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

描述（由申请人提供）：广泛开发和采用有希望的药物滥用刑事司法客户干预措施（例如，转移计划和精神药理学治疗）导致了建立其疗效的对照研究的激增。这类研究的扩大引起了人们的关切，即我们是否能够确保自主权，并尽量减少强迫参与这一双重弱势群体研究的感觉。尽管有许多机构和联邦的要求，旨在确保弱势研究参与者的自主权，该领域缺乏一个可靠和有效的方式来衡量参与研究的胁迫感。 针对这一需要，我们制定并开始评估胁迫评估量表，这是一种专门侧重于被要求参加研究的药物滥用罪犯可能经历的胁迫压力的工具。三个先前的研究的初步结果显示，有希望的内部一致性和收敛和判别效度的水平。 拟议的研究旨在进一步发展CAS作为一个全面的，可靠的，有效的工具，用于衡量胁迫药物滥用罪犯人群中参与研究。研究将分三个阶段进行。第一阶段涉及与客户和专业人士进行焦点小组，以开发更大的项目库，更全面地捕捉研究胁迫的结构。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。第三阶段涉及建立心理测量学属性的最终工具，包括项目响应特性，重测信度，内部一致性，因素结构，收敛效度，判别效度。 CAS的发展响应需要一个工具，以准确地衡量参与研究的药物滥用刑事司法客户之间的胁迫的看法。就像同意测验和认知功能测试一样，CAS将有助于识别那些因感知到的胁迫程度而不适合参与研究的个体。在这种情况下，CAS对研究人员、研究中介机构和IRB可能特别有用。在更学术的背景下，CAS将提供一种可靠和有效的方法来衡量感知胁迫的变化，以制定新的策略，改善同意和招募程序，并减少对人类研究参与者的潜在伤害。 公共卫生相关性：胁迫评估量表（CAS）的发展响应需要一个工具，以准确地衡量参与研究的药物滥用刑事司法客户之间的胁迫的看法。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胁迫水平而不适合参与研究的个体。在这方面，CAS可能对研究人员、研究中介机构和道德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.