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Research Forms and Resource Links

  • IRB Submission Check Sheet: To be used for all requests submitted to the IRB (including initial submission, continuing review, adverse event reporting and closing a study); provides listing of all required attachments
  • Medical Students Assisting with UTCOMC Research Check Sheet: To be used for requests submitted to the IRB when adding UT Medical Students to Research Projects
  • UTCOM Delegation Responsibilities: This form should be used to document all key research personnel involved in research projects and submitted to IRB for approval.
  • Form A Initial Submission: Used for new full board, expedited studies and CIRB submissions/acknowledgment.  The application has a set of questions which must be addressed for the IRB to conduct an adequate review and to comply with federal requirements.  Use the IRB submission check sheet as a guide and final check for preparing and submitting a complete application. 45CFR46.11
  • Form B Exempt Request: Used to confirm that full board and/or expedited review are not required.  Confirmation of IRB approval of exempt request may be required for publication. 45CFR46.101(b)
  • Form C Revision Change: Required when significant changes are made to the study, including changes in key personnel, revised protocol, consent form, editorial/administrative changes
  • Form D Continuing Review: IRB review of all studies (initially approved by full board or expedited) is required at intervals appropriate to risk, but not less than once per year (365 days).  Refer to IRB meeting schedule to insure adequate time for review. 45CFR46.109(e)
  • Form E - Significant Adverse Event Report: Used to report events reported by sponsor, unexpected adverse events, serious injury or death of a human subject.  Refer to UTCOMC policies and procedures for definition and timeframe for reporting.
  • Form F - Final Report: Required at the time the study is terminated (ie, no subjects are active or being followed)
  • Form G - Advertisement: Required for IRB review of all recruitment/solicitation materials (eg newspaper, posters, website, radio, TV, etc.)
  • Form H - HIPAA Waiver of Authorization: Required for access to protected health information (eg, retrospective or prospective chart review) without the subjects consent (this applies to living & deceased patients for electronic and hardcopy records) 45CFR.164
  • Form I - Protocol Deviation and Violation: Used to report a waiver (including exclusion/inclusion criteria) or a deviation from the IRB-approved protocol (eg consent not obtained, drug not given per protocol) (see protocol deviation algorithm in Research Resources)
  • Form J – QI Form: This form must be completed and submitted to the IRB for all QI projects.
  • Form K - BioStat Review Confirmation: To be used for all Investigator Initiated Projects and submitted to researchsupportservices@erlanger.org along with a copy of the research proposal and data collection sheet. 
  • Documentation of Assent in Children: Attachment for all consents for children (<18 yrs), whether assent is given or waived. 45CFR Subpart D
  • 2019 UTCOM EHS IRB Model Consent Form: Template for informed consent language, including all elements required by the DHHS, FDA, HIPAA, UTCOMC. 45CFR46.116
  • Care Report Consent Form Template: Template is for a Case Report involving an individual patient
  • 2012 Spanish Short Consent Form: Spanish short form consent and instructions for non-English speaking potential research subjects
  • 2012 English Short Consent Form: English translation of the Spanish short consent form
  • Exempt Review Categories: Description of research that may not require full board or expedited review.  This determination should be made by the IRB, not the investigator. 45CFR46.101(b)
  • Expedited Review Categories: Description of research that presents no more than minimal risk to human subjects and may not require full board review, but may be expedited. 45CFR46.110
  • UTCOM IRB Fee Invoice: Invoice to be used, as needed, for fees associated with submission of Form A
  • Survey Consent Elements: This language must be added to all survey research.  The language can be added to paper surveys or online surveys. 
  • IRB Exemption Categories

Reminder:
All expedited and exempt IRB submissions must be scanned and emailed to the IRB office on Monday’s by 5pm in order for IRB Chair review that week.  Submissions received after this deadline will be reviewed the following week.  Submissions that require SRC/IRB full Board review, submission deadline remains the 1
st Wednesday of every month.  The IRB submission page as well as the forms page have both been updated with this information.

Last Published: Sep 18, 2020