Medical Student Research Credentialing Sheena Tsai, Class of 2018 CWRU School of Medicine
What you should get out of this module Who to contact if you are a medical student interested in research The process for becoming research credentialed The process for building your own research project
To Begin the Process If you are a new medical student doing research, Human Subjects Protection Training must be completed before anything else (see links below) You must complete Basic Training and Group 1 in order to be be fully trained in human subject protection https://case.edu/research/media/caseedu/research/document s/education/instruction_sheet_citi_basic.docx https://www.citiprogram.org/ If you have already done research before, you must be affiliated with Case Western Reserve University in the CITI Program
Department Research Administrators To get an idea of who you should be contacting for later steps of Research Credentialing (see slide 8 and on), please review the table on the next slide To contact these Administrators, their email addresses should be FirstName.LastName@Uhhospitals.org
Anesthesiology and Perioperative Medicine Cindy Patrzuk Cardiothoracic Surgery Diane Gorbey CWRU, Bioethics Barb Daly CWRU, Epidemiology Joan Langan & Ann Nevar Dermatology Erich Zirzow and Mary Consolo Emergency Medicine William Qu Family Medicine Dan Knaup & Donna Bentley Genetics Wendy Lachowski Medicine, Cardiovascular Stacey Mazzurco Medicine, Critical Care & Sleep Medicine LeighAnn Searfoss Medicine, Endocrinology David Forsythe Medicine, Gastroenterology George Ata Medicine, Hematology/Oncology Mike Sainz & Salene Sanderson Medicine, Hypertension & Nephrology Mike Bruno Medicine, Infectious Diseases Debbie Rudisille & Mary Wenzel Medicine, Neurology Rebecca Kahl Medicine, Pharmacology Ron Cowan Medicine, Pulmonary LeighAnn Ferrall Medicine, Rheumatology Carmeline Jefferson Neurological Surgery Barbara Bryson Obstetrics & Gynecology Wendy Lachowski Ophthalmology and Visual Sciences Alicia Trybus Otolaryngology Alicia Trybus Pathology Don Landek Pediatrics, Critical Care Amy Knott Pediatrics, Gastroenterology Patrick Holzheimer Pediatrics, General Academic & Adolescent Medicine (Palliative and Comprehensive Care, Hospitalist) Sherry Pace Pediatrics, Hematology/Oncology Patrick Holzheimer Pediatrics, Infectious Diseases Sherry Pace Pediatrics, Neonatology Sherry Pace Pediatrics, Nephrology Amy Knott Pediatrics, Neurology Amy Knott Pediatrics, Psychology Susan Wood Pediatrics, Rainbow Clinical Research Center Amy Knott Pediatrics, Rheumatology Sherry Pace Pediatrics, Sports Medicine Patrick Holzheimer Plastic & Reconstructive Surgery Lisa DiNardo Psychiatry Kim Katusha Radiation Oncology Brenda Myers Radiology Marianne Chaloupek School of Nursing Gail Bromley School of Nursing Mary Anthony Surgery Bridget Ermlich Urology Kim Priban
UH Research Credentialing, A Complete the online application (which requires completion of all steps listed below): https://redcap.uhhospitals.org/redcap/surveys/?s=iwysi5 GGSJ Complete and upload Authorization and Release from Liability form Complete and upload UH Electronic Systems Agreement form: Complete CITI training modules and upload the Completion Report (this should already be done). Watch the HIPAA and Clinical Research Training video and complete the quiz: http://www.uhhospitals.org/clinicalresearch/research-compliance-and-education/researchcredentialing/hipaa-and-clinical-research-training
UH Research Credentialing, B You will be notified within 5-7 business days if your application is incomplete or needs additional information If all the required documentation is complete, you will receive an email Please follow the instructions in the email to complete the rest of the UH Research Credentialing Application (see next slide for more information)
UH Research Credentialing, B To complete the UH Research Credentialing Application, please complete: The IRB Projects/Chair Certification document Department Administrator form please select one department Authorization and Release from Liability form, only if this was uploaded 12 months ago All of these completed documents should be emailed to UHResearchCredentialing@Uhhospitals.org
UH Research Credentialing, C Once you receive an email that you are UHresearch credentialed, you should receive 2 links for 2 separate training modules: Non-Employee Compliance Training: SAVE this certificate for the Department Administrator Safety Training
UH Email Address Once you are UH-Research Credentialed and have completed the 2 training modules, the Department Administrator will start the set-up for your UH email account Please provide your Department Administrator with the following information needed (after all steps for UH Research Credentialing are completed) -- Non-Employee Request Form: Last 4 digits of Social Security Number Date of Birth Whether or not you will be handling PHI You will then receive an email when your UH email account has been set up.
Using your UH Email Address You must use your UH email address when sharing protected health information (PHI) What is considered PHI? Names Geographic information smaller than a state (except first 3 of ZIP) Account Number Certificate/License numbers All elements of dates (except year) relating to individual Vehicle identifiers, vehicle license numbers, serial numbers Telephone numbers Fax numbers Device identifiers, serial numbers Web Universal Resource Locators (URL s) Email addresses Social Security numbers Medical record numbers Health plan beneficiary numbers Internal Protocol Numbers (IP s) Biometric Identifiers Full face or comparable images Any other unique identifying numbers, characteristics or code (may assign unique code if key kept separate)
IRB Application Tips After discussing with your mentor what your project will be, you should meet with the Department Research Administrator to go over how to write and submit an IRB application (which includes the protocol and consent forms, if needed) Your Mentor needs to be listed as the Principal Investigator on your project. Medical Students are not considered Principal Investigators. Schedule a follow-up meeting to have the Department Research Administrator read over the drafted IRB application, before final submission Submission of IRB applications goes through https://cortex.case.edu/ IRB protocol turn-around time is very slow (6-8 weeks), as long as the IRB submission includes all required documents and signatures. Please plan accordingly. Once approved by the IRB, protocol-specific training should occur with the Department Research Administrator
Protocol-Specific Training Any study that requires patients to be consented for participation requires additional training & observation. If your research project involves blood draws, you will need to be certified by a medically licensed individual. You must do 10 independent successful blood draws, and have a signed letter indicating that this has occurred. If your research project involves chart review, the Department Research Administrator should go over enrollment numbers, dates, etc. with you. Please schedule a meeting accordingly.
IRB Protocol - Consents If your research project involves consenting patients: Please check with the Department Research Administrator to make sure that your consents are written correctly and have the IRB stamp (has approval date) on the upper right hand corner You should also undergo informed consent training with the Department Administrator prior to consenting *All informed consent documentation must be obtained at the time of informed consent.
RedCap UHRedCap (Research Electronic Data Capture) is a secure online application for building and managing online surveys and databases (https://redcap.uhhospitals.org/) Once you have an IRB-approved protocol, the Department Research Administrator can request a UHRedCap application
Questions? For further questions about research that have not been covered by this presentation, please contact Colleen Croniger, Assistant Dean for Medical Student Research: cmc6@case.edu