[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]
BILLING CODE 4150-36-P