Resources & Guidance
Throughout the lifecycle of a research study, many regulations, policies, and standard operating procedures apply – from the initial submission, through continuing reviews and modifications, and finally to study closure. Our resources can provide navigation for the research community, as well as for IRB analysts and reviewers.
- It is important to always download these resources directly from the IRB website, instead of saving a personal copy or re-using from a previous study, to ensure you have current information since our resources may be updated at any time.
Protocol Templates & Forms
Protocol templates and forms are ready-to-use documents that will guide you through the process of writing protocols and other supporting documents for your studies. It is important to use the correct template or form to ensure pertinent information is included. Use of our templates is required for most studies.
In addition, if your study does not meet, or you are unsure whether it meets, the definition of human subjects research, you may use the human research determination form.
Consent Templates & HIPAA Requirements
Consent templates & HIPAA requirements resources will guide you through the process of meeting consent and HIPAA requirements for your studies. Use of our consent templates or consent template language is required for most studies.
Study Support Resources
Recruitment Materials & Guidelines
Policies & Guidance
Policies include information on human research policies, guidance, and oversight.
Guidance documents offer the research community guidelines over more specific study instances.
Checklists & Worksheets
Checklists are documents that IRB members, Designated Reviewers, and Compliance Analysts are required to complete as they review the research study.
Worksheets are guidance materials used by IRB Reviewers and Designated Reviewers, for Human Subjects Research in initial reviews, continuing reviews, and modification reviews, to enhance compliance with federal, state, and local requirements.
Study teams are encouraged to review checklists and worksheets as they develop their studies to anticipate criteria for approval.