IRB The IRB Chair is responsible for seeing that the IRB discharges its functions in an appropriate and regulatory-compliant manner. (S)he holds ultimate responsibility for convening the Board and facilitating meetings, providing to the Institutional Official (IO) recommendations for IRB Membership (including recommendations for pairing primary members with alternates on the IRB roster), and ensuring the IRB operations are in compliance with applicable federal and state statute and regulations. (S)he may delegate some responsibilities to the Vice-Chairs or other experienced IRB Members. The IRB Chair determines whether an activity must be approved by the IRB and determines whether an activity requires IRB review and approval, and whether human research may be reviewed via exempt, expedited, or a full board review process. The IRB Chair or designate will make determinations regarding events reported to the IRB, or consult with the IRB, IO, Privacy Officer, Information Security Officer, or General Counsel as needed. IRB The Vice-Chairs assist the IRB Chair in carrying out the responsibilities noted in the IRB Chair section and are primarily responsible for the oversight of their designated Full Board meeting. When a Vice-Chair plans to be absent from a full board meeting, the Vice-Chair or IRB Chair may designate an experienced IRB Member to run the meeting, or the IRB Chair will fulfill this duty. IRB Below is an overview of the IRB review process. The IRB administrative staff performs a preliminary review of all protocol materials for determination of completeness, accuracy, and required initial signatures (Scientific Review Committee, Department Chair, PI, and any required ancillary reviewers). Only complete submissions can be approved. The PI will be informed through an email of any missing materials or requirements and applicable response deadlines. The IRB administrative staff will assign protocols for review, based on the scientific content of the protocol, the potential reviewer’s area of expertise, and ensure, where applicable, that a scientific and non-scientific perspective is represented. The IRB may use a primary and secondary reviewer process (e.g., two reviewers), or assign reviews based on special knowledge and expertise of the members (e.g., clinical expertise, informed consent reviewer, research design, statistics, regulatory and policy, ethics) or a combination thereof. When the IRB is presented with a protocol that may be outside of the
Event Type (*= Requires Full Review or SAE Subcommittee Review) See definitions in IRB guidance documents for a description of each event. Deadline from when the investigator first learns of an internal event for reporting to IRB for an internal event (e.g., those that occurred with within the DMC IRB’s jurisdiction) Comments *Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise within 5 days. The study team should alert the IRB when the inspection is scheduled or if an inspector arrives unannounced, so the IRB may help as needed. *Privacy Violation (or Breach). Immediately report this to IRB and Privacy Officer *Information (Data) Security Violation (or Breach). Immediately report this to IRB and Data Security Officer Incarceration of a research participant. Immediately, if participant is actively incarcerated; otherwise within 5 days Any FDA Actions or changes to a HUD. Immediate Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, UAE, or UADE, as described below. 24 hours, if in Clinical when the AE meets all of the following criteria: serious (SAE) or alarming, unanticipated, AND definitely, probably, or possibly related to the investigational agent. For more information, see . When reporting a death, please include the date of death, if known. Investigators are required to report promptly “to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately’”. Consult with the Sponsor or FDA for additional guidance. The term “alarming” is not defined by the FDA, so it is up to the PI’s or Sponsor’s discretion on how to interpret this term.
and the IRB may require that the currently enrolled research participants be re-consented, acknowledging receipt of this new information and for affirming their continued participation. Changes Initiated to Eliminate an Apparent Immediate Hazard days. 5 days Include an amendment, to propose any additional or permanent changes. Expanded Access, Emergency Use, or Compassionate Use of an Unapproved Drug, Unapproved Biologic, or Unapproved Device. Notify IRB Chair as soon as possible. Notify the IRB within 5 days of drug administration or device use Requires approval of the Department Chair and Medical Director before administration. Protocol Deviations (including minor modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full board if the event meets the requirements to be reported within 5 days. 5 days, if it adversely affects: the rights, safety, or welfare of the research participant; or the research participant’s willingness to continue participation; or the integrity of the research data, including information security requirements. Otherwise report to IRB before continuing review or project closure. Include an amendment, to propose any additional or permanent changes, as a corrective action. Any complaints involving translations or interpretations must also be reported to patient relations. *Termination or *Suspensions of research, Administrative Hold, FDA Clinical Hold, Enrollment Hold. 5 days The IRB may also elect to terminate or suspend IRB approval or place enrollment on hold, and all such actions require reporting to OHRP, and to FDA and sponsor when applicable, by the IO. All Local Unanticipated Problems Involving Risks to Participants or Others (UPIRPO). *Must be reported to the full board if the event meets the requirements to be reported within 5 days. 5 days, if serious; otherwise, within 30 days If the IRB concurs or determines that an event is an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable.