Research Compliance Overview

Links to topics and information involving research compliance.

• 21 CFR Part 11 Compliance- Read the statement on UCSD Epic Electronic Health Record system compliance with Food and Drug Administration Code of Federal Regulations Title 21 Part 11.
• Audit and Management Advisory Services- Internal and external audits, management advisory services, information technology security, and investigations.
• Controlled Substance Program- Learn about UC San Diego's Controlled Substances Program.
• Controlled Unclassified Information (CUI)- Guidelines for information that the government requires safeguarding or dissemination controls.
• Equipment Management- Learn about the responsibilities of equipment management.
• Health Data Oversight Committee (HDOC)- Learn about the approval requirements for the sharing of health data.
• Human Embryonic Stem Cells- Find out what you need to do to start a research project involving human Embryonic Stem Cells (hESCs).
• Human Fetal Tissue- Learn about NIH applications containing Human Fetal Tissue and Human Fetal Tissue from Elective Abortions.
• Lab Safety- Review the online Laboratory Safety Manual for policies, procedures and resources for campus research and teaching laboratories.
• Native American Graves Protection and Repatriation Act- Learn more about UC San Diego and the Native American Graves Protection and Repatriation Act.
• NDAA Prohibited Manufacturers- Learn about the National Defense Authorization Act (NDAA) that prohibits the use of equipment manufactured by a limited set of Chinese manufacturers. 
• NIH Certificates of Confidentiality- Learn about NIH Certificates of Confidentiality, their application and your responsibilities.
• OMB Uniform Guidance- Guidelines for federal grants management that became effective December 26, 2014 for all new awards and funding increments.  
• Privacy:
  • Patient Privacy- Learn about Health Insurance Portability and Accountability Act (HIPAA) national standards for the privacy and security of health information.
  • NSF Reporting of Breaches of Personally Identifiable Information- Learn about grantees' obligations to notify NSF upon learning that a breach of PII within the scope of an NSF award has occurred under Article 35 Breach of Personally Identifiable Information.
• Records Retention- Learn about the records retention schedule that defines the period of time that records should be retained and when they should be destroyed.
• Research Compliance and Integrity- Quality research requires adherence to the highest standards of integrity in proposing, performing, reviewing and reporting research. The Office of Research Compliance and Integrity has oversight and responsibility over the following areas:
  • ClinicalTrials.gov: Learn more about UC San Diego's requirements for ClinicalTrials.gov registration and reporting.  
  • Conflict of Interest: Find guidance relating to conflict of interest in research.
  • Dual Use Research of Concern (DURC): Learn about safety measures surrounding life sciences research that could be directly misapplied to pose a significant threat.
  • Export Control: Learn about export control.
  • Good Clinical Practices (GCP): Learn about GCP training policy for NIH-funded clinical trials.
  • Institutional Animal Care and Use Committee (IACUC): Find out more about the University's animal care and use program. 
  • Research Integrity: Learn more about integrity of research.
  • Responsible Conduct of Research (RCR): Learn about RCR training policy for certain NIH, NSF, and NIFA funded studies.
• Research Data Access, Use and Management: University and researcher obligations concerning access to, use of, and maintenance of research data and materials.
• Research Ethics Program- Find out about research ethics and requirements for ethics training.
• Research Policies- Links to UC San Diego and UCOP policies related to research.
• Risk Management- Find liability, loss control, and legal resources for managing risk.
• Senate Bill (SB) 13: Safeguarding Human Subjects' Personal Data- If you conduct research with human subjects, read about Senate Bill 13, legislation that safeguards personal data used in research.
• Hazardous Shipping- Learn about the shipping of biological materials and dry ice as well as online training and certification.
• Training- Links to required and recommended training for researchers and research support staff.