Fernandez Conrad V, Kodish Eric, Shurin Susan, Weijer Charles
Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada.
J Pediatr Hematol Oncol. 2003 Sep;25(9):704-8. doi: 10.1097/00043426-200309000-00006.
The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants.
An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs.
One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants.
Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified.
在临床研究结束后向参与者反馈结果总结有诸多潜在益处。作者确定了研究人员在建立向研究参与者反馈结果的项目时的当前做法、态度和需求。
2002年5月对儿童肿瘤研究组的所有236名主要研究者（PI）进行了一项网络调查，记录了PI和机构的人口统计学信息、当前做法以及PI在创建研究结果反馈项目时所感知到的障碍和需求。
150名（63.8%）PI做出了回应。很少有机构（n = 5）建立了全面的项目来提供结果反馈。PI表示实施此类项目的主要障碍包括编写通俗易懂的总结、时间限制、联系参与者的任务以及给参与者带来的潜在困扰。PI确定了在他们自己机构建立项目的以下促进因素：通俗易懂的总结、网站、肿瘤学家总结的编写以及经济奖励。对于何时应分享结果没有明确的共识：30%表示在研究结束后，24%表示在结果发表时。相当一部分受访者反对或强烈反对向研究参与者普遍提供结果。
儿童肿瘤研究组中很少有机构设有向研究参与者反馈结果的项目。已确定了这一过程中的重大障碍和促进因素。
