About Preliminary Information and General Principles of Research Ethics Course

Research Ethics Fundamentals and IRB Protocol Review Training | Knowture | Mansoura University

About This Course

This training course introduces the fundamental principles of medical research ethics and the procedures required for Institutional Review Board (IRB) protocol review in biomedical research involving human participants.

Participants will explore how Medical Research Ethics Committees (MRECs) evaluate research proposals to ensure compliance with international ethical standards and national regulations. The course explains the ethical responsibilities of researchers, the structure and role of research ethics committees, and the process required to obtain ethical approval before conducting clinical or biomedical research.

The course also addresses key ethical requirements such as informed consent, participant safety, data confidentiality, and responsible scientific conduct.

Training content aligns with internationally recognized ethical frameworks, including the Declaration of Helsinki developed by the World Medical Association and the international ethical guidelines published by the Council for International Organizations of Medical Sciences. These frameworks guide ethical research practices involving human participants worldwide.

Who Should Take This Course

This course is designed for:

• Postgraduate students preparing master’s and PhD research protocols
• Medical researchers conducting clinical research involving human participants
• Faculty members supervising postgraduate theses and research projects
• Institutional Review Board (IRB) members and ethics committee administrators
• Healthcare professionals involved in clinical trials and biomedical studies
• Academic institutions seeking to strengthen research governance and ethical compliance

What You Will Learn

By the end of this course, participants will be able to:

• Understand the fundamental principles of medical research ethics
• Apply international ethical guidelines in biomedical research
• Understand the structure and responsibilities of research ethics committees
• Navigate the IRB protocol submission and review process
• Ensure proper informed consent procedures in human research
• Protect participant privacy and maintain research data confidentiality
• Identify and manage ethical challenges in clinical research

International Ethical Frameworks Covered

This course introduces the key international frameworks governing ethical research involving human participants:

• Declaration of Helsinki – World Medical Association
https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

• CIOMS International Ethical Guidelines for Health-related Research Involving Humans
https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/

These global standards help ensure that biomedical research is conducted responsibly while protecting the rights, dignity, and safety of research participants.

Egyptian Regulations Governing Clinical Research

Participants will also learn about the regulatory framework governing clinical research in Egypt, particularly Clinical Medical Research Law No. 214 of 2020, which defines legal requirements for ethical approval, participant protection, and institutional oversight of clinical studies.

IRB Protocol Submission and Review Process

The course explains the step-by-step procedure for submitting research protocols to an ethics committee:

1. Registering on the ethics committee system

2. Preparing the research protocol and supporting documentation

3. Administrative review of submitted materials

4. Scientific and ethical evaluation by specialized reviewers

5. Final committee decision (approval, modification, or rejection)

This structured process ensures that research proposals meet both scientific and ethical standards before implementation.

Ethical Responsibilities of Researchers

Researchers conducting biomedical studies must adhere to several ethical responsibilities, including:

• Obtaining informed consent from participants
• Protecting personal data and maintaining confidentiality
• Avoiding conflicts of interest in research funding
• Ensuring participant safety throughout the study
• Maintaining scientific integrity and avoiding plagiarism or data falsification.

Why This Course Matters

Protecting Research Participants

Ethics committees ensure that individuals participating in research are treated with dignity and protected from potential harm.

Ensuring Responsible Scientific Conduct

Ethical oversight strengthens research quality by promoting transparency, accountability, and responsible data reporting.

Required for Ethical Research Approval

Most biomedical studies involving human participants require IRB approval before research can begin.

Strengthening Research Governance

Training researchers in ethical principles contributes to responsible innovation and strengthens public trust in scientific research.

Requirements

Add information about the skills and knowledge students need to take this course.

Course Staff

 Prof. Ahmed Shokeir

Professor of Urology, Urology & Nephrology Center, Editor-In-Chief, Arab Journal of Urology, Director of Center of Excellence for Genome and Cancer Research, X Head of Institutional Review Board (IRB) of Faculty of Medicine, Mansoura University

Frequently Asked Questions

What web browser should I use?

Knowture platform works best with current versions of Chrome, Edge, Firefox, or Safari.