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 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.