Regulatory & Ethics Consultation

Regulatory & Ethics Consultation provides help with:

  • Regulatory requirements (including FDA and IRB)
  • Interactions with regulatory authorities
  • Regulatory strategies across the spectrum of preclinical to late phase clinical research
  • Research Data Sharing
  • Ethical issues in research, such as:
    • Informed consent
    • Confidentiality
    • Clinical trial issues (including randomization, use of placebo)
    • Special populations (including children, prisoners, impaired decision-making)
    • Working in resource-poor countries
    • Genetic testing, gene transfer, stem cells
    • Payment of participants
    • Sensitive conditions (including HIV infection, injection drug use, major psychiatric illness)


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

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

We also help troubleshoot common results reporting issues on

  • 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
  • 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 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



Please send comments or questions to CTSI Consultation Services:
Email: [email protected]

If you have not been contacted by a member of the consulting team within three business days of submitting your request, please get in touch with us.

About Your Request

Cite CTSI CTSI heavily subsidizes consultations. Any publications that benefit from a consultation should cite the CTSI grant.

By submitting a request, you agree to provide feedback and a short evaluation of our services, providing the titles of manuscripts or grants resulting from your consultation(s) upon request.