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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: Develop Research Question "If we knew what it was we were doing, it would not be called research, would it?“ - Albert Einstein 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.
STEP 4:Good research question (cont.) Readings: • Designing clinical research: an epidemiologic approach, 3rd ed., by Stephen B. Hulley, et.al.Lippincott Williams & Wilkins, 2007ISBN: 07-8178210-4; • Research begins with the question.http://familymed.uthscsa.edu/facultydevelopment/elearning/ResearchQuestions.swf Research Course
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. INTERNET Web resource : http://www.bethesda.med.navy.mil/professional/research/responsible%5Fconduct See also Slide # 55 Research Course
Step 5: Research Protocol Preparation Cue Card Reference: 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 NNMC, Bldg. 1, 1st floor, rm 1633 Ms. Kimberly D. Adams, M.A., M.S., M.L.S. Reference Librarian at WRAMC Phone: (202) 782-6547 E-mail address: kimberly.adams3@amedd.army.mil Statistical Data Analysis help: Dr. Francois O. Tuamokumo Mathematical Statistician Phone: (301) 319 8788 Email: francois.tuamokumo@med.navy.mil NNMC, Bldg. 1, 4th floor, rm 4342 Research Course Research Course 24
Step 5: Research Protocol Preparation Research is to see what everybody else has seen, and to think what nobody else has thought. - Albert Szent-Györgi (1893-1986), a Hungarian-born U.S. biochemist, was the first to isolate vitamin C Research Course
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 27
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 58-62) 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 Research at NNMC NNMC’s goal remains to promote excellence in health care and militarily relevant researchand human subject protection. Our command supports effective and sustainable research, and encourages you to become part of that! Research Course
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. NNMC Publications Data 2009 2010 2011 245 Publications 310 Publications 80 Publications Research Course Research Course 37
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
LO 3:Know about research support available at NNMC. NNMC Research Resources Responsible Conduct of Research Service (RCRS) – HUMAN SUBJECT PROTECTION, Stitt library (new name: Darnall Biomedical Learning Resource Center) Research Protocol/Publication Help, Education/Mentoring Resources, ICEBERG, IT tools. External support: The Geneva Foundation Research Course
HUMAN SUBJECT PROTECTIONCue Card Reference: RCRS Research Course
RCRS information Bldg. 1, 4th floor, room 4394 RCRS Intranet https://nnmcintra/SiteDirectory/RCRS/default.aspx RCRS Internet http://www.bethesda.med.navy.mil/professional/research/Responsible_Conduct/index.aspx Questions: 301 295-2275 NNMC-ResearchQuestions@med.navy.mil Head of RCRS: Ms. Sheila Gaines sheila.gaines@med.navy.mil 301 295-6512 Head of the Clinical Investigation Department: CAPT Jeffrey Lenert, MD Jeffrey.Lenert@med.navy.mil Research Course
Darnall Biomedical Learning Resource Center (DBLRC) Bldg. 8, 3 rd floor, room 3458 • Hours Main Number Monday-Thursday 0700-1730Friday 0700-1600 301-295-1184 • After Hours Access is availableContact Ann Holman at Ann.Holman@med.navy.mil, or visit the Circulation Desk to sign up for an access account, and we'll contact you when your card is ready. Library Access Card Research Course
Darnall Biomedical Learning Resource Center (DBLRC) Intranet https://nnmcintra/SiteDirectory/Darnall/default.aspx Stitt Internet http://www.bethesda.med.navy.mil/professional/stitt_library Questions: 301 295-1184 NNMC-DBLRC@med.navy.mil Research Course
Research Protocol/Publication Help *Literature Search: Comprehensive DB specialist: Mr. Fredric Simms, MLS James.Simms@med.navy.mil 301 295-0080 Reference Librarian: Kimberly D. Adams, M.A., M.S., M.L.S. kimberly.adams3@amedd.army.mil 202-782-6547 *Statistical Data Analysis: Mathematical Statistician: Francois O. Tuamokumo, PhD francois.tuamokumo@med.navy.mil301 319-8788 *These specialists provide hands-on workshops. Research Course
Education/Mentoring Resources Head of Research Education: Marina Borovok, PhD marina.borovok@med.navy.mil301 295-2876 Cue Card Reference: Research Course
Educational Resources Research Course: 9 CME/CE, 2 days (0700-1200) Next 2011 Research Course events are: May 2-3, July 7-8, September 22-23, November 8-9. Course PP slide show is available at: https://nnmcintra/SiteDirectory/RCRS/default.aspx (under RCRS Research School) Research Course
Educational Resources Hands-on Research Preparation Course: Mar.-Dec., 2011, Th., noon-1400. Provides participants with the practical skills required for writing a research proposal, completing research project, submitting research results to the NNMC Research Competition and a peer- reviewed journal in their specialty field. Research Course