OVERSIGHT OF NIH AND FDA: BIOETHICS AND THE ADEQUACY OF INFORMED CONSENT THURSDAY, MAY 8, 1997 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HUMAN RESOURCES, COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT, Washington, DC. The subcommittee met, pursuant to notice, at 10:05 a.m., in room 2247, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Snowbarger, Pappas, Towns, and Kucinich. Staff present: Lawrence J. Halloran, staff director and counsel; Anne Marie Finley, professional staff member; R. Jared Carpenter, clerk; and Cherri Branson, minority counsel. Mr. SHAYS. I call this hearing to order. Next week the President will formally apologize to the survivors of the 40-year Tuskegee experiment, a federally funded study in which black men were allowed to suffer and die of a curable disease-syphilis-in the name of scientific research. Last week, this subcommittee heard testimony from Gulf war veterans ordered to take a potentially toxic drug for an experimental use without being informed of any possible side effects. The road from Tuskegee to Baghdad is lined with other landmarks of scientific arrogance and human tragedy. Thalidomide, radiation experiments, the EZ measles vaccine trials-those notorious lapses in the protection of human research subjects and the complex ethical implications of emerging biomedical issues like cloning, gene therapies, and AIDS vaccine trials compel us to ask: How effective are current mechanisms to review ethical issues and detect violations of informed consent requirements? What needs to be done so patient protections keep pace with scientific advances? Do we need a permanent national panel to serve as the arbiter of biomedical ethics issues? Physicians have a moral duty to inform human research subjects of the foreseeable risks of participation, and a duty to minimize those risks. The discipline of bioethics has evolved from the Hippocratic oath to the Nuremberg Code to current national and international standards to protect the health and human dignity of all who submit themselves to help advance scientific knowledge. But the current system of bioethics review appears to be showing signs of age and disrepair. Multiple layers of review and enforcement provide a false sense of security that difficult issues are being confronted. The regulatory scheme lacks specific provisions to pro (1) tect mentally ill, drug addicted and cognitively impaired persons involved in biomedical research. Local institutional review boardsthe IRBS-considered the cornerstone of the entire bioethics review structure, are often hard-pressed to monitor research protocols and informed consent procedures on an ongoing basis. By one recent estimate, more than half the federally funded research projects inspected by the FDA between 1977 and 1995 failed in some way to inform research subjects fully of the experimental nature of the medical procedure. Multi-site research studies further challenge the capacity of local IRBS to control the research nominally under their purview. The National Institutes of HealthNIH are charged with the potentially conflicting duties to fund research, conduct research, and enforce bioethics regulations. As a result, the NIH Office of Protection for Research Risks-the OPRRfaces both institutional barriers and logistic obstacles in attempting to police thousands of research projects. The third leg of what is supposed to be the national bioethics triad doesn't even exist. Department of Health and Human Services-HHS-regulations call for a permanent ethics advisory board the EAB-to advise the Secretary of bioethics issues. The EAB has been without members since 1979, supplanted by a series of temporary commissions to study particular bioethics problems. The latest, the National Bioethics Advisory Commission-the NBAC was directed in 1995 to make their first priority protection of the rights and welfare of human research subjects. Only recently staffed, the commission has now been directed by the President to focus their attention on cloning, and will not review ethical issues arising from specific research projects. Given these constraints, can the NBAC function in the role envisioned by the permanent Ethics Advisory Board? The weakness of the current system became more apparent recently when the NIH had to convene an ad hoc panel to review serious ethical questions presented by a proposed randomized needle exchange study in Alaska. Intravenous drug users are at high risk of contracting hepatitis and AIDS. For some, participation in the study to increase the avoidable risk of getting hepatitis B, for which there is an effective vaccine. A series of reviews by the local IRB and NIH failed to correct that ethical deficiency or detect flaws in the proposed informed consent materials. This self-policing, self-validating, and in some ways self-satisfied system of bioethics review and enforcement may be vulnerable to institutional pressures to conform and to cronyism. Missing are the periodic evaluations and