[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37460-37463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14917]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information and Comments on the Implementation of
Human Subjects Protection Training and Education Programs
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science, Office for Human
Research Protections.
ACTION: Notice.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science is seeking information and comments from
affected entities and individuals about (a) Whether OHRP should issue
additional guidance recommending that institutions engaged in human
subjects research conducted or supported by the Department of Health
and Human Services (HHS) implement training and education programs for
certain individuals involved in the conduct, review, or oversight of
human subjects research, or (b) whether HHS should develop a regulation
requiring the implementation of such training and education programs.
This request for information and comment stems from the 1998 report
from the HHS Office of Inspector General (OIG) recommending that
Federal requirements be enacted to help ensure that investigators and
institutional review board (IRB) members be adequately educated about,
and sensitized to, human subjects protections. More recently, the
Secretary's Advisory Committee on Human Research Protections (SACHRP)
recommended that OHRP require institutions to ensure that initial and
continuing training is provided for IRB members and staff,
investigators, and certain institutional officials. The implementation
of such training and education programs might help to ensure that
individuals involved in the conduct or review of human subjects
research at institutions holding OHRP-approved Federalwide Assurances
(FWAs) understand and meet their regulatory responsibilities for
protecting human subjects.
DATES: Submit written or electronic comments by September 29, 2008.
ADDRESSES: You may submit comments by any of the following methods:
E-mail: [email protected]. Include ``Human
Subjects Protection Training and Education'' in the subject line.
Fax: 301-402-2071.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health
Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Comments received within the public comment period, including any
personal information, will be made available to the public upon
request.
FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain,
U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, 240-453-6900; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under the HHS regulations for the protection of human subjects,
found at 45 CFR part 46, institutions or organizations that are engaged
in human subjects research that is conducted or supported by HHS must
file with OHRP an assurance of compliance with the human subjects
protection regulations. The assurance must be executed by an individual
authorized to act on behalf of the institution and authorized to
assume, on behalf of the institution, the obligations imposed by the
human subjects protection regulations [45 CFR 46.103(c)]. Thus, to
fulfill his or her regulatory responsibilities, the institutional
official must be knowledgeable about the requirements of the human
subjects protection regulations.
The institution's assurance of compliance must also designate one
or more IRBs to review research covered by the regulations, and the
institution must ensure that each designated IRB has sufficient staff
to support the IRB's activities [45 CFR 46.103(b)(2)]. IRB members must
be sufficiently qualified through experience and expertise and
diversity to promote respect for their advice and counsel in
safeguarding the rights and welfare of human subjects. IRB members also
must have the professional competence necessary to review human
subjects research activities of the institution, including the ability
to ascertain the acceptability of the proposed research in terms of
institutional commitments and regulations, applicable law, and
standards of professional conduct and practice; therefore, members must
be knowledgeable in those areas [45 CFR
[[Page 37461]]
46.107]. Thus, to fulfill their regulatory responsibilities, IRB
members must be informed about human subjects protection requirements.
Investigators involved in the conduct of human subjects research
that is conducted or supported by HHS play a crucial role in protecting
the rights and welfare of human subjects. Investigators have specific
responsibilities under the human subjects protection requirements
related to the conduct of IRB-approved research. For example, no
investigator may involve a human being in research that is conducted or
supported by HHS or covered by the institution's assurance unless the
investigator has obtained the legally effective informed consent of the
subject or the subject's legally authorized representative in
accordance with, and to the extent required by, HHS regulations at 45
CFR 46.116. Moreover, investigators are responsible for providing
required information to the IRB [45 CFR 46.103(b)(5), 46.111].
Investigators are responsible for obtaining prior approval from the IRB
for any modifications of the previously approved research, except those
necessary to eliminate apparent immediate hazards to subjects, and
investigators are responsible for ensuring that progress reports and
requests for continuing review and approval are submitted to the IRB in
accordance with the policies, procedures, and actions of the IRB as
referenced in the institution's OHRP-approved FWA [45 CFR 46.103(b)(4),
45 CFR 46.109(e), 45 CFR 46.115(a)(1)]. Thus, investigators need to be
informed about human subjects protection requirements. The HHS Office
of Inspector General (OIG), in its 1998 Report, ``Institutional Review
Boards: A Time for Reform,'' called for strong Federal action
concerning education of investigators conducting, and IRB members
reviewing, human subjects research (http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf). In that report, the OIG recommended enactment of
Federal requirements that help ensure that investigators and IRB
members are adequately educated about, and sensitized to, human
subjects protections.
