Exploitation in biomedical research

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless.     

Ethics, regulation, and biomedical research

Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States.     

Third-party payers and the cost of biomedical research

Four principal arguments have been offered in support of requiring public and private third-party payers to help fund medical research: (1) many of the costs associated with clinical trial participation are for routine care that would be reimbursed if delivered outside of a trial; (2) there is a need to promote scientific research and medical progress and lack of coverage is an impediment to enrollment; (3) to cover the costs of trials expands health care and treatment options for the sick; and (4) it is beneficial for private insurers to cover the costs associated with cancer clinical trials because doing so makes such companies more attractive to consumers. Although many see third-party-payer coverage as a victory for patients and for the future of research, requiring coverage of services provided in a trial beyond those that would be provided to a comparable patient outside the research context raises a number of concerns.     

Protecting people in research: a comparison between biomedical and traffic research

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed.     

Data management and accountability in behavioral and biomedical research.

Regulations recently enacted by the Public Health Service and the National Science Foundation to address misconduct in scientific research were designed primarily to curtail deliberate forms of misconduct, such as fabrication or falsification of findings; however, researchers may also be held accountable for inadvertent deficiencies in data management. This article examines some of the problems in data quality control, documentation, and data retention that can occur when computers are used in scientific research. It focuses on deficiencies that could make it difficult to verify the integrity of research data or to reproduce statistical analyses. Strategies for prevention of data management problems are recommended.     

Problems for biomedical research at the academia-industrial interface

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It is very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science.     

A framework for risk-benefit evaluations in biomedical research

Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.     

Protection of children's rights to self-determination in research

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.     

Limits on risks for healthy volunteers in biomedical research

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.     

Scientific research, museum collections, and the rights of ownership

This article examines the question of how can museum professionals and the interested public resolve the competing claims of traditional ownership and continuing scientific research in relation to museum collections. An earlier version of this paper was presented at a symposium entitled “Ethics in Science: Special Problems in Anthropology and Archaeology” held at the 1998 Annual Meeting of the American Association for the Advancement of Science (AAAS), Philadelphia, PA, 15 February, 1998.