external oversight needed to maintain a rigorous bioethical review system. We begin our part of that external oversight today. And we look to our witnesses for suggestions to improve patient protections and informed consent procedures. At this time I would recognize the ranking member and an equal partner in this effort, Mr. Towns. [The prepared statement of Hon. Christopher Shays follows:] Next week the President will formally apologize to the survivors of the 40-year Tuskegee Experiment, a federally funded study in which black men were allowed to suffer and die of a curable disease - syphilis - in the name of scientific research. Last week, this subcommittee heard testimony from Gulf War veterans ordered to take a potentially toxic drug for an experimental use without being informed of any possible side effects. The road from Tuskegee to Baghdad is lined with other landmarks of scientific arrogance and human tragedy -thalidomide, radiation experiments, the EZ measles vaccine trials. Those notorious lapses in the protection of human research subjects, and the complex ethical implications of emerging biomedical issues like cloning, gene therapies and AIDS vaccine trials, compel us to ask: How effective are current mechanisms to review ethical issues and detect violations of What needs to be done so patient protections keep pace with scientific advances? Physicians have a moral duty to inform human research subjects of the foreseeable risks of participation, and a duty to minimize those risks. The discipline of bioethics has evolved from the Hippocratic Oath, to the Nuremburg Code, to current national and international standards to protect the health and human dignity of all who submit themselves to help advance scientific knowledge. Statement of Rep. Christopher Shays May 8, 1997 Page 2 But the current system of bioethical review appears to be showing signs of age and disrepair. Multiple layers of review and enforcement provide a false sense of security that difficult issues are being confronted. The regulatory scheme lacks specific provisions to protect mentally ill, drug addicted and cognitively impaired persons involved in biomedical research. Local Institutional Review Boards (IRBs), considered the cornerstone of the entire bioethics review structure, are often hard-pressed to monitor research protocols and informed consent procedures on an ongoing basis. By one recent estimate, more than half the federally funded research projects inspected by the FDA between 1977 and 1995 failed in some way to inform research subjects fully of the experimental nature of the medical procedure. Multi-site research studies further challenge the capacity of local IRBs to control the research nominally under their purview. The National Institutes of Health (NIH) are charged with the potentially conflicting duties to fund research, conduct research and enforce bioethics regulations. As a result, the NIH Office for Protection from Research Risks (OPRR) faces both institutional barriers and logistical obstacles in attempting to police thousands of research projects. The third leg of what is supposed to be the national bioethics triad doesn't even exist. Department of Health and Human Services (HHS) regulations call for a permanent Ethics Advisory Board (EAB) to advise the Secretary on bioethics issues. The EAB has been without members since 1979, supplanted by series of temporary commissions to study particular bioethical problems. The latest, the National Bioethics Advisory Commission (NBAC), was directed in 1995 to make their first priority protection of the rights and welfare of human research subjects. Only recently staffed, the Commission has now been directed by the President to focus their attention on cloning, and will not review ethical issues arising from specific research projects. Given these constraints, can the NBAC function in the role envisioned for the permanent Ethics Advisory Board? The weakness of the current system became more apparent recently when the NIH had to convene an ad hoc panel to review serious ethical questions presented by a proposed randomized needle exchange study in Alaska. Intravenous drug users are at high risk of contracting hepatitis and AIDS. Statement of Rep. Christopher Shays For some, participation in the study could increase the avoidable risk of getting hepatitis B, for which there is an effective vaccine. A series of reviews by the local IRB and NIH failed to correct that ethical deficiency or detect flaws in the proposed informed consent materials. This self-policing, self-validating and in some ways self-satisfied system of bioethical review and enforcement may be vulnerable to institutional pressures to conform and to cronyism. Missing are the periodic evaluations and external oversight needed to maintain a rigorous bioethical review system. We begin our part of that external oversight today, and we look to our witnesses for suggestions to improve patient protections and informed consent procedures. Welcome. |