Friday, November 2, 2012

What Has OHRP Told Huron It Hasn't Told Me?

The Huron Consulting Group is advertising a free webinar on November 7 entitled "OHRP Regulatory Interpretations That You Need To Know, But Have Never Been Told." The press release explains:

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 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

I am troubled by the premise of this webinar: that OHRP has passed on important information to a private consulting firm without posting it for public use. For some topics, this may be puffery by Huron. For example, OHRP has issued public guidance on "What happens if a human subject becomes a prisoner during the course of a research study?" But I don't know of similar guidance on topics like "protocol exceptions for a single subject." If OHRP has in fact made such regulatory interpretations, why aren't they on its website?

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