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Managing incidental findings in human subjects research: analysis and recommendations. 总被引:8,自引:8,他引:0
Susan M Wolf Frances P Lawrenz Charles A Nelson Jeffrey P Kahn Mildred K Cho Ellen Wright Clayton Joel G Fletcher Michael K Georgieff Dale Hammerschmidt Kathy Hudson Judy Illes Vivek Kapur Moira A Keane Barbara A Koenig Bonnie S Leroy Elizabeth G McFarland Jordan Paradise Lisa S Parker Sharon F Terry Brian Van Ness Benjamin S Wilfond 《The Journal of law, medicine & ethics》2008,36(2):219-48, 211
No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. 相似文献
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Discharge planning is increasingly prioritized by correctional systems in order to prepare prisoners for their reintegration into society. A goal of discharge planning is to link prisoners with appropriate service providers in the community to meet their needs. A successful discharge plan requires that an optimal level of services exist and work in a coordinated and collaborative way in order to ensure a continuum of care and treatment during the reentry process (Queralt & Witte, 1999). This study utilized Geographic Information System (GIS) to assess the size, demographic characteristics, and needs of the Newark, New Jersey parolee population with the availability, location, and characteristics of health and human service agencies servicing their needs. A random sample of parolees (N = 800) released in 2006 was selected for this study. Social service agency data were obtained from an on-line service agency data base. Results of the analysis include the degree of spatial distribution, accessibility, and availability of services to where the parolees live and the degree of spatial overlap of specific services in an area. 相似文献
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How do the material aspects of intermediary work affect regulators, targets, and beneficiaries? To shed light on this question, we studied an information intermediary in the form of a website and the organizations who founded it. Specifically, we analyzed FracFocus, a self‐regulatory initiative with strong industry ties, charged with disclosing data pertaining to the chemicals used in oil and gas wells completed using hydraulic fracturing technology (fracking) in the United States and Canada. We found that between 2010 and mid‐2017, the vast majority of legislation in states and provinces where fracking actively occurred was updated to mandate or encourage disclosure via FracFocus, meaning that it had a considerable effect on the trajectory of official regulation on fracking disclosure. We also found that FracFocus disclosed important data but did so in a manner that limited accessibility and reduced the comprehensibility of environmental and public health risks to beneficiaries. Our analysis suggests that the public's experience of such a device is one of opaque transparency, in which the line between official and non‐official regulation is blurred. We traced these outcomes to the material affordances created by FracFocus. 相似文献
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Recent contributions in the domains of governance and regulation elucidate the importance of rule‐intermediation (RI), the role that organizations adopt to bridge actors with regulatory or “rulemaking” roles and those with target or “rule‐taking” roles. Intermediation not only enables the diffusion and translation of regulatory norms, but also allows for the representation of different actors in policymaking arenas. While prior studies have explored the roles that such RIs adopt to facilitate their intermediation functions, we have yet to consider how field‐level structuring processes influence (and are influenced by) the various and changing roles adopted by RI. In this study we focus on the mutually constitutive relations between field‐level change processes and the evolving roles of RIs by studying the rise of the International Council for Local Environmental Initiatives (ICLEI)/Local Governments for Sustainability, an RI serving as a bridge for sustainable urban development policies between the United Nations and local authorities. Using ICLEI as an illustrative case, we theorize four different processes of regulatory field structuration: problematization, role specialization, marketization, and orchestrated decentralization. We discuss their implications for RI roles in the field and further theorize the changing dynamics of trickle‐up intermediation processes as an RI gains power and influence. 相似文献
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