ethics-review_skill

Overview

This skill provides expert ethical review and IRB-focused guidance for research protocols, participant protection, and data privacy. It is designed to identify ethical risks, map mitigations, and prepare documents that meet international standards such as the Belmont Report and Declaration of Helsinki.

How this skill works

I deconstruct a study protocol to find participant touchpoints and data flows, then classify risks across physical, psychological, social, legal, and economic dimensions. For each risk I propose concrete mitigations, check compliance against relevant laws (GDPR, HIPAA, Common Rule), and produce a structured ethics appraisal with a clear recommendation.

When to use it

• Before submitting an IRB application or responding to IRB queries
• When designing participant recruitment, consent, or debriefing procedures
• When handling sensitive personal data or cross-border data transfers
• When research involves vulnerable populations or higher-than-minimal risk
• When preparing DPIAs or institutional compliance documentation

Best practices

• Apply Privacy by Design: minimize collection, use strong de-identification and encryption
• Make consent truly informed: plain language, option to withdraw, and accessible formats
• Document risk-to-benefit reasoning with evidence and mitigation timelines
• Explicitly justify inclusion/exclusion criteria to avoid unfair burden or benefit distribution
• Run a mock adverse-event and data-breach response plan before launch

Example use cases

• Drafting and refining an Informed Consent Form for an online behavioral study
• Assessing a multicenter clinical protocol for alignment with the Declaration of Helsinki
• Conducting a DPIA for a dataset containing health identifiers and location data
• Reviewing recruitment scripts to remove coercive language for vulnerable groups
• Preparing a compliance checklist for cross-border data sharing between EU and US sites