Index
- AAHRPP
-
Administrative Hold
- Adverse Events
-
Adverse Event Log Template (DOCX)
- Advertisement Guidance
- Alteration of Consent
- Amendments (Major Vs. Minor)
- Ancillary Reviews
- Appeals
-
Approval Criteria - WVU IRB
- Approval in Principle
-
Approved Technology for Research
- Assent - Child
- Assent - Diminished Capacity
- Case Study Types
- Commercial IRB
- Certificate of Confidentiality (NIH Portal)
- Change in PI (DOCX)
-
Children
- Child Online Privacy Protection Act (COPPA)
- Clinical Trials.gov
- Clinical Trials at WVU
- Closure (Study/Protocol)
- CITI Training
- CITI Administrator Access Request
- Code of Federal Regulations FDA 21 CFR 56
- Code of Federal Regulations HHS 45 CFR 46
- Common Rule 2018
- Complaints (Participants, Others)
- Conflict of Interest (Researchers)
- Conflict of Interest (IRB Members) (DOCX)
- Consent Form Development Guidance
- Continuing Reviews
- Data Protection Process (link to new site)
- Research Data and Technology at WVU
- Definitions
- Data Safety Monitoring Plan Template (DOCX)
- Data Safety Monitoring Board
- Data Destruction and Retention
- Data Agreements
-
Decedent Research HIPAA Authorization
- De-Identified Data (HIPAA)
- Department of Justice Research see National Institute of Justice (NIJ) if NIJ funded
- Department of Defense Research
- Delegation of Authority Log Template (DOCX)
- Deviations
- Deviation Log Template (DOCX)
- Devices (IDE)
- Drugs (IND)
- Duality of Interest
- Education - Research Community
- Electronic Informed Consent (eIC)
- Electronic HIPAA Authorizations
-
Emergency Use
- Enrollment (Close/Re-Open)
- Events - Research Events Definitions
- Events - Deviations and Adverse Events
- Event Reporting
- Exempt Categories
-
Expanded Access
- Expedited Categories
- External IRB
- Extra Credit Policies
-
Incidental Findings
-
iLab Access
- Informed Consent (IC) General Guidance
- Informed Consent (IC) Development Guidance
- Informed Consent (IC) Elements
- Information Access Request (WVU Build Form)
- IC - Assent Child Research
- IC - Assent Diminished Capacity
- IC - ICH Good Clinical Practice
- IC - dbGAP (NIH Database Gentypes and Phenotypes)
- IC - FDA
- IC- HHS
-
IC - Remote Consent
- Institutional Review Boards - WVU
- Institutional Review Boards - Other
- International Research
- Investigator Holds
- Investigational Device
- Investigator as a Sponsor (DOCX)
- Participant Photo/Media Authorization (DOCX)
- Participant Payment
- Pharmacy Policy
- Post Approval Actions
- Pre Approval Actions
- Pre-paid Card Program
- Pregnant Women, Fetuses and Neonates in Research
-
Prisoners
- Prisoners in Research (OHRP Guidance)
- Privacy and Confidentiality for Research Participants
- Program Evaluation
- Protected Health Information (PHI)
- Personally Identifiable Information (PII)
- Protected Populations in Research
- Protocol Types
- Publicly Available Data/Datasets Guidance
- Radiation Safety
- REDCap Access (via iLab)
- Reliance
- Recruitment Guidance
- Reportable Events
- Research Data Management (link to NIST framework on RC site)