A new study. The Hartford Hospital Research Application Form is used for all new study submissions. This is a combined application that includes the study’s grants and contract details and research subject involvement. The Human Studies Form, Waiver of Informed Consent Form, and instruction for completing both are included as part of the Research Application. Study materials, including the research protocol, informed consent document, investigator’s brochure and patient materials are included with the application for IRB review. Once the submission is received in Research Administration, the HRPP staff will process the study’s IRB review. The principal investigator will receive an IRB approval letter and IRB-stamped Informed Consent Document after the study is IRB approved.
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 via e-mail, IRB@harthosp.org, or via inter-office mail. The principal investigator will receive an IRB approval letter once the study change is IRB approved.
Adverse Events/Unanticipated Problems. An Adverse 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 Hospital or another institution overseen by the Hartford Hospital IRB. 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.
Project Renewal. IRB review is an on-going process. The principal investigator must submit a Hartford Hospital Research Project progress report, within the timeframe specified in the IRB approval letter. This is usually annually, but some studies may require more frequent reporting.
Final Report. A Hartford Hospital Research Termination Form and final report must be submitted to close out a research study. This is done when the human subject component is complete. The report may be e-mailed to IRB@harthosp.org or mailed via inter-office mail. Please note: The IRB will not review new research applications if the investigator has not completed the required termination form for another study.
If you have any questions about these requirements or the review process, please contact us (860) 545-2893 or IRB@harthosp.org.