UK Office of Research Integrity

Menu

Medical Institutional Review Board
Expedited Review Application

NOTE: These forms are best downloaded using Internet Explorer (IE) as your web browser. If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please click here.

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

 
3
Section 1:  Core Application [Forms A, A-1, & B]
3
Section 2:  Informed Consent/Assent Process [Forms C-H]
3
Section 3:  HIPAA Materials [Forms I-K]
3
Section 4:  Additional Study Material [Forms L-S]
3
Section 5:  Vulnerable Populations [Forms T-W]
3 (see Section 6 for details)
Section 6:  Materials for Primary Reviewer and Detailed Protocol/Grant Application Review [Forms Z-DD]
3
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, an Expedited 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.

Back to Top

Section 1

Core Application - completion of A, A-1, & B is required 

Include 3 copies of each.

Form A

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

Click here for help (under construction)
Form A-1 Expedited Certification Form - REQUIRED [WORD] [RTF] Revised 8/23/13 Form A-1 Instructions [HTML]
Form B Research Description with Appendices [WORD] [RTF] 2/21/14 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.

Back to Top

Section 2

Informed Consent/Assent Process

You must select applicable item(s) from Form C - F and include 3 copies of each applicable item. If Form G and/or H apply, include 3 copies.

Form C

Informed Consent Template: Revised 2/21/14
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 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]  

Back to Top

Section 3

HIPAA (Health Insurance Portability and Accountability Act)

If HIPAA applies to your research, attach 3 copies of each applicable item. [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]

Back to Top

Section 4

Additional Study Materials

Complete/attach all of the below items that apply to your research; include 3 copies.

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 9/4/13

Form O Instructions [HTML]

Form P Use of Any Device Being Tested in Research - Form [WORD] [RTF] Revised 2/10/14 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.

Back to Top

Section 5

Vulnerable Populations

Complete all of the forms below that apply to your research; include 3 copies of each applicable form.

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]

Back to Top

Section 6

Materials for Primary Reviewer and Detailed Protocol/Grant Application Review

Attach 3 copies of each applicable item. Note an original of Form Z is also required.

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 3 copies

Form Z Instructions [HTML]

Form AA

Grant/Contract Application

Attach 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)

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

Investigator Brochure

Attach if conducting research involving administration of drug(s)

Form DD Device/detail protocol proposal Attach 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.

Back to Top

Section 7

Other Required Committee/Review Approvals

For research falling under the purview of any of the below committees or offices, attach 3 copies of the review or final approval materials (1 for IRB records, 1 for the IRB Primary Reviewer, and 1 for the Committee).

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

 

Back to Top

In accordance with federal regulations, a research study can be reviewed through an expedited review procedure if:

  1. the research activities involve no more than minimal risk;
  2. the only involvement of human subjects is in one or more of several specified categories.

In addition, the IRB may also use the expedited review procedure to review minor changes in previously-approved research during the period for which approval is authorized.

Under the expedited review mechanism, the review is carried out by an experienced member(s) of the IRB. The reviewer(s) may exercise all of the authorities of the IRB, except that he/she may not disapprove the research.

A summary of the expedited review procedures is provided below:

  1. The preliminary determination that a research project is eligible for expedited review is made by the investigator. The EXPEDITED CERTIFICATION FORM (Form A-1) serves as a guide in making this determination. In addition, questions of interpretation may be directed to the Office of Research Integrity (859-257-6071).
  2. The investigator prepares an application following the instructions as specified on the Expedited Review IRB application instructions page.
  3.  3  copies of the Expedited Certification Form (Form A-1) should be completed and included in the application submitted to the Office of Research Integrity, 311 Kinkead Hall. Applications may be submitted at any time. There are no deadline dates to meet as the review process is initiated upon receipt of the application.
  4. The application is sent to the designated reviewer upon receipt in the Office of Research Integrity. The investigator is not required to appear before the IRB.
  5. The review process takes approximately two weeks. The outcome of the review usually falls into one of the following categories:
    1. protocol approved as submitted;
    2. approval withheld pending submission of revisions and/or additional information;
    3. protocol requires full review.
  6. The Office of Research Integrity notifies the investigator in writing of all IRB decisions.

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.

Back to Top