AAAS in Conference to Encourage
Accountability in Human Subjects Research

The cover story of the 22 April issue of Time magazine, "At Your Own Risk," was mentioned by many of the speakers at a conference on ensuring research accountability that took place in Indianapolis, 24-26 April.

But the article and its focus on the rare but tragic outcomes of research on human subjects did not lead the conference speakers to call for changes in the way journalists write about research. Instead, the speakers spoke of altering the conduct of research scientists and institutions, and of the public and private funders who underwrite their work.

"People were concerned about the impact on government regulations of the kind of negative events that get so much publicity," says Mark S. Frankel, a speaker at the event in Indianapolis and director of AAAS’s Scientific Freedom, Responsibility and Law Program. "But this was accompanied by a strong message about the importance of being open with research subjects about risks and their right to withdraw from the research at any time, and the importance of continued monitoring of research efforts on the part of institutions."

AAAS joined 14 other organizations in convening the conference entitled, "Accountability in Clinical Research: Balancing Risk & Benefit." The purpose of the event, which was sponsored by the National Patient Safety Foundation, was to examine accountability in research involving human subjects from the perspectives of patients and their families, research institutions, federal regulatory agencies, and to consider solutions to address public concerns about the safety of such research.

"It is clear that we have the potential for increased polarization between the need to conduct research involving human subjects, and the way that research is being viewed by the public because of things that have happened," says William Hendee, who chaired the organizing committee for the conference and is senior associate dean and vice president, Medical College of Wisconsin in Milwaukee.

Stakeholders Asked to Propose Solutions

The conference brought together "stakeholders," Hendee says, people who represent associations of physicians and nurses, academic health centers, research subjects, federal regulatory agencies, industry, bioethics organizations and public interest groups.

"We asked them to think about how we can achieve greater accountability and safety without interfering with the migration of new products into the patient care arena," Hendee says.

Among the actions being considered are ones that would strengthen and support institutional review boards (IRBs) that are in charge of reviewing and approving research that involves human subjects. This would include programs for voluntary IRB accreditation.

But David Lepay, Senior Advisor for Clinical Science in FDA's Office of the Commissioner suggests that we should not expect IRBs alone to bear responsibility for monitoring and communicating safety data. "This is not what IRBs are principally designed to do."

"Most research institutions are taking part in large, multi-site research programs, and we need a system that will make information meaningful and put data into context," Lepay says. "The federal government is going to have to play a role, as will academic institutions and industry. We all have to make sure that research subjects are protected."

Research as Partnership

The overwhelming theme of the conference focused on the importance of viewing the human research enterprise as a partnership comprised of the government, research institutions, and patients and their families, says Frankel, who organized a panel entitled, "What I am Taking Home From This Conference." He cites two "take home messages."

"First, researchers have to communicate to research subjects that their participation in research may not help them," Frankel says. "While the media and scientists may be jointly responsible for messages that create false hopes, it is the scientific community that must take responsibility for publicly pointing out cases in which research does not go as far as some scientists might claim. This may also include admonishing colleagues to be cautious when presenting their views on the promise of an experimental intervention."

The second message, Frankel says, is that while scientists should always "do the right thing," they need guidance in determining what that means when faced with a range of possible actions. "They would benefit from a support structure to help them identify the right thing to do, and we need to assess whether the educational programs and support structures that are in place are actually effective."

The outcome of the conference was clear, says Hendee. He outlines a course of action for research institutions, suggesting that they improve relations with hospitals and other sources of human research subjects, as well as with the communities in which most of their patients reside. "We must draw institutions and their communities into stronger dialogues that discuss the importance of research, the importance of protecting patients, the importance of accountability." And when things do go wrong, the response must be immediate, Hendee says. "There must be full and open disclosure, and the taking of full responsibility. It’s a very simple rule: You just tell the truth."

Among the topics that he will raise among his academic colleagues in coming months, he says, is the question of how to change an institution before mistakes come to light.

"We call it a transformative moment, when something serious happens," Hendee says. "The question is, can an institution change without that moment. How can we learn from other people’s problems."

—Coimbra Sirica

1 May 2002