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National Naval Medical Center Directorate for Professional Education Clinical Investigations Department. Introduction to Research at NNMC Marina Borovok, PhD Head of Research Education, Clinical Investigations Department, NNMC
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National Naval Medical CenterDirectorate for Professional EducationClinical Investigations Department Introduction to Research at NNMC Marina Borovok, PhD Head of Research Education, Clinical Investigations Department, NNMC “The National Naval Medical Center is an approved provider of continuing nursing education by the Navy Medicine Manpower, Personnel, Training and Education Command, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.”
Disclosure Statement : This CE/CME activitydoes not have commercial support,and has no conflicts of interest. Research Course Research Course 2
Learning Objectives • Describe clinical research and the research process steps • Discus research at NNMC and it’s unique opportunities. 3. Know about research support available at NNMC. • Recognize IT tools that support research collaboration and communication from anywhere at any time. Research Course Research Course 3
"There is always a better way to do it. Find it !!!" — Thomas A. Edison Research Course
How we can find “a better way to do it”? Only through the best available scientific knowledge, and research-based decision making. Research Course
LO 1: Describe clinical research and the research process steps Before you start your research at NNMC, you need to do the following THREE steps: Step 1: Obtaining a DKO/AKO account Step 2: Registering with IRBNet, e-portal for publications and protocolsubmission. Step 3: Completion of CITI training Research Course
Research Cue Card Research Course
Step 1: Obtaining a DKO/AKO account Go to the DMRN page on DKO/AKO website at https://www.us.army.mil/suite/page/596540 Cue Card Reference: Research Course
Step 1: Obtaining a DKO/AKO account(cont.) Login using your AKO/DKO username and password Research Course
Step 1: Obtaining a DKO/AKO account(cont.) You are at the DMRN site at https://www.us.army.mil/suite/page/596540 Click on the IRBNet Entry button Research Course
Step 1: Obtaining a DKO/AKO account(cont.) Instructions are at the RCRS website https://nnmcintra/SiteDirectory/RCRS/IRBNet/Forms/AllItems.aspx. Questions? Please contact Mr. Luis Calvo at Luis.Calvo@med.navy.mil, 301 295-2269. Research Course
Step 2: Registering with IRBNet, e-portal for publications and protocol submission. Cue Card Reference: Instructions are at the RCRS website https://nnmcintra/SiteDirectory/RCRS/IRBNet/Forms/AllItems.aspx. Research Course
Step 2: Registering with IRBNet, e-portal for publications and protocol submission (cont.) Questions? Please contact Mr. Luis Calvo at Luis.Calvo@med.navy.mil, 301 295-2269. Research Course
Step 3: Completion of CITI training Cue Card Reference: Principal Investigators, Associate Investigators, Research Staff, as well as anyone coming into contact with Human Subjects or involved with the consent process or study design are required to complete this course. Research Course
Step 3: Completion of CITI training The course is available at https://www.citiprogram.org First Time Users need to register at https://www.citiprogram.org/enroll/courseregistration1.asp?language=english. Questions? Please contact Mrs. Toby Perkins at Toby.Perkins@med.navy.mil, 301 319-8994. Research Course
Now you are done with the registrations and training. What is next? Research Course
Next steps: 4-5 The entire research writing process can be divided into easily manageable and clear steps: STEP 4: Develop a Research Question Select a topic Find Sources to support your ideas STEP 5: Research Protocol Preparation: Literature Review Start Writing Statistical Analysis Complete Detailed Study Protocol STEP 6: Submit your proposal via Proposal Approval Funding (if needed) Research Course
STEP 4:Good research question: could the "FINER" criteria be applied to it?F- Feasible. Is the question answerable? Do you have access to all the materials you will need to do the study? Do you have access to enough subjects? Will you have enough time and money? Do you have the expertise to do this study or can you collaborate with someone who does?I- Interesting. The question has to be interesting to the investigator, but should also be interesting to others.N- Novel. Has this study been done before? Does it add to the current body of medical knowledge?E- Ethical. Risk/benefit ratio? Can the study be done with a minimal risk? Will an IRB approve the study?R- Relevant. Will it further medical science? Will the results change clinical practice, health policy or point towards further avenues of research?If your question fails on any one of these 5 criteria, it is probably not worth putting much effort into.Additional reading:http://familymed.uthscsa.edu/facultydevelopment/elearning/ResearchQuestions.swf
Step 4: Research topic selection Cue Card Reference: In order to do that you need to consult with your Department Chair/Supervisor/Mentor. Need help to choose your Mentor? Please contact Dr. Marina Borovok at marina.borovok@med.navy.mil, 301 295-2876. Research Course
Step 4: Research topic selection (cont.)In case if you need HELP Choose your mentor, and ask him/her to help. Web resource : http://www.bethesda.med.navy.mil/professional/research/responsible%5Fconduct Research Course
