VA Studies

Conducting Human Research Studies at the Atlanta VA

Introduction

The Atlanta Veterans Affairs Medical Center research program is affiliated with Emory University in Atlanta, GA. In addition to Emory IRB approval, the Atlanta VA requires a separate approval process for conducting human subject research. The Atlanta Research and Education Foundation, Inc. (AREF) provides guidance to researchers interested in conducting clinical research at the Atlanta VA Medical Center.

On that webpage, you will see that the AVAMC has different and/or additional policies for many research-related activities. There are specific VA:

  • CITI and other training modules (see "Appointments and Credentialing" section at left)
  • Oversight offices (like Radiation Safety, Biosafety, Research and Development Committee)
  • Requirements to ensure that research is relevant to Veterans, and if non-veterans are recruited, there is adequate justification
  • Financial Conflict of Intest form (Emory investigators must also do annual and update disclosures in the Emory COI system as well)
  • Rules and a worksheet for collaborations between VA and non-VA sites ("collaborative research")
  • New investigator forms
  • Data security rules and forms
  • Disclosure accounting forms (for HIPAA purposes)
  • Policies on recruiting and recruitment materials
  • Records storage policies
  • Study start-up checklists and sign-offs
  • Informed consent and HIPAA templates
  • Device and drug accountability procedures, pharmacy procedures
  • Study monitor visit procedures
  • Protocol deviation, noncompliance, and reportable event guidelines
  • Policies on Tissue Banking and Data Repositories (including IRB submission requirements)
  • Other policies, forms, and regulations

There are people and offices ready to help you navigate VA research. Please see the "Help and Contacts" tab below.

Appointments & Credentialing

For More information, look at this link

Investigator

Investigators that wish to conduct clinical research studies at the Atlanta VA, recruit VA patients or use VA data, must have a VA appointment or designate a collaborator (Co-Investigator). This collaborator must be a VA staff physician or practitioner who agrees to assume full responsibility for all aspects of the study conducted at the VA.

Physicians may obtain an appointment by being sponsored by a clinical division and privileged through the VA Medical Center Chief of Staff’s Office. Appointments are coordinated through the Medical Staff Coordinator by calling 404-321-6111 ext. 6240.

To receive VA funding, Investigators must have a paid 5/8th VA appointment.

Research Staff

Non-VA research staff wishing to engage in human subjects’ research activities at the Atlanta VA must obtain a WOC (Without Compensation) appointment through the VA research office. As part of this process, staff must complete research credentialing requirements as follows:

To initiate the process for a WOC appointment, contact the WOC Coordinator at woccoordinator@atlaref.org, ph. (404) 321-6111 ext. 6177.

Training Requirements For Investigators and Research Staff:

VA Central Office requires that staff engaged in human subjects research complete several training courses.

Staff conducting research at the VA are required to complete the VA Human Subjects Protection training modules at least every three years. Credit is given for the Emory biomedical CITI module; then some additional sections are required. 

  • log onto the CITI website
  • select: “Affiliate with another institution”
  • select “Atlanta(Decatur)” under “Veterans Affairs”
  • Complete enrollment questions
  • Under “My Courses”complete human research course
  • Print or save your certificate electronically

Please reference https://www.atlanta.va.gov/services/research/investigators.asp  under“Training Requirements” document for more information.

In addition, Investigators and staff involved in human studies research are required to complete Human Studies Orientation held on the second and fourth Wednesday of each month at the Atlanta VA Medical Center. Contact the Director of the Clinical Studies Center at 404-321-6111 ext. 6933 for more information.

Research & Development (R&D) Committee Protocol Submission:

Research studies conducted at the VA require both the Emory IRB and VA R&D Committee approvals. Submission guidelines are available at:

http://www.atlanta.va.gov/services/research/Investigators.asp


Contact the VA SIO at (404)728-4827 for additional information

Meeting Dates:
The R&D Committee usually meets on the first Wednesday of each month.
The submission deadline is noon on the last Wednesday of the month.

VA Resources:

VA/IRB Liaison
The VA/IRB liaison functions include:

  • Monitor the status of VA research projects submitted to the Emory IRB
  • Verifying that the submitted research projects have the necessary components prior to review
  • Follow up on IRB requested changes
  • Keep the VA appraised of changes to IRB policies and procedures
  • Serve as a resource for the IRB submission processes
  • Liaison between the VA research staff and the IRB

The VA/IRB liaison is located both at the Emory IRB (phone (404) 712-9749) or at the Atlanta VA (phone (404) 321-6111 ext  251200).

 

Clinical Studies Center (CSC)

The CSC is a center designated to promote and facilitate human subject research studies at the VA. The Center is comprised of exam rooms and interview rooms for research visits, a dedicated subject waiting room and reception area, a work station for monitoring visits, and phlebotomy services for research participants. Contact the CSC at (404) 327-4934 for additional information.

VA Informed Consent/HIPAA Requirements and Template

For more information about VA informed consent and HIPAA requirements, please referecen this page: https://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp

VA Reportable Events

For information on how to report adverse events, unanticipated problems, deaths, protocol deviations for VA Research, please reference this link:  https://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp 

Investigational Drugs and Devices

More information can be found here.

Investigational Drugs

VA regulations require that drugs used for research studies (including FDA approved drugs) be handled by the VA Research Pharmacist. For more information, please reference this link: https://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp  

 

Investigational Devices

The AVAMC also has specific policies and procedures for Investigational Devices, described in documents found at https://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp   under "Investigational Devices and Investigational Tissue Products"

Research Agreements

Industry-sponsored research studies conducted at the VA must be administered through the Atlanta Research and Education Foundation, Inc. (AREF).

If a clinical trial is being conducted at both Emory and the VA, then there will be two separate agreements.

For more information, contact the Contracts and Grants Administrator at (770) 415-9189 or at this website: https://atlaref.org  

Help and Contacts

Assistance with VA Research

To help you navigate the VA requirements, the Emory IRB has on-staff a "VA/IRB Liaison"

The VA/IRB liaison can be reached at 404 321-6111 ext. 251200 (VA office) or at (404) 712-9749 (Emory Office)  

The VA/IRB liaison functions include:

  • Monitor the status of VA research projects submitted to the Emory IRB
  • Verifying that the submitted research projects have the necessary components prior to review
  • Follow up on IRB requested changes
  • Keep the VA appraised of changes to IRB policies and procedures
  • Serve as a resource for the IRB submission processes
  • Liaison between the VA research staff and the IRB

AVAMC Clinical Studies Center (CSC)

(404) 327-4934

The AVAMC CSC is a center designated to promote and facilitate human subject research studies at the VA. The Center is comprised of exam rooms and interview rooms for research visits, a dedicated subject waiting room and reception area, a work station for monitoring visits, and phlebotomy services for research participants.