If you have an approved E-IRB application, please see the E-IRB Video Tutorial on how to "Create a Modification Request".
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 you have an E-IRB approved application, please see the E-IRB Video Tutorial "Create a Modification Request" and "Add Informed Consent Section Attachments".
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.
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.
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.
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.
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 protocol violation 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 [PDF] and the Study Closure SOP [PDF] 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 they will continue to be responsible for completing the Continuation Review report requests.
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.
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 Report Form and submitting 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.
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. Advertisements to the public are required to go through Public Relations Review (PRR) for compliance. Find out how to request PRR and learn more about Participant Recruitment Advertising here: https://www.research.uky.edu/research-communications/participant-recruitment-advertising
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.
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 Human Subject Protection Training FAQs webpage for frequently asked questions on training requirements. Review the E-IRB Video Tutorial on how to create a Modification Request and then follow the instructions on the Study Personnel section page.
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