[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38343-38345]
From the Federal Register Online via the Government Publishing 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.

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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 [email protected], 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 http://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 http://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 [email protected].

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 
(http://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 http://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, http://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 [email protected].

    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