1. Current required training/Stanford programs
   
   
2. Proposed regulations
   
   
3. Stanford resources
   
   
4. Other resources
   
   

1. RCR Instruction for NIH "Trainees"

     Requirement

All competing applications for NIH training grants must include a description of the formal and informal activities related to instruction on the responsible conduct of research that will be incorporated into the proposed research training program. (See NIH Guide, Volume 21, Number 43, November 27, 1992)

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications.

The NIH encourages institutions to provide instruction in the responsible conduct of research to all individuals in a training program or department, regardless of the source of support.

     Response

At Stanford, this requirement is satisfied by a "Responsible Conduct of Research" Course (Med 255), offered Winter quarter as part of the PRECEPT program in the School of Medicine, directed by Professor Ernle Young. The course meets once a week for eight consecutive weeks. It is recommended for all fellows, but is REQUIRED for those supported by NIH training grants. The course is comprised of lectures and small group discussion sessions. There are no formal examinations, but attendance at 6 of the 8 sessions is required to receive credit for the course. The curriculum for the Winter 2000 course is described online at http://postdocs.stanford.edu/PRECEPT/ethics.html.

2. Instruction in the Protection of Human Subjects

     Requirement

Beginning on October 1, 2000, the NIH required education on the protection of human research participants for ALL investigators submitting applications for NIH funding for research involving human subjects. (See NIH NOTICE: OD-00-039, June 5, 2000) Proposals to the NIH must include a certification that all "key personnel" on the project either have been or will be trained in the protection of human subjects before funding will be awarded.

The NIH notice establishing this requirement went on to say:

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.

     Response

Stanford modified the NIH's online tutorial and made it available on the Stanford web (http://www.stanford.edu/dept/DoR/hs). Stanford extends the requirement to complete this tutorial to all researchers working with human subjects, regardless of their source of funding (see Research Policy Handbook 7.7). Those completing the tutorial record their names in an online data base.

On December 1, 2000, the Office of Research Integrity (ORI) adopted and published the final Public Health Service Policy on Instruction in the Responsible Conduct of Research. The proposed policy would require instruction for all research staff (defined as "staff at the institution who have direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training supported by PHS funds or who otherwise work on the PHS-supported research project even if the individual does not receive PHS support") in the following nine "core instructional areas:"

1. Data acquisition, management, sharing, and ownership
2. Mentor/trainee responsibilities
3. Publication practices and responsible authorship
4. Peer review
5. Collaborative science
6. Human subjects
7. Research involving animals
8. Research misconduct
9. Conflict of interest and commitment
   
   

On February 5, 2001, ORI received a Congressional inquiry raising concerns about the rule-making process used by ORI. In its response, ORI announced that the policy would be suspended while it was under review. The Congressional notice and ORI response are online at http://ori.dhhs.gov/html/programs/congressionalconcerns.asp.

Departmental and other resources available within Stanford University include:

• PIship tutorial
  A required tutorial (either online or in-person) required for all Principal Investigators, including overview discussion of the responsible conduct of research
  
  
• Stanford Center for Biomedical Ethics
  
  
• Stanford Ethics in Society Program
  
  
• IRB Manual for human subjects researchers
  
  
• University policies, including:
  • Principles Concerning Research (Academic Senate, 1971)
  • Scientific misconduct
  • Faculty Conflict of Commitment and Interest
  • On Academic Authorship (Kennedy paper)
  • RPH Chapter 7, policies on human subjects research
  • RPH Chapter 8, policies on use of laboratory animals

There are numerous resources on the internet in this area. The ones below provide a small sampling:

• On Being A Scientist: Responsible Conduct In Research
  National Academy Press, Washington, D.C. 1995
  
  
• NIH Bioethics resources on the web
  A " broad collage of annotated web links"
  
  
• RCR web site developed at UC Santa Cruz
  To "provide individuals and institutions with the tools and resources to refine existing programs or develop new programs to foster the responsible conduct of research"
  
  
• Online tutorials developed at UC Irvine
  Log in as a "guest" and explore tutorials on the protection of human subjects, lab animals, and environmental health & safety