Some projects last a few months, and some can go on for years. Over the life of a project, many things can change. Personnel may need to be added or removed, and the protocol may need to be changed or amended. Also, if your project lasts for more than one year, you will be required to submit a progress report.
If you are the principle investigator of the project, stay involved! You may have assembled a great team to help you, but ultimately the project is yours. Check in and see how it’s progressing!
Changes to a study.
The IRB must review all changes to a study. These include changes to the informed consent document, revised study procedures, changes in risk, and study ads. Changes may be submitted to the IRB by submitting a “Modification/Amendment Form” via the Hartford HealthCare (HHC) Integrated Research Information System (iRIS). The principal investigator will receive an IRB approval letter via the iRIS system once the study change is IRB approved.
Study Personnel Changes.
The IRB must be notified of any changes in personnel on a study. This includes any new personnel needing to be added to a study as well as any current personnel that need to be removed from a study. Changes to study personnel may be submitted to the IRB by submitting a “Study Personnel Change Request” via iRIS.
Adverse Events/Unanticipated Problems.
An “Unanticipated Problem/Event Report” must be submitted within 7 days of any serious or unanticipated event involving risk to subjects or others if the event occurred at Hartford HealthCare or another institution overseen by the Hartford HealthCare IRB. The Unanticipated Problem/Event Report form is submitted using the HHC iRIS system. Anticipated events (i.e., described in the protocol and ICD), and those of mild or moderate severity may be reported as they occur or at the time of review for continuation on an EVENT ACCUMULATIVE TRACKING LOG.
Project Renewal.
IRB review is an on-going process. The principal investigator must submit a “Continuing Review (Progress Report) - Human Studies” report, within the timeframe specified in the IRB approval letter. This is usually annually, but some studies may require more frequent reporting.
If you have any questions about these requirements or the review process, please contact us 860.972.2893 or IRB@hhchealth.org.