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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.
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, be sure to collate all applicable materials in the assigned alphabetical order.
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.
Core Application - completion of A & B is required
Include 20 copies of each for the entire IRB.
Form A |
Click here for help (under construction) | |
| Form B | Research Description with Appendices [WORD] [RTF] Revised 5/19/08 | 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. |
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 | Form C Instructions [HTML] For VA, click here |
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| Form D | Form D Instructions [HTML] |
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| 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 8/4/06 |
Form F Instructions [HTML] |
| Form G | If NIH-sponsored Cooperative Group Clinical Trial, attach the NIH 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] |
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 8/21/07 |
Complete Form I if you plan to de-identify the data. |
| Form J | Use Form J to create your proposed HIPAA Authorization Form. Authorization Form Guidance [HTML] |
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| Form K | Waiver of Authorization Guidance [HTML] |
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 8/3/06 | Form N Instructions [HTML] |
| Form O | Use of Investigational New Drug Form [WORD] [RTF] Revised 8/18/05 | Only complete & attach Form O if you are not using the Investigational Drug Service (IDS). Form O Instructions [HTML] |
| Form O-1 | Use of Approved Drug(s) for Unapproved Use [WORD] [RTF] Revised 4/18/05 | Form O-1 Instructions [HTML] |
| Form P | Use of Investigational New Device Form [WORD] [RTF] Revised 3/1/07 | 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 | VA Form 10-1223 [WORD] [RTF] | Include Form R for research using Veterans Affairs (VA) subjects, facilities, or resources. Form R Instructions [HTML] |
| 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. |
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 | Research Involving the Decisionally Impaired [WORD] [RTF] Revised 8/4/06 |
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 | Form V Instructions [HTML] |
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| Form W | Form W Instructions [HTML] |
Materials for Primary Reviewer and Detailed Protocol/Grant Application Review
Attach the indicated number of copies.
| Form X | Disclosure of Financial Interest Form (DFIF) for externally-funded research [PDF] |
2 copies of DFIF & approved management plan if "yes" to any questions on the DFIF (Form X). Form X Guidance [HTML] |
| Form Y | Disclosure of Financial Interest Form (DFIF) for non-externally funded research [WORD] [RTF] Revised 7/25/06 |
2 copies of completed DFIF (Form Y) Form Y Guidance [HTML] |
| Form Z | 1 Original and 2 copies Form Z Instructions [HTML] |
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| Form AA | Grant Application |
2 copies if seeking a grant or a grant received. |
| Form BB | Sponsor's detailed drug protocol |
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 proposal and/or the sponsor's contract | 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.
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 | Markey Cancer Center (MCC) Protocol Review Committee (PRC) |
Form GG Instructions [HTML] |
| Form HH | [previously for GCRC but no longer in use] |
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| 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 | Veterans Affairs Research & Development Committee (VA R&DC) | Form JJ Information Links [HTML] |
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.