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Research Course

National Naval Medical Center Directorate for Professional Education Clinical Investigation Department. Research Course

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Research Course

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  1. National Naval Medical Center Directorate for Professional Education Clinical Investigation Department Research Course “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.”

  2. 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.”

  3. Disclosure Statement : This CE/CME activitydoes not have commercial support,and has no conflicts of interest. 9/18/2014 Research Course Research Course 3

  4. Learning Objectives • Learn about Navy research and research at NNMC 2. Know about research support services available at NNMC • Become familiar with the ethical research issues • Questions 9/18/2014 Research Course Research Course 4

  5. LO 1: Learn about Navy research and research at NNMC History of Naval Medical Research • Establishment of the Navy, 13 October 1775 On Friday, October 13, 1775, meeting in Philadelphia, the Continental Congress voted to fit out two sailing vessels, armed with ten carriage guns, as well as swivel guns, and manned by crews of eighty, and to send them out on a cruise of three months to intercept transports carrying munitions and stores to the British army in America. The first American Naval Surgeon, Joseph Harrison, and two surgeon’s mates, Henry Tillinghast and John Scott, were aboard the Alfred 9/18/2014 Research Course Research Course 5

  6. Retrieved from http://www.awiatsea.com/Narrative/New%20Providence%20Expedition.html 9/18/2014 Research Course Research Course 6

  7. History of Naval Medical Research • 1798 - Congress established the Department of the Navy • 1842 – The Bureau of Medicine and Surgery (BUMED) was established by an Act of Congress. Dr. William P.C. Barton became the first Chief of the Bureau (later known as the Surgeon General). • 1850 - Navy surgeon E.R. Squibb set up a laboratory to manufacture, process, and test medicine. Research included standardizing large-scale production of ether and chloroform. • 1853 – An Act of Congress authorized the building of a Naval Medical Laboratory on the grounds of the Brooklyn Naval Hospital. 9/18/2014 Research Course Research Course 7

  8. Navy surgeon E.R. Squibb • In 1851, at the Brooklyn Naval Hospital, Dr. Squibb set up a laboratory and built the first still for making anesthetic ether. • Between 1852 and 1857, he discovered processes for making chloroform, fluid extracts, bismuth salts, and other preparations. 9/18/2014 Research Course Research Course 8

  9. Bristol-Myers Squibbwww.bms.com • After Squibb had resigned from the Navy, he started a laboratory of his own to supply the Army with reliable drugs. • By 1883, he was manufacturing 324 products and selling them all over the world. • Squibb retired in 1895 and passed most of the responsibility for managing the firm to his sons, Charles and Edward. The company became known as E.R. Squibb & Sons. • Currently, the company is known as with 30,000 employees, and $20.6 billion Net Sales in 2008 Research Course

  10. History of Naval Medical Research • 1924 - Division of Medical War Planning (BUMED) organized to study the experience of WW I • 1941 – The Research Division of BUMED was established. The Naval Research and Development Board was organized. • 1946 - Office of Naval Research established • 1947 Naval Institute for Dental and Biomedical Research established 9/18/2014 Research Course Research Course 10

  11. Naval Medical Research Today • Today, "Navy Medicine" encompasses a community of 51,000 Navy medical personnel, including 43,000 uniformed care-givers, nearly 4,000 medical corps, 3,000 nurse corps, 2,600 medical service corps, 1,500 dental corps, 27,000 hospital corpsmen and 3,500 dental technicians. • These professionals provide care for nearly 786,000 active duty Navy and Marine Corps personnel, 886,000 dependents and Navy and Marine Corps retirees and their dependents or survivors numbering 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. 9/18/2014 Research Course Research Course 11

  12. Naval Research Achievements • Heat stroke • Process of aging • Tropical disease • Blast injury protection • Adaptation to altitude • Extracellular fluid requirements • Influenza type B variant • Natural infection cycle West Nile Fever • Rubella vaccine • Anthrax detection 9/18/2014 Research Course Research Course 12

