RESEARCH ETHICS CASE DISCUSSIONS

NIH Policy on Instruction in the Responsible Conduct of Research

On December 1, 2000, the Office of Research Integrity (ORI) published the final PHS Policy on Instruction in the Responsible Conduct of Research (RCR) <http://ori.dhhs.gov/html/programs/finalpolicy.asp>. The NIH Intramural Program, as a federally funded research program, is required to satisfy the requirements of this policy. The purposes of RCR training are to promote the responsible conduct of research, and to discourage research misconduct and questionable research practices, through education.

All "research staff" in the NIH IRP who have "direct and substantive involvement in proposing, performing, reviewing or reporting research, or who receive research training" will be participating in RCR instruction. That includes senior investigators, tenure-track investigators, staff scientists and clinicians, research and clinical fellows, pre- and postdoctoral trainees, technicians, research nurses, and special volunteers or guest researchers involved in these activities.

Core areas defined for instruction include data acquisition, management, sharing and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; research misconduct; conflict of interest and commitment. Two additional core areas, human subjects and research involving animals, are covered by required courses at the NIH that are not taken by all staff, so they will be included to the extent necessary.

The policy requires one-time training in all of the above areas, to be completed by October 2003. The NIH Committee on Scientific Conduct and Ethics (CSCE) has proposed that the one-time training be met by preparation of a web-based computer module that will cover all the areas, to be taken by all current staff before the deadline and to be incorporated into a web-based orientation package for all new staff.

The policy also requires yearly follow-ups. The CSCE strongly recommends the use of research ethics case discussions, led by a trained facilitator and given to groups of 20-30 people at a time. The Committee has developed this web-site that will contain sets of cases to be used for each topic, has decided that each year a theme will be chosen to be used NIH-wide, and is in the process of training investigators to serve as facilitators.

This year (2001) the theme will be scientific misconduct, to ensure that all staff learn the new definition and the procedures for handling allegations of misconduct. The ICs will have some flexibility in how they choose to carry out the yearly training but will be expected to base it on the theme chosen for that year, since that mechanism will allow us to update staff on new policies in a relatively rapid and all-inclusive way.

The NIH procedure for handling scientific misconduct is outlined in a simplified form in A Guide to the Handling of Scientific Misconduct Allegations in the Intramural Research Program at the NIH.