Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2017

Key Topics

• Office for Human Research Protections Guidance
• Department of Health and Human Services regulations, 45 CFR 46
• HIPAA and HI-Tech
• The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814
• Coercion vs. undue influence
• ICH E6 Good Clinical Practices
• Vulnerable populations
• Recruitment of Research Subjects
• Inclusion of Women and Minorities
• Non-English speaking populations
• Waivers of consent vs. waivers of authorization
• Waivers of consent
• Wards of the State
• Assent vs. consent
• Levels of de-identification what they are and how they affect consent
• Certificates of confidentiality
• Study responsibilities: ICH vs. NIH
• Privacy vs. confidentiality
• Codes of Conduct
• Drug/Device Accountability
• Reporting responsibilities
• Conflicts of Interest
• Investigator-sponsor responsibilities
• Monitoring
• Special concern studies
• Study types
• Common compliance issues
• Standard operating procedures vs. protocol vs. IRB submission
• Adverse event monitoring and reporting including Serious adverse events and unanticipated problems
• Data safety monitoring
• Assurances and Agreements (e.g. MOU)
• Investigational Drug and Device use in clinical trials
• International Ethical Guidelines
• Site Responsibilities
• Applying ICH to international sites

Who should Attend

• Clinical Research Scientists (PKs, Biostatisticians,)
• Principal Investigators / Sub-investigators
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Safety Nurses
• QA / QC auditors and staff
• Recruiting staff
• Human Research Protection professionals
• Clinical Research Data managers