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More than 2 million people participated as human subjects in clinical research last year. Thousands more were subjects in other kinds of research studies. Billions of dollars are spent annually on research that uses human subjects. Precise data are not available because the United States has no national system for tracking research. Research with human subjects is an enormous — and growing — enterprise. It makes valuable contributions to medical progress. And sometimes it kills people. Jesse Gelsinger died in a University of Pennsylvania gene-transfer experiment in 1999. In 2001, Ellen Roche died in a Johns Hopkins University asthma study, and Elaine Holden-Able died in a study of amino acid metabolism by Case-Western Reserve University. In the past few years, the Office for Human Research Protections (OHRP), the federal agency responsible for human research protection in federally funded research, temporarily suspended funding to prestigious research universities for failure to comply with federal regulations to protect human subjects. Reports of deaths and injuries in clinical trials across America have encouraged the Senate Committee on Health, Education, Labor and Pensions to consider new federal legislation to protect research subjects better. This is a welcome step. The entire “system” of protecting human subjects has not received scrutiny for almost 30 years, despite reports by the General Accounting Office and the Inspector General warning that institutional review boards (IRBs), which review research risks to subjects in federally funded research, are overworked, underfunded and often ineffective. Of additional concern are conflicts of interest; some researchers have financial interests in companies that will market a product if proved successful by their studies. Even those without outside investments may find that their jobs and careers depend upon recruiting subjects into studies that bring needed revenues to their institution. Others may minimize research risks because they genuinely expect good results, both for their subjects and future patients. Sick people who enter research projects hoping for a cure may not appreciate the risks. How can we avoid unreasonable risks to people without losing the benefits that research offers? The National Bioethics Advisory Commission (NBAC) recommended that a single federal agency should regulate all research with human subjects, whether publicly or privately funded. This is the right approach. An independent, national authority for the protection of human subjects should be established outside any existing federal department or agency that funds or reviews research with human subjects — both to free it from the possibility of conflicts of interest and to enable it to acquire broad expertise and experience in protecting research subjects. The OHRP is now located in the Office of the Secretary of the Department of Health and Human Services. HHS includes the National Institutes of Health, the Food and Drug Administration and other agencies that fund or review research. NBAC suggested that remaining under HHS governance undermines OHRP’s independence to adequately pursue its mission. The new federal authority should also have jurisdiction over all research with human subjects. Research paid for by private companies — including genetic, cloning and stem cell research — is growing, but is not currently subject to federal regulation unless a product requires FDA approval. Protecting research subjects must be an integral — and enforceable — element of all research. Senators Edward Kennedy, D-Mass., and William Frist, R-Tenn., are considering requiring accreditation of IRBs that review research. Many in the research field prefer voluntary accreditation. Several entities are poised to offer IRB accreditation, including the National Committee for Quality Assurance, which accredits HMOs and the Association for the Accreditation of Human Research Protection Programs. Critics of accreditation question whether these entities can objectively audit the institutions that pay their fees. In any event, effective reform will take more than voluntary accreditation. It will require enforceable standards. Research institutions did not take protecting subjects seriously until federal regulators closed down their research. We need a new wholly independent federal agency to regulate all research with human subjects in the United States. Having one with authority to protect all research subjects will avoid conflicts of interest, ensure uniformity, reduce redundancy and jurisdictional confusion and focus expertise in research ethics on protecting people. All research subjects deserve better protection, regardless of who funds the research, what it seeks to learn or how it will be used. Wendy K. Mariner is a professor of health law at the Boston University School of Public Health and the university’s school of law. She is also a professor of socio-medical sciences at the university’s school of medicine.

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