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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.
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 11 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 11 copies of each applicable item for the entire IRB. If Form G and/or H apply, include 11 copies for the entire IRB.
| Form C | Form C Instructions [HTML] |
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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 | 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] |
HIPAA (Health Insurance Portability and Accountability Act)
If HIPAA applies to your research, attach 11 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 11 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 | Investigational New Drug Form: MEDICAL IRB ONLY | |
| Form O-1 | Approved Drug(s) for Unapproved Use: MEDICAL IRB ONLY | |
| Form P | Investigational New Device Form: MEDICAL IRB ONLY | |
| Form Q | Radioactive Materials: MEDICAL IRB ONLY | |
| Form R | VA Form 10-1223: MEDICAL IRB ONLY | |
| Form S | package insert or FDA approved label: MEDICAL IRB ONLY | |
Vulnerable Populations
Complete all of the forms below that apply to your research; include 11 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: MEDICAL IRB ONLY |
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| Form CC | Investigator Brochure: MEDICAL IRB ONLY |
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| Form DD | Device proposal: MEDICAL IRB ONLY | |
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 |
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| Form FF | Radioactive Drug Research Committee (RDRC): MEDICAL IRB ONLY |
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| Form GG | Markey Cancer Center (MCC) Protocol Review Committee (PRC): MEDICAL IRB ONLY |
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| Form HH | [previously for GCRC but no longer in use] |
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| Form II | Medical Center/College of Medicine: MEDICAL IRB ONLY | |
| Form JJ | Veterans Affairs Research & Development Committee (VA R&DC): MEDICAL IRB ONLY | |
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 John Ryan, Office of Research Integrity at 859-323-2446.
PLEASE NOTE: IF YOUR RESEARCH INVOLVES VA PATIENTS OR VA RESOURCES, THIS PROPOSAL MUST BE SUBMITTED TO THE MEDICAL IRB FOR REVIEW. IT MUST ALSO BE APPROVED BY THE VA RESEARCH AND DEVELOPMENT COMMITTEE. YOU SHOULD CONTACT THE OFFICE OF RESEARCH INTEGRITY FOR THE APPROPRIATE FORMS AS WELL AS THE VA RESEARCH OFFICE, 859-281-4927, FOR FURTHER INFORMATION.