  13. Research at NNMC • NNMC’s goal remains to promote excellence in health care and militarily relevant research and human subject protection. • Good research helps contribute to our knowledge and ultimately improve the quality of care we, and others, provide. 9/18/2014 Research Course Research Course 13

  14. 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 235 Publications 9/18/2014 Research Course Research Course 14

  15. Recent NNMC Publications 9/18/2014 Research Course Research Course 15

  16. Recent NNMC Publications 9/18/2014 Research Course Research Course 16

  17. Recent NNMC Publications 9/18/2014 Research Course Research Course 17

  18. Recent NNMC Publications 9/18/2014 Research Course Research Course 18

  19. Recent NNMC Publications 9/18/2014 Research Course Research Course 19

  20. Recent NNMC Publications 9/18/2014 Research Course Research Course 20

  21. LO 2: Know about research support services available at NNMC I. II. Administrative support III. Educational support IV. Resources: Darnall Resource Center, Stitt Library, IT tools. 9/18/2014 Research Course Research Course 21

  22. I. About ICEBERG Interdepartmental Collaborative Bethesda Research Group http://nnmcresearch.wikispaces.com 9/18/2014 Research Course Research Course 22

  23. About ICEBERG • In July of 2008, the administration of the National Naval Medical Center (NNMC) in Bethesda, MD allocated resources to enhance and support research at NNMC. The Interdepartmental Collaborative Bethesda Research Group (ICEBERG) was organized. The group’s primary function is to support research at NNMC. 9/18/2014 Research Course Research Course 23

  24. ICEBERG members • There are nine ICEBERG members, senior researchers with strong track records of research funding and success, who are dedicated to research in the following areas: CDR Brooks Cash (Gastroenterology) CDR Leonard Henry (Surgical Oncology)  LCDR Jonathon Forsberg (Orthopaedics) LCDR Michael Keith (Rheumatology)  LCDR Rachel Lewis (Radiology)  LCDR Edward Miller (Cardiology)  LCDR Arnaldo Rivera (Brain Injury) LCDR Jason Wong (OB/GYN)  Dr Mohamed Shakir (Endocrinology and Metabolism) 9/18/2014 Research Course Research Course 24

  25. ICEBERG members involvement in research-related activities at NNMC ICEBERG members are involved in many research-related activities at NNMC: • mentoring trainees on projects and protocols that may lead to professional presentations and publication of research results, and helping researchers with protocols on an as-needed basis • conducting various research lectures, workshops, and presentations • serving on the Institutional Review Board and the Scientific Review Panel • working on their own rigorous research projects, • publishing books, book chapters, andpeer-reviewed articles in leading journals. 9/18/2014 Research Course Research Course 25

  26. ICEBERG Mission and Vision Help National Naval Medical Center to become a premier research organization in the Department of Defense. Important dimensions of this mission are: • establishing research visibility; • improving research productivity; • offering mentorship opportunities; • fostering academic excellence through education, professional training and development, and diverse scholarship. 9/18/2014 Research Course Research Course 26

  27. How the NNMC research community could benefit from ICEBERG now? Mentored Research Initiative Mentored Research Objectives: • Provide the opportunity to work with NNMC research mentor on a current project at NNMC that may lead to professional presentation and publication of research results. 9/18/2014 Research Course Research Course 27

  28. How to Apply for Mentored Research • Please complete application form provided during this presentation and on the web athttp://nnmcresearch.wikispaces.com/MENTORSHIP • Please return the completed form along with a copy of your current CV to Dr. Marina Borovok via emailmarina.borovok@med.navy.mil • Questions? Please call 301-295-2876 9/18/2014 Research Course Research Course 28

  29. II. Administrative Support of Research at NNMC Responsible Conduct of Research Service (RCRS) • Website: https://nnmcintra/SiteDirectory/RCRS/default.aspx • Questions? Please call RCRS: Ms. Toby Perkins, RCRS Coordinator, at (301)295-2269, or e-mail: Toby.Perkins@med.navy.mil Ms. Elizabeth Narvaez, RCRS Coordinator, at (301)295-2275, or e-mail:elizabeth.narvaez@med.navy.mil 9/18/2014 Research Course Research Course 29

