Guidance

Governmental Agencies Guidance (OHRP and FDA)
• HHS.gov Decision Charts – Human Subject Regulations Decision Charts
• FDA Guidance on Reportable Events

Initial Review Submissions or New Protocol Submissions Guidance
• Required Elements of a Protocol
• Writing a Research Protocol
• Determining Human Subjects Research
• Submitting a New Application
• Investigator Responsibilities
• Special Issues Concerning Protocol Development for Genetic Research and Guidelines for Genetic Research
• Recruitment of Subjects
• Advertisements for Research Subjects

• Guidance for Data Monitoring Plans

Informed Consent Process and Documentation/ Waivers of Consent and Authorization
• Consent Process and Documentation
• Verbal Consent
• Requests for Waiver of Consent

Guidance on Other IRB Submissions
• Amending a Protocol
• Continuing Review and Final Closures
• Reportable Events and Reporting Unanticipated Problems
• Emergency Use of an IND/IDE
• Treatment Use and Other Types of Expanded Access Uses of Drug, Biologic or Device
• Compassionate Use Device Policy
• Research Data Compilations
• Reviews Preparatory to Research

Research with Children and other Vulnerable Populations
• Involving Children in Research
• Assent of a Minor
• Waiver of Parental Permission
• Research with Pregnant Women, Human Fetuses and Neonates
• Research with Prisoners

NYU SoM Special Populations
• Involving Non-English Speaking Subjects in Research
• Enrolling Students and Employees in Research
• Involving the Cognitively Impaired in Research

Studies Involving Investigational New Drugs and Devices
• Essential Documents for a Clinical Trial
• Using a FDA Regulated Project
• Responsibilities of the Investigator as a Sponsor
• Letter for Sponsors – Reportable Event Policy Enforcement

The IRB makes every effort to provide all guidance in the most recent format on our website. Using expired or out-of-date guidance may delay a timely review of your IRB submission.

Contact Us if you have any questions or comments.