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

描述（由申请人提供）：对滥用药物的刑事司法客户的有前途的干预措施的广泛发展和采用（例如，转移计划和精神药理学治疗）导致了对照研究的扩散，以确定其有效性。这类研究的扩大引起了人们的关注，即我们是否能够确保自主权，并最大限度地减少在这个双重弱势群体中参与研究的强迫观念。尽管有许多机构和联邦要求旨在确保弱势研究参与者的自主权，但该领域缺乏一种可靠和有效的方法来衡量参与研究的感知强迫。为了应对这一需求，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药物滥用者可能经历的胁迫压力的工具。先前三项研究的初步发现揭示了有希望的内部一致性、收敛效度和判别效度。本研究旨在进一步发展CAS作为一个全面、可靠和有效的工具来衡量强迫参与药物滥用罪犯群体的研究。这项研究将分三个阶段进行。第一阶段包括与客户和专业人员进行焦点小组讨论，以开发一个更大的项目库，更充分地捕捉研究强制的结构。第二阶段涉及测试工具的协议分析，以确保参与者正确理解项目并改进其措辞。第三阶段是建立定稿工具的心理测量特性，包括项目反应特性、重测信度、内部一致性、因素结构、收敛效度和判别效度。CAS的发展回应了需要一种工具来准确衡量参与研究的药物滥用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将有助于识别因其感知到的强迫程度而可能不适合参与研究的个人。在这种情况下，CAS可能对研究人员、研究中介机构和内部审查委员会特别有用。在更学术的背景下，中科院将提供一种可靠和有效的方法来衡量在制定新策略以改善同意和招募程序以及减少对人类研究参与者的潜在伤害的过程中感知强迫的变化。

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.