigators, research
subject advocacy groups, ethicists, and
the regulated community at large. This
meeting and the written comments are
intended to assist HHS, through the
Office for Human Research Protections
(OHRP), Office of the Assistant
Secretary for Health (OASH), in
developing guidance regarding what
constitutes reasonably foreseeable risk
in research involving standard of care
interventions such that the risk is
required to be disclosed to research
subjects. HHS is seeking input on a
number of specific questions but is
interested in any other pertinent
information participants in the public
meeting would like to share.
DATES: Meeting: The public meeting will
be held on August 28, 2013, from 9 a.m.
to 5 p.m.
Deadline for Registration for
Participants (not Presenting) at the
Public Meeting and Submitting Requests
for Special Accommodations:
Registration to attend the public
meeting and requests for special
accommodations must be received no
later than 5 p.m. on August 14, 2013.
SUMMARY:
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38344
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
Deadline for Registration of Presenters
at the Public Meeting: Registration to
present at the public meeting must be
received no later than 5 p.m. on August
7, 2013.
Deadline for Submission of Written
Comments for the Public Meeting:
Written comments for discussion at the
public meeting must be received no
later than 5 p.m. on August 7, 2013. In
addition to materials submitted for
discussion at the public meeting,
individuals may submit other written
comments after the public meeting, as
specified in the ADDRESSES section of
this notice. These comments must be
received no later than 5 p.m. on
September 9, 2013, for consideration by
HHS.
ADDRESSES: The Public Meeting will be
held at the Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Ave. SW.,
Great Hall, Washington, DC 20201;
Metro: Federal Center SW station.
In addition, we are providing an
alternative to attending the meeting in
person; participants may view the
public meeting via live streaming
technology. Information on that option
is provided in section II.D. of this
notice.
Registration and Special
Accommodations: While there is no
registration fee, individuals planning to
attend the public meeting in person
must register to attend. Registration may
be completed by sending an email to
OHRP@hhs.gov, with the subject line
‘‘Registration for HHS Public Meeting’’;
or a request to register may be sent to:
Registration for HHS Public Meeting,
Office for Human Research Protections,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852. Please
include your name, address, telephone
number, email address, and fax number.
If you would like to present at the
public meeting, please state this in the
registration submission.
Registration to attend the public
meeting will be accepted on a firstcome, first-served basis. If seating
capacity has been reached, you will be
notified that the meeting has reached
capacity.
Registration to present at the public
meeting will be accepted on a firstcome, first-served basis. HHS has
included questions for comment in
section III of this document. Please
identify by number each question you
wish to address in your presentation
and the approximate time requested.
HHS will do its best to accommodate
requests to speak. HHS will determine
the amount of time allotted to each
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presenter and the approximate time that
each oral presentation is scheduled to
begin. Once HHS notifies registered
presenters of their scheduled times,
presenters should submit a copy of each
presentation, identified with docket
number HHS–OPHS–2013–0004, to
https://www.regulations.gov.
Individuals who need special
accommodations should contact staff
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Submission of Comments for the Public
Meeting
Submit electronic comments,
identified with docket number HHS–
OPHS–2013–0004, to https://
www.regulations.gov.
Submit written comments to
Comments for HHS Public Meeting,
Office for Human Research Protections,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Dr.
Jerry Menikoff, Director, Office for
Human Research Protections,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852; phone 240–
453–6900; email
Jerry.Menikoff@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. HHS Protection of Human Subjects
Regulations
HHS, through OHRP, regulates
research involving human subjects
conducted or supported by HHS in
regulations. The HHS human subjects
protection requirements pertain to
several different entities, including the
IRB charged with reviewing non-exempt
human subjects research.
The IRB is an administrative body
that takes the form of a board,
committee, or group, and is responsible
for conducting the initial and
continuing review of research involving
human subjects. The IRB must have
authority to approve, require
modification in (in order to secure
approval), or disapprove all research
activities regulated by HHS. An IRB’s
primary purpose in reviewing research
is to ensure the protection of the rights
and welfare of human research subjects.
In order to approve research, an IRB is
required to make certain
determinations, including that the
following criterion is met:
Risks to subjects are reasonable in relation
to anticipated benefits, if any, to subjects,
and the importance of the knowledge that
may reasonably be expected to result. In
evaluating risks and benefits, the IRB should
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consider only those risks and benefits that
may result from the research (as
distinguished from risks and benefits of
therapies subjects would receive even if not
participating in the research). The IRB should
not consider possible long-range effects of
applying knowledge gained in the research
(for example, the possible effects of the
research on public policy) as among those
research risks that fall within the purview of
its responsibility.
