Medical IRB #1
Full review and Periodic/Renewal report
Meeting calendar and submission deadlines
Items required to meet a submission deadline are:
- New Full IRB applications
- Periodic reports/renewals (Periodic reports must be received by the scheduled meeting deadline in advance of protocol expiration date).
Please Note: New Expedited, Exempt, Letters of Determination and Case Report/Study applications are reviewed when received and do not adhere to the deadline calendar.
Federal regulations require that all research involving human subjects be reviewed at least annually. If IRB approval expires, i.e., if the project is not re-approved prior to the expiration date, all research activities must stop. No further research can be conducted until the IRB has re-approved the project and validated the consent form, if applicable. Research activities include but are not limited to recruitment and enrollment of subjects, collection of specimens, research on previously collected specimens, review of medical records or other health information, and the performance of research tests/procedures, treatment or follow-up on previously enrolled subjects.
If your study is going to expire or has expired, and treatment or follow-up of subjects is necessary for subject safety and welfare, the IRB must be informed immediately in writing. The IRB will consider these requests on a case-by-case basis. Federal regulations require that the IRB consider only what is in the best interest of the subjects when determining whether continuation of previously enrolled subjects is appropriate while continuing review is in process.
Human Research Protection sends Reminder Notices by email 60 and 30 days prior to the expiration date. The email reminder notice will also include the Periodic/Continuing Report form as an attachment.
If you are continuing the study for another period or year, or filing a final report, please submit your Periodic Review/Continuing Report Form in accordance with the posted schedule below. Completed Periodic/Continuing Reports must be sent in electronic format to email@example.com with a CC to firstname.lastname@example.org.
You must follow the schedule below for your project to be approved in a timely manner without lapse. It is the investigator’s responsibility to make sure that the projects are approved for the following year.
When IRB requires conditions to be met, please respond to the committee conditions without delay so that the project can be reviewed and approved on time. Please note that responses to pending conditions may require review and approval at a convened meeting of the IRB. Thus, your prompt reply is indicated for your project to proceed for an additional approval period. Should you have any questions please contact Human Research Protection at 215-255-7857 for guidance. The following calendar is included so that you can prepare the Periodic/Final Report forms on time.
Medical IRB #1 Deadline and Meeting Calendar 2014
Medical IRB #1 Deadline and Meeting Calendar 2013