Policies and Guidance
- Applicable Clinical Trial (ACT) Checklist
- Artificial Intelligence -DeepSeek ban
- Artificial Intelligence -AI Toolkit (Framework for Review of Clinical Research Involving
AI)
- Belmont Report
- Conflict of Interest (COI) Disclosures and Training Requirements
- Definitions for Clinical Research and Clinical Trials
- Determining which IRB to Use, which Agreements are required, and which IRB fees to
budget
- Enrolling or Excluding Pregnant People, Contraception, Pregnancy Testing, and Partners
of Participants Who Become Pregnant
- Fee Schedule
- Form 11-A4 Guidance (How to successfully submit and get approval for Form 11-A4: Application
for Determination Letter (IRB Decision Aid) for "Not Research, Not Human Research,
or Institution Not Engaged in Human Research"
- ICH GCP (E6-R2) 2016
- Information Security
- IRB Member Nomination
- Injury Language
- IRBNet (IRB Application and Reporting System)
- Lay-Person Summary
- Levels of IRB review
- Local Context for Reviewing (External) IRB
- Obtaining Legally Effective Informed Consent and HIPAA Research Authorization
- Quality Assessment Program
- Quality Assessment Program -Template Letters to PI
- Recruitment, Referral, Screening, Advertising, and Incentives
- Rescinding COVID-19 Risk Mitigation Strategies
- Students, Residents, Fellows, Volunteers, or Employees as Research Participants
- Training Requirements
- Zoom to Teams/Doxy.Me IRB Amendment