The HHS human subjects protections
further require that, unless this
requirement is waived by the IRB, an
investigator must obtain informed
consent from research subjects prior to
the subjects’ participation in the
research, and that, in this informed
consent process, the subjects must be
provided ‘‘a description of any
reasonably foreseeable risks or
discomforts to the subject.’’
B. OHRP’s Compliance Oversight
Investigation of SUPPORT
On March 7, 2013, OHRP issued a
compliance oversight determination
letter regarding its investigation into
‘‘The Surfactant, Positive Pressure, and
Oxygenation Randomized Trial’’
(SUPPORT) clinical trial (https://
www.hhs.gov/ohrp/detrm_letrs/YR13/
mar13a.pdf), in which OHRP
determined that certain risks related to
the interventions being studied in the
SUPPORT trial were required by the
HHS protection of human subjects
regulations to be disclosed to the
research subjects, and the subjects were
not informed of these risks. OHRP’s
view of the SUPPORT trial, as described
in this determination letter, triggered
extensive public discussions regarding
(1) what risks to subjects are presented
by clinical trials studying interventions
that are standard of care in the clinical
treatment context, such that an IRB
must evaluate those risks in relation to
the anticipated benefits of the research;
and (2) how an IRB should assess
whether those risks are reasonably
foreseeable such that the risks must be
described to subjects in informed
consent. Through the public reaction to
OHRP’s determination letter, HHS has
become aware of differing perspectives
in the scientific, research, and ethics
communities about these issues and
how the relevant requirements of the
HHS protection of human subjects
regulations should apply to research
studying standard of care interventions.
II. Public Meeting
A. Purpose and Scope of the Meeting
The public meeting is intended to
provide an opportunity for broad public
participation and comment concerning
how the HHS human subjects
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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
protections requirements should be
applied to research studying one or
more interventions which are used as
standard of care treatment in the nonresearch context. HHS specifically is
requesting input regarding how an IRB
should assess the risks of research
involving randomization to one of more
standard of care interventions, and what
reasonably foreseeable risks of the
research should be disclosed to research
subjects in the informed consent
process. This meeting and the written
comments are intended to assist HHS,
through the OHRP, OASH, in
developing guidance regarding what
constitutes reasonably foreseeable risk
in research involving standard of care
interventions such that the risk is
required to be disclosed to research
subjects.
While HHS is considering whether
other processes should be incorporated
into OHRP’s compliance oversight
procedures and guidance, including, but
not limited to, consultation with subject
matter experts during the course of a
compliance oversight investigation, and
an administrative process for appealing
OHRP determinations of
noncompliance, this meeting is not
intended to specifically address possible
revisions to OHRP’s compliance
oversight procedures.
B. Format of the Meeting
The meeting will be conducted by a
panel of HHS officials, including the
Director of OHRP. The majority of the
meeting will be reserved for
presentations of comments,
recommendations, and data from
registered presenters. The time for each
presenter’s comments will be
determined by HHS and will be based
on the number of registered presenters.
Presenters will be scheduled to speak in
the order in which they register. Only
the HHS panel members may question
any presenter during or at the
conclusion of each presentation. The
meeting will be recorded and
transcribed.
In addition, written comments will
also be accepted and presented at the
meeting, time permitting, if they are
received by the date specified in the
DATES section of this notice.
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C. Security and Building Guidelines
Because the public meeting will be
located on federal property, for security
reasons any persons wishing to attend
this meeting must register by the date
specified in the DATES section of this
notice. Attendees should allow
sufficient time to go through the
security checkpoints. Attendees should
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arrive at the Hubert H. Humphrey
Building no later than 8:30 a.m.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Guard Service personnel.
• Passing through a metal detector
and inspection of items brought into the
building; note that all items brought to
HHS are subject to inspection.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting in person. The public may not enter
the building earlier than 45 minutes prior to
the convening of the meeting(s). All visitors
must be escorted while in the building.
D. Live Streaming Information
For participants who cannot attend
the public meeting in person there will
be an option to view the public meeting
via live streaming technology.
Information on the option to view the
meeting via live streaming technology
will be posted at a later time on the
OHRP Web site at https://www.hhs.gov/
ohrp. Any other updates to information
on the meeting will be posted on the
OHRP Web site.
