Veterans Affairs
Investigators (using VA time)who are seeking to conduct research at the James H. Quillen Veterans Affairs Medical Center (VAMC) must additionally seek approval from the VA Research and Development Committee (VA R&DC) prior to initiating research activity. VA R&DC approval is contingent upon IRB approval.
Submit a new VA study by completing the VA New Protocol Submission xform in OneAegis (formerly IRBManager).
VA Forms
- R&D Overview & Submission Guideline
- Request to Review Research Proposal/Project
- Informed Consent Document - For use with FDA studies
- Informed Consent Document combined with HIPAA
- VA Form 10-0493 HIPAA
- VA Form 10-10116 Revocation of Authorization for Use & Release of Individually Identifiable Health Information
- VA Form 10-250 Privacy Review Checklist NEW
- VA Investigational Drug Information Record Form 10-9012
- VA Research Protocol Safety Survey Form 10-0398
- Investigator Data Page 18
- Investigator Data Page 18 Codes
- Rules of Behavior Form
- Abstract Template
- WOC Intellectual Property Agreement
- VA Financial Conflict of Interest Overview
- VA Financial Conflict of Interest Form (Contact VA R&D service for fillable and electronically signable version)
- VA Financial Conflict of Interest (FCOI) and 208 Waivers
- VA Form 10-0521: HIPAA Waiver of Authorization for Recruitment
- VA Form 10-0521 Attachment: HIPAA Identifiers
- VA Medical Record Flagging Instructions
- VA Research Presentation and Publication Policy
- VA Data Use Agreement
- VA Data Management and Access Plan
- VA Funding Source Codes
Resources
- VA/IRB Contacts
- VHA Directive 1200.05 Requirements for the Protection of Human Subjects in Research
- VHA Directive 1200.01 Research and Development Committee
- VHA Directive 1200.08 Safety of Persons Engaged in Research
- VHA Directive 1200.18 Determination of Rights for Inventions and Discoveries
- VHA Directive 1200.19 Presentation of Research Results Handbook
- VA R&D Policies and Handbooks
- VHA Handbook 1108.04 Investigational Drugs and Supplies
- Medical Center Memorandum No. 151-16-02 Policy for Allocation of Research Time
- Medical Center Memorandum No. 151-16-01 Research & Development Committee
- VA Policy on Use of the Collaborator Feature
- HRPP SOP
- R&DC SOP
- VHA ORD Guidance on HSP Issues Related to COVID-19 Concerns
- VA Memo: ORD-funded HSR Administrative Hold and FAQs
Other Links
- VA Homepage
- James H. Quillen VAMC
- VA Forms (off-site)
- Veterans History Project
- Million Veteran Program (MVP)