The following is a list of helpful resources and websites that study teams can access for support in recruiting patients at Zuckerberg San Francisco General Hospital (ZSFG), the San Francisco Health Network (SFHN), the San Francisco Department of Public Health (SFDPH), and UCSF.
UCSF ZSFG Research Protocol Application
All research activity involving the recruitment of patients based at the San Francisco Department of Public Health (SFDPH), Zuckerberg San Francisco General Hospital (ZSFG), or San Francisco Health Network (SFHN) clinics requires additional approval through completion of the UCSF Research at SFDPH Research Protocol Application. Any interaction with SFDPH (ZSFG) patients, their data, or use of SFDPH (ZSFG) personnel, resources, funding, facilities, and space, including your own office, requires SFDPH research approval. To download the application or obtain more information about this process, please visit the SFDPH Research Protocol Application webpage.
Disclaimer: The content provided here is a summary based on information from the SFDPH Research Protocol Application webpage and is intended for informational purposes only. Please note that this information is subject to change. SFDPH is a separate entity; for specific inquiries, please refer directly to them. For the most up-to-date information, contact the UCSF ZSFG Dean’s Office at [email protected] or visit the ZSFG Research Protocol Applications webpage.
Overview of UCSF Research Protocol Approval Process at ZSFG
Step | Description |
---|---|
I. PI/Study Team Steps | |
1. Complete the UCSF Research Protocol Application Form | Complete the UCSF Research Protocol Application Form: This form requires detailed information about the study, including IRB information, subject categories, study protocol description highlighting SFDPH resources requested, and resource utilization (patient volume or dataset sample size; human resources; CTSI/CCRC). |
2. Obtain Pre-Submission Approval Signatures | Pre-Submission Approval Signatures (Pages 5-8): After IRB approval, the PI is required to gather pre-submission approval signatures for space utilization, dataset representatives, and equity review. - Space and Clinical Research or Patient Recruitment: 1-2 signatures (may vary if multiple spaces are used) - Dataset Representatives: 1-2 signatures (may vary if multiple datasets are used) - Equity Review: 0-1 signature (not applicable for data-only research) |
3. Complete DPH/ZSFG Resource Checklist | Complete the DPH / ZSFG Resource Checklist (Page 9): Identify and list all SFDPH/ZSFG resources your study will use, such as medical records and IT needs. |
4. Submit Application | Email the Application: Submit the Research Protocol Application to the UCSF SOM Vice Dean's Office at ZSFG, including the IRB Outcome Letter Notification, full UCSF IRB Application, and signed Research Statement of Work (signed by PI). |
II. Dean's Office Steps | |
1. Application Review | Dean's Office Review: The Dean's Office will review the application and obtain necessary approvals based on your study's specifics. Incomplete applications will be returned for revision. |
2. DocuSign Routing | This checklist will be routed via DocuSign. - Medical Records / Patient Data: 1 signature (PI initials) - IT Build Needs, Data Access, and/or Data Sharing: 1 signature - Privacy: 1 signature (automatically required if Medical Records are needed) - Laboratory Medicine Services: 1 signature (if applicable) - Radiology Services: 1 signature (if applicable) - Pharmacy Services: 1 signature (if applicable) |
3. Executive Approval Signatures | Executive Approval Signatures: Might include 2-6 signatures based on the administrative structure of the study's reach within SFDPH. |
4. UCSF | SFDPH Research Data Sharing Statement of Work Approval | UCSF | SFDPH Research Data Sharing Statement of Work (Appendix A) Approval: 1 signature from the PI |
5. Final Approval and Notification | Final Approval and Notification: Once approved, the Dean's office will email a PDF of the signed application to the Principal Investigator (PI) and any additional contacts. |
Note: Not considering multiple datasets or space utilizations, a minimum of 7 signatures is required to complete this form (if all sections are applicable and only one signature is needed per section). This number could be significantly higher if the study involves multiple spaces, datasets, or requires additional executive or departmental approvals.
Updated 6/21/24
ZSFG Flyer Policy
Recruitment Resources