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VA Information
This site is provided as a guide to James H. Quillen VAMC investigators, and to ETSU investigators who are actively conducting or are seeking approval to conduct VA approved research.
The research of this institution is governed by VHA, DHHS and FDA regulations
protecting the rights, safety, and confidentiality of human subjects in
research. An approved Federalwide Assurance for the East Tennessee State
University/James H. Quillen Veterans Affairs Medical Center Institutional Review
Board (ETSU/VA IRB) is on file with the Department of Health and Human Services
Office for Human Research Protection.
Completion of various compliance courses in the ethical conduct of human subject research is required prior to submission. Compliance education is verified by the VA R&D and the IRB Administration at the time of submission. Research proposals/protocols will not be accepted by the Human Research Protections Program IRB Administration until credentialing has been verified by the VA R&D and the Principal Investigator and the study members of the research team (e.g., co- sub-investigator, research coordinators, etc.) have completed the required compliance course(s) or equivalent course(s) (written proof of course completion will be required prior to proposal submission).
Investigators who are seeking to conduct research at the
James H. Quillen Veterans Affairs Medical Center (VAMC) (using veteran patients,
the VA facilities, equipment or VA time) must additionally seek approval from the VA Research and Development Committee (VA R&D) prior to initiating research activity. VA R&D approval is contingent upon IRB approval.
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For assistance, click here for
contacts.
VA Forms
Appendix A-
Training Certificates and Personnel Documentation Checklist
Request to
Review Research Proposal/Project Instructions and Funding Codes
Request to
Review Research Proposal/Project
Guidelines for Informed Consent
VA Form 10-1086 Informed Consent Document
(Note: to be used for all studies approved after March 31,
2011)
HIPAA
(Note:
to be used for all studies
approved after March 31, 2011)
VA
Form 10-1086 Informed Consent Document (ICD) with embedded HIPAA
(Note: to be used for all studies approved on and prior to March 31,
2011)
VA
Narrative
VA Investigational Drug
Information Record Form 10-9012
VA Personnel List
VA Research
Protocol Safety Survey Form 10-0398
Investigator Data Page 18
Investigator Data Page 18 Codes
Scope of Practice
VA Certification Memo
Rules of Behavior
Form
Abstract Template
WOC Intellectual
Property Agreement
VA
Form 10-3203
VA Financial Conflict of Interest Overview
VA Financial Conflict of Interest Form
HIPAA Waiver of Authorization for Recruitment
VA Medical Record Flagging Instructions
VA Research Presentation and Publication Request to Review Form
VA
Research Presentation and Publication Policy
VA Data Use Agreement
Resources
VA Staff
VA Compliance Education Requirements
Click
here to access
VA-specific training
VA Investigator's Handbook
VHA
Handbook 1200.5 Requirements for the Protection of Human Subjects in Research
VHA
Handbook 1200.01 Research and Development (R&D) Committee
VHA Handbook 1200.08 Safety of Persons Engaged in Research
VHA Handbook 1200.18 Intellectual Property
VHA Handbook 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. 151-07-01 Policy for Allocation of Research Time
R&D HRPP
Guide and Procedures
Other Links
VA Homepage
James H. Quillen VAMC
VA Forms (off-site)
Veterans History Project
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