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IRB Review Types

IRB Introduction [PDF]

NEW!!! INSTRUCTIONS FOR SUBMITTING PROTOCOLS 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 (instructions on how to perform this are provided next to the applicable review type below). 

Email completed PDF submissions to 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.

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).

To jump to a review type, click on your choice below:

Send IRB materials to: irbsubmission@uky.edu

Office of Research Integrity
315 Kinkead Hall
University of Kentucky
Lexington, KY 40506-0057
Ph: (859) 257-9428
FAX: (859) 257-8995
Hours of Operation: 8am-12pm; 1pm-5pm


Exemption

Research that involves no more than minimal risk and meets criteria specified by federal regulations may qualify for exemption.

Note: Effective June 21, 2017, new Exemption Applications must be submitted via the new web-based application system: E-IRB. You are NOT required to submit a paper copy when submitting through the E-IRB system. Visit the E-IRB information web page for more info and the link to video tutorials.

***Modifications for Exempt protocols will still be submitted electronically in PDF format to IRBSubmission@uky.edu. Please contact Joe Brown at Joe.Brown@uky.edu, or Michelle Hill at Michelle.Hill@uky.edu for any additional information.***

Contact:

Joe Brown, jrbrow3@uky.edu
859-257-9084

  • Exemption Certification Request (application) [HTML]
  • Issues to Be Addressed When Conducting Exempt Review [PDF]

    This document helps explain the exemption categories and the issues that IRB reviewers must address when making a determination about Exemption Certification. 

  • Exempt Review SOP [PDF]

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Initial Expedited Review

The Institutional Review Board (IRB) uses an expedited review process to review studies that meet the categories adopted by the Department of Health and Human Services (DHHS), or the Food and Drug Administration (FDA) and that involve no greater than “minimal risk.” Expedited review procedures allow the IRB to review and approve studies that meet the criteria in the attached document without convening a meeting of the full IRB.

Contacts:

For both Medical and Nonmedical Initial Expedited Review, contact Michelle Hill at (859) 257-9428 or Michelle.Hill@uky.edu, to be forwarded to the appropriate ORI staff person.

  • Medical Expedited Review Application [HTML]

  • Nonmedical Expedited Review Application [HTML]

  • Issues to Be Addressed When Conducting Expedited Review [PDF]

This document helps explain the expedited categories and the issues that IRB reviewers must address when making a determination about the research's eligibility for expedited review.


  • Expedited Review SOP [PDF]

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Initial Full Review

Research that cannot meet the criteria for exempt or expedited review must be submitted for full review.

 

  • Requested Revisions From a Full Review -- Major versus Minor Determination: "Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4)" [PDF]

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Modification of a Currently Approved Protocol

A modification is defined as any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.  Should protocol changes be made without prior IRB approval to eliminate apparent hazards to the subject(s), submit a memorandum immediately to the IRB addressing the nature of the change, why it was necessary, and the outcome.  

Information relating to protocol modifications should be relayed to subjects when such information might relate to the subject’s willingness to continue to take part in the research. How this information will be relayed to the subject (e.g., through a re-consent process using a modified consent form, or a letter sent to the subject) should be included in a modification request, and IRB approval obtained prior to implementation. 

Discontinuing a study (e.g., PI leaves UK) or completion of a study is considered a change in the protocol’s status and therefore the IRB should be promptly notified in writing. See the Continuation Review SOP and the Study Closure SOP [http://www.research.uky.edu/ori/human/SOPs_&_Policies.htm] for procedures on reporting an activity status change to the IRB.  If the investigator fails to notify the IRB about discontinuation or completion of a study, then he/she will continue to be responsible for completing the Continuation Review report requests.

To request changes to your current IRB approved protocol, submit two copies of the completed Modification Request Form, and materials relating to your modification request to the Office of Research Integrity. 

Approval of the modification request is on the advice of the IRB chairperson or a designated representative unless the nature of the proposed changes warrants review by the full IRB. The IRB may determine the modification relates to subjects’ willingness to continue to participate in the research, and request that the PI relay pertinent information to subjects. The investigator is notified in writing of the IRB’s decision. 