III. Issues for Discussion
HHS invites comment at the public
meeting about how an IRB should assess
the risks of research involving
randomization to one or more standard
of care interventions, and what risks of
the research should be disclosed to
research subjects in the informed
consent process. HHS is specifically
interested in public input on the
following questions:
1. How should an IRB assess the risks
of standard of care interventions
provided to subjects in the research
context?
a. Under what circumstances should
an IRB consider those to be risks that
may result from the research?
b. Under what circumstances should
an IRB refrain from considering those
risks as unrelated to the research?
c. What type of evidence should an
IRB evaluate in identifying these risks?
2. What factors should an IRB
consider in determining that the
research-related risks of standard of care
interventions, provided to research
subjects in the research context, are
reasonably foreseeable and therefore
required to be disclosed to subjects?
a. What criteria should be used by the
IRB to evaluate whether the risks to
subjects are reasonably foreseeable?
3. How should randomization be
considered in research studying one or
more interventions within the standards
of care? Should the randomization
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38345
procedure itself be considered to
present a risk to the subjects? Why or
why not? If so, is the risk presented by
randomization more than minimal risk?
Should an IRB be allowed to waive
informed consent for research involving
randomization of subjects to one or
more standard of care interventions?
Why or why not?
4. How, and to what extent, does
uncertainty about risk within the
standard of care affect the answers to
these questions? What if the risk
significantly varies within the standard
of care?
5. Under what circumstances do
potential risks qualify as reasonably
foreseeable risks? For example, is it
sufficient that there be a documented
belief in the medical community that a
particular intervention within the
standard of care increases the risk of
harm, or is it necessary that there be
published studies identifying the risk?
IV. Transcripts
As soon as a transcript of the public
meeting is available, it will be accessible
on the OHRP Web site, https://
www.hhs.gov/ohrp. A transcript also
will be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the PHS FOIA
Office, 7700 Wisconsin Avenue, Suite
#920, Bethesda, MD 20857; telephone
(301) 492–4800; fax (301) 492–4848;
email FOIARequest@psc.hhs.gov.
Dated: June 19, 2013.
Howard K. Koh,
Assistant Secretary for Health.
[FR Doc. 2013–15160 Filed 6–25–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Group on
Prevention, Health Promotion, and
Integrative and Public Health
Office of the Surgeon General
of the United States Public Health
Service, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
In accordance with Section
10(a) of the Federal Advisory Committee
Act, Public Law 92–463, as amended (5
U.S.C. App.), notice is hereby given that
a meeting is scheduled to be held for the
Advisory Group on Prevention, Health
Promotion, and Integrative and Public
Health (the ‘‘Advisory Group’’). The
meeting will be open to the public.
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38343-38345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15160]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of a Department of Health and Human Services Public
Meeting and Request for Comments on Matters Related to the Protection
of Human Subjects and Research Studying Standard of Care Interventions
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice of meeting and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) is
announcing a public meeting to seek public input and comment on how
certain provisions of the HHS requirements related to the protection of
human subjects should be applied to research studying one or more
interventions which are used as standard of care treatment in the non-
research context. HHS specifically is requesting input regarding how an
institutional review board (IRB) should assess the risks of research
involving randomization to one or more treatments within the standard
of care for particular interventions, and what reasonably foreseeable
risks of the research should be disclosed to research subjects in the
informed consent process. HHS is seeking participation in the meeting
and written comments from all interested parties, including, but not
limited to, IRB members, IRB staff, institutional officials, research
institutions, investigators, research subject advocacy groups,
ethicists, and the regulated community at large. This meeting and the
written comments are intended to assist HHS, through the Office for
Human Research Protections (OHRP), Office of the Assistant Secretary
for Health (OASH), in developing guidance regarding what constitutes
reasonably foreseeable risk in research involving standard of care
interventions such that the risk is required to be disclosed to
research subjects. HHS is seeking input on a number of specific
questions but is interested in any other pertinent information
participants in the public meeting would like to share.
DATES: Meeting: The public meeting will be held on August 28, 2013,
from 9 a.m. to 5 p.m.
Deadline for Registration for Participants (not Presenting) at the
Public Meeting and Submitting Requests for Special Accommodations:
Registration to attend the public meeting and requests for special
accommodations must be received no later than 5 p.m. on August 14,
2013.
[[Page 38344]]
Deadline for Registration of Presenters at the Public Meeting:
Registration to present at the public meeting must be received no later
than 5 p.m. on August 7, 2013.
Deadline for Submission of Written Comments for the Public Meeting:
Written comments for discussion at the public meeting must be received
no later than 5 p.m. on August 7, 2013. In addition to materials
submitted for discussion at the public meeting, individuals may submit
other written comments after the public meeting, as specified in the
ADDRESSES section of this notice. These comments must be received no
later than 5 p.m. on September 9, 2013, for consideration by HHS.
