IRB: Required Reporting

Required Reporting

Status Reports

IRB approval of research is only valid for one year. The IRB requires the submission of a status report 6 months following approval. If the research has been completed at that point, the IRB will close the file. If the research continues beyond 6 months, but will end prior to the expiration, a second and final status report must be submitted. If it is expected that the research will continue beyond the 1-year approval period, the Principal Investigator (PI) must apply for renewal, allowing ample time for review so there is no lapse. All research activities must cease as of the expiration date, unless the board approves a renewal. Studies are not considered closed until both data collection and analysis have been completed. Researchers must reapply if they don't finish analysis prior to the approval's expiration.

Failure to Submit a Status Report

Marywood University's management and submission system, IRBNet, sends an automatic e-mail notice to the PI, and anyone else granted "full" access in IRBNet's system, 15 days prior to the first status report's due date. If the IRB Administrator discovers that a status report has not been submitted, s/he will attempt contact with the Principal Investigator (PI) via e-mail or telephone. Failure to respond may result in suspension of research activities. Please see our failure to submit a status report procedure.

Deviation or Violation Reports

Research investigators are responsible for reporting to the Institutional Review Board (IRB) or Exempt Review Committee (ERC) any instance of non-compliance with IRB/ERC policies and procedures or the requirements or determinations of the IRB/ERC.

If inadvertently or intentionally, an approved research protocol was not followed, the researcher must submit a Deviation/Violation report to the IRB or ERC within 10 business days of the incident. A report form may be found on our IRB Forms page.

Deviation or violation reports are acknowledged by the IRB within 3-5 business days.

Failure to Report Deviations or Violations

If the IRB or ERC Administrator discovers an unreported deviation or violation, s/he will attempt contact with the Principal Investigator (PI) via e-mail or telephone. The PI will have one week to respond with a revised application and other materials, as necessary. Failure to respond may result in suspension of research activities. Please see our failure to report deviations or violations procedure.

Adverse Event and Safety Reports

Research investigators must report all serious "internal" adverse events (SAEs), for example the death or serious injury of a research participant, regardless of relatedness or expectedness to study drug or interventions, immediately within 24 hours of the event to the Institutional Review Board (IRB). All other "internal" adverse events (AEs) must be reported within 10 business days of the event.

"Internal" means that the event involved a participant enrolled by the investigator at Marywood University or at a site conducted by an investigator affiliated with Marywood University, whereas "external" means that the event involved a participant enrolled by an investigator at another institution participating in a multi-study or trial (i.e., clinical trials that have arms in other countries).

Safety reports are a type of adverse event report used in clinical trial studies. They are required by the Food & Drug Administration (FDA) to be sent to the IRB by the investigator for any serious and unexpected adverse event taking place during a clinical trial, regardless of the location of the event. Once an investigator receives a safety report, it should be submitted to the IRB within 10 business days.

Adverse event report forms may be found on our IRB Forms page.

Safety and adverse event reports are acknowledged by the IRB within 3-5 business days.