Investigator Guidance Series

This page serves as a hub for all of the Investigator Guidance Series documents. Each document is an abbreviated version of one of our HRPP Policies and Procedures intended for investigators, coordinators, and other study team members. This page is a good starting point for any study team member with a question about a policy on a specific topic. A link to the full policy/procedure is included in each document.

Document Updated Advertisements 12/13/2023 Authority of the IRB 12/13/2023 Change Requests 12/13/2023 cIRB 12/13/2023 Closure of Research 12/13/2023 Compensation 12/13/20239/2024 Confidentiality 12/13/2023 Continuing Review 02/05/2024 Contraception Requirements 12/13/2023 Data and Safety Monitoring 12/13/2023 Data Registries 12/15/2023 Emergency Research - Waiving Consent 12/13/2023 Emergency Use of a Test Article 01/25/2024 Employees as Subjects 12/13/2023 Ethical Access 12/9/2024 Exempt Research 01/25/2024 Expanded Access to Investigational Drugs and Devices 12/14/2023 Expedited Review 12/13/2023 Financial COIs 01/25/2024 Full Board Review 12/13/2023 Humanitarian Use Device (HUD) 12/13/2023 Incidental Findings 12/13/2023 Increased monitoring, interim Continuing Review, and verification 12/15/2023 Informed Consent 12/13/2024 International Research 12/13/2023 Investigational and Marketed Devices 1/26/2024 Investigational and Marketed Drugs 12/13/2023 IRB Approval Criteria 12/15/2023 Obtaining Informed Consent for Non-English Speaking Persons 12/13/2023 Obtaining Informed Consent for Persons with Additional Needs 12/13/2023 PI Qualifications and Responsibilities (job description) 12/13/2023] Placebos 12/13/2023 Post-Approval Monitoring of Research 12/9/2024 Pregnancy Testing 12/13/2023 Privacy 1/26/2024 Recruitment 12/13/2023 Reimbursement 12/13/2023 Research Involving Children 12/13/2023 Research Involving Decisionally Impaired Persons 12/13/2023 Research Involving Neonates 12/13/2023 Research Involving Pregnant Women and Fetuses 12/13/2023 Research Involving Prisoners 1/25/2024 Research Personnel Qualifications & Responsibilities (study team job descriptions) 12/13/2023 Short Form Consent 12/13/2023 sIRB 12/13/2023 Students as Subjects 12/13/2023 Study Hold 12/13/2023 Suspension 12/13/2023 Termination 12/13/2023 Using PHI in Research 12/13/2023 Vulnerable Populations - Additional Protections 12/13/2023 Waiving Consent Process 12/13/2023 Waiving Signed Consent 12/13/2023 Wash Out 12/13/2023 What requires IRB review and approval? 1/10/2024