ADDRESSES: The Public Meeting will be held at the Department of Health
and Human Services, Hubert H. Humphrey Building, 200 Independence Ave.
SW., Great Hall, Washington, DC 20201; Metro: Federal Center SW
station.
In addition, we are providing an alternative to attending the
meeting in person; participants may view the public meeting via live
streaming technology. Information on that option is provided in section
II.D. of this notice.
Registration and Special Accommodations: While there is no
registration fee, individuals planning to attend the public meeting in
person must register to attend. Registration may be completed by
sending an email to OHRP@hhs.gov, with the subject line ``Registration
for HHS Public Meeting''; or a request to register may be sent to:
Registration for HHS Public Meeting, Office for Human Research
Protections, Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852. Please include your name,
address, telephone number, email address, and fax number. If you would
like to present at the public meeting, please state this in the
registration submission.
Registration to attend the public meeting will be accepted on a
first-come, first-served basis. If seating capacity has been reached,
you will be notified that the meeting has reached capacity.
Registration to present at the public meeting will be accepted on a
first-come, first-served basis. HHS has included questions for comment
in section III of this document. Please identify by number each
question you wish to address in your presentation and the approximate
time requested. HHS will do its best to accommodate requests to speak.
HHS will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
Once HHS notifies registered presenters of their scheduled times,
presenters should submit a copy of each presentation, identified with
docket number HHS-OPHS-2013-0004, to https://www.regulations.gov.
Individuals who need special accommodations should contact staff
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Submission of Comments for the Public Meeting
Submit electronic comments, identified with docket number HHS-OPHS-
2013-0004, to https://www.regulations.gov.
Submit written comments to Comments for HHS Public Meeting, Office
for Human Research Protections, Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Dr. Jerry Menikoff, Director, Office
for Human Research Protections, Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; phone
240-453-6900; email Jerry.Menikoff@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. HHS Protection of Human Subjects Regulations
HHS, through OHRP, regulates research involving human subjects
conducted or supported by HHS in regulations. The HHS human subjects
protection requirements pertain to several different entities,
including the IRB charged with reviewing non-exempt human subjects
research.
The IRB is an administrative body that takes the form of a board,
committee, or group, and is responsible for conducting the initial and
continuing review of research involving human subjects. The IRB must
have authority to approve, require modification in (in order to secure
approval), or disapprove all research activities regulated by HHS. An
IRB's primary purpose in reviewing research is to ensure the protection
of the rights and welfare of human research subjects. In order to
approve research, an IRB is required to make certain determinations,
including that the following criterion is met:
Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of the knowledge
that may reasonably be expected to result. In evaluating risks and
benefits, the IRB should consider only those risks and benefits that
may result from the research (as distinguished from risks and
benefits of therapies subjects would receive even if not
participating in the research). The IRB should not consider possible
long-range effects of applying knowledge gained in the research (for
example, the possible effects of the research on public policy) as
among those research risks that fall within the purview of its
responsibility.
The HHS human subjects protections further require that, unless
this requirement is waived by the IRB, an investigator must obtain
informed consent from research subjects prior to the subjects'
participation in the research, and that, in this informed consent
process, the subjects must be provided ``a description of any
reasonably foreseeable risks or discomforts to the subject.''
B. OHRP's Compliance Oversight Investigation of SUPPORT
On March 7, 2013, OHRP issued a compliance oversight determination
letter regarding its investigation into ``The Surfactant, Positive
Pressure, and Oxygenation Randomized Trial'' (SUPPORT) clinical trial
(https://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf), in which OHRP
determined that certain risks related to the interventions being
studied in the SUPPORT trial were required by the HHS protection of
human subjects regulations to be disclosed to the research subjects,
and the subjects were not informed of these risks. OHRP's view of the
SUPPORT trial, as described in this determination letter, triggered
extensive public discussions regarding (1) what risks to subjects are
presented by clinical trials studying interventions that are standard
of care in the clinical treatment context, such that an IRB must
evaluate those risks in relation to the anticipated benefits of the
research; and (2) how an IRB should assess whether those risks are
reasonably foreseeable such that the risks must be described to
subjects in informed consent. Through the public reaction to OHRP's
determination letter, HHS has become aware of differing perspectives in
the scientific, research, and ethics communities about these issues and
how the relevant requirements of the HHS protection of human subjects
regulations should apply to research studying standard of care
interventions.
