Regulatory & Ethics Consultation

Get help with:

  • Regulatory requirements (including FDA and IRB)
  • Interactions with regulatory authorities
  • Regulatory strategies across the spectrum of preclinical to late phase clinical research
  • 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)

We also help with reporting results on

  • Editing, updating and reporting results for applicable UCSF clinical trials
  • Summarizing trial results in the standardized format
  • Training for results reporting

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
  • FDAAA 801 requires all applicable clinical trials to (a) be registered within 21 days of enrolling the first participant and (b) report results within 12 months of last participant visit into the database system. Penalties for noncompliance may include withholding of NIH grant funding and civil monetary penalties of up to $10,000 a day.

Request Consultation

This service is free for the entire consultation period.

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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.