Medical Students and Residents

 
  • Submitting Case Studies for publication

    This requires acknowledgement from the IRB. It is a simple process.

    • Make sure you have an IRBNet profile. This is the mechanism for submitting anything to the IRB. Get help setting up an IRBNet profile here.
    • Complete a human subjects research determination form found in the "forms and templates" button on IRBNet, and upload it into your project package.
    • Complete the Part 1 Cover Sheet. This is a wizard that walks you through the contact information for the personnel involved on the project. Most of the responses will be N/A as case studies are not considered human subjects research
      • Responsible Official:
        Mark Riddle, MD, DrPH
        Associate Dean of Clinical Research, University of Nevada Reno, School of Medicine
        mriddle@unr.edu
        Ph: 775 784 4131
        Fax: 775 682 9840

    1. Upload the journal abstract or description of your case study.
    2. Sign the package electronically, and then submit the package for review.

    If you have any questions, please contact Valerie Smith, 775-682-9838.

    General Guidence on Preparing Case Studies

  • Getting started with an IRB: Human Subject Research Guide

    Getting Started with an IRB


    Step 1

    Complete the required online training. UNR Med requires all investigators planning on conducting research with human participants to receive relevant human research protection training. Find our more about the preferred training program

    • The UNR Research Integrity Office will accept the Renown required human research protection ethics training. 
    • More specifics on which training is relevant for your project.    

    Step 2

    Create a profile in IRB Net. The UNR Research Integrity Office uses IRB Net, an online submission platform, to review research projects, your profile will provide you with access to your project.

    Step 3

    Assist the student in completing an initial narrative protocol and email to OMR@med.unr.edu  for assignment to scientific review.  Submission of the project to the IRB cannot proceed until scientific review is complete.

    Step 4

    Assist the student in completing the necessary paperwork for his/her research project submission. Steps for building a submission in IRB Net.

    • The protocol application will ask all of the important information about the research project. This form along with the cover sheet will direct the student to the other relevant forms to include.
    • Share full access on the submission with the research team, Danielle Eaton, Valerie Smith, Mark Riddle, and “Research Dept, Renown Clinical” when applicable under UNR-Reno for projects at Renown or using Renown EMR data.
    • Include CVs and human research training records for the research team; ensure training is in place for the team at time of submission to avoid review delays.
    • The cover sheet asks for the "Responsible Official" on the project. Dr. Mark Riddle serves in this capacity at UNR Med and confirms the project meets requirements as outlined in the Research Integrity Office policy manual.
    •  When working with a community physician, include the Investigator Community Physician Agreement found in the 'forms and templates' tab on IRBNet in the submission to comply with the Human Research Protection Policy Manual, Item 35 in accordance with the University of Nevada, Reno Office of Research Integrity. 
    • Once your submission is ready, email Valerie Smith for a completion check and Mark Riddle for electronic review and sign off.

    Step 5

    Allow sufficient time for the student to prepare the IRB submission. Please keep timelines in mind and mentor the student in completing the package (as needed).

    • For basic, minimal risk research in populations which are not considered vulnerable, allow a minimum of 4-6 weeks from preparation of submission to IRB approval.
    • For more involved, complex studies, including research with vulnerable populations, international research, and clinical research, allow a minimum of 10 weeks from preparation of submission to IRB approval.

    Step 6

    Renown Clerkships: For projects at Renown Regional Medical Center, complete the required clerkship packet and return to Valerie Smith for Sr. Director signatures and submission to Renown.

    The Office of Medical Research, and the UNR Research Integrity Office, are available to assist in your research endeavors. Should you have any questions, please contact the following individuals.   

    Danielle Eaton, UNR Director, Research Operations and Administration, Office of Medical Research, daniellee@med.unr.edu, (775) 784-4125.

    Valerie Smith, Clinical Research Coordinator, Office of Medical Research, valeries@unr.edu, (775) 682-9838.

    Additional information on Training Requirements for Human Research

  • Protocol Development and Publication Guides

    Types of studies in Medical Research

    Generating research questions, hypotheses, and objectives

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2912019/pdf/0530278.pdf

    Templates to prepare research protocols

    There is no required protocol template which you need to use, however we suggest using the Narrative protocol template as a start.  When you are just getting started in developing a research proposal or concept, you may want to use the protocol synopsis to formulate your initial research idea.  Then move to the protocol narrative to more fully develop the project.  In addition, we have also included links to other protocol templates which you may draw upon to modify your protocol and add sections and content as needed.  One important element for student and resident research is to have a mentoring plan as part of the protocol (this is included in our the UNR SoM Narrative protocol template).

    1. Protocol synopsis template(Request document by emailing omr@med.unr.edu)
    2. Narrative protocol template(Request document by emailing omr@med.unr.edu)
    3. Protocol templatesfor descriptive, observational, registry, and clinical trials
    4. NICD observational protocol template

    Part 2 of 13 of a series on evaluation of scientific publications

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689572/

    Writing and publishing health research

    Equator network

    Preparing an abstract

    https://www.acponline.org/system/files/documents/about_acp/chapters/az/great_abstract.pdf

    Preparing a case report

    https://www.care-statement.org/

  • Data De-identification Instructions to Comply with HIPAA

    The guidance at this link describes best practices to comply with the Health Insurance Portability and Accountability Act (HIPAA) in protecting private identifiable health information gathered for research practices, and how to properly de-identify datasets and maintain master code lists prior to safely sharing data for collaboration or data analytics.

    Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule

  • Submitting external research rotations and internships for documentation to the IRB

    UNR IRB policy requires that faculty, staff, students, and trainees, conducting research with humans, including offsite rotations and internships, register a protocol with the IRB. The following are steps to complete an IRBNet submission covering external research rotations and internships involving research with humans, even though reviewed by an external IRB.  Submissions in this class are prepared for documentation and compliance purposes and receive administrative review.

    See Guidance on how to register and use the IRBNet online system for submissions.

    • Register in IRBNet
    • CreateNew Project in IRBNet.
    • List your faculty mentor at the site of the research as the PI
    • AddPart I, Cover Sheet with Dr. Mark Riddle listed as Responsible Official (RO)

    Mark Riddle, MD, DrPH

    Associate Dean of Clinical Research, University of Nevada Reno, School of Medicine

    mriddle@unr.edu

    Ph: 775 784 4131

    Fax: 775 682 9840

    The Part I cover sheet is a wizard form you activate on the Designer page in IRBNet. See the buttons at the bottom of Designer page:

     Screenshot of the upl;oad button within the aplication

    • List yourself under the CO-I section of the cover sheet
    • Add the completed Human Research Determination- UNR Med External Research Rotation form
    • Add your CITI/THOR training records
    • ShareIRBNet access for all study personnel, Valerie Smith, Danielle Eaton, and Dr. Mark Riddle for metrics tracking and electronic sign off.