Human Subjects Protection 2014

Key Topics

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

Who should Attend

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