II. Public Meeting
A. Purpose and Scope of the Meeting
The public meeting is intended to provide an opportunity for broad
public participation and comment concerning how the HHS human subjects
[[Page 38345]]
protections requirements should be applied to research studying one or
more interventions which are used as standard of care treatment in the
non-research context. HHS specifically is requesting input regarding
how an IRB should assess the risks of research involving randomization
to one of more standard of care interventions, and what reasonably
foreseeable risks of the research should be disclosed to research
subjects in the informed consent process. This meeting and the written
comments are intended to assist HHS, through the OHRP, OASH, in
developing guidance regarding what constitutes reasonably foreseeable
risk in research involving standard of care interventions such that the
risk is required to be disclosed to research subjects.
While HHS is considering whether other processes should be
incorporated into OHRP's compliance oversight procedures and guidance,
including, but not limited to, consultation with subject matter experts
during the course of a compliance oversight investigation, and an
administrative process for appealing OHRP determinations of
noncompliance, this meeting is not intended to specifically address
possible revisions to OHRP's compliance oversight procedures.
B. Format of the Meeting
The meeting will be conducted by a panel of HHS officials,
including the Director of OHRP. The majority of the meeting will be
reserved for presentations of comments, recommendations, and data from
registered presenters. The time for each presenter's comments will be
determined by HHS and will be based on the number of registered
presenters. Presenters will be scheduled to speak in the order in which
they register. Only the HHS panel members may question any presenter
during or at the conclusion of each presentation. The meeting will be
recorded and transcribed.
In addition, written comments will also be accepted and presented
at the meeting, time permitting, if they are received by the date
specified in the DATES section of this notice.
C. Security and Building Guidelines
Because the public meeting will be located on federal property, for
security reasons any persons wishing to attend this meeting must
register by the date specified in the DATES section of this notice.
Attendees should allow sufficient time to go through the security
checkpoints. Attendees should arrive at the Hubert H. Humphrey Building
no later than 8:30 a.m.
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Guard Service personnel.
Passing through a metal detector and inspection of items
brought into the building; note that all items brought to HHS are
subject to inspection.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting in person. The public may not enter the building earlier
than 45 minutes prior to the convening of the meeting(s). All
visitors must be escorted while in the building.
D. Live Streaming Information
For participants who cannot attend the public meeting in person
there will be an option to view the public meeting via live streaming
technology. Information on the option to view the meeting via live
streaming technology will be posted at a later time on the OHRP Web
site at https://www.hhs.gov/ohrp. Any other updates to information on
the meeting will be posted on the OHRP Web site.
III. Issues for Discussion
HHS invites comment at the public meeting about how an IRB should
assess the risks of research involving randomization to one or more
standard of care interventions, and what risks of the research should
be disclosed to research subjects in the informed consent process. HHS
is specifically interested in public input on the following questions:
1. How should an IRB assess the risks of standard of care
interventions provided to subjects in the research context?
a. Under what circumstances should an IRB consider those to be
risks that may result from the research?
b. Under what circumstances should an IRB refrain from considering
those risks as unrelated to the research?
c. What type of evidence should an IRB evaluate in identifying
these risks?
2. What factors should an IRB consider in determining that the
research-related risks of standard of care interventions, provided to
research subjects in the research context, are reasonably foreseeable
and therefore required to be disclosed to subjects?
a. What criteria should be used by the IRB to evaluate whether the
risks to subjects are reasonably foreseeable?
3. How should randomization be considered in research studying one
or more interventions within the standards of care? Should the
randomization procedure itself be considered to present a risk to the
subjects? Why or why not? If so, is the risk presented by randomization
more than minimal risk? Should an IRB be allowed to waive informed
consent for research involving randomization of subjects to one or more
standard of care interventions? Why or why not?
4. How, and to what extent, does uncertainty about risk within the
standard of care affect the answers to these questions? What if the
risk significantly varies within the standard of care?
5. Under what circumstances do potential risks qualify as
reasonably foreseeable risks? For example, is it sufficient that there
be a documented belief in the medical community that a particular
intervention within the standard of care increases the risk of harm, or
is it necessary that there be published studies identifying the risk?
IV. Transcripts
As soon as a transcript of the public meeting is available, it will
be accessible on the OHRP Web site, https://www.hhs.gov/ohrp. A
transcript also will be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the PHS FOIA Office, 7700 Wisconsin Avenue, Suite
920, Bethesda, MD 20857; telephone (301) 492-4800; fax (301)
492-4848; email FOIARequest@psc.hhs.gov.
Dated: June 19, 2013.
Howard K. Koh,
Assistant Secretary for Health.
[FR Doc. 2013-15160 Filed 6-25-13; 8:45 am]
BILLING CODE 4150-36-P
