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Module 1: Introduction to research ethics

Key topics: Risks of research involving human subjects; basic principles of research ethics; roles of the research ethics committee; types of research that require ethics review; key research organisations and guidelines in Malaysia.

Estimated length: 1 hr 30 min

Module 2: Research protocol and protocol-related documents  

Key topics: Basic structure of a research protocol; types of documents required for ethics review.

Estimated length: 45 min

Module 3: Background review and research design

Key topics: Performing a thorough background review; setting objectives and outcome measures; ethical study design; fair selection of subjects.

Estimated length: 40 min

Module 4: Recruiting and getting informed consent

Key topics: Criteria for valid consent; participant information sheet and consent form; communication techniques; people who lack capacity to consent; waiver or alteration of consent.

Estimated length: 1 hr

Module 5: Managing adverse events

Key topics: Definition of 'adverse event'; strategies to prevent, detect and manage AEs; detection of individual health-related findings.

Estimated length: 45 min

Module 6: Managing personal data and biological samples

Key topics: Identifiable personal information; maintaining privacy and confidentiality; responsible data management; big data.

Estimated length: 45 min

Module 7: Conflicts of interests

Key topics: Recognising conflict of interest; managing COIs; industry-sponsored research; institutional COIs.

Estimated length: 30 min

Module 8: Ethics review

Key topics: Ethics evaluation criteria; preparing for an ethics meeting; protocol amendment; non-compliance; adverse events reporting; interim reporting; site inspection.

Estimated length: 1 hr

Module 9: Closing a study 

Key topic: Post-study care of research subjects.

Estimated length: 15 min