Ancillary Care in Community-Based Research: Deciding What to Do

描述（由申请人提供）：社区研究中的辅助护理：决定该做什么拟议的4年跨学科多方法项目的目标是建立一个基于经验的规范账户，以说明研究人员在资源匮乏的社区研究中提供辅助护理的义务。辅助治疗（AC）被定义为研究对象所需要的，但不是安全性或科学有效性所必需的医疗保健。在以社区为基础的研究中，与在诊所或医院环境中进行的以设施为基础的研究相比，半熟练的当地研究人员经常在人们的家中和其他功能性生活空间开展研究活动。资源匮乏的收容社区可能缺乏足够的营养、清洁水、卫生设施以及基本的预防和治疗保健服务。我们的初步研究表明，研究人员在与受试者的互动中经常遇到严重的，有时甚至是绝望的未满足健康需求。这种情况提出了一个令人困惑的伦理挑战，因为研究人员必须决定该怎么做。研究人员在多大程度上有提供AC的道德义务？美国国立卫生研究院将AC确定为国际研究伦理中的一个重要问题，并呼吁研究评估利益相关者如何回应提供AC的要求或请求（PA-07-277）。关于研究人员实际提供交流的程度，以及他们如何决定是否这样做，缺乏经验数据。现有的交流规范模型没有考虑社区研究，因为它假设研究发生在临床设施中。在这个项目中，一名社会科学家、一名道德哲学家和一名活跃在全球卫生研究领域的公共卫生科学家将把经验数据收集与哲学分析结合起来，以实现三个具体目标：(1)描述在低资源环境下的低功能卫生系统和高功能卫生系统中进行基于社区和基于设施的卫生研究的研究人员的交流决策经验；(2)确定在低资源环境中预测AC提供的因素之间的关系和关联，确定这些因素在基于社区的研究和基于设施的研究之间以及在低功能和高功能的卫生系统环境之间是否存在差异以及如何存在差异，并根据初步发现完善描述性概念模型；(3)开发和完善研究人员交流义务的规范模型，特别关注低资源环境下基于社区的研究。目标1和目标2将通过进行定量调查来实现。目标3将通过使用标准的哲学方法来开发和系统地测试候选规范模型来完成。拟议项目的广泛、长期目标是帮助研究人员在社区研究中面对AC需求时做出对社会负责的决定。

DESCRIPTION (provided by applicant): Ancillary Care in Community-Based Research: Deciding What to Do The goal of the proposed 4-year interdisciplinary multi-method project is to establish an empirically informed normative account of researchers' obligations to provide ancillary care in community- based research in low-resource settings. Ancillary care (AC) is defined as health care needed by research subjects, but not necessary for safety or scientific validity. In community-based research, by contrast with facility-based research conducted in a clinic or hospital setting, semi-skilled local study workers often carry out research activities in people's homes and other functional living spaces. Host communities in low-resource settings may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic health services. Our preliminary study indicates that researchers often encounter serious and sometimes desperate unmet health needs in their interactions with subjects. Such situations present a perplexing ethical challenge as researchers must decide what to do. To what extent do researchers have an ethical obligation to provide AC? The NIH identifies AC as an important issue in international research ethics, and calls for research to assess how stakeholders respond to requirements or requests to provide it (PA-07-277).There is a lack of empirical data on the extent to which researchers actually provide AC, and how they decide whether to do so. The existing normative model of AC fails to consider community-based research, as it assumes that research occurs in clinical facilities. In this project, a social scientist, a moral philosopher, and a public health scientist active in global health research will integrate empirical data collection with philosophical analysis to accomplish three specific aims: (1) describe the AC decision-making experience of researchers who conduct both community- based and facility-based health research in low and high functioning health systems in low-resource settings; (2) identify the relationships between and associations among factors that predict provision of AC in low-resource settings, determine if and how these differ between community-based and facility- based research and between low and high functioning health system settings, and refine a descriptive conceptual model based on preliminary findings; and (3) develop and refine a normative model of researchers' AC obligations focused specifically on community-based research in low-resource settings. Aims 1 and 2 will be accomplished by conducting a quantitative survey. Aim 3 will be accomplished by using standard philosophical methods to develop and systematically test candidate normative models. The broad, long-term objective of the proposed project is to help researchers make socially responsible decisions when faced with AC needs in community-based research. PUBLIC HEALTH RELEVANCE: Project Narrative International research intended to promote the health of the poor often brings researchers into contact with research subjects who need health care. When research subjects cannot get the care they need from local providers, are researchers ethically required to provide care if they can? The goals of this project are: to find out how researchers actually decide what to do about such needs and to understand what kind of response is ethically required.