Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible cond...
--- name: research-ethics description: Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible conduct of research. --- ## When to Trigger Activate this skill when the user mentions: - IRB (Institutional Review Board), ethics committee approval - Informed consent, assent forms, consent waivers - Human subjects research, vulnerable populations - IACUC, animal research protocols, the 3Rs - Research integrity, fabrication, falsification, plagiarism - Data management plans, data sharing obligations - Conflicts of interest, dual-use research - HIPAA, GDPR, data privacy in research ## Step-by-Step Methodology 1. **Determine regulatory framework** - Identify applicable regulations: Common Rule (45 CFR 46) for US federally funded human research, FDA regulations for clinical trials, IACUC guidelines for animal research. Determine if international guidelines apply (Declaration of Helsinki, ICH-GCP). 2. **Risk assessment** - Classify research risk level: exempt, expedited, or full board review. Identify potential physical, psychological, social, legal, and economic risks to participants. Evaluate risk-benefit ratio. 3. **Protocol development** - Draft IRB protocol including: study objectives, design and procedures, participant population and recruitment methods, inclusion/exclusion criteria, risks and benefits, data security measures, and compensation plans. 4. **Informed consent preparation** - Write consent documents at appropriate reading level (8th grade for general populations). Include: purpose, procedures, risks, benefits, alternatives, confidentiality protections, voluntary participation statement, and contact information. Address special populations (children require assent + parental consent, prisoners, cognitively impaired). 5. **Data protection planning** - Develop data management plan addressing: identifiable vs. de-identified data, encryption and storage, access controls, retention period, sharing and archival policies. Ensure HIPAA compliance for health data, GDPR for EU participants. 6. **Research integrity framework** - Establish responsible conduct practices: proper authorship attribution (ICMJE criteria), conflict of interest disclosure, data integrity protocols, record keeping standards, and procedures for reporting misconduct. 7. **Ongoing compliance** - Plan for: annual continuing review, adverse event reporting, protocol amendments, audit readiness, participant withdrawal procedures, and study closure. ## Key Resources - **OHRP (Office for Human Research Protections)** - Federal guidance documents - **Belmont Report** - Foundational ethical principles - **CIOMS Guidelines** - International ethical guidelines - **ARRIVE Guidelines** - Animal research reporting standards - **NIH Data Management and Sharing Policy** - Data sharing requirements ## Output Format - IRB protocol as a structured document with all required sections. - Informed consent forms with proper formatting and reading level. - Risk assessment as a table: risk category, likelihood, severity, mitigation strategy. - Data management plan following funder-specific templates (NIH, NSF). - Ethics checklist for study-specific considerations. ## Quality Checklist - [ ] Applicable regulatory framework identified and cited - [ ] Risk level classification justified - [ ] Informed consent written at appropriate reading level - [ ] Vulnerable population protections addressed if applicable - [ ] Data security measures commensurate with data sensitivity - [ ] Confidentiality and anonymization procedures specified - [ ] Conflict of interest disclosures complete - [ ] Adverse event reporting procedures defined - [ ] Cultural sensitivity considered in consent and recruitment materials--- name: research-ethics description: Guides research ethics compliance including IRB protocol preparation, informed consent document drafting, research integrity standards, data management plans, and ethical considerations for human/animal subjects; trigger when users discuss IRB, ethical approval, consent forms, or responsible conduct of research. --- ## When to Trigger Activate this skill when the user mentions: - IRB (Institutional Review Board), ethics committee approval - Informed consent, assent forms, consent waivers - Human subjects research, vulnerable populations - IACUC, animal research protocols, the 3Rs - Research integrity, fabrication, falsification, plagiarism - Data management plans, data sharing obligations - Conflicts of interest, dual-use research - HIPAA, GDPR, data privacy in research ## Step-by-Step Methodology 1. **Determine regulatory framework** - Identify applicable regulations: Common Rule (45 CFR 46) for US federally funded human research, FDA regulations for clinical trials, IACUC guidelines for animal research. Determine if international guidelines apply (Declaration of Helsinki, ICH-GCP). 2. **Risk assessment** - Classify research risk level: exempt, expedited, or full board review. Identify potential physical, psychological, social, legal, and economic risks to participants. Evaluate risk-benefit ratio. 3. **Protocol development** - Draft IRB protocol including: study objectives, design and procedures, participant population and recruitment methods, inclusion/exclusion criteria, risks and benefits, data security measures, and compensation plans. 4. **Informed consent preparation** - Write consent documents at appropriate reading level (8th grade for general populations). Include: purpose, procedures, risks, benefits, alternatives, confidentiality protections, voluntary participation statement, and contact information. Address special populations (children require assent + parental consent, prisoners, cognitively impaired). 5. **Data protection planning** - Develop data management plan addressing: identifiable vs. de-identified data, encryption and storage, access controls, retention period, sharing and archival policies. Ensure HIPAA compliance for health data, GDPR for EU participants. 6. **Research integrity framework** - Establish responsible conduct practices: proper authorship attribution (ICMJE criteria), conflict of interest disclosure, data integrity protocols, record keeping standards, and procedures for reporting misconduct. 7. **Ongoing compliance** - Plan for: annual continuing review, adverse event reporting, protocol amendments, audit readiness, participant withdrawal procedures, and study closure. ## Key Resources - **OHRP (Office for Human Research Protections)** - Federal guidance documents - **Belmont Report** - Foundational ethical principles - **CIOMS Guidelines** - International ethical guidelines - **ARRIVE Guidelines** - Animal research reporting standards - **NIH Data Management and Sharing Policy** - Data sharing requirements ## Output Format - IRB protocol as a structured document with all required sections. - Informed consent forms with proper formatting and reading level. - Risk assessment as a table: risk category, likelihood, severity, mitigation strategy. - Data management plan following funder-specific templates (NIH, NSF). - Ethics checklist for study-specific considerations. ## Quality Checklist - [ ] Applicable regulatory framework identified and cited - [ ] Risk level classification justified - [ ] Informed consent written at appropriate reading level - [ ] Vulnerable population protections addressed if applicable - [ ] Data security measures commensurate with data sensitivity - [ ] Confidentiality and anonymization procedures specified - [ ] Conflict of interest disclosures complete - [ ] Adverse event reporting procedures defined - [ ] Cultural sensitivity considered in consent and recruitment materials
Imported from the listed AgentSkill.sh category. Complete supplied package files and notices are retained. Required external tools and credentials are not installed. No bundled code was executed during import. Individual agent task behavior has not been tested.