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<TITLE>NOT-OD-00-039: REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS NOT-OD-00-039. NIH">
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<pre>REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
Release Date: June 5, 2000 (Revised August 25, 2000)
NOTICE: OD-00-039
<p class=regulartext><b>Update:</b> The following update relating to this announcement has been issued:</p>
<a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-10-139.html">September 24, 2010</a> - See Notice NOT-OD-10-139 Spanish On-line Tutorial on
Human Research Participants Protections Launched by NIH Office of Extramural Research.
(Also see Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html">NOT-OD-08-054</a>)
National Institutes of Health
Policy: Beginning on October 1, 2000, the NIH will require education
on the protection of human research participants for all investigators
submitting NIH applications for grants or proposals for contracts or
receiving new or non-competing awards for research involving human
subjects.
Background
To bolster the Federal commitment to the protection of human research
participants, several new initiatives to strengthen government
oversight of medical research were announced by HHS Secretary Shalala
on May 30, 2000. This announcement also reminds institutions of their
responsibility to oversee their clinical investigators and
institutional review boards (IRBs). One of the new initiatives
addresses education and training. This NIH announcement is developed
in response to the Secretary&rsquo;s directive.
Implementation
Before funds are awarded for competing applications or contract
proposals involving human subjects, investigators must provide a
description of education completed in the protection of human subjects
for each individual identified as key personnel in the proposed
research. Key personnel include all individuals responsible for the
design and conduct of the study. The description of education will be
submitted in a cover letter that accompanies the description of Other
Support, IRB approval, and other information in accordance with Just-
in-Time procedures. The use of a cover letter is also acceptable for
contract proposals. After October 1, 2000, investigators submitting
non-competing renewal applications for grants or annual reports for
research and development contracts that involves human subjects
research must also include a description of such education in their
annual progress reports. This NIH policy will eventually be superceded
by the DHHS Office of Research Integrity&rsquo;s institutional assurance on
the responsible conduct of research, which is described below.
Related Training Requirement
The Office of Research Integrity (ORI), Department of Health and Human
Services, is developing a policy to implement an extension of the
training requirement on the responsible conduct of research (RCR) to
all persons supported by PHS research. The protection of human
subjects in research will be included in the RCR institutional
assurance. A draft of this policy will be posted for comment on the
ORI website in June, 2000.
Educational Resources
While all investigators need education in the basics of human subjects research,
some may elect more intensive study if their work involves especially difficult
topics or special populations. Many institutions already have developed
educational programs on the protection of research participants and have made
participation in such programs a requirement for their investigators. The NIH
does not plan to issue a list of endorsed programs. Rather, the NIH points
out that a number of curricula are readily available to investigators and
institutions. For example, all NIH intramural investigators and research
administrators who oversee clinical projects are required to complete an on-line
tutorial on the protection of human research subjects. This training can be
accessed on the web site of the NIH Office of Human Subjects Research at
<a href="http://ohsr.od.nih.gov/">http://ohsr.od.nih.gov/</a>. While this training module was developed for NIH
staff, it can be used by other institutions seeking to meet training
requirements in this area.
To facilitate education and the development of curricula, the NIH
launched a website on bioethics in 1999.
(See <a href="http://www.nih.gov/sigs/bioethics/">http://www.nih.gov/sigs/bioethics/</a>)This site is replete with resources
(>4500 references) on a broad range of relevant topics, including human subjects
in research, medical and healthcare ethics, and the implications of genetics and
biotechnology. This website also contains a broad set of annotated web links,
including some attached to training programs. In addition, the
University of Rochester has made available its training program for
individual investigators. Their manual can be obtained through
CenterWatch, Inc. (<a href="http://www.centerwatch.com" Title="Link to Non-U.S. Government Site">http://www.centerwatch.com</a>)
To address longer-term needs, the NIH has two program announcements to
support training on ethical issues related to research and human
subjects. The first announcement provides support (T15) for
institutions to conduct short-term courses in research ethics. (See
<a href="//grants.nih.gov/grants/guide/pa-files/PA-99-051.html">http://grants.nih.gov/grants/guide/pa-files/PA-99-051.html</a>) The
primary objectives of the T15 program are to increase knowledge among
investigators regarding research ethics and to protect human
participants in clinical protocols. The second announcement supports
career development of individuals who are committed to a career in
research ethics. These individuals will be able to serve as resources
in the institutions and as catalysts in discussions of critical ethical
issues in research.
(See <a href="//grants.nih.gov/grants/guide/pa-files/PA-99-050.html">http://grants.nih.gov/grants/guide/pa-files/PA-99-050.html</a>)
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=06-09-00">Weekly TOC for this Announcement</A><br>
<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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