How to start research at NNMC 2010 National Naval Medical Center (NNMC) Directorate for Professional Education Clinical Investigations Department How to start research at NNMC September, 2010 Marina Borovok, PhD Head of Research Education, Clinical Investigations Department, NNMC Research Course

"There is always a better way to do it. Find it !!!" — Thomas A. Edison 3/25/2017 NNMC Research Guide

How we can find “a better way to do it”? Only through the best available scientific knowledge, and research-based decision making. 3/25/2017 NNMC Research Guide

Presentation Outline I. How to start research at NNMC: - Obtaining a DKO/AKO account, - Registering with IRBNet, - Completion of CITI training, - Research topic selection, - Research protocol/publication preparation, - Research protocol/publication submission. II. NNMC Research Resources : - Responsible Conduct of Research Service (RCRS), - Stitt library, - Research Protocol/Publication Help, - Education/Mentoring Resources, - ICEBERG; 3/25/2017 NNMC Research Guide

Research Cue Card 3/25/2017

I. How to start research at NNMC 2010 Step 1: Obtaining a DKO/AKO account at https://www.us.army.mil/suite/page/596540 (DMRN page on DKO/AKO website). Cue Card Reference: In my presentation I’d like to accomplish the following… 3/25/2017 NNMC Research Guide 6 Research Course

Step 1: Obtaining a DKO/AKO account (cont.) Login using your AKO/DKO username and password 3/25/2017 NNMC Research Guide

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 3/25/2017 NNMC Research Guide

Step 1: Obtaining a DKO/AKO account (cont.) Instructions are at the RCRS website https://nnmcintra/SiteDirectory/RCRS/IRBNet/Forms/AllItems.aspx. (see Appendix 1) Questions? Please contact Mr. Luis Calvo at Luis.Calvo@med.navy.mil, 301 295-2269. 3/25/2017 NNMC Research Guide

Instructions are at the RCRS website 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. (see Appendix 2) 3/25/2017 NNMC Research Guide

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. 3/25/2017 NNMC Research Guide

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. 3/25/2017 NNMC Research Guide

Step 3: Completion of CITI training The course is available at https://www.citiprogram.org 3/25/2017 NNMC Research Guide

Completion of CITI training 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. 3/25/2017 NNMC Research Guide

Now you are done with the registrations and training. What is next? 3/25/2017 NNMC Research Guide

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 3/25/2017 NNMC Research Guide

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. 3/25/2017 NNMC Research Guide

2010 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 Appendix 3 Research Preparation 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 Scientific Writing for Manuscripts and Protocol Preparation help: Dr. Brian Deevey, Medical Editor, Email: brian.deevey@med.navy.mil Phone: (301) 319 8911 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 Cue Card Reference: 3/25/2017 NNMC Research Guide 19

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. 3/25/2017 NNMC Research Guide

Next steps are: SRP,IRB approval These steps will be successful if you worked on the Research Protocol with help of the NNMC specialists (Step 5)  3/25/2017 NNMC Research Guide

IMPORTANT TO REMEMBER !!! Cue Card Reference: You may not begin your research until you have received an IRB Approval and Approval Letter from the Commander, NNMC.   3/25/2017 NNMC Research Guide

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. 3/25/2017 NNMC Research Guide

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 3/25/2017 NNMC Research Guide

Questions? 3/25/2017 NNMC Research Guide

II. NNMC Research Resources Responsible Conduct of Research Service (RCRS) – HUMAN SUBJECT PROTECTION Stitt library Research Protocol/Publication Help, Education/Mentoring Resources, ICEBERG; 3/25/2017 NNMC Research Guide

HUMAN SUBJECT PROTECTION Cue Card Reference: RCRS 3/25/2017 NNMC Research Guide

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 the Clinical Investigation Department: CAPT Jeffrey Lenert, MD Jeffrey.Lenert@med.navy.mil 3/25/2017 NNMC Research Guide

STITT LIBRARY Cue Card Reference: Bldg. 8, 1st floor, room 1390 (subject to change) Stitt Intranet https://nnmcintra/SiteDirectory/STITT/default.aspx Stitt Internet http://www.bethesda.med.navy.mil/professional/stitt_library Questions: 301 295-1184 Stitt@med.navy.mil 3/25/2017 NNMC Research Guide

STITT LIBRARY Hours Main Number Monday-Thursday   0700-1730 Friday                    0700-1600 301-295-1184 Staff Email Stitt@med.navy.mil After Hours Access is available Contact 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 3/25/2017 NNMC Research Guide

Research Protocol/Publication Help Literature Search: Comprehensive DB specialist: Mr. Fredric Simms, MLS James.Simms@med.navy.mil 301 295-0080 Scientific Writing : Medical Editor: Brian Deevey, PhD brian.deevey@med.navy.mil 301 319-8911 Statistical Data Analysis: Mathematical Statistician: Francois O. Tuamokumo, PhD francois.tuamokumo@med.navy.mil 301 319-8788 All specialists provide hands-on workshops. Cue Card Reference:   3/25/2017

Education/Mentoring Resources Research Course: 9 CME/CE, 2 days (0630-1100); 2010: 9/23-24, 11/1-2. Hands-on Research Preparation Course: April-December, 2010, Th., noon-1400. PubMed Search Course: October 15, 2010 Head of Research Education: Marina Borovok, PhD marina.borovok@med.navy.mil 301 295-2876 Cue Card Reference: 3/25/2017 NNMC Research Guide

Interdepartmental Collaborative Bethesda Research Group http://nnmcresearch.wikispaces.com/ 3/25/2017 NNMC Research Guide

Help National Naval Medical Center a premier research organization ICEBERG Mission Help National Naval Medical Center to become a premier research organization in the Department of Defense. 3/25/2017 NNMC Research Guide 34

Questions? 3/25/2017 NNMC Research Guide

Thank You! My Contact Information: Marina Borovok, PhD Head of Research Education Clinical Investigation Department Professional Education Directorate National Naval Medical Center 8901 Wisconsin Avenue, Bldg. 1, Rm. 4372, Bethesda, MD 20889 Phone: 301-295-2876 Fax: 301-295-1490 E-mail: marina.borovok@med.navy.mil 3/25/2017 NNMC Research Guide 36