medstar union memorial hospital orthopaedic research manual - 7 - contacts position name phone email

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  • MedStar Union Memorial Hospital

    Orthopaedic Research Manual

    2018-2019

  • - 2 -

    CONTENTS

    Key Directories and Websites ............................................................................................................................ - 4 -

    Your Orthopaedic Research Timeline ............................................................................................................... - 5 -

    Goals ............................................................................................................................................................................. - 6 -

    Contacts .............................................................................................................................................................. - 7 -

    Initiation of Research Program ......................................................................................................................... - 8 -

    Research Orientation ......................................................................................................................................... - 9 -

    Orthopaedic Research Committee / IRB Review ............................................................................................ - 10 -

    Members ..................................................................................................................................................................... - 10 -

    Schedule of Meetings ................................................................................................................................................. - 10 -

    Submitting a Proposal to the ORC ........................................................................................................................... - 10 -

    Research Projects ............................................................................................................................................. - 11 -

    Topic Options ............................................................................................................................................................. - 11 -

    Faculty Advisors ........................................................................................................................................................ - 11 -

    Designing a Research Project ................................................................................................................................... - 13 -

    Determining Authorship ........................................................................................................................................... - 15 -

    Non-MUMH Investigators ........................................................................................................................................ - 15 -

    Intellectual Property .................................................................................................................................................. - 16 -

    Resident Research and Project Timetable............................................................................................................... - 16 -

    Fellow Research and Project Timetable .................................................................................................................. - 18 -

    Funding ............................................................................................................................................................ - 20 -

    Internal Sources ......................................................................................................................................................... - 20 -

    External Sources ........................................................................................................................................................ - 20 -

    Studies Involving Patient contact .................................................................................................................... - 23 -

    Mandatory Pre-initiation Approvals ....................................................................................................................... - 23 -

    Institutional Review Board .............................................................................................................................. - 24 -

    CITI training .............................................................................................................................................................. - 24 -

    Conflict of Interest Disclosure .................................................................................................................................. - 24 -

    Resources .......................................................................................................................................................... - 25 -

    Research Conferences ............................................................................................................................................... - 25 -

    Libraries ..................................................................................................................................................................... - 25 -

    Laboratories ............................................................................................................................................................... - 27 -

    OBERD: Outcome Based Electronic Research Database ...................................................................................... - 34 -

    Roger H. Michael Annual Research Award ................................................................................................... - 36 -

    Choosing the Recipients ............................................................................................................................................ - 36 -

  • - 3 -

    Appendix 1: Resident Research Rotation Objectives and Assessment Criteria ............................................. - 37 -

    Appendix 2: Institutional Review Board Guidelines ...................................................................................... - 39 -

    Appendix 3: Institutional Animal Care and Use Committee.......................................................................... - 40 -

    Appendix 4: Proposals for Orthopaedic Research Projects ........................................................................... - 43 -

    Appendix 6: Excel ............................................................................................................................................ - 51 -

    Appendix 7: Determining Sample Size for Study ........................................................................................... - 52 -

    Appendix 8: Research /Biomechanical Lab Evaluation ............................................................................... - 54 -

    Appendix 9: List of Vendors for Poster Production ....................................................................................... - 57 -

    Appendix 10: Institutional Review Board fees................................................................................................ - 58 -

    Appendix 11: Fees for Use of Biomechanical Research Facilities ................................................................ - 59 -

    Appendix 12: Histology Fee schedule ............................................................................................................. - 60 -

    Appendix 13: Cadaver Tissue Disposal ........................................................................................................... - 61 -

    Appendix 14: Roger H. Michael Research Award Application Form .......................................................... - 62 -

  • - 4 -

    KEY DIRECTORIES AND WEBSITES Frequently used acronyms:

    • CITI Collaborative Institutional Training Initiative • GCP Good Clinical Practice • IACUC Institutional Animal Care and Use Committee • IRB Institutional Review Board • MHRI MedStar Health Research Institute • MOA Maryland Orthopaedic Association • MUMH MedStar Union Memorial Hospital • OBERD Outcome Based Electronic Research Database • OEL Orthopaedic Education Luncheon • ORC Orthopaedic Research Committee • ORI Office of Research Integrity at MHRI • STAT Lab Surgical Techniques and Technology Lab at MUMH

    The MedStar Union Memorial Orthopaedic Research Office can be reached at 410-554-2970. The Orthopaedic Research website can be accessed from the MedStar Union Memorial Hospital web site: http://www.medstarunionmemorial.org under For Physicians, select Orthopaedic Research. The MedStar Health Research Institute (MHRI) website http://www.medstarhealth.org/mhri can be accessed for MHRI requirements

    • IRB and IACUC forms, guidelines, and proposal submission instructions • Informed patient consent forms (required for clinical study) • All applicable HIPAA requirements for research (CITI training exam) • Direct all question and inquiries to the general email MHRI-ORIHelpDesk@medstar.net

    MedStar Union Memorial Hospital on StarPort, http://starport.medstar.net, can be accessed for Hospital protocols, policies, and procedures. The MedStar Union Memorial Hospital network shared drive, subfolder Orthopaedics can be accessed for:

    • Research proposal application forms for the Orthopaedic Research Committee • Request for presentation or publication funds f

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