In October 2000, the National Institutes of Health (NIH) instituted
a policy that requires education on the protection of human research
participants for all key personnel as a condition of funding grant
applications or contract proposals involving human subjects research
(http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-010061.html).
Key personnel include all individuals who are responsible for the
design and conduct of research studies involving human subjects.
In its 2001 report, ``Ethical and Policy Issues in Research
Involving Human Participants,'' the National Bioethics Advisory
Committee (NBAC) recommended that all institutions and sponsors engaged
in research involving human participants should provide educational
programs in research ethics to appropriate institutional officials,
investigators, IRB members, and IRB staff (http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf). NBAC also recommended that the
Federal Government, in partnership with academic and professional
societies, should enhance research ethics education related to
protecting human research subjects, as well as stimulate development of
innovative educational programs.
In its 2002 report commissioned by HHS, ``Responsible Research: A
Systems Approach to Protecting Research Participants,'' the Institute
of Medicine (IOM) recommended that research organizations should ensure
that investigators, IRB members, and other individuals substantively
involved in research with humans are adequately educated to perform
their respective duties (http://www.nap.edu/books/0309084881/html/).
On March 29, 2007, SACHRP recommended that OHRP require that
institutions ensure that initial and continuing training is provided
for IRB members and staff, investigators, and certain institutional
officials, including the official that signed the institution's FWA.
Over the past several years, OHRP has identified serious, systemic
noncompliance with the requirements of HHS regulations for the
protection of human subjects at a significant number of major
institutions engaged in human subjects research conducted or supported
by HHS. In OHRP's experience, inadequate training and education of
individuals involved in the conduct or review of human subjects
research has been a major root cause of such noncompliance.
OHRP developed the FWA as a new type of assurance in December 2000.
Initially, OHRP proposed that the FWA include requirements for training
and education regarding human subjects protection regulations for
institutional officials, IRB members, IRB staff, investigators and
other institutional personnel. Following public comment on the proposed
FWA, OHRP issued a revised version of the FWA on March 20, 2002 that
strongly recommended, rather than required, such training and
education. This decision was based, in part, on a determination that
rulemaking would be a more appropriate mechanism for requiring such
training and education.
In the current FWA terms of assurance, OHRP strongly recommends
that the institutional official, human protections administrator, and
IRB chairperson(s) designated under the assurance complete the OHRP
Assurance Training Modules available on the OHRP Web site at http://137.187.172.153/CBTs/Assurance/login.asp. Furthermore, OHRP recommends
that the institution and the designated IRB(s) establish educational
training and oversight mechanisms appropriate to the nature of the
institution's research portfolio to ensure that research investigators,
IRB members, IRB staff, and other appropriate personnel maintain
continuing knowledge of, and comply with, relevant ethical principles,
relevant Federal regulations, OHRP guidance, other applicable guidance,
state and local laws, and institutional policies for the protection of
human subjects. OHRP also recommends that IRB members and staff
complete relevant educational training before reviewing human subjects
research; and that research investigators complete appropriate
institutional educational training before conducting human subjects
research.
II. Request for Information and Comments
Based on the recommendations of the OIG, NBAC, IOM, and SACHRP, as
well as OHRP's own experience in compliance activities, which has
revealed that many individuals involved in the conduct or review of
HHS-supported or conducted research at numerous institutions had a
significant gap in knowledge about human subject protections, OHRP is
seeking comment from affected entities and individuals about (a)
whether OHRP should issue additional guidance recommending that
institutions engaged in human subjects research conducted or supported
by HHS implement training and education programs for certain
individuals involved in the conduct, review, or oversight of human
subjects research, or (b) whether HHS should develop a regulation
requiring the implementation of such training and education programs.
The implementation of such training and education programs might help
to ensure that individuals involved in the conduct or review of human
subjects research at institutions holding OHRP-approved FWAs understand
and meet their regulatory responsibilities for protecting human
subjects.
[[Page 37462]]
OHRP specifically seeks comment on the following questions.
Comments should also include a reference to the specific numbered
question being addressed:
(1) For the past 5 years OHRP has strongly recommended through the
Terms of the FWA that:
Institutional signatory officials, human protections
administrators, and the IRB chairpersons personally complete the
relevant OHRP Assurance Training Modules (see http://137.187.172.153/CBTs/Assurance/login.asp), or comparable training that includes the
content of these modules;
Institutions and their designated IRBs establish
educational training and oversight mechanisms (appropriate to the
nature and volume of its research) to ensure that research
investigators, IRB members and staff, and other appropriate personnel
maintain continuing knowledge of, and comply with, the following:
Relevant ethical principles; relevant federal regulations; written IRB
procedures; OHRP guidance; other applicable guidance, state and local
laws; and institutional policies for the protection of human subjects;
IRB members and staff complete relevant educational
training before reviewing human subjects research; and
Research investigators complete appropriate institutional
educational training before conducting human subjects research.
