April 15, 2007

Human Subjects Updates

New Forms
The Committee for Protection of Human Subjects posted revised forms on March 5, 2007, and is now requiring use of these new forms. Forms are available on the CPHS web site at http://cphs.berkeley.edu/content/forms.htm. Please delete all old versions that you may have downloaded to your local PC.

SPO Proposal Number
The Office for the Protection of Human Subjects must have the SPO Proposal Number on the CPHS Cover Sheet for all funding supporting human subjects research when the funding requests have been submitted through the Sponsored Projects Office. Please make sure you list the SPO Proposal Number in the appropriate box under Part III of the Application Cover Sheet if the funding is pending or even if an award has been made.

The SPO Proposal Number is an eight-digit number beginning with the fiscal year (e.g., 20071234) and is available for Coeus web users immediately after proposals are logged in by SPO. The number is included in the proposal notice that is sent by email to investigators and administrative staff after the proposal has been submitted.

For access to Coeus web site reports, please check with your departmental administrator. For more information about Coeus department accounts, please contact Neil Maxwell or Nancy Han in RAC Information Systems.

Revised Requirements for Continuing Review Submissions
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. Effective immediately, 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.

Submit Protocols Early
CPHS/OPHS is in the midst of the busiest time of the year as investigators want to get protocols reviewed and approved in time for summer research activities. OPHS strongly advises investigators to submit their projects as soon as possible as all but the full committee protocols are reviewed on a rolling, first-come, first-served basis. Between March and June we are essentially unable to handle “rush” requests due to the huge volume of protocols, so get your protocols in as soon as possible!