This page provides background information related to:

1. increasing burden of complying with Administrative Panel review requirements, e.g., protocols for human subjects and lab animal research at Stanford
   
   
2. new PHS requirements for mandatory training of all researchers in the responsible conduct of research, encompassing protection of subjects, as well as conflict of interest, research misconduct, publication/authorship, collaborative science, and other topics.
   
   

1. STANFORD ADMINISTRATIVE PANELS

• Administrative Panels for Research Compliance
  a description of the Panels, their membership and charges
  
  
• Annual schedule of Panel meetings
  
  
• Current Panel membership,
  
  • Human Subjects Panels (IRBs):
    • Panel 1 (Medical)
    • Panel 2 (Non-Medical)
    • Panel 3 (Medical)
    • Panel 4 (Medical)
      
      
  • Panel on Lab Animal Care (IACUC)
    
    
  • Panel on Radiological Safety
    
    
  • Panel on Biosafety
    
    
  
  
  

2. NEW EDUCATION REQUIREMENT

On December 1, 2000, the Office of Research Integrity (ORI) adopted and published the final PHS Policy on Instruction in the Responsible Conduct of Research. This will require universities to deliver "a basic program of instruction in the responsible conduct of research" to all "research staff."

     FULL TEXT of the regulation

NOTE: On February 5, 2001, ORI received a Congressional inquiry raising concerns about the "PHS Policy on Instruction in the Responsible Conduct of Research" that was announced on December 1, 2000. In it's response, ORI announced that the policy would be suspended while it was under review. A notice of the suspension was posted on the ORI website February 20, 2001 and submitted for publication in the Federal Register.

Definitions:

"Instruction/Program of Instruction" means completion of an educational activity, such as reading a self-study guide; attending a lecture, formal course, workshop, or seminar; making a presentation; working through a CD-ROM or Internet program; leading or participating in a discussion of case studies; or participating in any other educational activity that is consistent with the terms of the policy.

"Research staff" means 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. The institution may make reasonable determinations regarding which research staff fall within this definition.

The PHS also recommends, but does not require, that the institution consider the need for providing RCR instruction to (1) non PHS-supported research staff at the institution, including those supported by institutional, private, and other governmental sources of support and (2) departmental and sponsored research/administrative staff and other support staff, with instruction relevant to their jobs and roles in the research enterprise (as determined by the institution). This policy does not limit the authority of the institution to expand the policy's scope or to impose broader requirements for "Responsible Conduct of Research" education.

The core instructional areas are defined as:

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
   
   

DEADLINES:

Oct. 1, 2001
Institutional assurance that a program is in place to meet this requirement

Oct. 1, 2003
Completion of initial training for all PHS-funded research staff

These and other requirements stem in part from a situation at the University of Pennsylvania where a patient in a gene therapy trial died. Resulting investigation revealed problems both in the protection of subjects and in the management of conflicts of interest. An editorial in the New England Journal of Medicine by Donna Shalala, September 14, 2000, describes the incident and the Government's response.