Other Reviews

Principal investigators are responsible for submitting continuing reviews of their study as determined by the IRB, but not less than once per year. At that time, you will be asked to divulge the number of subjects enrolled in the past year, any adverse events (including death, disability, or study-related problems that resulted in unscheduled hospitalization or withdrawal of subjects from the protocol).

Principal investigators are also responsible for notifying the IRB and providing a final report when the study is closed.

Requests for study reapproval must be completed and submitted for IRB review prior to the expiration date of IRB approval. If the investigator fails to provide continuing review information and the IRB has not provided reapproval by the expiration date, the research must stop, unless the IRB finds that it is in the best interest of individual subjects to continue participating in the research interventions or interactions. However, enrollment of new subjects cannot take place after the expiration date.

The following information must be included:

  1. A completed Continuing Review of Research Involving Human Subjects form
  2. Copy of most recent consent document
  3. Updated Conflict of Interest Form from the investigator(s)

The following information must be included for a termination/closure request:

  1. A completed Continuing Review / Termination of Research Involving Human Subjects Form
  2. A protocol progress report/summary, if applicable