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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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Sarah Krähenbühl Mark Blades Christine Eiser 《Legal and Criminological Psychology》2009,14(2):263-278
Purpose. In police interviews children may be asked the same question many times. We investigated how the number of repetitions and the interval between those repetitions affected the accuracy and consistency of children's responses. Methods. 156 children aged 4–9 years watched a staged event and were interviewed individually 1 week later. Children were asked eight open‐ended questions, which were each repeated a further four times (making a total of forty questions). Half these open‐ended questions could be answered from information in the event, and half were unanswerable (so children should have said ‘don't know’ in response to these questions). The questions were repeated in gist form. The interval between an initial question and its repetitions was varied by use of other questions and twenty non‐repeated filler questions. The intervals between repetitions were immediate repetition, repetition after a delay of three intervening questions, after a delay of six intervening questions, and after ten or more intervening questions. Results. Over a quarter of children's responses to repeated questions changed, usually resulting in a decline in accuracy, particularly after the first repetition. Subsequently, the number of repetitions and delay interval had little effect on responses to answerable questions although accuracy to unanswerable questions continued to decline. Conclusions. Question repetition had a negative affect on children's consistency and accuracy. For unanswerable questions in particular, the more often a question was repeated the more likely children were to invent a response. 相似文献