  30. II. Administrative Support of Research at NNMC Main message from RCRS to prospective researchers: PLEASE CONTACT RCRS TO REVIEW YOUR DRAFT PROTOCOL BEFOREOFFICIAL SUBMISSION 9/18/2014 Research Course Research Course 30

  31. III. Educational support Research Course • 8 CME/CE CREDITS – 2 days (7:00-13:00 ) • Provides guidelines for research protocol design, successful navigation through the SRP and IRB processes, and funding for research projects. • Course PP slide show is available at: https://nnmcintra/SiteDirectory/RCRS/default.aspx 9/18/2014 Research Course Research Course 31

  32. IV. Resources: Darnal Resource Center, Stitt Library, IT tools, Research links Darnall Resource Center https://nnmcintra/SiteDirectory/gear/darnall/default.aspx Services: • Literature Search, • Scientific Writing for Manuscripts and Protocol Preparation, • Statistical Analysis and more. Need help with protocol? Please call Darnall: 301-319-8856 9/18/2014 Research Course Research Course 32

  33. IV. Resources: Darnall Resource Center • Literature Search help: Mr. Fredric Simms, MLS Medical Researcher, Phone: (301) 295-0080 E-mail address: James.Simms@med.navy.mil • 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 Fax: (301) 295 6001 Email: francois.tuamokumo@med.navy.mil 9/18/2014 Research Course Research Course 33

  34. IV. Resources: Darnall Resource Center WORKSHOPS Workshops are offered all year long at NNMC on a per-request basis. Topics: • Literature Search • Scientific Writing for Manuscripts and Protocol Preparation • Statistical Analysis Please call Darnall to schedule a workshop: 301-319-8856 9/18/2014 Research Course Research Course 34

  35. IV. Resources: Stitt Library Websites: Intranet: https://nnmcintra/SiteDirectory/STITT/default.aspx Internet: https://www.bethesda.med.navy.mil/professional/stitt_library/index.aspx Services: - Access to online content; - Additional Research Services. Need access to Online Content at any time from anywhere? Interested in a Workshop on How to Access Multiple Literature DB via Athens? Please contact Mrs.Ann Holman Email: ann.holman@med.navy.mil , Phone: 301-319-8411 Need help with In-Depth Reference Questions Related to Patient Care? Please contact Mrs. Tahirih Fusscas E-mail: Tahirih.Fusscas@med.navy.mil Call: 301-295-1185 9/18/2014 Research Course Research Course 35

  36. IV. Resources: IT tools Virtual meeting room DCO https://www.dco.dod.mil • DCO– Defense Connect Online - provides DoD users worldwide with a second option for enterprise collaboration services. • The DCO meeting room capabilities are: the DCO Portal, webconferencing, instant messaging, screen and file sharing, whiteboard, video and audio capabilities, hosting large meetings, and more. 9/18/2014 Research Course Research Course 36

  37. Understand the importance of ethical research and learn about the HRPP at NNMC • Scientific research with human subjects has provided valuable information to help characterize and control risks to public health. • Its use has also raised particular ethical concerns for the welfare of the human participants in such research, as well as scientific issues related to the role of such research in assessing risks. 9/18/2014 Research Course Research Course 37

  38. Virtual meeting room DCO Live Training Sessions: https://www.dco.dod.mil/public/dsp/liveTraining.cfm Recorded Training Sessions: https://www.dco.dod.mil/public/dsp/tutorials.cfm# To schedule a training session for your department please contact Dr. Marina Borovok: 301-295-2876, or via e-mail at Marina.borovok@med.navy.mil 9/18/2014 Research Course Research Course 38

  39. IV. Resources: IT tools Turnitin Turnitin is a Plagiarism Prevention Software. Website: http://www.turnitin.com/static/index.html • Plagiarism Prevention:Instantly identifies papers containing unoriginal material. • Peer Review:Participants can review and respond to their colleagues' work online. 9/18/2014 Research Course Research Course 39

