Insights

OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told

By: Madeleine A. Williams, Frank Conte

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During this webinar, the presenters will share the knowledge Huron has gained through communications with the Office for Human Research Protections (OHRP) about topics such as:

  • How to handle "protocol exceptions for a single subject"
  • When an unanticipated problem involving risks to subjects or others does not have to be reported to OHRP
  • Whether the IRB has to require the submission of the names of all study staff on a research study
  • When Subpart C does not apply to a subject who becomes incarcerated

Webinar: OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told

Slides: OHRP Regulatory Interpretations That You Need To Know But Have Never Been Told

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