Merz, Jon F
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Publication Protecting Subjects' Interests in Genetics Research(2002-04-01) Merz, Jon F; Magnus, David; Caplan, Arthur L.; Cho, Mildred KBiomedical 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.Publication The prevalence of patent interferences in gene technology(2004-02-01) Merz, Jon F; Henry, Michelle RUnlike all other countries in the world, the United States awards patents to the first to invent, not to the first to file an application for a patent. In cases where two or more inventors submit patent applications claiming the same invention, an interference may be declared. Interference is the process by which the US Patent & Trademark Office (USPTO; Washington, DC, USA) determines which of the applicants was the first to invent and diligently reduce the invention to practice. More than half of these are resolved in favor of the inventor who was the first-to-file, raising questions about whether this unique system is worth retaining. Interferences are relatively rare. For the period 1998-2002, an average of four interferences were declared for every 10,000 patent applications filed. Data we have gathered suggest that interference proceedings in gene discovery and biotechnology are much more prevalent than other areas of technology. The resulting legal fees are costing the biotechnology industry millions of dollars each year.Publication What Are Gene Patents and Why Are People Worried about Them?(2005-10-01) Merz, Jon F; Cho, Mildred KThis article examines what it means to patent a gene. Numerous ethical concerns have been raised about the effects of such patents on clinical medical practice as well as on research and development. We describe what kinds of inventions are covered by human gene patents, give several examples and summarize the small body of empirical research performed in the US examining the effects of these patents. There is little evidence that early fears about gene patenting placing substantial restraints on research and clinical medicine have come to fruition. Nonetheless, there are areas of concern, and policy makers, physicians and the public should be alert to ensure that the net social benefits of patenting human genes are maintained.Publication A qualitative study of women’s views on medical confidentiality(2005-09-01) Merz, Jon F; Jenkins, G; Sankar, PamelaContext: The need to reinvigorate medical confidentiality protections is recognised as an important objective in building patient trust necessary for successful health outcomes. Little is known about patient understanding and expectations from medical confidentiality. Objective: To identify and describe patient views of medical confidentiality and to assess provisionally the range of these views. Design: Qualitative study using indepth, open ended face-to-face interviews. Setting: Southeastern Pennsylvania and southern New Jersey, USA. Participants: A total of 85 women interviewed at two clinical sites and three community/research centres. Main outcome measures: Subjects’ understanding of medical confidentiality, beliefs about the handling of confidential information and concerns influencing disclosure of information to doctors. Results: The subjects defined medical confidentiality as the expectation that something done or said would be kept "private" but differed on what information was confidential and the basis and methods for protecting information. Some considered all medical information as confidential and thought confidentiality protections functioned to limit its circulation to medical uses and reimbursement needs. Others defined only sensitive or potentially stigmatising information as confidential. Many of these also defined medical confidentiality as a strict limit prohibiting information release, although some noted that specific permission or urgent need could override this limit. Conclusions: Patients share a basic understanding of confidentiality as protection of information, but some might have expectations that are likely not met by current practice nor anticipated by doctors. Doctors should recognise that patients might have their own medical confidentiality models. They should address divergences from current practice and provide support to those who face emotional or practical obstacles to self-revelation.Publication Diagnostic testing fails the test: The pitfalls of patents are illustrated by the case of hemochromatosis(2002-02-01) Merz, Jon F; Kriss, Antigone T; Leonard, Debra G. B.; Cho, Mildred KQuestions about the effects of patents and licensing are becoming critical in the United States, Europe and other developed countries as more genes are discovered and patented, and as genetic testing becomes an integral part of standard medical care. The award of patents for the diagnostic test for haemochromatosis, a progressive iron-overload disease, joins an ever-growing list of such tests that have been, or will very soon be, patented. We have found that US laboratories have refrained from offering clinical testing services for haemochromatosis because of the patents. A lot of clinical study is needed to validate and extend the early discovery of a disease gene such as that for haemochromatosis, so our results give us reason to fear that limiting clinical testing will inhibit further discovery as well as the understanding that emerges naturally from broad medical adoption.Publication Disease Genes Are Not Patentable: A Rebuttal of McGee(1998-10-01) Merz, Jon FDr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We’re convinced he’s wrong. An analogy will help explain why.Publication All Gifts Large and Small(2003-07-01) Caplan, Arthur L.; Katz, Dana; Merz, Jon FMuch 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.Publication Pilot Study: Does the White Coat Influence Research Participation?(2002-07-01) Merz, Jon F; Rebbeck, Timothy R; Sankar, Pamela; Meagher, Emma AIn health care, the white coat symbolizes professionalism, trustworthiness, and competence; it also represents power. This suggests that the wearing of a white coat could influence the decisions of potential subjects who are asked to participate in clinic-based research.Publication Building Research Capacity in Botswana: A Randomized Trial Comparing Training Methodologies in the Botswana Ethics Training Initiative(2013-02-01) Kasimatis-Singleton, Megan; Barchi, Francis Harper; Kasule, Mary; Merz, Jon F; Khulumani, PilateBackground Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.Publication A Pilot Survey on the Licensing of DNA Inventions(2003-09-01) Henry, Michelle R; Cho, Mildred K; Weaver, Meredith A; Merz, Jon FDespite ethical concerns about gene patents, virtually no empirical evidence exists to support claims about either positive or negative effects, and extremely little is known about the intellectual property protection strategies of firms and universities. This article discusses the results of a pilot study to examine patenting and licensing philosophies, policies, and practices of different types of institutions and to describe the contractual conditions for licensing DNA sequence inventions.