Medical Institutional Review Board
Full Review Application

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INSTRUCTIONS:

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. The number of copies required for submission of a complete application is noted below, and within the instructions for each section.

No. of Copies for Each Applicable Form
20	Section 1:  Core Application [Forms A & B]
20	Section 2:  Informed Consent/Assent Process [Forms C-H]
20	Section 3:  HIPAA Materials [Forms I-K]
20	Section 4:  Additional Study Material [Forms L-S]
20	Section 5:  Vulnerable Populations [Forms T-W]
2 or 3 (see Section 6 for details)	Section 6:  Materials for Primary Reviewer and Detailed Protocol/Grant Application Review [Forms Z-DD]
2	Section 7:  Other Committee/ Review Approval [Forms EE-JJ]

Each component of the application has been assigned a letter of the alphabet (as shown under the left-hand "Form" column). For each Form, there are guidelines/instructions to assist you in completing that component. When preparing your application, sort applicable materials alphabetically and then collate into the required number of packets (i.e. each packet has applicable forms A-Z).  Un-collated or insufficient number of applications are subject to being sent back to the PI.

For your convenience, a Full Review Application Checklist [PDF] has been developed to assist you in assembly of your materials. Use is optional.

Note: The Sections include a combination of Forms to fill out, and guidance/ instruction for documents you may need to provide copies 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.

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Section 1

Core Application - completion of A & B is required 

Include 20 copies of each for the entire IRB.

Form A	General Information Sheet [WORD] [RTF] Revised 4/5/13	Click here for help (under construction)
Form B	Research Description with Appendices [WORD] [RTF] Revised 7/20/12	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 applicable item(s) from Form C - F and include 20 copies of each applicable item for the entire IRB. If Form G and/or H apply, include 20 copies for the entire IRB.

Form C	Informed Consent Template: English-Revised 1/25/13 [WORD] [RTF]; Spanish-Revised 1/25/13 [WORD] [RTF] Informed Consent/HIPAA Combined Template: English-NEW 4/5/13 [WORD] [RTF]; Spanish-NEW 4/5/13 [WORD] [RTF]	Form C Instructions [HTML]
Form D	Assent Form Template: Revised 6/22/07 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)

If HIPAA applies to your research, attach 20 copies of each applicable item for the entire IRB. [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] [RTF] Revised 11/16/12	Complete Form I if you plan to de-identify the data.
Form J	HIPAA Authorization Template: Revised 4/5/13 English- [WORD] [RTF]; Spanish- [WORD] [RTF]	Use Form J to create your proposed HIPAA Authorization Form. Authorization Form Guidance [HTML]
Form K	HIPAA Waiver of Authorization [WORD] [RTF] 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; include 20 copies for the entire IRB.

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	Off-site research [WORD] [RTF] Revised 7/21/09	Form N 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 12/13/11	Form O Instructions [HTML]
Form P	Use of Any Device Being Tested in Research - Form [WORD] [RTF] Revised 2/13/13	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; include 20 copies of each applicable form for the entire IRB.

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 8/2/06	Form U Instructions [HTML]
Form V	Research Involving Prisoners [WORD] [RTF] Revised 3/15/13	Form V Instructions & Suggested Consent Form Language [HTML]
Form W	Research Involving Children [WORD] [RTF] Revised 11/10/09	Form W Instructions [HTML]

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Section 6

Materials for Primary Reviewer and Detailed Protocol/Grant Application Review

Attach the indicated number of copies.

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	Signature Assurance Sheet [WORD] [RTF] Revised 7/22/10	1 Original and 2 copies 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

For research falling under the purview of any of the below committees or offices, attach 2 copies of the review or final approval materials (1 for IRB records and 1 for the IRB Primary Reviewer).

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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