How can a medical center foster a culture of ethics in research?

Sep 17 2007

An article published in the September issue of Academic Medicine, titled "Developing a Research Ethics Consultation Service to Foster Responsive and Responsible Clinical Research," argues for the importance of collaboration between researchers and ethicists and describes the establishment of a new Research Ethics Consultation Service at Weill Cornell Medical College.

"While clinical ethics has become a central, and welcome, component of the health-care landscape, many still view research ethics as a nuisance to investigators and an obstacle to science," says lead author Dr. Inmaculada de Melo-Martín, associate professor of public health in the Division of Medical Ethics at Weill Cornell Medical College. Dr. de Melo-Martín, a philosopher with formal training in molecular biology, is a member of the Weill Cornell Research Ethics Consultation Service.

"As recent public debates about conflicts of interest, exploitation of human subjects and scientific fraud remind us, ethical problems also arise within research contexts," she continues.

While Institutional Review Boards (IRBs) and similar oversight mechanisms that protect human subjects are necessary, the authors assert that a merely regulatory approach, devoid of deeper ethical analysis, underemphasizes the ethical concerns inherent in scientific research and promotes the dubious idea that following regulations is all that is needed to achieve ethically responsible research. On the other hand, a Research Ethics Consultation Service that can identify ethical problems and issues while a research study is still in development or throughout the research process can serve as a partner to researchers in understanding and working out potential ethical quandaries.

"It is becoming increasingly clear that collaborations between investigators and research ethicists are as essential as those between physicians and clinical ethicists. Promoting research integrity needs to go beyond regulation -- it has to be integrated into the fabric of scientific research," says senior author Dr. Joseph J. Fins, chief of the Division of Medical Ethics; professor of medicine, public health, and medicine in psychiatry; and director of the Weill Cornell Research Ethics Consultation Service. "By supporting collaborations between ethicists and investigators, institutions can promote an environment that encourages critical reflection on all aspects of research," he says.

The Weill Cornell Research Ethics Consultation Service was formed as a result of the recommendations of the University Research Ethics Advisory Committee (UREAC), a campus-wide committee established in 2002 by former Cornell University President Hunter R. Rawlings III and Weill Cornell Medical College Dean Antonio M. Gotto Jr., to help ensure that the University's biomedical research involving human subjects met the highest ethical standards. UREAC was co-chaired by Dr. Fins, with Dr. Lisa-Staiano-Coico (now Provost at Drexel University), and was composed of clinical researchers, ethicists, lawyers and IRB personnel.

The resulting research consultation service is composed of faculty in the Division of Medical Ethics. In addition to Drs. Fins and de Melo-Martín, the other member is Cathleen A. Acres, R.N., M.A., lecturer in public health and research subject advocate. Oversight of the service is shared by Dr. Alvin I. Mushlin, chairman and Nannette Laitman Distinguished Professor of Public Health, and Dr. Harry Lander, associate dean for research administration at Weill Cornell Medical College.

"The Research Ethics Consultation Service at Weill Cornell Medical College has been an attempt to add a non-regulatory element to the research process," says Dr. Lander. "As with ethics consultations in the healthcare environment, the process is non-confrontational and non-punitive. The aim is to inspire trust among researchers and foster collegiality and shared reflection."

The service is available, free of charge, to provide guidance to Weill Cornell individual investigators and research teams prior to submission of research protocols to the IRB and throughout the course of the study. Members of the Weill Cornell Research Ethics Consultation Service provide timely responses to general and specific questions, and work with researchers throughout the research process. This service is not intended, however, to duplicate IRB efforts, but to complement them.

Researchers can also request research ethics consultations through the Institute for Clinical Research (ICR) at Weill Cornell Medical College. The ICR, part of the Medical School's Office of Research and Sponsored Programs (RASP), assists investigators in the development, negotiation and completion of the contract process for all clinical trials.

The Research Ethics Consultation is now a formal part of the process of the ICR. More details about the services offered and contact information can be found on the ICR Web site at http://www.med.cornell.edu/icr/resources_and_services/bioethics.html, and on the Medical Ethics Division Web site at http://www.med.cornell.edu/public.health/ethics/index.html.

Although the Research Consultation Service is still fairly new, it has been well received by researchers at the Medical College. It is likely to be expanded with the hiring of ethicists with knowledge in a variety of scientific areas.

Larry I. Palmer, L.L.B., professor emeritus in the School of Law at Cornell University and a professor at the University of Louisville School of Medicine, also served on the UREAC Committee and was a co-author of this publication.