TABLE 2—

Functions of Study Participants, Community Advisory Boards, and Investigators in the Research Process

	Functions and Responsibilities
Elements	Participant	Community Advisory Board	Investigators
Threshold elements
Competence—The capacity to understand and reasonably decide about participants' rights and the process of research participation	Is legally competent to decide about research participation	Is competent to sponsor research and to act in an accountable manner to represent community perceptions of research	Are obligated to maximize participants' ability to make decisions; are obligated to follow ethical guidelines of informed consent; are scientifically competent to produce and disseminate valid research findings
Voluntariness—The exercise of free choice in making a decision about research participation; the absence of coercion in research participation	Exercises individual free choice in deciding about research participation	Expresses the community' desire to participate in research; conveys to participants their right to refuse	Are obligated to construct a situation that ensures voluntary participation
Informational elements
Disclosure—The process of making known relevant risks, benefits, conflicts of interests, and research issues to those directly or indirectly affected or involved in research	Is honest when enrolling in research by revealing information needed by researchers	Elicits from researchers information that the community needs to have; disseminates necessary information to participants, researchers, and community members	Are obligated to fully reveal relevant information and ramifications of research to institutional review board, community advisory board, and participants
Understanding—The ability to evaluate information and recommendations	Is able to evaluate whether to give consent for a specific research study	Evaluates and communicates risks and benefits of research	Anticipate and provide information needed by communities and participants to evaluate research
Consent elements
Decision to act—The process of agreeing or disagreeing with a research plan	Determines whether to give consent for enrollment in a specific research study	Formulates recommendations to potential participants, community members, and researchers; includes decision to proceed with and monitor or to withdraw support from a specific research study	Are able to accommodate to community and individual concerns about the design or conduct of a specific research study
Authorization—Legal sanctioning of participation in a chosen research plan	Legally and formally agrees to enroll in a specific research study	Facilitates autonomous decision making and authorization by participants	Are obligated not to initiate research on a subject without legal authorization

Note. Threshold, informational, and consent elements were adapted from Beauchamp and Childress.31