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DAVID GRANT USAF MEDICAL CENTER - CLINICAL INVESTIGATION FACILITY

Posted 4/4/2012 Printable Fact Sheet
 
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Lt. Col. Robert Couse-Baker
Sarah Torres, 60th Medical Support Squadron molecular biologist at David Grant USAF Medical Center's Clinical Investigation Facility, analyzes a sample. DGMC is one of seven Air Force medical facilities with formal clinical investigation programs and resources specifically designated to support such operations. (U.S. Air Force photo/ Lt. Col. Robert Couse-Baker)
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David Grant USAF Medical Center is one of seven Air Force medical facilities with formal clinical investigation programs and resources specifically designated to support such operations. The primary mission of the 60th Medical Group's Clinical Investigation Facility is to support DGMC personnel in the implementation of approved clinical investigation and training projects. It is our aim to facilitate the research process and make it as easy as possible for the researcher to accomplish his or her objective.

Our Vision: The flagship Air Force Clinical Investigation program fostering a culture of inquiry through research, education, and training.
 
Our Mission: Provide expert research and training to support graduate medical education, en route care, and clinical investigations.

The CIF provides oversight for and conducts cutting-edge research to meet the future needs of the Department of Defense, medical readiness, force protection, clinical medicine, and homeland defense initiatives. In support of the medical readiness, the CIF hosts many training projects, labs, and workshops. These training opportunities are open to all DoD and Department of Veterans Affairs medical personnel. We also provide integral corps competency training, and assist course instructors in research methods and applications focused toward preparing the medical staff for the ever-changing healthcare environment.

What constitutes a Clinical Investigation?
As a general rule, a clinical investigation is defined as an organized study designed to answer a medical question with a detailed methodology and process for analyzing the data collected.

Would administering an investigational drug to a single patient under a compassionate use protocol be considered a clinical investigation? MOST DEFINITELY! How about using an FDA-approved medication for a non-approved use? That depends. Use of an FDA-approved drug or device for therapeutic effects that are widely reported and are generally accepted within the scope of normal medical practice would not constitute a clinical investigation or research unless one is collecting outcome data such as therapeutic response, side effects data, or changes in laboratory parameters, in a systematic manner for publication or presentation. Would review of patient records to obtain statistical information be a clinical investigation? The answer is yes if the intent is to publish or present the results in any public forum.

How is the CIF organized and what can we do for you?
The CIF is organized to help the prospective investigator from the time he or she first gets an idea to submission of a polished manuscript to a professional journal. To perform these services, the CIF provides the following support:

- Protocol management & development support including protocol and informed consent document preparation, administrative and legal coordination, data analysis, and research fund management.

- Research animal housing and colony support including versatile indoor and outdoor animal housing to accommodate a wide range of laboratory animal species; radiography, and necropsy services.

- Surgical research and training includes two state-of-the-art surgery suites with endoscopic and microsurgery capabilities

- Research and development laboratory support includes chemistry, microbiology, hematology, flow cytometry, molecular biology, histology, and material stress testing.

What governs and defines Clinical Investigations?
Clinical investigations governed by Air Force Instruction 40-402, Protection of Human Subjects in Biomedical and Behavioral Research, are those involving the biological, behavioral, or psychological study of a person's body or surroundings, conducted by or in collaboration with Air Force Medical Service personnel generally in Medical Treatment Facility and/or clinical investigation facilities. These include, but are not limited to:
 
Medical or surgical procedures;
Withdrawal or removal of body tissue or fluid;
Administration of a chemical or biological substance;
Deviation from normal diets or daily regimens;
Active manipulation of body processes, behavior, or environment; and; Compassionate use of investigational drugs or devices.

Starting a research protocol
Even when things go well, preparation and approval of a clinical investigation proposal may take eight to ten weeks (considerably shorter for exempt studies).  Time can be saved and frustration averted by consulting with CIF staff throughout all stages. Once the investigator decides to pursue a clinical investigation project, he or she should discuss the proposed clinical investigation with the department chairperson to:
 
(1) Confirm that the proposed activity is indeed a clinical investigation (IAW AFI 40-402) and not simply normal medical or surgical management of patients;
 
(2) Determine that the research project will not likely compromise the performance of patient care duties, and;
 
(3) Assess the availability of local experts in the proposed research area that can be tapped for scientific review and critique (In the past, an occasional prospective investigator has attempted to pursue a project that was excessive in scope, or that had been previously conducted).