Step 5: Research Protocol Preparation Literature Search help: Mr. Fredric Simms, MLS Medical Researcher, Phone: (301) 295-0080 E-mail address: James.Simms@med.navy.mil Bldg. 1, 1st floor, rm 1633 Statistical Data Analysis help: Dr. Francois O. Tuamokumo Mathematical Statistician Phone: (301) 319 8788 Email: francois.tuamokumo@med.navy.mil Bldg. 1, 4th floor, rm 4342 Research Course Research Course 21
Step 5: Research Protocol Preparation (cont.) Literature Review Finding Sources to support your ideas Sources come in many forms, such as magazine and journal articles, books, newspapers, videos, films, computer discussion groups, surveys, or interviews. The trick is to find and then match appropriate, valid sources to your own ideas. Research Course
Step 5: Research Protocol Preparation (cont.) Comprehensive Lit DB search Need help with multiple literature DB? Please contact Mr. Fredric Simms, MLS Medical Researcher, E-mail address: James.Simms@med.navy.mil Call: 301-295-0080 Research Course Research Course 23
Step 5: Research Protocol Preparation (cont.) Start Writing, Complete Detailed Study Protocol Human Use Protocol is available on the web at: http://www.bethesda.med.navy.mil/professional/research/responsible_conduct/Forms/index.aspx Research Course
Step 6: Protocol submission via Cue Card Reference: Submission instructions are available on the IRBNet portal, under Forms and Templates. Questions? Please contact RCRS at NNMC-ResearchQuestions@med.navy.mil, 301 295-2275. Research Course
Next steps are: Proposal Approval (SRP,IRB approval), Funding (if needed) These steps will be successful if you worked on the Research Protocol with help of the NNMC specialists (Step 5) Research Course
Research Funding Information on Research Funding is provided By Dr. Kaminsky (Day 2, Module 9). Another resource: The Geneva Foundation (slides 65-69) Research Course
IMPORTANT TO REMEMBER !!! Cue Card Reference: You may not begin your research until you have received an IRB Approval andApproval Letter from the Commander, NNMC. Research Course
The Walter Reed Army Medical Center (WRAMC) The Walter Reed Army Medical Center (WRAMC) processes are very similar to NNMC, since both centers follow most of the same regulations. Research Course
The National Capital Region Military Medical Centers POCs: National Naval Medical Center (NNMC) , Responsible Conduct of Research Service Sheila Gaines 301-295-6512 Walter Reed Army Medical Center (WRAMC), Department of Clinical Investigation Verna Parchment 202-782-7828 Malcolm Grow Medical Center (MGMC), IRB Office Cheryl James 240-857-8216 The Uniformed Services University (USU), Research Office Maggie Pickerel 301-295-0819 Research Course
Questions? Research Course
LO 2: Discus research at NNMC and it’s unique opportunities Naval Medical Research Today • 51,000 Navy medical personnel • Patients: 786,000 active duty Navy and Marine Corps personnel, 886,000 dependents, Navy and Marine Corps retirees, and their TOTAL: 1,126,600 of a total beneficiary population of almost 3,000,000 people. • Navy Medicine operates 33 hospitals, 213 medical clinics, 168 dental clinics and five drug screening laboratories. • In addition, the community includes a research and development command, which includes medical and dental health research institutes, units and laboratories. The community has its own health sciences education and training command which operates four schools. Research Course
Research at NNMC NNMC’s goal remains to promote excellence in health care and militarily relevant research and human subject protection. Our command supports effective and sustainable research, and encourages you to become part of that! Research Course Research Course 33
Research at NNMC • Current research efforts at NNMC are ongoing: head injury/TBI, stroke, colon, breast cancer, leukemia and lymphoma, investigational chemotherapy, virtual colonoscopy, diabetes management, infectious disease, dental imaging. 2009 NNMC Publications Data 245 Publications Research Course Research Course 34
Recent NNMC Publications Inflammatory Biomarkers in Combat Wound Healing Hawksworth, Jason S. MD; Stojadinovic, Alexander MD; Gage, Frederick A.; Tadaki, Doug K. PhD; Perdue, Philip W. MD; Forsberg, Jonathan MD; Davis, Thomas A. PhD; Dunne, James R. MD; Denobile, John W. MD; Brown, Trevor S. PhD; Elster, Eric A. MD Annals of Surgery • Volume 250, Number 3, September 2009 There was an article in USA Today about this study: “Navy research could speed troops’ recovery” (see next slide) Research Course
Recent NNMC Publications http://www.videomd.com/AntibioticsandProbioticsinIBS-fv-2444.aspx Dr. Brooks Cash, Chief of Gastroenterology at NNMC Videopresentation by Dr. Cash Antibiotics and Probiotics in IBS from Brooks Cash, MD Research Course
Recent NNMC Publications Prosthesis Retention, Serial Debridement, and Antibiotic Bead Use for the Treatment of Infection Following Total Joint Arthroplasty By LT Scott M. Tintle, MD, MC, USN; LCDR Jonathan A. Forsberg, MD, MC, USN; MAJ Benjamin K. Potter, MD, MC, USA; Richard B. Islinger, MD; LTC Romney C. Andersen, MD, MC, USAORTHOPEDICS 2009; 32:87 Dr. Forsberg Research Course Research Course
Open Protocols at NNMC List is available on the Intranet at: https://nnmcintra/SiteDirectory/RCRS/Lists/Open%20Protocols/AllItems.aspx?View=%7b40123BB7%2dBE3A%2d4899%2d9423%2dB28C17B522E1%7d Go to the Responsible Conduct of Research Service (RCRS) Intranet site at https://nnmcintra/SiteDirectory/RCRS/default.aspx and click on Open Protocols Research Course
Questions? Research Course