Research Forms & Resource Lists

Go to: IRB Forms Research Forms (Non-IRB) Research Resources

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
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
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. 45CFR46.111
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 & 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)
Documentation of assent in children	Attachment for all consents for children (<18 yrs), whether assent is given or waived 45CFR Subpart D
2012 UT COMC/EHS Model Consent Form	Template for informed consent language, including all elements required by the DHHS, FDA, HIPAA, UTCOMC 45CFR46.116
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	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

Go to: IRB Forms Research Forms (Non-IRB) Research Resources

*Research Forms (non-IRB)*	*Description*
Online research office consultation request form	Initial request for research support, including literature review, study design, statistical planning & analysis, grants
UTCOMC grant request form	To be submitted (with detailed project & budget) to seek grant funding
UTHSC contract certification form	Investigator confirmation of contract terms, obligations, etc.
UTHSC routing sheet	Cover sheet to accompany all grant/research submissions
Graphics request form	Request for poster or other research display; IRB approval number required for human subject research or case study
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
2014 Erlanger MCA Research Checklist	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
2018 Clinical Research Billing	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*	*Description*
Grant review timeline	Overview of grant submission process
Research submission timeline	Overview of research submission process
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	Overview for timely reporting of protocol deviations, protocol violations, and serious adverse events; see Form I in IRB Forms
Scientific Review Committee proposal format	Outline of project requirements for submission and presentation to the SRC
2017 IRB Membership List 2018 IRB Membership List	List of IRB members, speciality, and affiliation
IRB policies & procedures 2012	UTCOMC Institutional Review Board policies and procedures
Erlanger FWA	Erlanger's Federalwide Assurance for the Protection of Human Subjects
Research Manual	UTCOMC how-to instructions for new and experienced investigators, mentors, and support staff
Tools for multi-site research	Resources and tools used in other research networks covering collaborations, proposal development, study start-up, study conduct, study closure, and resources for training.
Qualtrics	Link to information about Qualtrics, a web-based survey service that is available to all UTHSC faculty, staff, and students.
Quality Improvement Guidlines	Quality Improvement (QI) Projects and IRB Review

Go to: IRB Forms Research Forms (Non-IRB) Research Resources