Research scandals: Public wants to know who’s minding the store?
Research scandals: Public wants to know who’s minding the store?
Have ethics oversight groups failed to do their job?
Recent suspension of federal research funds at public and private institutions alike is creating growing public skepticism of the way human subjects are treated in research projects. The incidents are causing critics of human research and the general public to question whether bioethics oversight groups are failing them and, more importantly, the patients who unwittingly suffer from not knowing all the facts.
For example, prominent research suspensions over the past several months at venerable institutions are sending shock waves through the academic community, while patient rights advocates and patients themselves are cheering. At the center of the controversy — and central to the role of any ethics committee — are the issues of informed consent and whether patients were adequately informed of the risks. A more serious allegation is that patient requests to notbe included in research studies were ignored.
Just in the past two months, for example, federal research grants were pulled from two Los Angeles Veterans Affairs Administration facilities. Investigations are under way at facilities in Cincinnati, Philadelphia, and Tampa, FL. And federal research dollars in government facilities aren’t the only funds in jeopardy. Duke University recently lost its research grant funding. In fact, "half a dozen other university research programs are under investigation, and at least a couple of inquiries have revealed serious problems," says Gary Ellis, federal ethics office director for the Office of Protection from Research Risks (OPRR). The OPRR is the watchdog office of the National Institutes of Health (NIH) in Bethesda, MD, and is responsible for ensuring patient safeguards are in place for both human and animal research subjects. The OPRR found as part of a five-year review that the West Los Angeles VA hospital violated federal research guidelines by failing to obtain legal informed consent from veterans before enrolling them in research studies. (For more on what to include in informed consent documents, see story, p. 76. For a comprehensive look at OPRR documents, visit our Hot Topics page at http://www.ahcpub. com/ahc_roothtml/hot/ournews.html.)
The most serious allegations involving the West Los Angeles VA hospital claim that four cardiac patients in 1995 were not given informed consent or they explicitly denied permission. Medical research at VA hospitals is nothing new. In fact, it’s a routine activity at nearly all the nation’s 173 veterans’ hospitals and is one of four statutory mandates of the Veterans Affairs Administration.
What appears to be isolated incidents could be indicative of a larger problem, warns Daniel Greenberg, a visiting scholar at Johns Hopkins University in Baltimore. Greenberg wrote an editorial in the Washington Post stating that no one knows for certain the extent of the problem because the "science establishment runs like a bank without auditors."
Patient groups created a coalition in June to coincide with a public opinion poll showing that a majority of Americans favor research, including studies involving stem cells. Specifically, 74% of those polled favor the NIH’s funding of stem cell research. The national survey was conducted by Opinion Research Corporation International in May. As a result, several organizations banded together and formed the Patients’ Coalition for Urgent Research. The umbrella group consists of:
• American Cancer Society in Atlanta;
• Juvenile Diabetes Foundation International in New York City;
• Christopher Reeve Paralysis Foundation in New York City;
• Parkinson’s Action Network in Santa Ana, CA;
• Paralyzed Veterans of America in Washington, DC;
• National Health Council in Washington, DC;
• Spina Bifida Association of America Foundation in Washington, DC.
The coalition has started a national awareness campaign to urge Congress to support stem cell research.
So how did we get here?
Federal regulators, it seems, have turned a blind eye to the scientific community by granting it autonomous self-governance. The Office of Research Integrity within the Depart ment of Health and Human Services, implemented to detect scientific fraud and plagiarism, has had only an acting director since 1996.
What’s more, the OPRR within the NIH has two full-time and two part-time investigators and a staff of 30 who are responsible for policing approximately 4,000 institutions. The number of patients and experiments, however, is even higher.
No one knows a definitive figure, but the Association of American Medical Colleges in Washington, DC, estimates that between 16,000 and 20,000 human research experiments take place each year.
Last December, bioethicists at the University of Pennsylvania Health System’s Penn Center for Bioethics urged that the current regulations concerning using human subjects in biomedical research be updated. Even though existing practices have served the medical community for the past two decades, researchers say, the pace of current research outdistances the present system. The recommendations appeared in the Dec. 9, 1998, Journal of the American Medical Association.1
"Change is essential if the same level of protection is to be afforded human subjects who participate in research in the future," says co-author Paul Root Wolpe, PhD. The study was conducted by the Project on Informed Consent of the Human Research Ethics Group at the Penn Center for Bioethics.
Changes suggested by the group include:
• protecting the rights of the mentally ill through durable power of attorney and advance directives;
• monitoring studies involving persons with cognitive impairment more closely;
• creating clearer and more specific consent forms for cases in which research subjects can expect no benefit from participation;
• fortifying local peer review boards;
• informing internal review boards of all potential conflicts of interest that exist for investigators and institutions.
"One of the most important recommendations is the extension of any existing and future protection for human research in the United States, regardless of whether they are publicly or privately funded or whether the research is aimed at producing commercial products," says Arthur L. Caplan, MD, director of Penn’s Center for Bioethics and co-author of the study.
Is more legislation needed?
Recent suspensions of research funds make some ethicists and researchers question current legislation regarding human research. Some are saying that further legislation is necessary, while others defend the current system. The president of the Washington, DC-based Association of American Medical Colleges, Jordan J. Cohen, MD, defends the current internal review board (IRB) system. But he urges members of his organization to be informed and diligent in maintaining any current human research project standards.
"The AAMC believes it is essential that nothing be done to compromise the integrity and credibility of the IRB process in which the Congress and the public have placed their trust," he says.
The NIH announced in the May 25, 1999, Federal Register a request for comments on a policy consisting of principles and guidelines for obtaining and sharing biomedical research resources. (For information on how to respond to the NIH request, see source box, p. 79.)
Reference
1. Moreno J, Caplan A, Wolpe P, et al. Updating protections for human subjects involved in research. JAMA 1998; 280:1,951-1,958.
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