  40. IV. Resources: IT tools Turnitin To schedule a training session or to create an account please contact Ms. Ann Holman: 301-319-8411, or via e-mail at Ann.Holman@med.navy.mil Or Dr. Marina Borovok: 301-295-2876, or via e-mail at Marina.borovok@med.navy.mil 9/18/2014 Research Course Research Course 40

  41. IV. Resources: IT tools IRBNet www.irbnet.org • RCRS is pleased to announce the adoption of the industry leading IRBNet software, a robust set of electronic tools supporting the management, submission, review and oversight of our research protocols. • IRBNet is secure, web-based, and easy to use. 9/18/2014 Research Course Research Course 41

  42. IRBNet • Effective 15 June 2009,  all the submissions for publication clearance will be accepted via IRBNet; and the approval steps remain the same. Please stay tuned for further announcements • Questions? Please call RCRS: Mr. Luis Calvo is the NNMC IRBNet expert. His e-mail address is Luis.Calvo@med.navy.mil, phone # is 301-295-2275. 9/18/2014 Research Course Research Course 42

  43. IRBNet submission site • IRBNet submission site is accessible through the Defense Medical Research Network (DMRN) portal available at https://www.us.army.mil/suite/page/596540 • This site is being developed as a research resource center containing in addition to your IRBNet resource, your IRBNet local helpdesk contacts, training session, tutorials, surveys, links to CITI training, and many other and future research related resources. 9/18/2014 Research Course Research Course 43

  44. IRBNet submission siteaccess instructions Step 1 – Obtain your AKO/DKO Login Navy military members and government civilians should register for DKO unsponsored accounts. Here are instructions: 1) Proceed to AKO/DKO Login screen (https://www.us.army.mil) 2) Click the "Register for DKO" link 3) Select "Create Joint Account" 4) Enter SSN and DOB 5) Complete registration Navy contractors should register for DKO sponsored accounts. Here are instructions: 1) Proceed to AKO/DKO Login screen (https://www.us.army.mil) 2) Click the "Register for DKO" link 3) Select "Create Sponsored Account" 4) Choose "Contractor" account type 5) For Sponsor enter the DKO username of a Navy military member or Navy civilian 6) Complete registration Navy sponsor must log in and confirm sponsorship (My Account > Settings >Sponsorship Management) before contractor will have access to his/her account. 9/18/2014 Research Course Research Course 44

  45. IRBNet submission siteaccess instructions Step 2 – Access the DMRN portal 1). Proceed to the DMRN site at https://www.us.army.mil/suite/page/596540 2). Login using your AKO/DKO username and password 9/18/2014 Research Course How to stimulate research at NNMC 45

  46. IRBNet submission siteaccess instructions Step 2 – Access the DMRN portal (cont.) 3).Click Login; you are at the DMRN site 9/18/2014 Research Course How to stimulate research at NNMC 46

  47. IRBNet submission siteaccess instructions Step 3 – Access the IRBNet Submission site 1). Click on the IRBNet Entry button ; You are at the IRBNet Submission site. 9/18/2014 Research Course How to stimulate research at NNMC 47

  48. LO 3: Become familiar with the ethical research issuesEthical and Regulatory Foundation

  49. Human Protections History…Good, Bad and UglyThe Development of Ethics Rules Historical events that contributed to formulation of research regulations: • 1947 Nuremberg Code : International Code of Research Ethics • 1955 Wichita Jury Study : Protection of Social Institutions • 1962 Thalidomide Experience : Federal Enforcement of Informed Consent • 1964 Declarationof Helsinki : Expansion of Principles from the Nuremberg Code 9/18/2014 Research Course Research Course 49

  50. The Nuremberg CodeAugust 1947 Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics). The Basic Elements of the Nuremberg Code are requirements for: • voluntary and informed consent, • favorable risk/benefit analysis, and • the right to withdraw without penalty. Research Course

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