Deviation

A one-time departure from the current IRB approved protocol once a subject has actually been enrolled is considered a protocol deviation.  Examples: drawing a 13th tube of blood from a subject where the protocol specifies that 12 samples will be collected for the study; or, instituting a procedure on one or more enrolled subjects that is not specified in the protocol.

Exception

A one-time enrollment of a research subject in a protocol that fails to meet current IRB approved protocol inclusion criteria, or falls under protocol exclusion criteria, is considered a protocol exception. Examples: enrollment of a 70 year old patient when the inclusion criteria specifies 25-65 years of age; or, enrollment of a patient with a serious disease that is precluded from participation in the protocol exclusion criteria.

It is IRB policy that deviations and/or exceptions to IRB approved protocols be reviewed and approved prior to their implementation. Most sponsors also require approval prior to implementation of any deviations from the protocol. You may use the IRB's Modification Request Form to submit a request to the IRB for a deviation or exception to a currently approved protocol. Please note, a deviation and/or exception should be a one-time event and IRB approval for its implementation does not change the entire protocol.

Protocol Violation

If either a protocol deviation or protocol exception occurs without prior IRB review and approval, the Principal Investigator is responsible for completing a Protocol Violation Reporting Form and submitting one original and one copy to the IRB for review within 14 days of the occurrence. If applicable, the Principal Investigator is responsible for reporting protocol violations to the sponsor, and/or FDA.

Consent/Assent

If the proposed changes necessitate a change in the consent/assent form(s), then a revised consent/assent document in which the changes are underlined should be submitted. Also include a clean copy of the revised consent document(s) without underlining. If approved, the clean copy of the revised consent document(s) with the valid "IRB Approval" stamp will accompany the approval letter.

If requesting either a waiver from the requirement for the informed consent process, or a waiver from the requirement for obtaining documentation of the informed consent process, complete the corresponding form and submit it with the modification request materials (refer to Section 2 of the IRB application for Form E or Form F).

Vulnerable Populations

If the modification request involves adding a vulnerable population (e.g., children, pregnant women, decisionally impaired, prisoners), complete the corresponding form (refer to Section 5 of the IRB application for Form T, U, V, or W) and include it with your modification request submission. 

Study Personnel / PI

If the modification request involves updating study personnel, use the Study Personnel List Template (or the General Information Sheet in the IRB Initial Review application) to list all study personnel (SP) who should be approved by the IRB (including SP previously approved who continue to hold responsibilities with the study). Two copies of the list of all SP should accompany the completed Modification Request Form. Changes from the previously approved study personnel list should be described in the space provided on the Modification Request Form, or attachment(s).  Please confirm new SP have completed the mandatory human subject protections training and all existing SP are up-to-date on training BEFORE you submit your modification request to ORI. See the Mandatory Human Subjects Protections Training web page for frequently asked questions on training requirements.

Note that a change in the principal investigator (PI) should be reported to the Office of Research Integrity and a new GENERAL INFORMATION SHEET submitted. If the address or contact person to whom correspondence should be sent has changed, notify the Office of Research Integrity in writing with a memorandum signed by the principal investigator.  If the PI is leaving the University, and research activities are to be continued at the University under the direction of another investigator who is affiliated with these institutions, then a request for approval of a change in investigator must be submitted to the IRB by the current PI. The new PI should include a completed Signature Assurance Sheet (Form Z) with the request.   

Extension of Project End Date

If the research study is expected to extend beyond the estimated project end date initially approved by the IRB, then the investigator should submit a request for an extension of time to the Office of Research Integrity.

Recruitment Materials

If the modification request involves the addition or revision of recruitment materials such as advertisements, the IRB reviews the recruiting materials to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. In addition, print and media advertisements to the public are required to be reviewed by UK Public Relations (PR) for compliance. The Clinical Research Development and Operations Center (CRDOC) collaborates with the Office of Research Integrity (ORI) and Public Relations (PR), to streamline both the PR and IRB approval processes by incorporating a number of checks and balances to promote compliant advertisement development, preferably at the beginning. Visit CRDOC's Participant Recruitment and Marketing Unit web page for more details and contact information.

