Improving Ethics in Research Development of the Coercion Assessment Scale (CAS)

描述(由申请人提供)：广泛发展和采用有希望的针对滥用药物刑事司法客户的干预措施(例如，转移注意力的方案和精神药理学治疗)，导致了建立其有效性的对照研究的激增。这类研究的扩大引发了人们的担忧，即我们是否能够确保自主性，并最大限度地减少在这一双重脆弱群体中参与研究的胁迫感觉。尽管许多机构和联邦要求旨在确保弱势研究参与者的自主性，但该领域缺乏可靠和有效的方法来衡量参与研究的感受到的胁迫。针对这一需要，我们开发并开始评估胁迫评估量表(CAS)，这是一种专门关注被要求参与研究的滥用药物罪犯可能经历的胁迫压力的工具。之前的三项研究的初步结果显示，内部一致性和会聚和区分效度是有希望的水平。拟议的研究旨在将CAS进一步发展为一种全面、可靠和有效的工具，用于衡量强迫行为，以参与对滥用药物犯罪者群体的研究。研究将分三个阶段进行。第一阶段涉及与客户和专业人员进行焦点小组，以开发更大的项目库，更全面地捕捉研究强制的结构。第二阶段涉及对测试版文书进行协议分析，以确保参与者正确理解项目并改进他们的措辞。第三阶段包括建立最终工具的心理测量学特性，包括项目反应特性、重测信度、内部一致性、因素结构、收敛效度和区分效度。CAS的发展回应了对一种工具的需要，以准确衡量参与研究的滥用物质刑事司法客户对胁迫的看法。就像同意测验和认知功能测试一样，CAS将有助于识别那些可能因为他们感知到的强迫程度而不适合参与研究的个人。在这方面，中科院可能对研究人员、研究中介机构和IRBs特别有用。在更具学术性的背景下，中科院将提供一种可靠和有效的方法来衡量在制定新战略以改进同意和招聘程序并减少对人类研究参与者的潜在伤害方面感受到的胁迫的变化。 公共卫生相关性：制定胁迫评估量表(CAS)是为了满足对一种工具的需要，以准确衡量参与研究的滥用物质刑事司法服务对象对胁迫的看法。就像同意测验和认知功能测试一样，CAS将有助于识别由于感知到的强迫程度而不适合参与研究的个人。在这方面，中科院可能对研究人员、研究中介机构和伦理审查委员会特别有用。

DESCRIPTION (provided by applicant): The wide-spread development and adoption of promising interventions for substance abusing criminal justice clients (e.g., diversionary programs and psychopharmacological treatments) has led to a proliferation of controlled studies to establish their efficacy. The expansion of this type of research raises concerns about whether we can ensure autonomy and minimize perceptions of coercion to participate in research within this doubly vulnerable population. Despite numerous institutional and federal requirements aimed at ensuring the autonomy of vulnerable research participants, the field lacks a reliable and valid way of measuring perceived coercion to participate in research. In response to this need, we developed and have begun to evaluate the Coercion Assessment Scale (CAS), an instrument that focuses specifically on coercive pressures that may be experienced by substance abusing offenders asked to participate in research. Preliminary findings from three prior studies have revealed promising levels of internal consistency and convergent and discriminant validity. The proposed study seeks to further develop the CAS as a comprehensive, reliable, and valid instrument for measuring coercion to participate in research among substance abusing offender populations. The study will proceed in three phases. Phase 1 involves conducting focus groups with clients and professionals to develop a larger item pool that more fully captures the construct of research coercion. Phase 2 involves a protocol analysis of the beta instrument to ensure that items are correctly understood by participants and to improve their wording. Phase 3 involves establishing the psychometric properties of the finalized instrument including item response properties, test-retest reliability, internal consistency, factor structure, convergent validity, and discriminant validity. Development of the CAS responds to the need for an instrument to accurately measure perceptions of coercion among substance abusing criminal justice clients participating in research. Much like consent quizzes and tests of cognitive functioning, the CAS will be useful for identifying individuals who may not be appropriate for research participation because of their level of perceived coercion. In this context, the CAS may be particularly useful to research staff, research intermediaries, and IRBs. In a more academic context, the CAS will provide a reliable and valid way to measure changes in perceived coercion in the development of new strategies for improving consent and recruitment procedures and reducing potential harms to human research participants. PUBLIC HEALTH RELEVANCE: Development of the Coercion Assessment Scale (CAS) responds to the need for an instrument to accurately measure perceptions of coercion among substance abusing criminal justice clients participating in research. Much like consent quizzes and tests of cognitive functioning, the CAS will be useful for identifying individuals who are not appropriate for research participation because of their level of perceived coercion. In this context, the CAS may be particularly useful to research staff, research intermediaries, and ethics review boards.