The Emergence of the Responsible Conduct of Research (RCR) in PHS Policy and Practice

Abstract

The Responsible Conduct of Research (RCR) is now an established academic field taught at virtually every major American research university and generates a growing volume of research and pedagogical literature. Paradoxically, it is a field without a consensually agreed upon definition, goals, foundational theories, research agenda, and pedagogical methodology. It has been suggested that RCR as currently being taught is ineffective in preventing misconduct and improving the quality of research. The following short history of RCR, focused mainly on Federal policy and practice, explains how this curious state of affairs developed and persists and concludes with some suggestions for the future of RCR instruction.

ACKNOWLEDGMENT

This project was supported in part by an appointment of Dr. Raju Tamot and Dr. Diana Arsenieva to the Research Participation Program at the Center for Drug Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration.

Notes

This article is not subject to US copyright law.

1. Public Law 99-158-Nov. 20, 1985; http://history.nih.gov/research/downloads/PL99-158.pdf

2. Key members of the Committee were Dr. William Raub, Dr. Lyle Bivens, and Dr. Lawrence Rhoades.

3. Letter to Chris Pascal, Director of ORI, Office of Public Health and Science, HHS, from W. J. “Billy” Tauzin, Chairman of The House of Representatives Committee on Energy and Commerce, February 5, 2001.

4. In addition to the efforts of ORI to promote responsible practices, the (AAMC) published Teaching the Responsible Conduct of Research Through a Case Study Approach: A Handbook for Instructors in 1994. The NIH sponsored the production of this handbook and it included 34 topically organized case scenarios addressing such issues as authorship standards, peer review, conflict of interest, the use of animal and human subjects, and the ethical implications of genetic research. Similarly, the American Association for the Advancement of Science (AAAS) produced a series of five short video vignettes and a Resource Guide on scientific research integrity in May 1996 (re-released in February 2002). The video vignettes presented realistic and concrete problems and challenged scientists, students, fellows, technicians, and administrators to define ethical problems, identify options for responding, and assess those options in light of their own experiences. They were primarily designed to help improve their ability to develop informed and well-reasoned responses to ethical issues that arise in scientific research. The project was sponsored by AAAS in collaboration with Amram Nowak Associates, Inc. and the Medical College of Georgia. Later in 2003, Shamoo and Resnik published their book Responsible Conduct of Research (re-published in 2009). It provided a comprehensive introduction to the ethical issues at stake in the conduct of biomedical research and included chapters on data management, collaboration in research, mentoring and authorship, publication and peer review, intellectual property, research misconduct, conflicts of interest, and the use of human subjects and animals in research. The contents of this book paralleled the recommendations of the Ryan Commission Report that was published two years later.

5. Accountability in Research (since 1989); Science and Engineering Ethics (since 1995); and Research Ethics (SAGE Journals, since 1995).

6. The authors noted that over 50 diverse and distinct goals were reported by 67 instructors.