Human Subjects

 

Protecting Participants in Clinical Research

VMRF is committed to protecting the participants in VMRF administered clinical trials and encourages all investigators to review the fourteen (14) minute video which can be downloaded following the link below.  We invite you to incorporate this informative video into your standard enrollment processes as you educate your human volunteers about their participation in clinical research.  The video was produced by your VASDHS/VMRF colleagues under the direction of Barton Palmer, Ph.D. and with funding from the NIH (Grant #S07 RR018238-02).

Please click the following link to download the Research Video  Human Subjects


REVIEW OF PROPOSED HUMAN SUBJECT PARTICIPATION IN VMRF STUDIES

 

AN OVERVIEW FOR INVESTIGATORS AND THEIR STAFF

 

OVERVIEW

 

The VA San Diego Healthcare System (VASDHS) and the Veterans Medical Research Foundation (VMRF) use the University of California, San Diego (UCSD) Human Research Protections Program (HRPP) as their affiliate Institutional Review Board (IRB). The UCSD IRB is a research oversight committee charged with assuring, both in advance and by periodic review that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies. For specific information please contact the VA Research Service Staff.

 

SUBMISSION GUIDELINES

 

All submissions must start at the VA Research Service which will assign an application number necessary for completion of the IRB application materials.

 

The Human Research Protections Program website (www.irb.ucsd.edu), provides all necessary forms, templates and fact sheets for protocol submissions. The Consent Assistant feature allows creation of a VA 10-1086 informed consent form. VMRF administered studies will require a VA consent form with the VA harm clause.

 

Conflict of Interest

• VMRF Contracts & Grants will ask for completed Conflict of Interest forms in the course of the grant submission or CRADA process.

Advertisements, Flyers & Brochures

• Advertisements, flyers and brochures for VMRF-administered projects cannot include the UCSD logo or leave the impression that the project is connected to UCSD.
• When requesting VMRF to place an advertisement, the IRB approval stamp must be on the ad copy.

CALENDAR & DEADLINES

 

The UCSD IRB maintains a calendar of deadlines and committee meeting dates on its website at http://irb.ucsd.edu/dates.shtml for protocol submissions and renewals. Expedited protocols are processed and reviewed outside of the committee meetings, upon receipt by the UCSD IRB.

 

A deferred protocol being resubmitted must be submitted to the same committee that initially reviewed the protocol.

 

All project terminations must be reported to the VA Research Service, the UCSD IRB and the VMRF Contracts & Grants department.