Purpose Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders—Institutional Review Board (IRB) reviewers—has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. Methods In depth interviews with 31 IRB professionals at six sites across the United States. Results IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants wanted to know the result. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research, and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., CLIA lab certification required for return), in practice, the guidance has been overruled to allow return (e.g., no CLIA lab performs the assay). Conclusion An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.
Background: Research suggests that multidisciplinary genomic tumor boards (MGTB) can inform cancer patient care, though little is known about factors influencing how MGTBs interpret genomic test results, make recommendations, and perceive the utility of this approach. This study's objective was to observe, describe, and assess the establishment of the Breast Multidisciplinary Genomic Tumor Board, the first MGTB focused on interpreting genomic test results for breast cancer patients with advanced disease. Methods: We conducted a qualitative case study involving participant observation at monthly MGTB meetings from October 2013 through November 2014 and interviews with 12 MGTB members. We analyzed social dynamics and interactions within the MGTB regarding interpretation of genomic findings and participants' views on effectiveness of the MGTB in using genomics to inform patient care. Results: Twenty-two physicians, physician-scientists, basic scientists, bioethicists, and allied care professionals comprised the MGTB. The MGTB reviewed FoundationOne™ results for 40 metastatic breast cancer patients. Based on findings, the board mostly recommended referring patients to clinical trials (34) and medical genetics (15), and Food and Drug Administration-approved (FDA) breast cancer therapies (13). Though multidisciplinary, recommendations were driven by medical oncologists. Interviewees described providing more precise care recommendations and professional development as advantages and the limited actionability of genomic test results as a challenge for the MGTB. Conclusions: Findings suggest both feasibility and desirability of pooling professional expertise in genomically-guided breast cancer care and challenges to institutionalizing a Breast MGTB, specifically in promoting interdisciplinary contributions and managing limited actionability of genomic test results for patients with advanced disease.
The use of interventions claiming to prevent, retard, or reverse aging is proliferating. Some of these interventions can seriously harm older persons and aging baby boomers who consume them. Others that are merely ineffective may divert patients from participating in beneficial regimens and also cause them economic harm. "Free market regulation" does not seem to weed out risky, ineffective, and fraudulent anti-aging treatments and products. Public health messages, apparently, are having little effect. What more can be done to achieve better protection for older consumers? An analysis of the potential for federal and state action reveals many barriers to effective governmental regulation of anti-aging interventions. In view of dim prospects for stronger public regulation, physicians and other professionals--especially geriatricians and gerontologists--will need to be more aggressive in protecting older consumers. In particular, The Gerontological Society of America and the American Geriatrics Society should undertake a sustained program of specific educational efforts, directed at health professionals and the general public, in which they sort out as best they can the helpful, the harmful, the fraudulent, and the harmless anti-aging practices and products.
Anti-aging practitioners' adoption of the rhetoric of successful aging reflects the success of successful aging models in shaping popular conceptions of what aging is and an ethos of management and control over the aging process. The overlap between anti-aging and successful aging rhetoric also highlights some of the most problematic social, cultural, and economic consequences of efforts made to reconceptualize old age.
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