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Jon F Merz

Publications and source records attributed to Jon F Merz.

13 recordsLinked to original sources
PubMed2003

Effects of patents and licenses on the provision of clinical genetic testing services.

The growth of patents that include genetic sequences has been accompanied by concern about their impact on the ability of physicians to provide clinical genetic testing services and to perform research. Therefore, we conducted a survey of clinical laboratory directors that perform DNA-based genetic tests to examine potential effects. We performed a telephone survey between July and September in 2001 of all laboratory directors in the United States who were members of the Association for Molecular Pathology or who were listed on the GENETESTS:org website. One hundred thirty-two of 211 (63%) laboratory directors were interviewed. Ten of these were excluded because they did not conduct DNA-based genetic tests. Almost all performed genetic tests for clinical purposes. Half performed tests for research purposes as well. Twenty-five percent of respondents reported that they had stopped performing a clinical genetic test because of a patent or license. Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license. In total, respondents were prevented from performing 12 genetic tests, and all of these tests were among those performed by a large number of laboratories. We found 22 patents that were relevant to the performance of these 12 tests. Fifteen of the 22 patents (68%) are held by universities or research institutes, and 13 of the 22 patents (59%) were based on research funded by the United States Government. Overall, respondents reported that their perceptions of the effects of patents on the cost, access, and development of genetic tests, or data sharing among researchers, were negative. In contrast, most respondents felt that patents did not have an effect on the quality of testing. We conclude that patents and licenses have had a significant effect on the ability of clinical laboratories to develop and provide genetic tests. Furthermore, our findings suggest that clinical geneticists feel that their research is inhibited by patents. The effects of patents and licenses on patients' access to tests, and the costs and quality thereof, remains to be determined.

Data Collection↗
PubMed2003

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.

Awareness↗
PubMed2002

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.

Altruism↗
PubMed2002

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.

Coercion↗