Jon F. Merz

All Gifts Large and Small Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated.

All Gifts Large and Small

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated.

Diagnostic testing fails the test

The pitfalls of patents are illustrated by the case of haemochromatosis.

Patient Perspectives of Medical Confidentiality: A Review of the Literature

OBJECTIVE: To lay the groundwork for a better understanding of patient views on medical confidentiality.DESIGN: Studies were found by searching MEDLINE, BIOETHICSLINE, and selected bibliographies. Articles concerning physician perspectives or implications of legal and administrative regulations were excluded. Only peer-reviewed journal articles reporting original research on patients’ confidentiality views and conduct were included.MAIN RESULTS: Many patients are unaware of or misunderstand their legal or ethical right to medical confidentiality protections, which leads them to both over- and underestimate confidentiality protections. The possibility that medical information might be revealed, intentionally or not, to acquaintances in a clinic or other social community troubles patients as much as information release to insurers or employers. A significant minority of patients distrust confidentiality protections, leading some to report that they delay or forgo medical care. If doubtful that confidentiality will be upheld, patients will act independently to protect information.CONCLUSIONS: Our review found a wider variety of understandings and beliefs about medical confidentiality among patients than are often indicated in the writings of practitioners or legal experts. As medical confidentiality regulations evolve, these differences need to be recognized and accounted for in interactions between practitioners and patients.

Patient perspectives on medical confidentiality

OBJECTIVE: To lay the groundwork for a better understanding of patient views on medical confidentiality.DESIGN: Studies were found by searching MEDLINE, BIOETHICSLINE, and selected bibliographies. Articles concerning physician perspectives or implications of legal and administrative regulations were excluded. Only peer-reviewed journal articles reporting original research on patients’ confidentiality views and conduct were included.MAIN RESULTS: Many patients are unaware of or misunderstand their legal or ethical right to medical confidentiality protections, which leads them to both over- and underestimate confidentiality protections. The possibility that medical information might be revealed, intentionally or not, to acquaintances in a clinic or other social community troubles patients as much as information release to insurers or employers. A significant minority of patients distrust confidentiality protections, leading some to report that they delay or forgo medical care. If doubtful that confidentiality will be upheld, patients will act independently to protect information.CONCLUSIONS: Our review found a wider variety of understandings and beliefs about medical confidentiality among patients than are often indicated in the writings of practitioners or legal experts. As medical confidentiality regulations evolve, these differences need to be recognized and accounted for in interactions between practitioners and patients.

Voluntariness of consent for research: an empirical and conceptual review.

This article explores the vulnerability of research subjects either to undue influence or to coercion. The authors present a brief review of the requirement for voluntariness in research, and what is known about research participation. They then examine characteristics of potential subjects, researchers, researcher actions, and the research setting that can influence the voluntariness of subject’s decisions to participate. Throughout the paper, empirical work that relates to voluntariness is used to illustrate the conceptual material. Voluntariness is viewed as an issue of self-control. Threats to voluntariness can arise from vulnerabilities of potential subjects as well as from characteristics of the researcher, the researcher’s acts, and the research setting. Moral concerns about potential influences may be assessed by the likelihood that they will control or dominate a potential subject’s decision to participate in research. Policy responses may be appropriate where the probability of control is too high.

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.

Iceland Inc.?: On the ethics of commercial population genomics

A detailed analysis of the Icelandic commercial population-wide genomics database project of deCODE Genetics was performed for the purpose of providing ethics insights into public/private efforts to develop genetic databases. This analysis examines the moral differences between the general case of governmental collection of medical data for public health purposes and the centralized collection planned in Iceland. Both the process of developing the database and its design vary in significant ways from typical government data collection and analysis activities. Because of these differences, the database may serve the interests of deCODE more than it serves the interests of the public, undermining the claim that presumed consent for this data collection and its proprietary use is ethical. We believe that there is an evolving consensus that informed consent of participants must be secured for population-based genetics databases and research. The Iceland model provides an informative counterexample that holds key ethics lessons for similar ventures.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Personal Characteristics of Older Primary Care Patients Who Provide a Buccal Swab for Apolipoprotein E Testing and Banking of Genetic Material: The Spectrum Study

Objective: To determine the personal characteristics and reasons associated with providing a buccal swab for apolipoprotein E (APOE) genetic testing in a primary care study. Methods: The study sample consisted of 342 adults aged 65 years and older recruited from primary care settings. Results: In all, 88% of patients agreed to provide a DNA sample for APOE genotyping and 78% of persons providing a sample agreed to banking of the DNA. Persons aged 80 years and older and African-Americans were less likely to participate in APOE genotyping. Concern about confidentiality was the most common reason for not wanting to provide a DNA sample or to have DNA banked. Conclusion: We found stronger relationships between sociodemographic variables of age and ethnicity with participation in genetic testing than we did between level of educational attainment, gender, function, cognition, and affect.