Once you have received IRB approval, you are free to begin research activities, including data collection. Full review studies expire one year after initial or renewed approval; if you wish to continue collecting data beyond this point, you need to complete and submit a Renewal Report before the expiration date of your study. (Exempt and expedited review studies do not expire or need to be renewed.) You will receive an email reminder from IRBNet when the study expiration is approaching. Once a study has expired, all research activities must stop immediately and cannot resume until a new application has been completed and approved.
If you would like to many any changes to the research protocol that has been approved by the IRB, you need to submit a modification/amendment to the original project. Changes may include but are not limited to the addition of research personnel, changes in participants, changes in the data collection procedures (e.g., changes to questionnaires or interviews), changes to consent forms or recruitment scripts, and changes to the research questions. Please make the appropriate changes to your application form and/or other research materials and submit these as an “amendment/modification” to the original project. It is helpful to the committee if the researcher provides a cover letter or document detailing the changes in addition to highlighting them in the documents themselves.
If any unexpected adverse events occur during the course of your study, the Adverse Event form should be completed and submitted to the IRB as soon as possible. An adverse event is defined as “any untoward or unfavorable [physical or psychological] medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research” (Unanticipated Problems Involving Risks & Adverse Events Guidance, 2007). Please see this OHRP webpage to learn more about what might qualify as an unanticipated adverse event.
Once you have completed a study, you should submit a Final Report to the IRB.
To make any additional submissions to a project (including renewals, modifications or amendments, adverse event reporting, and final reports), do not create a new project in IRBNet. Rather, log into IRBNet.org, and click on the appropriate project. Then select “Designer” (on the left), “then “Attach New Document,” then “Create New Package,” then “Attach New Document” (again). Choose your document type, upload this form, and “Sign this Package” (on the left). Finally, select “Submit this Package” (on the left), select the IRB, select the correct submission type, and click submit.