REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

Release Date:  June 5, 2000 (Revised August 25, 2000)

NOTICE:  OD-00-039  


Update: The following update relating to this announcement has been issued:


September 24, 2010  - 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 NOT-OD-08-054)

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’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  This NIH policy will eventually be superceded 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’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 
http://ohsr.od.nih.gov/.  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 http://www.nih.gov/sigs/bioethics/)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. (http://www.centerwatch.com)

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 
http://grants.nih.gov/grants/guide/pa-files/PA-99-051.html)  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 http://grants.nih.gov/grants/guide/pa-files/PA-99-050.html)

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