Atlanta VA Health Care System
Conducting Human Research
Conducting Human Research at the Atlanta VA
Below are policies, procedures, and forms guiding the conduct of Human Research at the Atlanta VAMC. Questions can be directed to the following:
Collaborative Research Worksheets, Data Inventory and eRRRP Submissions:
David Knight, Science Information Officer: david.knight2@va.gov
Derek Key, Assistant SIO: Derek.Key@va.gov
For IRB Submissions and eIRB processes: Daniel Roysden, Ph.D., VA/IRB Liaison: droysde@emory.edu
For preparing a project submission in both eRRRP: Contact the SIO Office-
David Knight, Science Information Officer: david.knight2@va.gov
Derek Key, Assistant SIO: Derek.Key@va.gov
For Data Repositories, Quality Improvement/Engagement questions, Reportable Events, and Protocol Deviations: Jennifer Whelan, Human Research Protection Program Quality Manager: jennifer.Whelan@va.gov
For preparing a project submission in both eRRRP and IRB, the conduct of Research, CPRS and Reportable Events: Jane Guidot, Clinical Studies Center Manager: jane.guidot@va.gov
IF YOU CANNOT FIND WHAT YOU ARE LOOKING FOR CONTACT JENNIFER WHELAN AT EXT. 3452
Access to Emory IRB: http://www.irb.emory.edu/
VA Clinical Studies - Human
Subject Reimbursements- Research Participants Reimbursement Procedures
- Direct Express Forms
IRB Staff Matrix Form
Accounting of Disclosures
Clinical Studies Center
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Human Studies Orientation PowerPoint Presentation
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Essential Things to do before, during, and after research studies
Close Out and Storage of Research Records
CPRS and Documentation
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CPRS Flags
HIPAA Authorization
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HIPAA Alteration (Waiver) Worksheet (this will take you to the Emory IRB site)
Informed Consent
- VA Informed Consent Tempates
- VA Informed Consent Form Template - Old
- VA Informed Consent Form Template - New January 2019
- VA Informed Consent Form Template Combined with HIPAA - New January 2019
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Informed Consent Process Coming Soon!
- 2018 Common Rule Emory IRB Consent Checklist January 2019
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Scanning the Informed Consent Form Optional
- Radiation Safety Form for Proposals
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Worksheet for Waiver of Documentation of Consent - Emory (this will take you to the Emory IRB site)
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Worksheet for Waiver of Consent or Elements of Consent - Emory (this will take you to the Emory IRB site)
Investigational Devices and Investigational Tissue Products
Investigational Drugs
Laboratory
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Laboratory Reference Ranges - VA Lab
Monitor Visits
Notice of Privacy Policy (NOPP)
Protocol Deviations and Noncompliance
- Steps to Filling out an eIRB Protocol Deviation
- ORO Guidance Research Information Security
- Issue Brief Form
Recruitment
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- Logo - Local AVAMC (Download only and insert into document)
- Logo - National (Download only and insert into document)
Regulatory Binder
Reportable Events (This Section is completely revamped)
Research Compliance
Research Data Repositories and Biorepositories