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Research Forms & Resource Lists
All requests for expedited and exempt review must be received by the IRB Administrator no later than 5:00 p.m. on Monday to be reviewed within the week. Requests for expedited and exempt review should be scanned and submitted via email to Stacey Hendricks.
IRB Forms |
Description
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IRB Submission Check Sheet
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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
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Form A: Initial Submission
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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.
45CFR46.111
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Form B: Exempt request
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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)
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Form C: Revision change
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Required when significant changes are made to the study, including changes in key personnel, revised protocol, consent form, editorial/administrative changes
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Form D: Continuing review
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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)
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Form E: Significant adverse event report
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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.
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Form F: Final report
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Required at the time the study is terminated (ie, no subjects are active or being followed)
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Form G: Advertisement
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Required for IRB review of all recruitment/solicitation materials (eg newspaper, posters, website, radio, TV, etc)
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Form H: HIPAA waiver of authorization
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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
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Form I: Protocol deviation & violation
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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)
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Documentation of assent in children
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Attachment for all consents for children (<18 yrs), whether assent is given or waived
45CFR Subpart D
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2012 UT COMC/EHS Model Consent Form |
Template for informed consent language, including all elements required by the DHHS, FDA, HIPAA, UTCOMC
45CFR46.116
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Case 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
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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)
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Expedited review categories
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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
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UTCOM IRB Fee Invoice |
Invoice to be used, as needed, for fees associated with submission of Form A |
Research Forms (non-IRB)
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Description
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Online research office consultation request form
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Initial request for research support, including literature review, study design, statistical planning & analysis, grants
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UTCOMC grant request form
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To be submitted (with detailed project & budget) to seek grant funding
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UTHSC contract certification form
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Investigator confirmation of contract terms, obligations, etc.
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UTHSC routing sheet
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Cover sheet to accompany all grant/research submissions
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Graphics request form
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Request for poster or other research display; IRB approval number required for human subject research or case study
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Department Research Review Form 2011.9.7 |
Department/Program Approval prior to SRC/IRB submission |
Erlanger Radiology Research Collaboration Form 20119 |
Request for Erlanger radiology services to be used in research (i.e., x-ray, nuclear medicine, mammograpy, fluoroscopy, MRI, DEXA, CT, ultrasound, interventional radiology) |
Erlanger Pharmacy Research Collaboration Form |
Request for pharmacy services to be used in research (i.e., storage, blinding, randomization, dispensing of investigational drugs) |
Erlanger Pharmacy Investigational Drug Service Fees-2017 |
Set up and maintenance fees for Erlanger pharmacy services |
2018 Medicare Clinical Research Check Off |
Checklist of required documents to submit for Medicare Coverage Analysis |
2011.9 Medicare Coverage Analysis |
Required to confirm that a trial qualifies for Medicare to cover reasonable and necessary items and services
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2018 Clinical Research Billing
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Determines what services are delivered to patient while on clinical trial, who will provide the service, who should be billed |
Erlanger Investigator Agreement - Rev 09/2015 |
Contract language between an investigator and EHS for all prospective trials conducted at Erlanger (including trials that involve only standard of care) |
Erlanger Clinical Research Master Agmt UTCOMC, 2012.4.3 |
Contract language between UT and Erlanger to conduct research |
E-Signature Certification |
Agreement between Erlanger and FDA allowing e-signatures |
Clinical Trials Gov ACT Checklist |
Checklist to determine if Investigator Initiated Trials meet the definition of "Applicable Clinical Trial" and require registration on Clinicaltrials.gov |
Research Resources
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Description
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Grant review timeline
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Overview of grant submission process
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Research submission timeline
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Overview of research submission process
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SRC timeline |
Overview of Scientific Review Committee process |
Erlanger Research and Billing Flowcharts |
Overview for the UTCOMC and EHS IRB and contracting process |
UTCOMC protocol deviation algorithm
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Overview for timely reporting of protocol deviations, protocol violations, and serious adverse events; see Form I in IRB Forms
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Scientific Review Committee proposal format
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Outline of project requirements for submission and presentation to the SRC
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2017 IRB Membership List
2018 IRB Membership List
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List of IRB members, specialty, and affiliation |
IRB policies & procedures 2012 |
UTCOMC Institutional Review Board policies and procedures
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Erlanger's FWA |
Erlanger's Federalwide Assurance for the Protection of Human Subjects |
Tools for multi-site research
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Resources and tools used in other research networks covering collaborations, proposal development, study start-up, study conduct, study closure, and resources for training.
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Qualtrics |
Link to information about Qualtrics, a web-based survey service that is available to all UTHSC faculty, staff, and students. |
Quality Improvement Guidelines |
Quality Improvement (QI) Projects and IRB Review |
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