Trust in medical research based on ethics, disclosure
Conference emphasizes overcoming obstacles
Ensuring that medical research is conducted ethically, objectively, and with the trust of the public is getting more difficult, even as the urgency for new research in pharmaceuticals and procedures increases. Presenters at the "Ethics and Trust Across Boundaries," the 2005 Annual Human Research Protection Programs (HRPP) conference held in Boston in December, discussed many of the historical obstacles medical research is still trying to overcome, and offered some suggestions for strengthening research programs.
The HRPP conference is sponsored by Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA). PRIM&R is dedicated to creating, implementing, and advancing ethical standards in the conduct of research, and ARENA’s mission is to enhance human and animal research subject protections and the responsible conduct of research through the educational and professional development of its members.
"In many settings, conflicting interests of research subjects, sponsors, and researchers are seen as insurmountable," says A. Cornelius Baker, a Washington, DC-based health policy consultant who has specialized in public policy regarding people with AIDS.
Chief among those conflicting interests have been issues involving informed consent and conflicts of interest.
The fact that nearly all of today’s medical ethic codes can trace their beginnings to the Nuremberg trials of 1947, when Nazi physicians were tried and imprisoned or executed for conducting inhumane experiments on prisoners of war, can be viewed as one example of the negative impression some people have of medical research. Because minority and ethnic groups were used as subjects in experiments in Nazi concentration camps and in the notorious "Tuskegee syphilis study" that went on in the rural southern U.S. from the 1930s through the 1970s, many minorities have been shown to be mistrustful of clinical trials, and have participated at very low rates. (See Medical Ethics Advisor, April 2005.)
Baker says the Tuskegee experiment "is described as the singular reason for African-Americans’ distrust of the medical community" — not just distrust of medical research. A recent report from the National Institutes of Health, however, indicates that that mistrust may be fading, and that minorities may be as willing as non-Hispanic Caucasians to participate in clinical trials if proximity is not a problem.
Because the federally conducted Tuskegee experiments continued long after the Nuremberg codes were created, they serve as an example that "ethical measures are only as good as the people who carry them out," Baker notes.
Because some physicians don’t know much about current clinical trials themselves, their patients may approach trials with a meager understanding of what they are getting themselves into. Properly informing patients is not only ethically necessary, say clinical trial experts, but it also ensures better trials and data.
Recent reviews of clinical trial trends show that while many millions of people say they have considered participating in trials, only a few million do each year. Many say they are dissuaded from participating by an informed consent process they find confusing and daunting. (Information on patient education regarding clinical trials is available from CenterWatch, at www.centerwatch.com.)
Everywhere in health care — in clinical care, hospital administration, medical publishing, and research — conflicts of interest and disclosure of financial and other ties to any entity connected to the work being done are being held to stricter and more specific scrutiny.
In 2005, the NIH released a preliminary report that indicated 44 government scientists violated ethics rules on collaborating with pharmaceutical companies, and nine of the scientists may have violated criminal laws, prompting Rep. Joe L. Barton (R-TX) to remark "the ethical problems are more systemic and severe than previously known."
The NIH review found that the 44 scientists had either failed to disclose income from outside work, had failed to get permission to consult, or had done the work on government time rather than their own. Earlier in the year, the NIH banned all consulting deals between agency researchers and drug or biotechnology companies, and top NIH scientists were forbidden to own shares in such companies or to accept many research prizes, a move met with bitter objections from many NIH researchers who thought the measures were too harsh.
"The bottom line is, no matter how proud we are of the work we are doing, the participant must come first," ahead of sponsors, institutions, and results, notes HRPP presenter Jeremy Sugarman, MD, MPH, MA, professor of bioethics and medicine and deputy director of the Berman Bioethics Institute at Johns Hopkins University.
Resources
- Public Responsibility in Medicine and Research (PRIM&R) and Applied Research Ethics National Association (ARENA). Address: 126 Brookline Avenue, Suite 202, Boston, MA 02215. Phone: (617) 423-4112. E-mail: [email protected]. Web site: www.primr.org.
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