Sponsor Initiated Changes

The IRB is responsible for assessing additional risks or benefits when conducting review of proposed changes. Please understand it is difficult to make these assessments based upon detailed, lengthy summaries of the amendments from the sponsor without a short summary from the investigator. All amendments should be submitted using the Modification Request Form, and include a short letter signed by the principal investigator, summarizing the key changes in the amendment that will affect the study procedures for the subjects and, thus, may alter the risk-benefit ratio. If the proposed changes necessitate a change in the consent/assent form, then a revised consent/assent form in which the revisions are underlined should be submitted. Also, one clean copy of the revised form without underlining should be submitted.

  • Modification Request Form [WORD] [RTF]
    form[PDF]
    • How to prepare your Modification Request e-mail submission: [PDF]

       

  • Study Personnel List Template [WORD] [RTF]

  • Expedited Review of Minor Modifications [PDF]

    IRBs may utilize expedited procedures to review a proposed change to previously approved research if it represents a minor change.  For more information, download this document.

  • Modification, Deviations & Exceptions, Review SOP [PDF]

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Protocol Violation

A protocol violation is any exception or deviation involving a single subject that is not approved by the IRB prior to its initiation or implementation. These protocol violations may be major or minor violations. If either a protocol deviation or protocol exception occurs without prior IRB review and approval, the Principal Investigator is responsible for completing a Protocol Violation Reporting Form and submitting one original and one copy to the IRB for review within 14 days of the occurrence. If applicable, the Principal Investigator is responsible for reporting protocol violations to the sponsor, and/or FDA.

  • Protocol Violation Reporting Form [WORD] [RTF]
    form[PDF]
    • How to prepare your Protocol Violation e-mail submission: [PDF]


  • Protocol Violation Review SOP [PDF]

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Continuation Review

Federal regulations dictate that previously approved research protocols must be re-reviewed by the respective IRB at least once a year. Continuation review by the IRB requires the investigator to complete and return a report form sent to him/her by the Office of Research Integrity.

Contacts:

For both Medical and Nonmedical Expedited Continuation Review, contact Michelle Hill at (859) 257-9428 or Michelle.Hill@uky.edu, to be forwarded to the appropriate ORI staff person.

For both Medical and Nonmedical Full Continuation Review, refer to the contacts listed above for Initial Full Review.

Continuation Review Related Materials:

  • Office for Human Research Protections (OHRP) Guidance on Continuing Review  - January 2007 [PDF]

    This document describes the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.109(e) for the continuing review of human subjects research by an Institutional Review Board (IRB).

  • Continuing Review After Study Approval [PDF]

    Guidelines from the Food and Drug Administration (FDA) Information Sheets.

  • OHRP Compliance Oversight Activities: Determinations of Noncompliance [HTML]

    This document by the Office for Human Research Protections (OHRP) provides a list of determinations of noncompliance that OHRP has made over the last several years. See the Initial and Continuing Review section for continuation review related determinations.

  • Time-Saving Tips for Continuation Review of an IRB-Approved Study [PDF]

    Tips developed to help researchers with submission of Continuation Review materials.

  • Continuation Review Report Form (SAMPLE) [PDF]
    • How to prepare your Continuation Review e-mail submission: [PDF]
  • Please note, the ORI database merges protocol specific information into each Continuation Review (CR) report form.  These fields are denoted with a code word in brackets on this CR sample; therefore, the SAMPLE CR report form does not contain protocol specific data and you should not complete and submit this form to meet the requirements for Continuation Review.  If you need a CR report form for your study, please contact the Office of Research Integrity and provide the IRB protocol number. A CR report form specific to your study will then be generated and sent to you.

  • Continuation Review SOP [PDF]
  • Requested Revisions From a Full Review -- Major versus Minor Determination: "Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4)" [PDF]

 

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Unanticipated Problems/Safety Reporting

(Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC)) 

  • IRB Policy on Unanticipated Problem and Safety Reporting [PDF] Policy Effective June 15, 2006; Revised March 22, 2016

  • 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]

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