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.
Definitions
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 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.
The Northwestern University IRB provides tools and resources to support investigators in properly organizing paper based or electronically retained regulatory documentation and research data.
All materials aimed at recruiting participants into a research study including the final copy of printed advertisements, scripts, audio or video tapes, or web sites must be reviewed and approved by the IRB prior to use.
Policies include information on human research policies, guidance, and oversight.
Guidance documents offer the research community guidelines over more specific study instances.
SOPs, or standard operating procedures, are documents that outline the relevant policy and the IRB Office practices in accordance with Human Research Protections (HRP). If you have questions about the IRB Office policies and practices, please review our SOPs.
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.
Questions?
- If you have any questions about the Social Behavioral templates and resources, please contact the Social Behavioral Team at: sbsirb@northwestern.edu
- If you have any questions about the Biomedical templates and resources, please contact the Biomedical team at: irb@northwestern.edu