Submitting a Protocol to SCI – What do you need to do?

All research studies utilizing VA resources or facilities or which involve VA patients or staff, including part-time staff; without compensation employees (WOC); fee-basis contract and consultants, must be approved by the R&D Committee and its appropriate subcommittees.  No research project may commence prior to final approval by the R&D Committee.  These Procedures apply to all research projects regardless of funding source.

All initial submission documents and IRB approvals must be submitted to the Research Office, room E579-1 and signed in on the clipboard or mail to Jaime Passaro(151).  Refer to the memorandum for Meeting Dates and Submission Deadlines.

Investigators have three options for submitting protocols to SCI for review and Approval.
1)  Submit to the SCI first and submit to the UF-IRB-01 once you have SCI approval, or
2)  Submit to the UF-IRB-01 first, then submit to the SCI once you have IRB approval, or
3)  Submit to SCI and UF-IRB-01 simultaneously.

*It is the recommendation of the SCI Chairperson that protocols are submitted to SCI first.

Submission Document Checklist:

Please submit 1 COMPLETE paper copy (including signatures) and 1 COMPLETE electronic copy of the following:

*Submit electronic documents in Word and Excel format. Only Protocols will be accepted as PDF documents.

Protocol

Introductory Questionnaire:  Please remember to submit Addendums as applicable.

 Informed Consent(If already IRB approved, submit copies of the stamped approved informed consent and the signed IRB approval letter). Please see the “ SCI reviewer checklist” for required details and items in Informed Consent and Introductory Questionnaire.

Study Resource Utilization Assessment form – To facilitate the VA SCI review of your project relative to VA resource utilization, please answer the questions on the form. More information on VA policy 151-4 can be accessed in the Policies Section

 Data Security Checklist and  PI Certification:  This is a VHA Mandate as per memorandum dated February 6, 2007 by the Deputy Under Secretary of Health.  The complete ORD Directive can be reviewed on the ORD website.  The Memorandum and Data Security Forms can be found in the “Forms” section of the SCI website main page.

 Abstract  – also, PLEASE include an electronic copy of the abstract with your study submission to *  Jaime Passaro  No study may be initialized without an abstract.

  Compliance PI signature page – By signing and submitting this memo, the PI indicates that s/he has read, understands the importance of, and agrees to the VA Annual Reports and IRB Continuing Renewals and Training SOPs

 Request to Review Research Proposal/Project form When answering question 11 “Funding Source and Fund Adminstration,” please enter the Title of the funding source (i.e. Pfizer, etc.) as well as who the funding will be administer by (i.e. UF, NFFRE, VA, etc.).

Project Budget

Investigational Drugs:

* Submit each of the following electronic documents in Word or PDF format with your study submission.

   Investigator’s Brochure

   FDA Form 1572*

   VA Form 10-9012 Please submit a workable electronic copy of the 10-9012 to *  Matthew Morrow  prior to the submission of your study.  Mr. Morrow will review the form for completeness and correctness and return the electronic copy to you.  You must submit the complete, correct 10-9012 with an original PI signature along with the submission of your study.
(see instructions).

Investigational Devices:

 Research Involving Investigational Devices

 NF/SG VHS Guidelines for Investigator Using Investigational Devices

Radiation, Radioactive Materials, Biological Specimens, Gene Therapy or Genetic Testing:

1.  If you have answered “yes” to Question 3a, 3c, 3e, 3f, 3j and/or 3K of the Introductory Questionnaire, you must contact the Safety Committee Secretary* Darion Glover ext. 6481 to discuss the  the completion of the Research Protocol Safety Survey and subsequent review by the Subcommittee for Research Safety.  Hand written submissions of the Safety Survey will not be accepted.  Please do not submit Research Protocol Safety Survey’s to Jaime, submit one paper copy and one elctronic copy of your study subbmission to * Darion Glover.
2. If you have answered “yes” to Questions 3e of the Introductory Questionnaire, you must submit two additional paper copies of your study submission to the SCI for approval by the Radiation Safety Committee.