(1a) Have institutions holding OHRP-approved FWAs routinely
implemented OHRP's recommendations?
(1b) What, if any, are the reasons for institutions not
implementing OHRP's recommendations?
(1c) Has any failure of institutions to implement OHRP's
recommendations been a significant contributing factor to noncompliance
with the requirements of 45 CFR part 46 and inadequate protection of
the rights and welfare of human subjects? If so, please provide
examples.
(1d) If failure of institutions to implement OHRP's recommendations
has been a significant contributing factor to noncompliance with the
requirements of 45 CFR part 46 and inadequate protection of the rights
and welfare of human subjects, would promulgation of a regulation
requiring institutions to implement training and education programs for
certain individuals involved in the conduct, review or oversight of
human subjects research be the best mechanism to address this problem,
or should different mechanisms be used (for example, would it be better
if OHRP instead issued additional guidance regarding training and
education programs)?
(1e) Even if there are no data suggesting that failure of
institutions to implement OHRP's recommendations regarding education
and training has been a contributing factor in non-compliance with the
requirements of 45 CFR part 46, are there other sound reasons for
developing further guidance or a regulation regarding education and
training, and if so, what are they?
(2) If HHS decided to propose further guidance recommending, or a
regulation requiring, that institutions implement training and
education programs for certain individuals involved in the conduct,
review, or oversight of human subjects research, which of the following
categories of individuals should receive training and education and
why: IRB chairpersons; other IRB members; IRB staff; principal
investigators; others involved in the conduct of human subjects
research (e.g., co-investigators, study coordinators); FWA signatory
officials; human protection administrators; or any other category of
individuals (please specify)?
(3a) Should further guidance or a regulation include provisions
stipulating specific content for the training and education programs?
If so, what should the specific content include and why (for example,
should a regulation require inclusion of any or all of the following in
the content of the training and education programs: The commitments and
responsibilities of the institution under the FWA; relevant ethical
principles cited in the institution's FWA; relevant Federal regulations
for human subjects protection; OHRP guidance; other applicable
guidance; relevant state and local laws; institutional policies for the
protection of human subjects; or other content (please specify))?
(3b) Should the training and education recommendations or
requirements differ depending upon the nature of the individual's
involvement in research? If so, in what manner?
(3c) Notwithstanding whether training should be tailored according
to an individual's role in the clinical research process, is there a
minimum level of knowledge and skill that should be expected of anyone
working in some aspect of the research enterprise?
(3d) How often should the content of the materials used for this
training be updated?
(4) Should further guidance or a regulation include provisions
stipulating that proficiency in human subjects protection requirements
be demonstrated in some way (please specify)?
(5) Should further guidance or a regulation include recommendations
or requirements for individuals to complete some minimum amount of
training and education prior to any involvement in the conduct, review,
or oversight of human subjects research?
(6) Should further guidance or a regulation include recommendations
or requirements for periodic continuing training and education? If so,
should the guidance or regulation stipulate a specific time interval
for such periodic training and education (for example, should the
regulation require individuals to complete continuing training and
education activities every 1, 2, or 3 years)?
(7) Should further guidance or a regulation include recommendations
or requirements for institutions to prepare and maintain written
procedures for ensuring implementation of the training and education
requirements?
(8) Should further guidance or a regulation include recommendations
or requirements for institutions to prepare and maintain written
documentation that individuals covered by the regulation have completed
the required training and education activities?
(9) If HHS decided to propose a regulation, what would the
estimated costs of the regulation be to institutions in terms of
infrastructure and man-hour costs? OHRP is interested in receiving
specific information on such estimated costs from all types and sizes
of institutions that hold OHRP-approved FWAs. OHRP recognizes that the
HHS human subjects protection regulations extend to a wide-range of
institutions, from very small organizations and businesses that employ
no more than a total of 5-10 individuals, to major academic research
and health centers that may have literally thousands of individuals
affected by any new training and education regulation. When providing
comments regarding cost estimates, please include a description of
assumptions that were made for calculating cost estimated (for example,
assumptions made regarding the number and types of individuals who
would be required to undergo training and education, the modalities
that would be used for delivering the training and education, the time
it would take for covered individuals to complete initial and
continuing training and education, and how often continuing training
and education would need to occur).
[[Page 37463]]
Dated: June 19, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections.
[FR Doc. E8-14917 Filed 6-30-08; 8:45 am]
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