Human Subject Protection: DHHS and the FDA

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Course Description

Human subject protection (HSP) regulations haven’t kept pace with the evolution of clinical research. As a result, the regulatory requirements are unclear, inconsistent, and outdated. In response, the DHHS, the United States’ agency that houses both OHRP and the FDA, released its announcement for proposed rule changes to the regulations that govern the conduct of human subject research in an effort to streamline, modernize, and increase their effectiveness.

The FDA has also issued new regulations, guidance, and procedures to improve the conduct of clinical trials, assess the accuracy and reliability of clinical trial data, and secure the protection of human research participants. Guidance documents and legislation will be reviewed to highlight how the FDA’s response to the recommendations will impact the conduct of clinical trials.

Learning Objectives

  • Describe causal factors and their relationship to the current clinical research environment
  • Identify the relevant regulatory requirements and industry working groups
  • Review the proposed model for more efficient IRB review
  • Assess how amendments to the consent document and process can enhance HSP
  • Examine how changes in risks have necessitated alterations to protected information
  • Explore the impact of risk-based monitoring on HSP

Who Should Attend

  • Professionals from Academia
  • Clinical Quality Assurance Auditors
  • Clinical Research Associates
  • Project Managers
  • Regulatory Affairs and Compliance Professionals
  • Investigators, Sponsor-Investigators, Clinical Research Coordinators
  • IRB Professionals and Institutional Officials involved in oversight of clinical research


Elizabeth Ronk Nelson, M.P.H.

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Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-13-021-L01-P. Released: 3/13.

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 





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