Training:

All investigators, research coordinators and research assistants involved in VA human studies research must receive appropriate training in the ethical principles and accepted practices on which human studies research should be conducted. The Overview of GCP and Human Subjects Protection  satisfies the annual training requirement for research personnel in both GCP and human subjects’ protection education. Effective January 1, 2007, the Overview of Good Clinical Practice & Human Subjects and the Good Clinical Practice – Update courses will be available only through Collaborative IRB Training Initiatives (CITI). They will no longer be available through the Employee Education System (EES). The VA Office of Research & Development (ORD) will accept the completion of the CITI group called “VA Only” (see instructions for registering(25 KB, MS Word)). 

Co-Investigators, Sub-Investigators and Research Staff who do not work at the VA and do not come to the VA to perform research and/or to enroll VA patients do not have to complete the VA “Overview” training. If applicable, written documentation that the staff member does not have VA involvement must be sent to the Research Service ( Request for Training Exemption).

Research staff members are required to do HIPAA training in order to access VA Personal Health Information (PHI). The VHA/HIPAA Privacy Training Course can be accessed at www.VHAprivacytraining.net . 

 Other Required Documents :
In addition to the above training, all non-M.D. members of the research team including the principal investigator, co-investigator, sub-investigators, study coordinators, and research assistants (including WOC’s who perform independent clinical activities) must provide:

(1) verification of their licensure and education;
(2) a scope of practice or a job description ; and
(3) must apply for a “ Without Compensation” clearance if they are not VA employees.

For more information on training, contact Shelley Jenkins at extension 4204, Room E556-1

VA Employment : Prior to conducting research in any capacity at the VA, any research support staff member who is not VA-compensated must be completely processed as a VA- WOC ( Without Compensation ) by contacting the Research Service Program Support Assistant at ext. 4204, Room E-579-1.

Electronic Medical Record (CPRS) Entry of Research Participation for VA subjects:

The purpose of CPRS documentation is to make pertinent research information readily available to providers and to comply with mandated Federal standards. The electronic document eliminates the need to file the Informed Consent in the subject’s paper medical record. The template must be added to CPRS on the date that the subject signs the informed consent. Study drugs will not be dispensed until the consent is in the subject’s CPRS record. It is very important that you check to make sure that the patient is not already on another study by looking at the patient’s clinical notes for any research titles, also checking for future and past appointments in Research. Some studies prohibit dual enrollment and all VA Cooperative studies prohibit dual enrollment unless pre-approved by the respective Co-op office. If the patient has past or future appointments in Research please contact the study coordinator to determine if the patient is allowed to participate in an additional study. It is the responsibility of the research coordinator to prevent dual enrollment. Investigators and Research Coordinators must have VA computer access to enter research information for VA subjects in the electronic medical record (CPRS). If you have not previously received access, please complete the CPRS Access form and return it to the Shelley Jenkins in Room E556, x. 4204. New VA and WOC employees receive their initial VISTA access when processed, if you do not have VISTA access contact Human Resource Services (x.6009).

VA Research & Development Committee (R&D) Approval: 

R&D Committee approval is required for all human subject research protocols conducted at the VA or utilizing VA resources. R&D Committee approval is contingent upon prior approval by the SCI and Health Science Center IRB and evidence of appropriate grants administration. SCI and IRB approved protocols are reviewed at monthly R&D meetings. Research may begin following R&D Committee approval and completion of all training and staff clearance. A VA approval form (form 10-1223) will be sent to you in addition to a letter from the R&D Committee as confirmation of VA Research and Development Committee approval.

Note: VHA Directive 2001-028 states that children can not be included in VA-approved research conducted by VA investigators while on duty or conducted at VA facilities or approved off-site locations unless a waiver has been granted by the Chief Research and Development Officer (CRADO). Please contact the Research Office for details.

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