The Bioethics and Regulatory Engagement (BRE) program provides free, collaborative consultations to help UCSF researchers navigate complex ethical and regulatory challenges throughout the research lifecycle.
BRE is also working with UCSF stakeholders, patients and community leaders to ensure that patients have a say in how their health data is used for research. See our report below, including perspectives and quotes from UCSF patients.
Bioethics & Regulatory Consultations
- Designing and running an effective informed consent process, even in complex or unconventional study designs
- Navigating ethics and regulations in AI-enabled research, including use of algorithms and automated decision-making
- Understanding when and how research data can be shared, and what rules apply
- Recruiting participants responsibly, including appropriate use of incentives, without pressure or coercion
- Using large datasets and existing data responsibly, including secondary data analysis
- Handling situations where full disclosure is difficult, such as deception or partial disclosure studies
- Understanding FDA requirements for clinical research, including drug and device studies
- Working with community partners, including roles, expectations, and power dynamics
- Navigating authorship and credit fairly within research teams
- Talking through nuanced or unique ethical or regulatory challenges, even when there’s no clear rule or answer
CTSI’s Bioethics and Regulatory Consultations are purely advisory and do not substitute for mandated oversight by regulatory bodies (e.g., IRB, COI, GESCR, OEC). Our role is to complement these bodies by providing nonbinding guidance. BRE will refer you to the appropriate group for further consideration. Recommendations carry no regulatory authority and should not be represented as an endorsement of any project.
(Please note: CTSI BRE does not make consultations related to human resource issues, conflicts of interest, research misconduct, or intellectual property.)
Data Sharing Resources
What do patients think about how UCSF uses their health data?
