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Medical Institutional Review Board
Full Review Application

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NEW!!! INSTRUCTIONS FOR SUBMITTING PROTOCOLS TO irbsubmission@uky.edu MAILBOX

Effective April 11, 2016, all new protocol submissions, modifications, adverse events, violations and continuation reviews may be submitted by e-mail. 

To submit by e-mail, all IRB forms and study documents should be submitted as one PDF that is readable, searchable, and contains standardized bookmarks.
 
See step-by-step instructions on how to prepare your Initial Full application submission: [PDF]

Should you need to submit a response to requested revisions, see these step-by-step instructions: [PDF]

Email completed PDF submissions to irbsubmission@uky.edu. You will receive an automated notification of receipt by email. Please contact Heather Gozzard at Heather.Gozzard@uky.edu or Michelle Hill at Michelle.Hill@uky.edu with any questions.

Application Contents:
Section 1:  Core Application [Forms A & B]
Section 2:  Informed Consent/Assent Process [Forms C-H]
Section 3:  HIPAA Materials [Forms I-K]
Section 4:  Additional Study Material [Forms L-S]
Section 5:  Vulnerable Populations [Forms T-W]
Section 6:  Materials for Primary Reviewer and Detailed Protocol/Grant Application Review [Forms Z-DD]
Section 7:  Other Committee/ Review Approval [Forms EE-JJ]

There are seven sections to the IRB application. Depending on the nature of your research, some sections will apply to your research, some will not. Please review each section to determine applicability to your research, and include the Forms appropriate for your study in your IRB application submission. When preparing your application, sort applicable materials alphabetically (e.g., each packet has applicable forms A-Z).  Incomplete or inappropriately compiled applications are subject to being sent back to the PI.

Note: The Sections include a combination of Forms to fill out, and guidance/ instruction for documents you may need to provide duplicates of or that you may need to develop. Forms to fill out (when applicable to your research) are denoted by the option to download either a WORD or RTF document.

Note: The form icon indicates a document that is a PDF E-form.

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Section 1

Core Application - completion of A & B is required 

Form A

General Information Sheet [WORD] [RTF] Revised 8/27/15

Form B Research Description with Appendices [WORD] [RTF] 8/25/16 The WORD or RTF version may be saved to the location of your choice, and then used as a guideline while editing for your specific protocol.

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Section 2

Informed Consent/Assent Process

You must select at a minimum, applicable item(s) from Form C - F.

Form C

Informed Consent Template: Revised 12/16/15
English- [WORD] [RTF]; Spanish- [WORD] [RTF]

*Informed Consent/HIPAA Combined Template*: Revised 2/9/16 English- [WORD] [RTF]; Spanish- [WORD] [RTF]

*Mandatory if in HIPAA Covered Entity*

Form C Instructions [HTML]

HIPAA Authorization Regulations [PDF]

Issues and Sample Language for Specimen Studies [PDF]

Sample Research Repository Consent [PDF]

Form D

Assent Form Template: Revised 12/16/15
English- [WORD] [RTF]; Spanish- [WORD] [RTF]

Form D Instructions [HTML]

Form E

Request for Waiver of Informed Consent Process [WORD] [RTF] Revised 7/28/06

Form E Instructions [HTML]

Form F

Request for Waiver of Documentation of Informed Consent Process [WORD] [RTF] Revised 2/15/12

Cover Letter Template for survey/questionnaire
research: Revised 10/22/12
English- [WORD] [RTF]; Spanish- [WORD] [RTF]

Form F Instructions [HTML]

Form G If Department of Health and Human Services (DHHS)-approved protocol (such as NIH-sponsored Cooperative Group Clinical Trial), attach the DHHS-approved Sample Informed Consent Form Form G Instructions [HTML]
Form H For recruitment of Non-English speaking subjects, attach translated consent document

Form H Instructions & info pertaining to subjects from a foreign culture [HTML]  

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Section 3

HIPAA (Health Insurance Portability and Accountability Act)

Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA Privacy Regulation.

Form I

HIPAA De-identification Certification Form [WORD] [PDF]form Revised 2/20/14

Complete Form I if you plan to de-identify the data, however, if you retain a link the HIPAA Waiver of Authorization (Form K) applies.

Form J

Effective 12/5/13, this form has been eliminated. If HIPAA Authorization is required for your research, you must use the Informed Consent/HIPAA Combined Template as a guide to develop your consent/authorization document.

 

Form K

HIPAA Waiver of Authorization [WORD] [PDF]form Revised 8/21/07

Waiver of Authorization Guidance [HTML]

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Section 4

Additional Study Materials

Complete/attach all of the below items that apply to your research.

