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HRPP 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 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 is included in each document.

Policy Topic HRPP Policy Number
Advertisements 3.5
Change Requests 2.4
cIRB 1.4
Closure of Research 2.9
Collection, Storage, and Use of HBM in Research 7.2
Compensation 3.8
Confidentiality 3.3
Continuing Review 2.7
Data and Safety Monitoring 3.2
Data Registries 7.3
Emergency Research - Waiving Consent 5.6
Emergency Use of a Test Article 6.4
Employees as Subjects 4.7
Ethical Access 3.12
Exempt Research 2.6
Expanded Access to Investigational Drugs and Devices 6.5
Expedited Review 2.3
Financial COIs 1.25
Full Board Review 2.2
Humanitarian Use Devices (HUD) 6.3
Incidental Findings 3.15
Informed Consent 5.1
International Research 1.5
IRB Approval Criteria 2.5
Investigational and Marketed Devices 6.2
Investigational and Marketed Drugs 6.1
Obtaining Informed Consent for Non-English Speaking Persons 5.7
Obtaining Informed Consent for Persons with Additional Needs 5.7
PI qualifications and responsibilities 1.26
Placebos 3.13
Post-Approval Monitoring of Research 1.21
Pregnancy Testing 3.10
Privacy 3.3
Recruitment 3.6
Reimbursement 3.8
Remote Consent 5.3
Research Involving Children 4.4
Research Involving Decisionally Impaired Persons 4.6
Research Involving Neonates 4.2
Research Involving Pregnant Women and Fetuses 4.2
Research Involving Prisoners 4.3
Research Personnel Qualifications and Responsibilities 1.27
Retention of Research Records 1.17
Short Form Consent 5.5
sIRB 1.3
Students as Subjects 4.7
Study Holds, Suspension, and Termination 8.6
Using PHI in research 3.4
Vulnerable Populations - Additional Protections 4.1
Waiving Consent Process 5.2
Waiving Signed Consent 5.4
Wash-Out 3.13
What requires IRB review and approval 1.8