During the life of a study, problems and changes can occur. For this reason, IRBs are required to conduct reviews of the research at frequencies appropriate to the level of risk presented by the study.
Although review of the research actually continues through out the life of a study, by way of investigator and/or sponsor provided reports of unanticipated problems, serious adverse events, and new information, all studies, and the investigators responsible for their conduct, must undergo a continuing review of risks, potential benefits, informed consent, and safeguards for human subjects, typically by full committee review, within a set timeframe established during the initial review.
The initial continuing review term will be clearly stated on each of the Sponsor and Investigator approval documents. The continuing review term may be changed at any time to ensure it is appropriate to the level of risk presented by the study, but the approval period can never exceed one year.
As part of the information gathered for continuing review, E&I will require the investigator to provide information related to how the study is progressing at their site, as well as how it is progressing overall. If the study is being conducted at other sites where E&I is not serving as the IRB, E&I may request information from the sponsor related to the progress of the study at those locations.
Obtaining continuing review, in the timeframe required is the obligation of the investigator. If continuing review is not obtained prior to the designated expiration date, the investigator must stop all study related activity, except where to prevent immediate harm to a subject, until the review is obtained.
As a courtesy to the investigator, E&I will schedule a continuing review of your study and approximately 45 days prior to the scheduled review, E&I will send an E&I Continuing Review Report Form (Form 42?) requesting the required reporting information. This form must be completed and returned by the date printed on the document.
Failure to return the required reporting forms prior to the scheduled Continuing Review will result in the expiration of the Investigator's approval.