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 | 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 |
| 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 |
| 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 |