VBRI

Veterans Biomedical Research Institute New Jersey

 

VBRI Home

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NAVREF

Board Meeting Minutes and Members Only

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AAHRPP

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Reporting Misconduct

Research Home VANJHCS

 

PROCEDURES/REQUIREMENTS

 

                           Local Procedures
                Federal wide assurance   Terms
 1. IRB Role/Function    Tracked Changes
 2. Human Studies Educational requirements
 3. Informed Consent   
 4. Investigator Responsibilities 
 5. Recruitment of subjects 
 6. Investigational Drugs/Devices
 7.  Initial Reviews     
 8. Exemption from IRB Review
 9. Expedited Review
 10.Adverse Events
 11.Continuing Review
 12. Amendments
 13. IRB Records Retention
14. Privacy and Confidentiality of Data
15. Study Closure, Suspension or Termination
16. HIPAA Compliance
17. Identifying Research Patients in CPRS
18. Human Research Protection Program-HRPP
19. Non-Vets as Subjects
20. Reporting to ORO
21. Conflicts of Interest
22. Complaints
23. Hazardous Materials in Research Labs
24. Site Monitor and PI Responsibilities
25. Participant Outreach
26. Sponsor Obligations
27. Intake of  IRB Submissions
28. Retention of IRB Records
29. Human Subject Applicability Determination
30. Impaired Decision Making Capacity Subjects
31. Research Committee Handbook New Jersey
32. Just In Time Submissions
33. Human Research Protection Process Improvement Procedures
34. Process Improve/Quality Improvement  versus Research Activity
35. R&D Subcommittee Reviews SOP
36. R&D Preliminary Reviews SOP
                             National Policies
Nuremberg Code        Declaration of Helsinki
Handbook 1200.1 Research Committee  Policy
Calendar IRB Meetings
Handbook 1200.1 Research Committee Policy
Handbook  1200.5 Human Subjects Protection
Handbook 1050.3 Assurance of Human Protection
Handbook Safety 1200.8
Handbook 1200.16 Off Site Research
Handbook 1200.06 HazMat
Handbook 1202 Merit Review
Handbook 1204 Health Services Research
Handbook 1204.3 Health Services Research Centers
Handbook 1204.4 Health Services Research Award
Handbook 1108.1 Controlled Substances Pharmacy
Handbook 1605.1 Privacy and Release of  Information
Handbook 1108.04 Investigational Drugs
Handbook 1054.04 Debarment and Suspension
CFR-Protection of Human VA Regs Title 38 CFR16
CFR-Patient Rights Title 38 CFR 17.33
CFR-Treatment of Res Related Injuries Title 38 CFR 17.85
CFR-FDA-Investigational New Drugs Title 21 CFR 312
CFR-FDA-Investigational Biol Products Ttile 21 CFR600
CFR-FDA-Investigational Devices Title 21 CFR 812
Education Directive
Minors as Research Subjects     
Tissue Banking
HIPAA Guidance
Privacy Notice for Patients   Large Version
Credentialing of Researchers
Travel for Beneficiaries
WOC appointees in Research HR-27-1004 Policy
WOC Credentialing HR-26-0804
WOC minors in Animal Research
 
 
Send mail to robert.eng@post.harvard.edu with questions or comments about this web site.  Last updated 4/28/2008