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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, 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 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.
Core Application - completion of A, A-1, & B is required
Include 6 copies of each.
|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] Revised 7/30/14||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.|
Informed Consent/Assent Process
You must select applicable item(s) from Form C - F and include 6 copies of each applicable item. If Form G and/or H apply, include 6 copies.
Form C Instructions [HTML]
Authorization Form Guidance [HTML]
*Mandatory if in HIPAA Covered Entity
HIPAA Authorization Regulations [PDF]
Form D Instructions [HTML]
Form E Instructions [HTML]
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 6 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.]
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.
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.
Waiver of Authorization Guidance [HTML]
Additional Study Materials
Complete/attach all of the below items that apply to your research; include 6 copies.
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|
Complete all of the forms below that apply to your research; include 6 copies of each applicable form.
Adults with Impaired Consent Capacity: Web-Based Tool [to determine research risk level and likelihood of consent impairment]
Form T Instructions [HTML]
Form U Instructions [HTML]
Form V Instructions & Suggested Consent Form Language [HTML]
Form W Instructions [HTML]
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]
1 Original and 2 copies
Form Z Instructions [HTML]
2 copies if seeking a grant or a grant received.
Sponsor's detailed drug protocol: MEDICAL IRB ONLY
Investigator Brochure: MEDICAL IRB ONLY
|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).
Institutional Biosafety Committee (IBC): MEDICAL IRB ONLY
Radioactive Drug Research Committee (RDRC): MEDICAL IRB ONLY
Markey Cancer Center (MCC) Protocol Review Committee (PRC): MEDICAL IRB ONLY
[previously for GCRC but no longer in use]
|Form II||Medical Center/College of Medicine: MEDICAL IRB ONLY|
Please note that the Nonmedical IRB Expedited Review Subcommittee meets once every three weeks. 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.
In accordance with federal regulations, a research study can be reviewed through an expedited review procedure if:
- the research activities involve no more than minimal risk;
- 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:
- 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).
- The investigator prepares an application following the instructions as specified on the Expedited Review IRB application instructions page.
- 6 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. Complete expedited applications are reviewed by a subcommittee that meets on the same schedule as full reviews. See the Nonmedical IRB meeting dates and deadlines schedule [PDF].
- 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.
- The review process takes approximately three weeks. The outcome of the review usually falls into one of the following categories:
- protocol approved as submitted;
- approval withheld pending submission of revisions and/or additional information;
- protocol requires full review.
- 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.