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


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 VMRF at VMRFirbinfo@vmrf.org, or stop by the VMRF Contracts and Grants office on the first floor of Building 13, which is the new building on the East side of the VA campus.

 

SUBMISSION GUIDELINES

 

All IRB applications should utilize the UCSD Human Research Protections Program “Biomedical Research Application Form.” The application consists of application instructions, an application face page, research plan and informed consent form.

 

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, which will incorporate the VMRF harm clause when the project is specified to be administered by VMRF.

• There are two VMRF harm clauses: one for grants and another for industry sponsored studies.
• Under Item 4 in the Consent Assistant, “Sites where participants will be enrolled,” only the VA box should be checked.
• Under Item 5, “Sponsorship/Administration,” either “Commercial” or “Grant funded” should be checked, along with “Study is administered by the Veterans Medical Research Foundation.”
• All “prompts” (questions/triggers that help to fill in specific information) should be removed from the final consent and text revisions may be made at the discretion of the Principal Investigator.
• VMRF reviews all amendments to the protocol. Email or paper drafts may be submitted for review.
• VMRF approvals are communicated to VMRF’s affiliate IRB on paper or electronically via the “HRPP Project Tracking Database.”
• VMRF review is necessary before a study is reviewed for approval by the VA Research and Development Committee

APPLICATION ITEMS REVIEWED BY VMRF

 

Applications are mainly reviewed for specific liability information. The areas VMRF reviews include: personnel, facilities use and funding structure, as well as use of the appropriate harm clause in the consent form. Language in the research plan or consent form which contradicts the intent of the harm clause is forwarded to the VMRF Chief Executive Officer for review. VMRF recommends that investigators contact their Contracts & Grants Administrator in regards to grant submissions or clinical trial agreements to make sure that the contract or grant agreement is processed in parallel with the protocol.

 

Personnel

• Personnel listed on Page 3, Section 7, of the face page, “Other Persons Associated with This Project,” should match the personnel listed in the research plan.
• In the face page, under “Institution,” please list either “UCSD” or “VA” affiliation or both, as appropriate.

Facilities

• Under Section 5 of the face page, “Facilities Where Study Will Be Conducted,” please put a check by the institution/s where the project will take place.
• Please describe any additional locations under “Other.” This includes office space, as well as where subjects will be seen.

**Note: Use of facilities has a direct impact in determining the extent of VMRF’s liability. Please note that recruitment of subjects at a particular site does not constitute “facilities use,” unless subjects are being seen and/or consented at that location.

Funding

• Section 6 of the face page, “Funding,” please check all that apply under “Funding Source/Funding Mechanism,” including the “VMRF funded” box.
• Please be sure to insert the sponsor name in the space allotted.
• Use Items 21, “Industry-Sponsored Or Collaborating Studies,” and 22, “Other Funding Support For This Study,” of the research plan to clearly define the funding structure and that the funding is being administered through VMRF. Please include grant numbers, etc. where available.

Conflict of Interest

 

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

Informed Consent Forms

 

• Use the information under “Submission Guidelines” above to create the appropriate informed consent document/s. The appropriate verbiage may be found at http:\\www.vmrf.net/services/cg/humsub-harm.html
• If a project is industry-sponsored, please insert the sponsor name in place of “and the Study Sponsor” in the generic consent form harm clause for VMRF administered industry-sponsored studies.

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, both the IRB and VMRF stamp must be on the ad copy. (Both stamps are necessary for use of a flyer but only the IRB stamp should be on the posted copy, in order to avoid confusion for the subject.)
• Brochures, patient letters, and handouts should all be approved by VMRF prior to IRB submission. A sample will be kept on file, which has VMRF and IRB stamps. The printed brochures, etc., do not need to have stamps on them.

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.

 

IRB approval letters carry an expiration date of no more than 365 days after the original approval date. Prior to the first year’s expiration date, the Principal Investigator is to submit a “Year 1 Follow up Form” and “Summary of Progress” Form directly to the UCSD IRB. VMRF does not review these documents, as no amendments are allowed at the time of this review.

 

Prior to the second year’s expiration date, the Principal Investigator is to prepare a “Two Year Resubmission,” which consists of a new application with any updated project information included. Drafts of these documents should be forwarded to VMRF for review and approval prior to IRB submission. Upon submission to the UCSD IRB, a new protocol number will be assigned to the project, which replaces the expiring protocol. All project terminations must be reported to the UCSD IRB and VMRF Contracts & Grants department.