Human Subjects Protection

Human Subjects Protection is a seminar that covers topics such as:

  • 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

Human Subjects Protection is intended for:

  • 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

Future Events

Human Subjects Protection 2020


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

Other Events with Similar Categories

Other Events with Similar Location or Organizer