Bioethics & Regulatory Consultation

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. Examples of topics include: 

• 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 any 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. 

The ClinicalTrials.gov Regulatory Support Team provides assistance to researchers with ClinicalTrials.gov compliance requirements, Including:

• Registration
• Resolving review comments
• Record maintenance
• Results reporting

We also help troubleshoot common results reporting issues on ClinicalTrials.gov:

• Review before submission to PRS
• Help address PRS review comments

Did you know?

• Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to submit study results of clinical trials to ClinicalTrials.gov.
• UCSF Clinical Trial Registration & Reporting policy requires all clinical trials to (a) be registered before enrolling the first participant and (b) report results within 12 months of last participant visit in the ClinicalTrials.gov database system, for Applicable Clinical Trials (ACTs). Penalties for noncompliance may include withholding of NIH grant funding for the entire institution and civil monetary penalties of up to $10,000 a day.

Request Consultation

This service is free for the entire consultation period.

Related Resources

• IRB / Human Research Protection Program
• Clinical Research Resource HUB
• Conflict of Interest/Commitment
• Regulatory Support (FDA) Consultation