The CIF maintains all completed 60 MDG protocols, can obtain information on protocols in progress or completed at other DoD facilities, and can advise on searchable research databases available.

If the investigator needs hands-on support from the CIF, confer with the Research Program Manager who will refer you to the appropriate CIF staff member. The CIF staff includes a wide variety of specially trained personnel to assist investigators; these include a veterinarian; laboratory animal specialists, operating room technicians, laboratory officers, epidemiologists, and statisticians for assistance with study design and statistical review. The CIF staff will help make decisions concerning equipment and supply requirements and manpower support needed to complete your study.

If an investigator develops a survey or questionnaire designed specifically to assess the attitudes or opinions of AF military or civilian personnel, this form may have to be reviewed and given a control number by AFMPC/DPMYPS, Randolph AFB, TX (See AFI 36-2601AF Personnel Survey Program, for additional details). If a survey or questionnaire is developed solely to gather information as part of a larger clinical investigation it will be reviewed by the DGMC Institutional Review Board in cooperation with the Medical Law Office for accuracy, structure, content, and protection of the privacy of respondents.

Publications and Presentations
The Air Force encourages publishing scientific papers in military and civilian professional journals, and presentations to professional societies. In accordance with AFI 40-402 and Medical Group Instruction 35-1, Release of Information to the Public, all items submitted for publication or presentation consideration must be coordinated through the CIF, the respective flight commander, and the Chief of Medical Staff (or Director of Dental Services, as appropriate) prior to submission to a journal or presentation to a peer organization. These items include, but are not limited to:

Full journal articles
Abstracts
Letters to the editor
Books or book chapters
Professional exhibits
Videos
Lectures to civilian groups and institutions

For more guidance on what must be coordinated prior to submission, contact the CIF staff. In most cases, the CIF will prepare the necessary documents. Works prepared by offices or employees of the United States Government as part of the person's official duties are defined in 17 U.S.C. Section 101 as a "work of the United States Government" and are prohibited from being copyrighted.

Publications/presentations of research results are a big payoff for the Air Force Clinical Investigation program. The CIF is interested in receiving copies of all finished products accepted for publication, and abstracts are reviewed for the 60 MDG "Top Pub" awards program. Let's say the investigator develops a medical device, diagnostic test, or other potentially marketable commodity. The investigator could make money from it! The process is a little complicated but there are patent attorneys and other individuals available to assist in this regard.

Where can I find more information?
The two publications of primary interest to the DGMC investigator are: AFI 40-402 and MDGI 40-4, Clinical Investigations. We have outlined much of the information in these instructions. The CIF Investigator's Guide is available by contacting the CIF. It is an in-depth reference manual that contains complete guidelines, and current documentation formats required for the conduct of clinical research. The text of the guide is on the CIF Knowledge Exchange website which can be linked from our DGMC SharePoint site. Lastly, we encourage interested investigators to visit the Clinical Investigation Facility where you will find a dedicated and enthusiastic staff always ready to assist you with your clinical research needs.

Gifts & Grants
Financial grants and gifts of tangible or intangible property from non-DoD organizations are important to our clinical investigation program. However, these grants/gifts must be received in accordance with AFI 51-601, Gifts to the Department of the Air Force, and properly accounted for. Therefore, the investigator:

- Cannot solicit gifts from private individuals or private or commercial enterprises;
- Cannot personally accept funds or gifts of tangible or intangible property for use in DGMC clinical investigations;
- Must notify drug companies and other institutions who have interest in DGMC clinical investigations that funds or gifts must not be given directly to individual DGMC investigators.

Since the investigator cannot personally receive funds or gifts of property, what are the alternatives?
Funds/gifts can be given directly to DGMC through the CIF Gifts and Grants Manager. Three likely sources of funds/gifts are: grants from the National Institutes of Health, grants from non-profit, non-federal organizations, or unsolicited gifts from non-profit or for-profit organizations or commercial enterprises.

The CIF has a dedicated Gifts & Grants Manager who will guide you through the process and assist you with processing required documentation:

Recent Research Topics
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Hours of Operation:
Monday - Friday: 7:30 a.m. to 4:40 p.m.
Weekends and Federal Holidays: Closed
(707) 423-7400

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