Form L

Proposed advertisement(s) of any type for recruiting subjects

Form L Instructions [HTML]

Form M Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) Form M Instructions [HTML]
Form N Effective 8/28/13, this form has been eliminated. Applicable off-site questions have been incorporated into other parts of the IRB application. Please be sure to complete the most recent versions of Form A and Form B for your application submission.

Off-Site Research - IRB Application Instructions [HTML]  

Form O Use of Any Drug* Being Tested in Research - Form *May include dietary supplements, or substances generally recognized as safe (GRAS) when used to diagnose, cure mitigate, treat or prevent disease
[WORD] [RTF] Revised 8/26/16

Form O Instructions [HTML]

Form P Use of Any Device Being Tested in Research - Form [WORD] [RTF] Revised 7/28/15 Form P Instructions [HTML]
Form Q Use of Radioactive Materials (Radiation Safety Form) [WORD] [RTF] Revised 4/19/05 Form Q Instructions [HTML]
Form R [previously for VA Form 10-1223] Click HERE for new information

 

Form S Copy of the package insert or FDA approved label (PDR reference) Include for drug or device studies using the FDA approved medication/device for approved medical indication.

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Section 5

Vulnerable Populations

Complete all of the forms below that apply to your research.

Form T

Adults with Impaired Consent Capacity: Web-Based Tool [to determine research risk level and likelihood of consent impairment]

Form T Instructions [HTML]

Form U

Research Involving Pregnant Women, Fetuses, &/or Neonates [WORD] [RTF] Revised 5/6/14

Form U Instructions [HTML]

Form V

Research Involving Prisoners [WORD] [RTF] Revised 6/4/15

Form V Instructions & Suggested Consent Form Language [HTML]

Form W

Research Involving Children [WORD] [RTF] Revised 5/5/15

Form W Instructions [HTML]

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Section 6

Materials for Primary Reviewer and Detailed Protocol/Grant Application Review

Form X Form Y Note "Form X" and "Form Y" for Disclosure of Financial Interest (DFI) have been replaced by a question in "Form A" and the Office of Sponsored Projects Administration (OSPA) online financial disclosure form.

Instructions for OSPA's online financial disclosure form [PDF]

OSPA's Disclosure of Financial Interest Survey Sample [PDF]

Form Z
*Required

Signature Assurance Sheet [PDF] Revised 2/9/16

Form Z Instructions [HTML]

Form AA

Grant/Contract Application

2 copies if seeking a grant or a grant received.

Form BB

Sponsor's detailed drug protocol and/or the complete Department of Health and Human Services (DHHS)-approved protocol (such as NIH-sponsored Cooperative Group Clinical Trial)

3 copies if conducting research involving administration of drug(s).
Form CC

Investigator Brochure

3 copies if conducting research involving administration of drug(s)

Form DD Device/detail protocol proposal 2 copies if conducting research involving the use of a device(s).

NOTE: The Office of Research Integrity will forward to the University of Kentucky Hospital Investigational Drug Service (IDS) the detailed protocol and IRB application form per UK Hospital Policy on drug research. Please contact the IDS at 859-323-6969 for additional information. IDS may contact investigators directly if additional documentation is needed to meet Hospital policy.

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Section 7

Other Required Committee/Review Approvals

Form EE

Institutional Biosafety Committee (IBC)

Form EE Instructions [HTML]

Form FF

Radioactive Drug Research Committee (RDRC)

Form FF Instructions [HTML]

Form GG

[previously for Markey Cancer Center (MCC) Protocol Review Committee (PRC)] -- 3/18/10: IRB Review is independent of PRC Review

See Other Review Committees Info: [HTML]

Form HH

[previously for GCRC but no longer in use]

 

Form II Medical Center/College of Medicine

[For involvement of Medical Center students and/or College of Medicine students as research subjects.]

Form II Instructions [HTML]

Form JJ [previously for Veterans Affairs Research & Development Committee (VA R&DC)] Click HERE for new information

 

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Please note that the Medical IRB meets approximately six times per month. There are no deadline dates for submission of applications. Protocols are assigned on a "first come, first served" basis, and will be placed on the next available agenda. You are encouraged to submit your protocol as early as possible.

Full reviews require that the Principal Investigator attend the meeting at which the application is reviewed. A review date will be assigned to the protocol at the time of submission. If the PI is not available on this date, this should be made clear to staff of the Office of Research Integrity at the time of submission.

Note that all incomplete IRB applications will not be scheduled for review but returned to the PI.

If you have questions concerning submission of a research protocol for IRB review, please call the Office of Research Integrity at 859-257-9428.

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