The Curriculum

The content of the curriculum was developed using input from focus groups composed of investigators, program managers and experienced CHWs/Promotores. The initial information received from these focus groups was used to write the core components of the curriculum. CHWs/Promotores with a wide range of experience provided input on format, language, appropriate terminology and cultural relevance. Project TRES team members also reviewed the materials for content accuracy, writing style, vocabulary, and cultural relevance.

The curriculum is divided into three sessions that address the purpose of research; the roles and responsibilities of those involved in research (e.g., institution, IRB, investigator, and research team - including CHWs/Promotores); risk and benefits; confidentiality of information; and the components of the informed consent process (e.g., recruitment, enrollment and participation). In addition, each session includes examples and scenarios illustrating the concepts through real life situations. The curriculum also includes an assessment to evaluate change in trainee understanding of the concepts presented in each session.

Materials were initially developed in English and translated into Spanish. Training materials are planned for release in two formats - a bound self-study guide and a web based tutorial. The self-study guide and/or the web tutorial format can be used as stand alone self-study training or in conjunction with group training session. Instructions within the guide direct the CHW/Promotores in how to use the materials as a self-study. Instruction is also provided to investigators and project managers who plan to incorporate the TRES curriculum into a group training planned for a specific research project.

The following is a list of the learning objectives for each of the sessions of the curriculum:

Session 1: Laying the Foundation

At the end of Session 1, promotores will be able to:

• Define research and explain why it is important.
• Know the difference between research studies and service projects.
• Explain why current government protections for research participants were established.
• Name the four groups involved in the protection of research participants.
• Define five key areas of responsibility for a promotor when conducting ethical research practices.
• Apply one of the Three Principles of the Belmont Report.

Session 2: Protecting the Participant

At the end of Session 2, promotores will be able to:

• Explain how research may benefit the participant and community represented.
• Identify the four elements of risk associated with a research study.
• Define confidentiality.
• Explain why practices to protect confidentiality are important to ethical conduct of research.
• Describe two ways in which a promotor can protect confidentiality.
• Apply one of the Three Principles of the Belmont Report.

Session 3: Making the Decision

At the end of Session 3, CHWs/Promotores will be able to:

• Define the purpose of the informed consent process.
• Name the three components of the informed consent process.
• Describe what information is presented to the potential participant during the consent discussion.
• Define voluntary participation.
• Describe what factors may influence the decision to participate.
• Apply one of the Three Principles of the Belmont Report.