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PubMed1993

Bioethical catch-22: the moratorium on federal funding of fetal tissue transplantation research and the NIH revitalization amendments.

In 1988, a moratorium on the use of federal funds for fetal tissue transplantation research (FTTR) halted the promise of a cure for millions of Americans suffering from Parkinson's disease, diabetes, and other debilitating conditions. Since the moratorium began, private and international experimentation continues with mixed success. In the foreground, however, the debate rages over federal funding for fetal tissue transplantation from induced abortions into humans. In the House of Representatives and the Senate, the debate culminated with the passage of the National Institutes of Health (NIH) Revitalization Amendments. In addition to authorizing NIH programs, the $5.4 billion bill included measures designed to overturn the moratorium on federal funding for the transplantation research. Brimming with controversy, the bill was forwarded to the White House where it met President Bush's promised veto. The veto was sustained when the House failed to rally the two-thirds majority vote necessary to override a veto, leaving the moratorium intact and the controversy alive. Modified measures were introduced in both Houses of Congress, but a Senate filibuster in the last hours of the session foreclosed a second veto and placed the bill on the 1993 calendar. The field of fetal tissue research, currently a fraction of human health research but with the potential for a six billion dollar industry, is the focus of inevitable controversy. FTTR, as a sub-field, presents a volatile combination of the politics of abortion, the international research race, and the cries of millions of Americans suffering from Parkinson's disease and other crippling debilitations. Thus, using fetal tissue as a potential cure commands the interest and the passion of many. FTTR from induced abortions distinguishes itself from federally approved fetal tissue research because it connects a potentially beneficial health pursuit with a critically divisive moral issue of our day--abortion. By its very nature, FTTR cannot automatically enjoy the approval given to other research pursuits, primarily because at its very core lies an unresolved ethical issue. This issue is found in the connection between the procedures of aborting the fetus, harvesting the tissue, and transplanting it into a needy recipient. Unlike transplantation from ectopic pregnancies or spontaneous abortions, which are permitted by the ban, FTTR directly links decisions and procedures immersed in the moral controversy over induced abortion. This Comment outlines the debate over the transplantation research affected by the moratorium on the use of federal funds for FTTR. Whether fetal tissue from induced abortions should be procured for transplantation into humans, and if so, how its use can be regulated is a significant contemporary challenge for public policy makers. Part I of this Comment delineates the formation of public policy on the issue. Part II explains the content of the NIH Amendments as a new direction for public policy. Part III discusses the potential benefits and risks of federal funding of FTTR. Finally, part IV addresses whether the executive ban or the legislative measure is a sound, farsighted public policy.

Aborted Fetus↗
PubMed1998

Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group.

For decades, all federally funded research involving human subjects has been subject to regulations that require the informed consent of the subject and oversight by the local institution. These regulations last underwent major revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research support, and the institutional environment in which clinical research is conducted. In the intervening years, doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, in terms of time, bureaucracy, and delay, are justified by the level of protection afforded. The Human Research Ethics Group, administered by the Center for Bioethics at the University of Pennsylvania Health System, extensively reviewed the status of existing human subjects protections with the aim of making recommendations to improve and reform the regulations. Here, we present recommendations constituting a consensus of the group members for reform in 3 key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards, and regulatory policy.

Advisory Committees↗
PubMed2002

Improving Australia's ethical review processes--slow and steady wins the race.

In this response, the Australian Health Ethics Committee (AHEC) indicates that it shares, and has strategies in place to address, the majority of the concerns identified by Susan Dodds. AHEC believes it is too early to assess the full impact of the National Statement on Ethical Conduct in Research Involving Humans (1999) or to call for a major review of the ethics committee process. While some Human Research Ethics Committees (HRECs) are overstretched, the system is not on the verge of collapse.

Advisory Committees↗
PubMed1999

Handling of scientific dishonesty in the Nordic countries. National Committees on Scientific Dishonesty in the Nordic Countries.

Despite a widely recognised need, most countries still have no coherent system to deal with scientific misconduct. Committees have been established by the national medical research councils in Denmark (1992), Norway (1994), and Sweden (1997), and by the Ministry of Education in Finland (1994), to deal with scientific misconduct--ie, to initiate preventive measures, to investigate alleged cases, or both. Each committee includes both scientifically and legally qualified members. The employing institutions are responsible for possible sanctions or punishments. So far, 47 cases have been accepted for investigation, the majority (25) being Danish. Disputed authorship was the most frequent reason for investigation. Junior researchers made complaints in only three of the investigated cases. Investigations have been completed in 37 cases; in nine cases, dishonesty was revealed--two of them were related to the same researchers. Cooperation between the four Nordic committees has shown close agreement on specific issues and cases, despite minor differences in definitions, organisation, and procedures.

Advisory Committees↗
PubMed1991

Mapping the human genome: some thoughts for those who say "There should be a law on it.

... It appears from this discussion that the most effective method of regulating the problems that may arise from the human genome project is to concentrate, not on the research involved in the project, but rather on the uses that may be made of the information gained from it. Furthermore, there is already a good deal of legislation and administrative machinery that is directly or incidentally relevant to the matters in question. This should obviously be used as much as possible, rather than new legislation, to reduce bureaucracy, overlapping provisions and costs.

Abortion, Therapeutic↗
PubMedDate not supplied

Ethics committees in Italy--a time for change?

The Comitato Nazionale per la Bioetica (CNB) in Italy has recently produced an unprecedented discussion document on the state of ethics committees in Italy, with an invitation to interested parties to comment on proposed changes to their fundamental structure. After this consultation, and taking note of relevant official publications and the most recent national and international literature on the subject, the CNB proposes to produce a final, definitive document that will consider options for the future development of such committees.

Advisory Committees↗
PubMedDate not supplied

Hope in our hearts.

Explore the source record for details and available documents.

Advisory Committees↗