Paying research subjects: an analysis of current policies.

BACKGROUND: Few data are available on guidelines used by research organizations to make decisions about paying subjects. OBJECTIVE: To analyze existing guidance regarding payment of research subjects and to identify common characteristics and areas for further research. DESIGN: Descriptive content analysis of policies. MEASUREMENTS: Written policies and rules of thumb about paying subjects from 32 U.S. research organizations. RESULTS: Of 32 organizations, 37.5% had written guidelines about paying subjects; all but 1 reported having rules of thumb. Few (18.8%) were able to provide a confident estimate of the proportion of studies that pay subjects. Organizations reported that investigators and institutional review boards make payment decisions and that both healthy and ill subjects in some studies are paid for their time (87%), for inconvenience (84%), for travel (68%), as incentive (58%), or for incurring risk (32%). Most organizations require that payment be prorated (84%) and described in the consent document (94%). CONCLUSIONS: Most organizations pay some research subjects, but few have written policies on payment. Because investigators and institutional review boards make payment decisions with little specific guidance, standards vary.

Protecting subjects' interests in genetics research.

Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes. The concurrent rise in both the roles that subjects play and the commercial interests they have presents numerous ethical challenges. We examine the interests of different research participants, finding that these interests are not addressed by current policies and practices. We conclude that all participants should be given a voice in decisions affecting ownership, access to, and use of commercialized products and services, and that researchers and institutions should negotiate issues relating to control of research results and the sharing of benefits before the research is performed.

Market competition and patient-oriented research: the results of a national survey of medical school faculty.

PURPOSE: To understand the effect of market competition on patient-oriented research at U.S. medical schools and teaching hospitals. METHOD: From a multi-stage stratified, random sample, the authors surveyed 3,804 research faculty at 117 U.S. medical schools. The questionnaire assessed five variables, the type of research conducted by the respondent, changes in patient-oriented and non-clinical research in the preceding three years, amount of time spent on patient care, market stage of the respondent's institution, and research productivity. RESULTS: Of the 2,336 faculty who responded (62%), 84% of those conducting patient-oriented research and 80% of those engaged in non-clinical research reported conducting the same amount of research or more in 1996-1997 than in the preceding three years. However, both patient-oriented and non-clinical researchers in the most competitive health care markets and those with high levels of patient care duties were most likely to report decreases in the amounts of such research conducted in the previous three years. Further, researchers reporting such decreases had been as productive in recent years and over their careers as had those who did not report a decrease. CONCLUSIONS: This study provides additional evidence of the negative relationships that exist between high levels of market competition and patient care services on the patient-oriented and non-clinical research missions of teaching hospitals.

Is 'best proven' a useless criterion?

In this article, I examine some proposals for modification of ethical documents regulating research, particularly, the problems that introducing certain economic clauses may pose. I evaluate suggestions that reject the notion of providing the 'best proven diagnostic and therapeutic method' in favor of 'the highest attainable therapeutic method' or 'the proven effective prophylactic, diagnostic and therapeutic methods.' I analyze the plausibility and problems of introducing a double standard and the consequences it may have in developing countries. Finally I highlight the impact these changes may imply for these countries.

The payment of research subjects: ethical concerns.

PURPOSE/OBJECTIVES: To present models for the payment of research subjects, pros and cons of each, and the application of ethical principles in the current environment. DATA SOURCES: Federal regulations and guidelines, current and historical research, and opinions expressed in the nursing, medical, bioethics, pharmacology, and clinical trial literature. DATA SYNTHESIS: Relevant regulations are sparse. A variety of payment models exist, but all are somewhat problematic. Balancing the principles of respect for people and justice in our current society will not be entirely possible. Practice decisions must be made for individual situations. Special care must be taken with patients because they are subject to therapeutic misconception. CONCLUSIONS: No model fits all situations, but research nurses can use their skills to evaluate particular applications. As a society, nurses must promote participation in research as a socially responsible activity and prevent unethical payment models from predominating. IMPLICATIONS FOR NURSING PRACTICE: Oncology research nurses may be involved with the consent process, the development of protocols, and staff education. A thorough understanding of an issue that may impair the consent process or impinge upon subjects' rights is critical to effective and ethical practice.

Willingness to volunteer in future preventive HIV vaccine trials: issues and perspectives from three U.S. communities.

UNLABELLED: This study examined perceived risks, benefits, and desired information related to willingness to volunteer in preventive HIV vaccine trials. SAMPLE: Purposive sampling was used to select 90 participants among injecting drug users (Philadelphia, PA, U.S.A.); gay men (San Francisco, CA, U.S.A.); and black Americans (Durham, NC, U.S.A.). METHODS: A qualitative interview guide elicited perceived benefits, risks, and desired information relating to trial participation. Themes were developed from the transcribed texts and from freelists. RESULTS: Stated willingness to volunteer in a preventive HIV vaccine trial was similar across the three communities. Eight perceived benefits were reported, including self-benefits, altruism, and stopping the spread of AIDS. Seven perceived risks were reported, including negative side effects and vaccine safety issues, contracting HIV from the vaccine, and social stigmatization. Participants voiced the desire for eight types of information about issues relating to trust and confidentiality in the research process, health complications and later assistance, and vaccine trial methodology. CONCLUSIONS: In this study, many benefits as well as risks of preventive HIV vaccine trial participation were cited. Scientists conducting preventive HIV vaccine trials need to address community perceptions of risks and provide information about the research if trial enrollment is to be diverse and successful.

Money for research participation: does in jeopardize informed consent?

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make.