John Fletcher

Hospital ethics committees have become widespread over the last 25 years, stimulated by the Quinlan decision of the New Jersey Supreme Court, the report of a President's Commission, and most recently by the Joint Commission on Accreditation of Health Care Organizations , which now man dates that each hospital seeking accreditation have a functioning process for the consideration of ethical issues in patient care. Laws and regulations in several states require that hospitals establish ethics committees, and some states stipulate that certain types of cases and disputes be taken to such committees. At least one state grants legal immunity to those who implement recommendations of an ethics committee

As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: (1) problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and (2) ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression of genetic knowledge from therapy to mass genetic engineering in human reproduction. The author's viewpoint is that a consensus exists on the required moral approach to somatic cell therapy, but that no moral approach yet exists for experiments beyond this level, especially in the germline cells of human beings. Keywords: gene therapy, somatic cells, germ cells, institutional review boards, genetic engineering CiteULike Connotea Del.icio.us What's this?

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was the future of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s...

Although the incidence and composition of HECs has been well characterized, little is known about how HECs assess their performance. In order to describe the incidence of HEC self-evaluation, the methods HECs use to evaluate their performance, and the characteristics of HECs that influence self-evaluation, we surveyed the readers ofHospital Ethics. 290 HECs in 45 U.S. states, the District of Columbia, Puerto Rico and three Canadian provinces, completed questionnaires. Of the 241 HECs included in the data analysis, 97.9% had performed some self-evaluation. Responding committees largely made formative rather than summative evaluations and appeared to evaluate performance in light of their own objectives rather than basing assessments on specific structural, process, and outcome measures of quality. Responding committees used certain evaluation criteria more extensively than others — among these, the number of participants and staff knowledge of the service provided — with the choice of criteria differing with the function being evaluated. Eight characteristics of HECs influenced the probability of self-evaluation, including age, number of beds and meetings, the existence of a mission statement, and a budget. The presence of certain characteristics made HECs six times more likely to evaluate their performance than HECs without the characteristic

Incidental fndings of potential medical signifcance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography colonography studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defned plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical signifcance will be detected and reported in CTC research studies