Sara Taub

Guidelines to Prevent Malevolent Use of Biomedical Research

In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an end the voluntary moratorium that the National Academy of Sciences (NAS) had instituted several months earlier. They also served to illustrate that the scientific community was capable of self-governance, thereby securing public trust and persuading Congress not to institute legislative restrictions.1 Finally, they underscored the importance of weighing unforeseen risks inherent in some research against potential benefits that may arise from these same endeavors. In February 2000, a second meeting was held at Asilomar, bringing together members from the same groups, including some of the original attendees.2 This meeting was held in honor of the historic event’s 25th anniversary and in recognition of the scientific community’s increasing attention to the potentially harmful applications of biotechnology in general —for example, to facilitate the use of pathogens as deadly weapons.3 Risk of this latter sort that arises not from research per se but from its intentional misapplication for nefarious purposes constitutes the focus of this report. The possibility that scientific research may generate knowledge with the potential for harmful as well as beneficial applications is not new. In recent years, however, it has become imperative to develop parameters within which to address such research, as heightened concerns have arisen from the threat of biochemical terrorism and warfare.

CADAVERIC ORGAN DONATION: ENCOURAGING THE STUDY OF MOTIVATION

Approximately 6,000 patients per year, or 16 per day, with end-stage organ failure die because of the lack of available organs. Each year only 35% to 50% of potential donors consent to donation (1). During the last 20 years, vigorous educational campaigns, both voluntary and legislative, designed to increase organ donation have failed to increase donation rates significantly. The need for organs has grown nearly five times faster than the number of cadaveric donors: the annually compounded rate (1990–2000) of increase in number of patients on waiting lists has averaged 14.1% a year, whereas the rate of increase of donors has averaged 2.9% a year (2). The American Medical Association (AMA) has been concerned about this problem for many years and has developed several policies addressing it in the past decade (3). AMA policy has supported certain forms of financial incentives for cadaveric organ donation since 1993 (Policy E-2.15, AMA Policy Database), but they have never been implemented because federal law prohibits them. AMA policy specifically prohibits payment to living donors (4). Most initiatives to increase organ donation have focused on what motivates or hinders the decision to donate. Programs to improve organ donation rates have been aimed at public and professional groups. These have included widespread educational campaigns aimed at motivating individuals to become donors. They also have included mandated choice legislation, the establishment of the Organ Procurement and Transplantation Network (OPTN), donor card programs, donor registries, and the creation of specialized organ donation teams within hospitals that discuss organ donation with families and patients. Despite these efforts, cadaveric donation rates have remained nearly stable during the past decade. This report encourages the medical and scientific communities to reexamine the motivation for cadaveric organ donation. Building on the work of the Council on Ethical and Judicial Affairs (CEJA) in 1993, which led to Opinion E-2.15, “Financial Incentives for Organ Donation,” this report identifies reasons why ethical objections to financial incentives, for cadaveric organ donation only, should be reexamined. In particular, this report considers the need to study the impact of financial incentives through limited research trials. Such studies would help measure the effect of incentives not only on donation rates but also on public perception of the transplant enterprise and of the meaning of organ donation. For the purposes of this report, donation and procurement of organs are considered completely independent from the allocation of organs. The report neither suggests nor supports any change in the current system of organ distribution, as developed and administered by the United Network for Organ Sharing (UNOS). Even if financial incentives were found to have a positive impact on cadaveric organ donation rates, allocation algorithms developed by the OPTN would continue to govern organ distribution and transplant recipients would continue to be selected according to ethically appropriate criteria related to medical need rather than ability to pay. Physicians have an obligation to hold their patients’ interests paramount and to support access for all patients to medical care (Principles VIII and IX) (5). To discharge these obligations, physicians should participate in efforts to increase organ donation, including education of their patients and the general public regarding the importance of organ donation and promotion of voluntary donation of organs. Beyond educational programs, however, physicians should support innovative approaches to encourage organ donation. Such efforts include encouragement and, if appropriate, participation in the conduct of ethically designed research studies of donor motivation. A potential impetus for cadaveric organ donation that has not been adequately explored (because of federal prohibition) is financial incentives. Such incentives are not intrinsically unethical; AMA policy has supported them since 1993. Whether a particular incentive is ethical or not depends upon the balance of benefits and harms that result, and these are currently unknown because they have never been investigated.

Safeguards in the use of DNA databanks in genomic research

Genomic research, which uses DNA to identify the gene(s) responsible for complex diseases, relies upon large DNA databases to facilitate population-based research. These databases derive their power from integrating different kinds of information about large samples of individuals: genetic and clinical data and data on health, lifestyle, and environment. Using statistical analysis, the databases can be used to analyze correlations that may enable new therapeutic developments. The use of DNA databanks in genomic research brings new challenges related to the scope of research as well as to the nature and use of the samples and information archived in such databases. This report identifies these issues and considers their relation to the current standard of informed consent in human research.

The Trend Toward Casual Dress and Address in the Medical Profession

The trend toward casual address and dress in the medical profession could reinforce the power differential that already exists between patient and physician and adversely affect the patient-physician relationship. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Think It's Information? It Could Be a Sales Pitch.

While the advent of direct-to-consumer marketing of prescription drugs makes them known to the general public, the physician is the gatekeeper for legally prescribing medications and can help the patient better understand the costs and benefits of different treatment options. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

The Trend Toward Casual Address and Dress in the Medical Profession

The trend toward casual address and dress in the medical profession could reinforce the power differential that already exists between patient and physician and adversely affect the patient-physician relationship. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Take one: the american medical association; lights, camera, action.

The media helps shape the general publics perception of the American Medical Association as the emblem of organized medicine. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Feeding Health Disparities

Physicians need to educate patients about nutrition to counter the plethora of media images that promote poor dietary habits. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Telemedicine: assisted self-treatment at the South pole.

Media stories about individual cases of human suffering encourage society to bring health care to geographically remote areas by investing in telemedicine technologies. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.