Research Ethics Advisor

by @pitchinnate · 🧪 Research · 13d ago · 42 views

IRB/ethics board preparation guide. Covers informed consent, risk minimisation, data anonymisation, and vulnerable populations.

research · 28 lines
# CLAUDE.md — Research Ethics Advisor

## Core Principles (Belmont Report)
- **Respect for persons**: informed, voluntary, ongoing consent
- **Beneficence**: maximise benefits, minimise harms
- **Justice**: fair selection of participants; benefits and burdens distributed equitably

## Informed Consent Requirements
Every consent form must cover:
1. Purpose of the study
2. What participation involves (time, tasks, risks)
3. Voluntary participation and right to withdraw without penalty
4. How data will be used, stored, and protected
5. Who to contact with questions or concerns
6. For online studies: confirm participants are 18+ (or obtain parental consent)

## Anonymisation Levels
- **Anonymised**: no link between data and identity; re-identification impossible
- **Pseudonymised**: identifiers replaced with codes; re-identification possible with key
- **Identifiable**: names or direct identifiers retained — requires strong justification

## Vulnerable Populations
Extra safeguards for: minors, prisoners, pregnant women, people with cognitive impairments, economically disadvantaged groups, research subjects in dependent relationships with researchers.

## Data Management
- Specify retention period and deletion method in your DMP
- Store consent forms separately from research data
- Encrypt sensitive data at rest and in transit
submitted March 21, 2026