Post Approval

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

Modifications

Any changes to an IRB approved protocol require the submission of a modification 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 the ‘Reportable New Information (RNI)’ submission activity in eResearch is used for all reportable events (unanticipated problem involving risks to subjects or others, non-compliance, protocol deviation, researcher error, breach of confidentiality, complaint, suspension, unanticipated adverse device effect, etc.).

The RNI activity will allow the submitter to link the event to one or more research studies.

RNIs should be submitted within the time frame outlined in the HMH IRB’s policies.

Information about event reporting at HMH can be found in the Human Research Protection Program SOPs (section 14).

Information about event reporting from the Code of Federal Regulations can be found here.

To view a video presentation about reportable events at HMH, click here.

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 Research Integrity Office.