Post Approval

Your research may begin. Over the course of the study, you will need to submit continuing reviews, amendments, report AEs/SAEs, and submit to monitoring and audits. There are also ongoing educational offerings.

Amendments

Any changes to an IRB approved protocol require the submission of an amendment for IRB review and approval PRIOR to initiating those changes.

Continuing Reviews

Reports the progress of approved research to the IRB. The IRB determines the approval period (based on risk to subjects).

Reportable Events

Regulations require an organization to have written procedures for ensuring prompt reporting of changes in research activity; unanticipated problems involving risk to subjects or others; and any instances of serious or continuing non-compliance to the IRB, organizational officials, and applicable federal agencies.

Please note that when submitting a reportable event to the IRB via eResearch, it is crucial that study teams follow through on their submissions to ensure that they have been accurately submitted to the IRB.

Principal investigators must submit the reportable event form themselves. A research coordinator or other study team member may prepare the form, but like the initial application, only the principal investigator can submit it. Once a study team member completes the reportable event form, it is routed to the principal investigator (who receives an eResearch email notification) who needs to submit the application to change the state from ‘PI Review’ to ‘IRB Review’.

If the principal investigator determines that the event does not need to be submitted, s/he should retract the reportable event submission via the ‘Withdraw’ button under ‘My Activities.’

If a study team member other than the principal investigator begins the submission process, s/he should follow up with the principal investigator to ensure that the event was reviewed and submitted or retracted.

The reporting of these events is time sensitive, so incomplete reportable event forms should not be pending in the system. They should either be submitted within the time frame outlined in the HMH IRB’s policies or retracted by the principal investigator.

Please reach out to the Research Integrity Office with any questions by emailing hmhirb@hmhn.org.

Subject to Monitoring and Audits:

Audits could be internal (Corporate Compliance) or external (FDA, OHRP, NIH, Sponsor, etc.)

For more information, please contact Daniel Alderson, MS.