The following information is intended to guide investigators and research personnel through IRB processes and submission requirements after the Initial IRB approval of a study. More information can be found in the IRB Policies and Procedures Manual Section 9: Types of Reviews and Submissions.
IRB Notifications and Approval Period
If the IRB is satisfied with the application in Cayuse IRB in its current form, the IRB can approve the study. As with all submissions, investigators cannot begin any study activities until they are in receipt of the formal letter of IRB approval and stamped consent documents (when applicable). The IRB will notify the PI and research team of approval status in Cayuse IRB. The IRB approval letters (.pdf file) will be located on the Study Details page, under the tab titled "Letters".
For Initial applications and Renewals, the approval period expires on the last day of the month prior to the anniversary of approval. However, the approval period may be shorter than one year at the discretion of the IRB as directed by the degree of risk. If the IRB determines that a project would require review more often than once a year, the reasons for this will be documented.
Required Submissions during the Approval Period
All IRB submissions are required to be completed in the Cayuse IRB electronic system. More information is available on the Cayuse page in the Researcher Toolkit.
Amendments to approved research studies must be submitted to the IRB via a Modification application in Cayuse IRB, with both annotated and clean versions of revised documents. Proposed changes may not be implemented until the IRB has reviewed and approved the Modification, except when the changes are necessary to eliminate immediate hazards to subjects. In this case, the Modification must be submitted to the IRB within 72 hours and include the reason immediate action was taken.
The IRB approval will indicate if it is necessary for active participants to be re-consented with the revised informed consent form. Please see IRB Policies and Procedures Manual Section 11 for more information on the requirement of re-consent/assent.
All changes in study personnel (additions/removals) are also to be submitted to the IRB via a Modification application. When planning to leave the Institution, a PI of an active study must arrange the timely transfer of study responsibilities to a new PI within the Institution. A Modification must be submitted via Cayuse IRB and new PI must submit a New Principal Investigator Certification letter with the Modification sign off on this transfer responsibility. This transfer is to be completed before the PI leaves the Institution.
In accordance with federal regulations, all ongoing research protocols are required to undergo periodic review at intervals appropriate to the degree of risk, but not less than once per year. Each IRB approval notice designates a period of time during which activities involving human research subjects may be undertaken. No research project may continue to recruit, enroll, or treat subjects or analyze data after the expiration date of the IRB approved research unless the IRB find an overriding safety concern or ethical issue such that is in the best interest of the participants to keep participating. The IRB requires that each investigator complete a Renewal application in Cayuse IRB, which provides a summary report on the progress of the research to date prior to the expiration date. The IRB will review the Renewal submission to determine if the research continues to meet the criteria for approval and will issue a new approval period.
Unanticipated Problems, Adverse Event, and Protocol Deviation Reporting
Investigators are required to submit reports of all serious and unexpected adverse events experienced by human subjects that meet the criteria for reporting. These are to be submitted via an Incident Report in Cayuse IRB.
Reports of events that meet the below criteria must be submitted to the IRB as soon as possible, but no later than 10 days after the PI becomes aware of the event. The PI should comprehensively describe the event in context of the study protocol and provide his/her assessment of the event's relevance to the study. All deaths occuring subjects enrolled at our Institution, that were not expected given the population enrolled, need to be reported within two business days of the PI becoming aware of the event.
Criteria for reporting an event (all must be met):
The event occurred at the Institution (hospital, satellite sites or clinics, etc.);
The event is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures and (b) the characteristics of the subject population being studied;
The event is related or possibly related to participation in the research; and
The event suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
The IRB has also provided an Unanticipated Problems (UAP) Assessment Tool that may be used by investigators to determine if reporting an event meets the above criteria and requires submitting an Incident Report. Instructions on how to complete the tool is located on the form.
Please refer to the IRB Policies and Procedures Manual Section 13: Data Safety Monitoring and Regular Reporting Requirements for more information on reportable events.
Any information relevant to the participation of human subjects in a proposed or approved research project in which the Institution (including its employees or physicians) is engaged should be submitted to the IRB. Examples of relevant materials include, but are not limited to, documentation of temporary study suspension by the sponsor or PI, clarification of subject complaints, audit reports, study drug shortages, or notice of FDA approval of study drugs or devices.
The additional documents/reports are to be submitted via a Modification application in Cayuse IRB.
Investigators are required to close the study with IRB once all study activities have been completed to terminate the IRB approval. Investigators who wish to inactivate their studies with the IRB are to submit a Closure application via Cayuse IRB. Once the Closure has been approved by the IRB, study records must be kept for:
3 years post inactivation per Institutional policy;
2 years post drug/device approval or program closure per FDA policy (21 CFR 312.57);
As specified by the study contract or as stipulated by the study sponsor