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 ClinicalTrials.gov:

• 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 ClinicalTrials.gov.
• 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 ClinicalTrials.gov database system. Penalties for noncompliance may include withholding of NIH grant funding and civil monetary penalties of up to $10,000 a day.