This comprehensive training program is meticulously crafted for Research Ethics Committee Administrators (RECAs) and is structured around specific modules. The curriculum aims to empower RECAs with the essential knowledge, attitudes, and skills required for effective management of research ethics committees. The program not only addresses foundational administrative competencies but also delves into critical thinking, strategic planning, and emerging ethical issues. Participants will engage in a dynamic learning environment, combining theoretical insights with practical applications, ensuring they are well-prepared to navigate the complexities of research ethics administration.

This training program is designed to meet the Continuing Professional Development (CPD) requirements for RECAs. Participants who successfully complete the program will be awarded a professional certificate in Research Ethics Committee Administration, acknowledging their mastery of essential competencies. The certificate can be used to fulfill CPD points, demonstrating a commitment to continuous professional development.

This program is ideal for individuals serving or intending to serve as RECAs or in related roles within research oversight. It is suitable for those with a minimum of a bachelor's degree in relevant fields (e.g., life sciences, social sciences, healthcare, law) and practical experience in research, ethics, administration, or related fields. Participants should possess a foundational understanding of research processes, ethical considerations, and a commitment to upholding ethical standards in research.

By the end of this training, participants will:

1. Understand their roles and responsibilities: RECAs should have a comprehensive understanding of their roles and responsibilities.
2. Equip with necessary skills: RECAs should be equipped with the necessary skills to perform their duties effectively.
3. Keep up with latest developments: RECAs should be able to keep up with the latest developments in research ethics and implement them in their work.
4. Navigate the complex landscape: The learning outcomes aim to empower participants with the competencies needed to navigate the complex landscape of research ethics committee administration.
5. Foster efficiency and ethical conduct: The program aims to foster efficiency, ethical conduct, and continuous improvement in the field.
6. Equip participants with comprehensive knowledge, attitudes, and skills: The expected learning outcomes are designed to equip participants with comprehensive knowledge, attitudes, and skills necessary for effective management of research ethics committees.

The outcomes are structured across various modules and sessions. Here are the expected learning outcomes for each module:

1. Module 1: Foundations of Administration: Understand the regulatory framework in research ethics administration, recognize the role of regulatory bodies in accrediting and overseeing RECAs, demonstrate knowledge of the process of registering RECs and annual reporting, appreciate the importance of adherence to accreditation standards, analyze case studies to illustrate the impact of regulatory compliance, and engage in interactive activities for a comprehensive understanding of oversight dynamics.
2. Module 2: Fundamentals in Research Ethics part 1: Understand the importance of research ethics and its role in protecting human subjects, identify and apply core ethical principles in research involving human subjects, comprehend the informed consent process and its challenges, understand the ethical review process undertaken by RECs, identify and address ethical considerations when conducting research with vulnerable populations.
3. Module 3: Fundamentals in Research Ethics Advanced part 2: Gain comprehensive understanding of emerging ethical issues, the ethical implications of AI in research, ethical issues in biotechnology, genomics, and genetics, community engagement, and benefit sharing in research, along with the ability to apply these concepts in real-world scenarios. They will also develop skills in creating consent forms, facilitating discussions, and planning capacity-building initiatives.
4. Module 4: Ensuring Ethical Oversight and Review: Understand the legal frameworks and compliance requirements governing research ethics, develop tailored checklists for different types of research submissions, identify and manage protocol violations transparently, formulate and manage an effective budget for ethical oversight, and explore leadership roles in promoting ethical conduct in research environments.
5. Module 5: Research Integrity: Define and understand the significance of research integrity, identify and categorize research misconduct, develop organizational codes of conduct and policies, explore preventive measures against research misconduct, and gain practical knowledge of tools and techniques for detecting fabrication, falsification, and plagiarism (FFP).
6. Module 6: Achieving Operational Excellence and Effective Communication: Adhere to research guidelines and standardize processes, develop effective communication skills and emotional intelligence, leverage technology and communication platforms for IRB efficiency, perfect minute writing, agenda preparation, letter writing, and collaborative research skills.
7. Module 7: Building Capacity and Enhancing Administrative Skills: Train others on IRB processes and incorporate cultural competence in training methodologies, polish communication skills in oral, virtual, and written formats, and excel in report writing and secretariat responsibilities.
8. Module 8: Comprehensive Strategy for Research Management: Master proposal development and grant writing, navigate manuscript publishing and research methodology, and understand research management principles and the role of research in Africa.
9. Module 9: Transnational Research: Ethical Considerations, Regulatory Frameworks, and Best Practices: Understand ethical dimensions in transnational research, navigate regulatory landscapes across different countries, build collaborative partnerships and effective communication in multicultural settings, and ensure compliance through monitoring and auditing in transnational research.
10. Module 10: Optimizing Research Ethics Operations: Develop efficient checklists for processes, master customer service, time management, and conflict management, and cultivate effective collaborations with academic, local, and global researchers.
11. Module 11: Regulatory Compliance, Collaboration, and Continuous Improvement: Develop an inclusive monitoring and evaluation framework, implement codes of conduct and ensure compliance, and strategize for continuous improvement in research ethics administration.
12. Module 12: Advancing Diversity, Equity, Inclusivity in Research Ethics Administration (ADEIRA): Possess a comprehensive understanding of the historical context and ethical imperatives surrounding diversity, equity, and inclusivity in research, demonstrating the ability to apply inclusive principles in the evaluation of research protocols, governance of Research Ethics Committees, and the monitoring and evaluation of research performance across diverse dimensions.

