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Interested in the ethical conduct of human research? Want to know more about the IRB process? Then become an IRB member! The Office of the Vice President for Research and ORI appreciate volunteers and are always on the look out for interested and committed members. Contact Judi Kuhl for more information (859-257-9764).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Human Research Forms

                    

*** E-IRB Info & Log-in Page ***


If you are completing an IRB Application for research involving human subjects, please visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA Privacy Regulation.

 

Modification Requests

If you have an approved E-IRB application, please see the E-IRB Video Tutorial "How to Create a Modification Request"

 

For studies not established in E-IRB: INSTRUCTIONS FOR SUBMITTING MODIFICATION REQUEST (OR OTHER REVIEW) TO irbsubmission@uky.edu MAILBOX

To submit by e-mail, all IRB forms and study documents should be submitted as one PDF that is readable, searchable, and contains standardized bookmarks. Email completed PDF submissions to Office of Research Integrity at irbsubmission@uky.edu. You will receive an automated notification of receipt by email. Please contact Michelle Hill at Michelle.Hill@uky.edu with any questions.

See step-by-step instructions on how to prepare your MR or Other Review submission: [PDF]
Should you need to submit a response to requested revisions for an application reviewed prior to the E-IRB new application submission requirement, see these step-by-step instructions: [PDF]

 

Note: The form icon indicates a document that is a PDF E-form. If you are experiencing problems downloading or filling in a form from our page, try using an alternate browser (e.g., Firefox, Chrome, IE).

  • Modification Request Form [WORD] [PDF]form Revised 1/13/14
    • How to prepare your Modification Request e-mail submission: [PDF]

  • Continuation Review Report Form (SAMPLE) [PDF] Revised 10/2017

  • Study Personnel List Template [WORD] [RTF] Revised 3/10/14


  • Emergency Use Checklist [WORD] [RTF] Revised 7/24/07
    [PDF]form

 

OTHER REVIEWS


  • Deviation/Exception - Use Modification Request Form [WORD] [PDF]form

  • Protocol Violation [WORD] [PDF]form Revised 1/7/11
    • How to prepare your Protocol Violation e-mail submission: [PDF]

  • Unanticipated Problem/Safety Reporting (Effective starting June 15, 2006)

How to prepare your Unanticipated Problem/Safety Reporting e-mail submission: [PDF]

  • Internal Prompt Reporting Form [WORD] [RTF]
    form[PDF]

  • External Prompt Reporting Form [WORD] [RTF]
    form[PDF]

  • If the sponsor requires the PI to submit reports to the IRB that do not require prompt reporting according to UK’s policy, the PI may complete the “Cover Form for Non-Prompt Reporting of Problems/Events”: Cover Form for Non-Prompt Reporting of Problems/Events [WORD] [RTF]
    form[PDF]

  • Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [PDF] Revised 7/8/11
  • IRB Policy on Unanticipated Problem and Safety Reporting [PDF] Policy Effective June 15, 2006; Revised March 22, 2016

 

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