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VISN 5 MIRECC - Section One: New Protocol Approval for NON-MIRECC Mental Health Studies
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Section One: New Protocol Approval for NON-MIRECC Mental Health Studies in the VA Maryland Health Care System
The MIRECC and Director of the Mental Health (MH) Clinical Center at VA Maryland Health Care System (VAMHCS) have agreed that all MH research projects must be reviewed for scientific quality and adequacy of Human Subjects protections before the Director of MH Clinical Center will sign off and allow the project to be submitted to VA Research & Development. Non-MIRECC MH staff planning to conduct research at the VAMHCS should discuss their planned protocol with the Director of MH or his designee before drafting a proposal. While not a requirement, it is advisable for the investigator to contact the MIRECC Director (see Staff Directory for contact information) to discuss the science of investigator initiated projects (as opposed to Cooperative Studies or industry projects) prior to drafting the proposal.
I. MIRECC Review Prior to Human Subjects Recruitment
The MIRECC reviews all proposals as part of the broader human subjects recruitment approval process. To begin the MIRECC human subjects review process, all protocols must be entered into the IRB's CICERO System*. If you do not have access to the system, the website will tell you how to obtain it. CICERO training is also strongly recommended, and information about it is also found on the website. When the complete protocol, consent form(s), and other related documents are entered into CICERO, inform the MIRECC Director of Research Quality Management, Julia Evelly, by email that the protocol is ready for MIRECC review. She will print out the documents required for review and start the process.
After reviewing the documents for University of Maryland Institutional Review Board (IRB) readiness, Ms. Evelly will summarize any recommendations in an email to the PI and study coordinator and forward the protocol to the Research Review Committee (chair, Robert Buchanan, MD). The Research Review Committee may make recommendations to the investigator concerning the study design, integration of the protocol into VA services, the compatibility of the study with existing MIRECC protocols, and how the study fits with the priorities of the MIRECC. When the review is completed, the investigator will be notified and the Review Committee will work with the investigator in addressing any issues raised by the review. Depending on the extent of the changes, the protocol may need to be reviewed again by the MIRECC IRB Coordinator or the Review Committee.
The protocol will then be routed to the Director of the Baltimore VA Mental Health Clinical Center for review of resource utilization issues (i.e., physical space and patients) for studies that will be conducted in the VAMHCS. Studies that will be conducted in Washington and Martinsburg require a parallel review and approval process by those Institutional Review Boards and Service Line Managers. The Research Core staff will assist investigators in making the appropriate contacts at those sites. If a MIRECC study will be enrolling participants at non-VA sites, the investigator is responsible for obtaining prior approval from the appropriate authority at those sites.
When all approvals are obtained, Ms. Evelly will notify the PI and study coordinator via email. The investigator should then submit the protocol to the IRB and/or VA R&D Committee. Ms. Wharton will keep a copy of the documents for the MIRECC files. The investigator is responsible for maintaining all originals in the study file for the project (see "Section Two - Setting Up the Research Study").
II. University IRB Approval
A final approval letter will be sent by the IRB via CICERO. A copy of this approval letter should be sent to the MIRECC Research Core Administrative Assistant, Norma Wharton. NOTE: If a protocol is deferred or disapproved by the IRB, it must be re-routed through the MIRECC review process before being resubmitted to the IRB.
III. VA Research & Development Approval
A. You must have contingent IRB approval (this may be worded in the letter you receive as a "favorable review") or final IRB approval before submitting the protocol to the VAMHCS. B. Although the VAMHCS does not have its own IRB, all research proposals must go through a two-step approval process before subject recruitment can begin (see the VA Maryland Research & Development website at www.maryland.research.va.gov/research/human/human_subject.asp). All the submissions are on paper (vs. electronic), so any required forms previously submitted to the IRB should be printed from the CICERO system.
1. VA Human Studies Subcommittee
a. The Human Studies Subcommittee of the Research & Development Committee is different from the University IRB. All VA protocols must first be reviewed by this Committee.
b. All documents required by the Human Studies Subcommittee are listed on the R&D Human Studies Checklist. Note that all forms are required for all studies, unless noted on the Checklist. One copy of all required documents, plus the Checklist, should be sent to the Baltimore VA Research Services Department.
c. After approval by the Human Studies Subcommittee, the protocol will be forwarded to the Research & Development (R&D) Committee.
d. Investigational Drug Information Record (VA Form 10-9012) is required for VA R&D submission for all protocols involving study drug, whether or not the drugs are FDA approved. If the VA 10-9012 is required:
(1) The original will be returned to the PI with signatures from the IRB Chair and the VA R&D Chair. It should be put in the protocol regulatory binder.
(2) A copy will be forwarded by the Research Service to the VA Investigational Pharmacist.
(3) A copy should be placed in participant's source document.
(4) A copy must be attached to the participant's consent form for scanning into the participant's electronic medical record (CPRS). The VA 10-9012 and the consent form are brought to the Research Office 3A-125.
e. Human subject training requirements must be fulfilled for both the University of Maryland and the MIRECC.
2. VA R&D Committee - you will receive a Final Approval letter from the Chair of the VA R&D Committee. No subject recruitment can begin within the VAMHCS until the final approval letter is received from the VA R&D Committee.
IV. Washington DC and Martinsburg Approval
If you are planning to submit a protocol at the DC VAMC or the Martinsburg VAMC, contact Julia Evelly, MIRECC Director of Research Quality Management. Ms. Evelly will guide you through the process.
The Washington DC Research Office Institutional Review Board (IRB) issues approvals for human studies for both the DC VAMC and the Martinsburg VAMC. In order to begin the submission process, a Principal Investigator (PI), who is a full-time VA staff member, must be identified at the VAMC where you are planning to conduct your research. The same person may serve as PI for both Martinsburg and DC only if they have privileges at both hospitals. If not, the local PIs should submit the protocol for their respective sites, even if the procedures and details of the studies are identical.
After you have established a relationship with the local PI, s/he should contact Julia Evelly to request the documents needed to submit the study. (These forms are also available online, but only for full-time DC or Martinsburg employees who have access to the internal website.) The IRB prefers to communicate solely with the local PI, especially if the study coordinator is located off-site. In order to avoid confusion, then, the study coordinator should send all information to the local PI to submit to the IRB.
Once the DC IRB committee gives approval, the protocol is sent to the Research & Development Committee. As in Baltimore, no research activities can start until the R&D Committee has issued an approval letter. Depending on the type of protocol being submitted, this entire approval process may take from three to six months.
Go to Section Two: Setting Up the Research Study
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