The expected learning outcomes from the course are designed to equip participants with comprehensive knowledge, attitudes, and skills necessary for effective management of research ethics committees.

To enroll in the Training on Research Ethics Committee Administrators (RECAs), participants must meet the following entry requirements: (These entry requirements are designed to ensure that participants possess the foundational knowledge and experiences necessary to actively contribute to and benefit from the training program. Individuals who meet these requirements are encouraged to apply and enrich their capabilities in research ethics committee administration.)

1. Educational qualifications: A minimum of a bachelor's degree in a relevant field (e.g., life sciences, social sciences, healthcare, law).
2. Professional experience: Practical experience in roles related to research, ethics, administration, or a related field is preferred.
3. Occupational background: Individuals serving or intending to serve as RECAs or in related roles within research oversight.
4. Understanding of research processes: Foundational understanding of research processes, ethical considerations, and the role of ethics committees.
5. Language proficiency: Proficiency in the language of instruction (e.g., English) for active participation in lectures, discussions, and assessments.
6. Commitment to ethical practices: Demonstrate commitment to upholding ethical standards in research and protecting research participants.
7. Access to technological resources: Access to necessary technological resources, including a computer and internet connectivity.
8. Preparation for interactive learning: Preparedness for interactive and participatory learning methodologies, including group discussions, role plays, and practical exercises.
9. Willingness to collaborate: Willingness to collaborate with peers, share experiences, and contribute to a collaborative learning environment.
10. Commitment to continuous learning: Participants should express a commitment to continuous learning, as the training is designed to enhance skills and knowledge in the dynamic field of research ethics committee administration.

Purpose of Assessment

Evaluations or assessments are integral to RECAs' training, serving as guiding tools for both teaching and learning processes. These assessments encompass various methods, including continuous assessment tests (CAT), a final written examination, and practical assessments like community dialogue and project work. These methods ensure a comprehensive evaluation of learners' knowledge and skills acquisition throughout the training program.

The curriculum is organized into modules with specific sessions, ensuring a comprehensive coverage of essential topics. Participants will undergo a structured learning journey to acquire the necessary competencies.

20 January 2025. The full course comprises 165 contact hours, with each module lasting 10 to 20 hours.

1. Introduction to Human Health Research Ethics
2. Fundamentals of research ethics
3. Historical Perspectives of Health Research Ethics
4. Ethical approaches: Consequentialist, Deontology, Principlism, virtue ethics
5. Ethical decision-making
6. Emerging Issues in Health Research Ethics
7. Introduction to health research
8. Human Health Research
9. Overview of research protocol
10. Basic research designs
11. Independent research ethics review
12. Ethical framework for research ethics governance
13. Regulatory/legislative dimension

1. Introduction to Research Integrity
2. Differences between research integrity and research ethics
3. Responsible conduct of research
4. Managing research misconduct
5. Promoting responsible conduct of research
6. Publication Ethics
7. Replicability, trust, and validity in research
8. Managing conflict of interest in research
9. Open science
10. Fairness, diversity, and equity in research
11. Case studies, debates, and ethical dilemmas in research

1. Introduction to inspection and audit
2. Principles of GCP inspections and audits
3. Inspection and audit guidelines
4. Outline of SOPs for Audit Inspection
5. SOP preparation – practical session
6. Audit and Inspection preparation process
7. Audit and Inspection Conduct process
8. Roles and responsibilities
9. Selecting and inspecting research sites
10. Report writing and feedback to the audited/inspected team
11. Audit Report drafting practice

1. Introduction to the ethics of biotechnology research
2. Risks, safety and benefits of biotechnology research
3. Legal, ethical and social issues in biotechnology research
4. Ethical review, evaluation and oversight of biotechnology research
5. Introduction to the ethics of Artificial Intelligence Assisted Innovation (AIAI)
6. Legal, ethical and social issues in AIAI
7. Ethical review, evaluation and oversight AIAI
8. Introduction to biobanks and bio-repository
9. Legal, ethical and social issues in research involving biological materials
10. Risks, safety and benefits in research involving biological materials
11. Ethical review and oversight of research involving biological materials

1. Introduction to Clinical Health Research
2. Conducting research with vulnerable populations
3. Legal, ethical and social issues for research with vulnerable population
4. Ethical review and oversight of research with vulnerable population
5. Elements and instruments for the informed consenting process
6. Ethical evaluation and assessment of the informed consenting process
7. Introduction to Public Health Emergency Research
8. Legal, ethical and social issues for emergency research
9. Ethical review, evaluation and oversight of PH emergency research

1. Introduction to Ethics Review Process
2. Fundamentals and Elements of the review process
3. Applying the elements of the review process
4. Role/responsibilities of reviewers in the review process
5. Special considerations in the review process
6. Applying special considerations through case studies
7. Communicating with PIs, RA, and monitoring

1. Why do clinical research?
2. Purpose and Phases of Clinical Research
3. Overview of the history of clinical research
4. Overview of Good Clinical Practice
5. History & Background
6. Principles of GCP
7. Instruments for GCP
8. Understanding the new drug development process
9. Documentation and information management
10. The research project
11. Clinical Research and GCP: Regulations
12. Responsibilities of Players in Clinical Research
13. Roles of IRB/RA in Clinical Research
14. Clinical research designs and terminologies
15. Regulatory and ethical oversight in emerging circumstances
16. Detecting and reporting adverse events
17. Auditing and inspection of clinical trials
18. Applying GCP Guidelines in Clinical Trials