Viewpoint: "From the President to the Principal Investigator: Promoting the Responsible Conduct of Research"

By Chris B. Pascal, J.D., Director, Office of Research Integrity

For several years, the Office of Research Integrity (ORI) has increasingly turned its resources and staff time to the promotion of research integrity and the responsible conduct of research (RCR). While responding to individual incidents of research misconduct remains a core part of ORI's mission, ORI recognizes the need to take affirmative steps, in collaboration with our research partners, to instill key principles of responsible research into the mission, culture, and curricula of research institutions. This expanded mission was announced by the Department of Health and Human Services (HHS) in 2000. At that time, HHS stated that ORI would oversee and direct the research misconduct and integrity activities of the office, including "education and training in the responsible conduct of research, activities designed to promote research integrity and prevent misconduct, and research and evaluation programs." U.S. medical schools are the single largest source of biomedical research sponsored with Public Health Service funds. As a result, ORI relies heavily on AAMC's members to provide leadership in this area.

In ORI's view, responsible research practices are critical to the quality of research. Education in these practices is necessary to develop researchers' skills and competencies not only in integrity issues but also in the actual conduct of the research. Inability to distinguish between a legitimate exclusion of data because of problems with the study, such as a failed technique or an overly diluted catalyst, and the convenient exclusion of data to improve the reported results certainly affects the quality of the research and may lead to false, or falsified, results. Asserting improper authorship on a paper undercuts the common currency of a scientific career. Failure to disclose or manage an important conflict of interest may undermine public confidence in a study's results. All of these examples potentially lessen the quality of research, as well as its integrity. For these reasons, ORI recommends that academic institutions make RCR education a priority.

University leaders are uniquely able to promote system-wide RCR education and responsible research practices. They can show their commitment to research integrity by establishing effective, institution-wide RCR education programs, and demonstrating through their personal behavior the highest degree of integrity and intolerance for aberrant behavior in those under them. In this way, they set the moral tone for the institution. Department chairs can also play a significant role in promoting research integrity because RCR education appears to be most effective when delivered by leaders closest to researchers. Chairs provide more immediate advocacy and feedback to departmental researchers on the importance of integrity issues and, perhaps, provide personal guidance on particular issues. In addition, deans and chairs can play an important role, through advocacy and example, in making sure the medical school and research departments provide formal RCR instruction.

Lab chiefs and principal investigators (PIs) are on the front lines and have the most direct influence on the research practices of other research staff in the lab. Clear guidance by the laboratory chief or PI on what the appropriate norms are for the discipline and how the research staff can navigate these concerns can make a great deal of difference in creating a positive laboratory climate for quality research. Senior investigators can also contribute to responsible research practices by teaching these issues in formal graduate training programs and other RCR courses and by demonstrating such practices in mentoring junior investigators.

To provide support to AAMC member institutions and their individual investigators in promoting RCR, ORI and AAMC have engaged in a number of fruitful collaborations, including co-sponsoring conferences and workshops, developing guidance documents, and addressing other issues related to research integrity. Under our current cooperative agreement with AAMC to fund research integrity activities of scientific and academic societies, 15 projects from 13 societies were funded in the past year. In addition, ORI has a small RCR resource development program to provide funds up to $25,000 to research institutions to develop curricula materials on RCR topics. In the past two years, ORI has funded 28 projects from 27 different institutions. AAMC institutions and their investigators may apply for these awards.

ORI remains committed to fostering research integrity and RCR education in academic medical centers and relies heavily on institutional leaders to provide the ideas, energy, creativity, and commitment of the research community to make advances in this area viable and long lasting. As institutional leaders, you have an important role in fostering integrity in biomedical research to the ultimate benefit of your institutions, departments, laboratories, students and colleagues, and the general public. ORI invites your further contributions in this area.

For more information, visit the Office of Research Integrity Web site.

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