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 12/13/2023
Confidentiality 12/13/2023
Continuing Review 2/5/2024
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 1/25/2024
Employees as Subjects 12/13/2023
Exempt Research 1/25/2024
Expanded Access to Investigational Drugs and Devices 12/14/2023
Expedited Review 12/13/2023
Financial COIs 1/25/2024
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 12/13/2023
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
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 and Responsibilities (study team job description) 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
Wash Out 12/13/2023
Waiving Consent Process 12/13/2023
Waiving Signed Consent 12/13/2023
What requires IRB review and approval? 1/10/2024