UK Office of Research Integrity

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Nonmedical 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

 
13
Section 1:  Core Application [Forms A & B]
13
Section 2:  Informed Consent/Assent Process [Forms C-H]
13
Section 3:  HIPAA Materials [Forms I-K]
13
Section 4:  Additional Study Material [Forms L-S]
13
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 13 copies of each for the entire IRB.

Form A

General Information Sheet [WORD] [RTF] Revised 3/10/14

Click here for help (under construction)
Form B Research Description with Appendices [WORD] [RTF] Revised 8/28/13 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 13 copies of each applicable item for the entire IRB. If Form G and/or H apply, include 13 copies for the entire IRB.

Form C

Informed Consent Template: Revised 10/31/13
English- [WORD] [RTF]; Spanish- [WORD] [RTF]

*Informed Consent/HIPAA Combined Template*: Revised 2/17/14 English- [WORD] [RTF]; Spanish- [WORD] [RTF]

Form C Instructions [HTML]

*Mandatory if in HIPAA Covered Entity

HIPAA Authorization Regulations [PDF]

Form D

Assent Form Template: Revised 11/25/13
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 NIH Informed Consent Form:  MEDICAL IRB ONLY 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 13 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] [PDF] 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] 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 13 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 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 Investigational New Drug Form:  MEDICAL IRB ONLY
Form P Investigational New Device Form:  MEDICAL IRB ONLY
Form Q Radioactive Materials:  MEDICAL IRB ONLY
Form S package insert or FDA approved label:  MEDICAL IRB ONLY

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Section 5

Vulnerable Populations

Complete all of the forms below that apply to your research; include 13 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 10/4/13

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 Application

2 copies if seeking a grant or a grant received.

Form BB

Sponsor's detailed drug protocol:  MEDICAL IRB ONLY

Form CC

Investigator Brochure:  MEDICAL IRB ONLY

Form DD Device proposal:  MEDICAL IRB ONLY

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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):  MEDICAL IRB ONLY

Form FF

Radioactive Drug Research Committee (RDRC):  MEDICAL IRB ONLY

Form GG

Markey Cancer Center (MCC) Protocol Review Committee (PRC):  MEDICAL IRB ONLY

Form HH

[previously for GCRC but no longer in use]

 

Form II Medical Center/College of Medicine:  MEDICAL IRB ONLY

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Please note that the Nonmedical IRB meets twice per month. Investigators are encouraged to submit protocols as far in advance of a deadline date as possible. In an effort to decrease the number of pages, the investigator is encouraged to submit two-sided copies whenever 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 859-323-2446.

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