Effective Immediately – To ease the administrative burden on investigators, CPHS/OPHS has changed the submission requirements for applications for Expedited or Full Committee Continuing Review and Approval. Submission of copies of the current, approved protocol narrative will not be necessary under the following specific conditions:

1. At the time of renewal submission, NO CHANGES are being proposed to the protocol, including personnel or funding changes. The research that will be conducted in the coming year is exactly as described in the current, active approved protocol on file with CPHS/OPHS; and
2. The current, approved protocol – which includes any amendments that may have been approved and incorporated in the narrative during the past year – must be written in the CPHS narrative format of September 2005 or the most recent version revised in March 2007.

Also, for studies that are moving into a “data analysis-only” phase, investigators will no longer need to submit consent forms, recruitment materials, or a protocol narrative at the time of continuing review, as long as the only change to the approved protocol is that there is no longer any data collection or subject intervention occurring. If the protocol format has not been updated since September 2005, but the study is moving into a data analysis-only phase now, an updated protocol version will not be required. However, if an investigator wishes to collect additional data and/or recruit new subjects, the protocol narrative in the current version as required at that time must be submitted before the protocol amendment will be reviewed and approved.