Research, ethics need close collaboration

Ethics need not be a barrier to research, ethicist says

Research ethics is seen as a nuisance at best, an impediment to progress at worst, says a Cornell University medical ethicist, who adds that a closer collaboration between researchers and ethicists might lead to a change in that perception.

"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 Inmaculada de Melo-Martin, PhD, MS, associate professor of public health in the division of medical ethics at New York's Weill Cornell Medical College.

De Melo-Martin says hospitals and medical centers can foster a culture of ethics in their research programs by insisting on collaboration between researchers and ethicists from the early stages of research. In a recently published paper,1 she describes the establishment of Weill Cornell's research ethics consultation service.

Going beyond IRBs

Institutional review boards (IRBs) are the public face of research ethics, but de Melo-Martin says IRBs and other similar oversight mechanisms that protect human research subjects take a "regulatory approach" that, while necessary, does not delve deeply into ethical analysis. Relying on this regulatory approach alone underemphasizes the ethical concerns that accompany medical research and create a false sense that merely following regulations is enough to achieve ethically responsible research.

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

On the other hand, a research ethics consultation service that can identify ethical problems and issues while a research study is still in development and continue throughout the research process can help researchers understand and work 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," according to Joseph J. Fins, MD, FACP, chief of Weill Cornell's Division of Medical Ethics and director of the Weill Cornell Research Ethics Consultation Service. "Promoting research integrity needs to go beyond regulation — it has to be integrated into the fabric of scientific research."

Institutions that encourage collaboration between ethicists and researchers can promote an environment "that encourages critical reflection on all aspects of research," Fins adds.

The Weill Cornell Research Ethics Consultation Service is composed of faculty in the division of medical ethics, and represents the college's attempt to create a non-regulatory approach to research ethics. Similar to ethics consultations in the clinical setting, research ethics consults are non-confrontational and non-punitive, de Melo-Martin explains.

The service is provided free of charge to Weill Cornell individual investigators and research teams prior to submission of research protocols to their IRB and throughout the course of the studies. This service does not duplicate IRB efforts, de Melo-Martin says, but complements them.

Researchers request research ethics consultations through the college's Institute for Clinical Research (ICR), which 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 is available on the ICR web site at www.med.cornell.edu, and at the Medical Ethics Division web site, www.med.cornell.edu.

Reference

  1. de Melo-Martin I, Palmer LI, Fins JJ. Developing a research ethics consultation service to foster responsive and responsible clinical research. Acad Med 2007;82:900-904.

Source

For more information, contact:

  • Inmaculada de Melo-Martin, PhD, MS, assistant professor, division of medical ethics, Weill Medical College of Cornell University, New York, NY. Phone: (212) 746-1268. E-mail: imd2001@med.cornell.edu.