Bioethics Publications

  • Repackaging Cigarettes — Will the Courts Thwart the FDA?

    Bayer, R., Gostin, L., & Marcus-Toll, D. – Student

    The New England Journal of Medicine – November 29, 2012

    Legal and policy issues have emerged related to the proposed graphic warning labels on cigarette packaging.

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  • The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception

    Fisher, C. E., Dunn, L. B., Christopher, P. P., Holtzheimer, P. E., Leykin, Y., Mayberg, H. S., ... & Appelbaum, P. S. – Faculty

    Annals of the New York Academy of Sciences – July 19, 2012

    Research on deep brain stimulation (DBS) for treatment-resistant depression appears promising, but concerns have been raised about the decisional capacity of severely depressed patients and their potential misconceptions about the research. We assessed 31 DBS research participants with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a well-validated capacity measure, and with a scale to measure therapeutic misconception, which occurs when subjects do not recognize key differences between treatment and clinical research. Correlations with baseline depressive symptoms were explored. Subjects’ performance on the MacCAT-CR was excellent, but therapeutic misconception was still apparent. A trend toward significance was found in the correlation between baseline depression ratings and total therapeutic misconception score. Responses to open-ended prompts revealed both reassuring and concerning statements related to expectations of risk, benefit, and individualization. Even severely depressed patients did not manifest impairments in their capacity to consent to DBS research. Therapeutic misconception, however, remained prevalent.

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  • The Silent Majority: Who Speaks at IRB Meetings?

    Candilis, P. J., Lidz, C. W., Appelbaum, P. S., Arnold, R. M., Gardner, W., Garverich, S., ... & Simon, L. J. – Faculty

    IRB – July 14, 2012

    Institutional review boards (IRBs) are almost universally considered over-worked and under-staffed, at the same time requiring substantial commitments of time and resources. Although some surveys report average IRB memberships of 15 persons or more, federal regulations require only five. We present data on IRB meetings at 8 of the top 25 NIH-funded academic medical centers in the U.S., indicating substantial contributions from primary reviewers and chairs during protocol discussions but little from other members. The implications of these data for current IRB functioning are discussed and an alternative model proposed.

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  • How Closely Do Institutional Review Boards Follow the Common Rule?

    Lidz, C. W., Appelbaum, P. S., Arnold, R., Candilis, P., Gardner, W., Myers, S., & Simon, L. – Faculty

    Academic Medicine – July 12, 2012

    Between November 2006 and July 2009, the authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers. They also reviewed each of the applications discussed to identify the Common Rule criteria--(1) risk minimization, (2) risk/benefit comparison, (3) equitable subject selection, (4) informed consent, (5) data monitoring to ensure safety, (6) privacy protection and confidentiality, and (7) protection of vulnerable subjects--that were both relevant to the study and not adequately addressed in the application. They then determined if the IRB addressed each of the relevant and not discussed Common Rule criteria in their discussions.

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  • Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process

    Siegal, G., Bonnie, R. J., & Appelbaum, P. S – Faculty

    The Journal of Law, Medicine & Ethics – July 12, 2012

    Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means.

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  • Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations

    Rothenberg, K., Bush, L. – Student

    Houston Journal of Health Law and Policy – June 14, 2012

    Theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped-and been shaped by-personal and professional relationships.

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  • Attitudes and practices among internists concerning genetic testing

    Klitzman, R., Chung, W., Marder, K., Shanmugham, A., Chin, L. J., Stark, M., ... & Appelbaum, P. S. – Faculty

    Journal of Genetic Counseling – May 15, 2012

    Many questions remain concerning whether, when, and how physicians order genetic tests, and what factors are involved in their decisions. We surveyed 220 internists from two academic medical centers about their utilization of genetic testing. Rates of genetic utilizations varied widely by disease. Respondents were most likely to have ordered tests for Factor V Leiden (16.8 %), followed by Breast/Ovarian Cancer (15.0 %). In the past 6 months, 65 % had counseled patients on genetic issues, 44 % had ordered genetic tests, 38.5 % had referred patients to a genetic counselor or geneticist, and 27.5 % had received ads from commercial labs for genetic testing. Only 4.5 % had tried to hide or disguise genetic information, and <2 % have had patients report genetic discrimination.

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  • To protect human subjects, review what was done, not proposed

    Klitzman, R., & Appelbaum, P. S – Faculty

    Science – March 30, 2012

    Retrospective review could improve the efficiency—and perhaps the effectiveness—of human subjects research oversight.

    The Advance Notice of Proposed Rule-making (ANPRM) released in 2011 by the U.S. Department of Health and Human Services (HHS) (1) recommends many important changes to federal regulations on protection of human research subjects. Perhaps most important, through the 74 questions it poses, it offers the opportunity to rethink approaches to research oversight. The current regulatory model of prospective review, based on what researchers say they plan to do, focuses the attention of Institutional Review Boards (IRBs, which must approve proposed research) and researchers on perfecting protocols and consent forms rather than interacting with subjects.

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  • The Participation of Community Members on Medical Institutional Review Boards

    Lidz, C. W., Simon, L. J., Seligowski, A. V., Myers, S., Gardner, W., Candilis, P. J., ... & Appelbaum, P. S. – Faculty

    Journal of Empirical Research on Human Research Ethics – February 1, 2012

    The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.

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  • Ethics and Neuropsychiatric Genetics: A Review of Major Issues

    Hoge, S. K., & Appelbaum, P. S. – Faculty

    The International Journal of Neuropsychopharmacology – January 25, 2012

    Advances in neuropsychiatric genetics hold great hopes for improved prevention, diagnosis and treatment. However, the power of genetic testing to identify individuals at increased risk for disorders and to convey information about relatives creates a set of complex ethical issues. Public attitudes are inevitably affected by the shadow of eugenics, with its history of distorting scientific findings to serve socio-political ends. Nonetheless, the growing availability of genetic tests means that more patients will seek genetic information and physicians must manage the process of informed consent to allow meaningful decisions.

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