Patient perspectives on group benefits and harms in genetic research.

BACKGROUND: It is unclear how the possible effects of genetic research on socially identifiable groups may impact patient willingness to donate biological samples for future genetic studies. METHODS: Telephone interviews with patients at 5 academic medical centers in the U.S. examined how patients' beliefs about benefits and harms to ones racial or ethnic group shape decisions to participate in genetic research. RESULTS: Of the 1,113 patients who responded to questions about group harms and benefits, 61% of respondents indicated that potential benefits to their own racial or ethnic group would be a big or moderate part of their decision to donate a sample for genetic research. 63% of black respondents and 57% of white respondents indicated that they were 'very' or 'moderately concerned' about genetic research findings being used to discriminate against people by race or ethnicity. 64% of black and 34% of white respondents reported that their willingness to donate a blood sample would be substantially reduced due to these concerns. CONCLUSION: Our findings suggest that a key factor in many patients' decisions to donate samples for genetic research is how those studies may impact identifiable racial and ethnic groups. Given the importance of these considerations to many patients, our study highlights a need to address patients' concerns about potential group benefits and harms in the design of future research studies and DNA biobanks.

How physicians face ethical difficulties: a qualitative analysis.

BACKGROUND: Physicians face ethical difficulties daily, yet they seek ethics consultation infrequently. To date, no systematic data have been collected on the strategies they use to resolve such difficulties when they do so without the help of ethics consultation. Thus, our understanding of ethical decision making in day to day medical practice is poor. We report findings from the qualitative analysis of 310 ethically difficult situations described to us by physicians who encountered them in their practice. When facing such situations, the physicians sought to avoid conflict, obtain assistance, and protect the integrity of their conscience and reputation, as well as the integrity of the group of people who participated in the decisions. These goals could conflict with each other, or with ethical goals, in problematic ways. Being aware of these potentially conflicting goals may help physicians to resolve ethical difficulties more effectively. This awareness should also contribute to informing the practice of ethics consultation. OBJECTIVE: To identify strategies used by physicians in dealing with ethical difficulties in their practice. DESIGN, SETTING, AND PARTICIPANTS: National survey of internists, oncologists, and intensive care specialists by computer assisted telephone interviews (n = 344, response rate = 64%). As part of this survey, we asked physicians to tell us about a recent ethical dilemma they had encountered in their medical practice. Transcripts of their open-ended responses were analysed using coding and analytical elements of the grounded theory approach. MAIN MEASUREMENTS: Strategies and approaches reported by respondents as part of their account of a recent ethical difficulty they had encountered in their practice. RESULTS: When faced with ethical difficulties, the physicians avoided conflict and looked for assistance, which contributed to protecting, or attempting to protect, the integrity of their conscience and reputation, as well as the integrity of the group of people who participated in the decisions. These efforts sometimes reinforced ethical goals, such as following patients' wishes or their best interests, but they sometimes competed with them. The goals of avoiding conflict, obtaining assistance, and protecting the respondent's integrity and that of the group of decision makers could also compete with each other. CONCLUSION: In resolving ethical difficulties in medical practice, internists entertained competing goals that they did not always successfully achieve. Additionally, the means employed were not always the most likely to achieve those aims. Understanding these aspects of ethical decision making in medical practice is important both for physicians themselves as they struggle with ethical difficulties and for the ethics consultants who wish to help them in this process.

Variability among institutional review boards' decisions within the context of a multicenter trial.

BACKGROUND: Institutional review boards (IRBs) are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research. OBJECTIVE: To determine the extent of the variability among different IRBs on their approved research practices and informed consent forms within the context of a multicenter trial that used a common protocol. DESIGN: Descriptive analysis of survey information and informed consent forms. SETTING AND PARTICIPANTS: Sixteen IRBs from the institutions participating in a multicenter trial comparing lower vs. traditional tidal volume ventilation in patients with acute lung injury. MEASUREMENTS: Analysis of survey information on IRBs' approved research practices. Analysis of informed consent forms for the presence and the adequacy of description of each basic element of informed consent specified in the federal regulations. Reading levels of informed consent forms. MAIN RESULTS: Surveys and IRB-approved consent forms were obtained from all of the contacted IRBs (n = 16). Variability was observed among several of the research practices; one IRB waived the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled. Three consent forms contained all of the basic elements of informed consent outlined in the federal regulations, and 13 forms had varying numbers of these elements absent (six forms without one element, four without two, one without three, and two without four). Reading levels of the consent forms ranged from grades 8.2 to 13.4 (mean +/- sd was 11.6 +/- 1.2 grade level). CONCLUSIONS: Within a multicenter trial, IRBs reviewing a common protocol varied in several of their approved research practices and in the extent to which the basic elements of informed consent were included in their consent forms.

Reading between the lines: direct-to-consumer advertising of genetic testing in the USA.

This article critiques an advertisement in a theatre playbill by a bio-technology company for its commercial test for the BRCA1 and BRCA2 genetic mutation, which may indicate a higher risk for breast and ovarian cancer. The advertisement targets a vulnerable audience attending a play about one woman's isolated and painful death from ovarian cancer. It promotes a product with incomplete and at times incorrect information, and it misguides women by suggesting that they contact the company directly about this test, rather than encouraging them to talk to their health care providers about genetic testing and their personal risk of breast cancer. In an era in which more genetic tests will be integrated into clinical practice, we can expect an increase in direct-to-consumer marketing for such tests. This advertisement is an example of what we need to be on guard against.