Merz, Jon F
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PublicationBuilding 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. PublicationProtecting 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. PublicationEmpirical developments in retraction(2008-01-01) Redman, B K; Yarandi, H N; Merz, Jon FThis study provides current data on key questions about retraction of scientific articles. Findings confirm that the rate of retractions remains low but is increasing. The most commonly cited reason for retraction was research error or inability to reproduce results; the rate from research misconduct is an underestimate, since some retractions necessitated by research misconduct were reported as being due to inability to reproduce. Retraction by parties other than authors is increasing, especially for research misconduct. Although retractions are on average occurring sooner after publication than in the past, citation analysis shows that they are not being recognised by subsequent users of the work. Findings suggest that editors and institutional officials are taking more responsibility for correcting the scientific record but that reasons published in the retraction notice are not always reliable. More aggressive means of notification to the scientific community appear to be necessary. PublicationImproving Informed Consent: The Medium Is Not the Message(2003-09-01) Agre, Patricia; Campbell, Frances A; Goldman, Barbara D; Kass, Nancy; Boccia, Maria L; McCullough, Laurence B; Merz, Jon F; Miller, Suzanne M; Mintz, Jim; Rapkin, Bruce; Sugarman, Jeremy; Sorenson, James; Wirshing, DonnaAn important type of research on informed consent involves empirically testing interventions designed to improve the consent process. Here we report on the experience of eight teams that conducted research involving interventions designed primarily to impact one of three categories: decision-making, knowledge, and the therapeutic misconception. PublicationA 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. PublicationPilot 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'Iceland Inc.'?: On the ethics of commercial population genomics(2004-03-01) Merz, Jon F; McGee, Glenn E; Sankar, PamelaA 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. PublicationAll 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. PublicationThe 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. PublicationDisease 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.