Research Ethics, Consent & Protocols
Plan scientifically worthwhile research with independent oversight and respect for the people whose participation makes it possible.
Quick revision ↓ Medical Dictionary
01Ethical foundations
Research should address a worthwhile question using methods capable of answering it. Avoid exposing people to burdens through a poorly designed study that cannot yield useful knowledge. Consider anticipated benefits, physical and social harms, fair recruitment and protection of privacy. Independent ethics review and ongoing oversight are central safeguards. The Declaration of Helsinki provides international ethical principles; investigators must also follow the applicable institutional and national requirements.
02Consent as a process
Explain purpose, procedures, alternatives, foreseeable burdens, confidentiality arrangements and the voluntary nature of participation in understandable language. Allow questions and time for consideration, checking understanding rather than merely collecting a signature. Research and ordinary clinical care should not be confused. Capacity, appropriate representation and assent require context-specific safeguards; a waiver or emergency exception must follow the applicable approved framework and cannot be invented by a student researcher.
03Protocol before recruitment
A protocol should define the question, design, eligibility, recruitment, interventions or measurements, outcomes, sample-size rationale, analysis and safety arrangements. Include roles, resources, data handling and plans for communicating results. Seek required approvals before beginning. Record amendments with dates and reasons; do not silently rewrite methods after observing findings. For trials, prospective registration helps make the planned question and outcomes publicly visible.
04Privacy and vulnerable circumstances
Collect only information justified by the purpose and separate identifiers from analysis data where possible. Limit access, use approved secure storage and define retention and sharing arrangements. Pseudonymised data remain potentially linkable; they are not automatically anonymous. Avoid pressure from clinical dependence, financial hardship or unequal power. Explain safeguards and provide appropriate opportunities to decline without undermining access to ordinary care.
05Practical student scenario
A student wants to survey classmates about distress and publish the results. Before collecting responses, clarify the institutional review route, consent process, privacy plan and support arrangements for distress. Avoid recruiting in a way that makes participation appear compulsory. Supervisory oversight is needed even when the project seems low risk. Share findings honestly, protect identities in small groups and distinguish research participation from course assessment.
High-Yield Revision
- A signature alone does not establish informed consent.
- Obtain the required review before recruitment.
- Pseudonymised information can still be identifiable through a key.
Common Pitfalls
- Do not assume a student project is automatically exempt from review.
- Do not promise anonymity if the information can be linked back to a person.
References & Further Reading
Use the full methods and relevant chapters when appraising a paper. These sources support further study; the examples and questions above are original teaching exercises.
- Oxford CEBM — Critical appraisal tools
- Cochrane Handbook — Methods for evidence synthesis
- CDC — Analysing and interpreting epidemiological data
- ASA — Statement on p-values and statistical significance
- Oxford CEBM — Likelihood ratios
- Cochrane — GRADE and summary of findings
- WMA — Declaration of Helsinki, 2024 revision
- EQUATOR — Reporting guideline library
- NIH OBSSR — Mixed-methods research resources
- Institute for Healthcare Improvement — Model for Improvement