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
12/13/2024
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
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 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
