Lesson 03
On Ethics Clearances
Research Ethics and Integrity · Research
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Summary, mindmap and highlights
A research ethics committee examines whether a study involving people has social and scientific value and whether its design can answer the question. Weak design can expose participants to burden or risk without producing useful knowledge, so methodology belongs inside ethical review.
The committee considers fair participant selection, risks and anticipated benefits, informed consent, privacy, confidentiality, data handling, community context, compensation, conflicts of interest, and protections for people who may face added vulnerability. It also checks whether the research team and site can carry out the protocol safely.
Approval normally comes before recruitment, data collection, or access to identifiable records. Researchers should submit the protocol, participant materials, consent process, tools, recruitment plans, data plan, and relevant agreements. Amendments, safety events, deviations, continuing review, and closure may require later reporting. Local rules determine which activities need full review, expedited review, exemption, or another form of institutional determination.
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- 01
Ethical review includes social value and sound scientific design.
- 02
Committees assess selection, risk, benefit, consent, privacy, and confidentiality.
- 03
Community context and protections for vulnerability shape the review.
- 04
Approval usually precedes recruitment, data collection, and identifiable-record access.
- 05
Protocols, participant materials, tools, recruitment, and data plans support review.
- 06
Amendments and reportable events may require continuing oversight.
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Additional resources
Use these readings and tools to check sources, extend the topic or apply it in your teaching.
Pan American Health Organization
PAHO Ethics Review Committee
The official companion page describing review scope, submissions, and committee responsibilities.
Indian Council of Medical Research
ICMR Bioethics Unit
Indian ethical guidelines, committee resources, training, and national research-ethics material.
World Health Organization
WHO research ethics governance
International guidance on research ethics review and governance for health-related studies.