Ulrich Connie M, Knafl Kathleen A, Ratcliffe Sarah J, Richmond Therese S, Grady Christine, Miller-Davis Claiborne, Wallen Gwenyth R
University of Pennsylvania School of Nursing.
University of North Carolina.
AJOB Prim Res. 2012;3(2):10-23. doi: 10.1080/21507716.2011.653472.
Recruiting and retaining human participants in cancer clinical trials is challenging for many investigators. Although we expect participants to identify and weigh the benefits and burdens of research participation for themselves, it is not clear what burdens adult cancer participants perceive in relation to benefits. We identify key attributes and develop an initial conceptual framework of benefit and burden based on interviews with individuals enrolled in cancer clinical research.
Semistructured interviews were conducted with a purposive sample of 32 patients enrolled in cancer clinical trials at a large northeastern cancer center. Krueger's guidelines for qualitative methodology were followed.
Respondents reported a range of benefits and burdens associated with research participation. Benefits such as access to needed medications that subjects otherwise might not be able to afford, early detection and monitoring of the disease, potential for remission or cure, and the ability to take control of their lives through actively participating in the trial were identified. Burdens included the potentiality of side effects, worry and fear of the unknown, loss of job support, and financial concerns.
Both benefit and burden influence research participation, including recruitment and retention in clinical trials. Dimensions of benefit and burden include physical, psychological, economic, familial, and social. Understanding the benefit-burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research.
对于许多研究者而言，在癌症临床试验中招募并留住人类受试者颇具挑战性。尽管我们期望受试者能够自行识别并权衡参与研究的益处和负担，但尚不清楚成年癌症受试者相对于益处而言所感知到的负担是什么。我们通过对参与癌症临床研究的个体进行访谈，确定关键属性并构建益处和负担的初始概念框架。
对来自东北部一家大型癌症中心的32名参与癌症临床试验的患者进行了有目的抽样的半结构化访谈。遵循了克鲁格的定性研究方法指南。
受访者报告了一系列与参与研究相关的益处和负担。确定的益处包括获得受试者原本可能负担不起的所需药物、疾病的早期检测和监测、缓解或治愈的可能性，以及通过积极参与试验掌控自己生活的能力。负担包括副作用的可能性、对未知的担忧和恐惧、失去工作支持以及经济方面的担忧。
益处和负担都会影响研究参与，包括临床试验中的招募和留住受试者。益处和负担的维度包括身体、心理、经济、家庭和社会方面。理解人类受试者自愿同意过程中涉及的益处 - 负担平衡是研究的基本原则，对于确保受试者就参与临床研究的决定做出明智决策至关重要。
