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Reactive  Proactive

Reactive  Proactive. Assuring Human Subject Protection and Regulatory Compliance in a High-Visibility Environment. Timothy J. O’Leary. VA Research – the “5H Club”. Highly important Highly regulated Highly visible Highly vulnerable Highly reactive

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Reactive  Proactive

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  1. Reactive  Proactive Assuring Human Subject Protection and Regulatory Compliance in a High-Visibility Environment Timothy J. O’Leary

  2. VA Research – the “5H Club” • Highly important • Highly regulated • Highly visible • Highly vulnerable • Highly reactive • Something happens  New rule (more opportunities to fail) + more inspections (more opportunities to identify failures) Demand for more rules

  3. Areas of Vulnerability • Human Subject Protection • Animal Welfare • Primates • Companion Animals • Safety and Biosafety (including Select Agents and Toxins) • Environmental Protection

  4. “Hidden Vulnerabilities” • Are investigators actually doing the work they say they are doing? • Are investigators spending less time on research than they committed to on their funding applications? • Are funds being spent prudently (and legally)? • Is there appropriate stewardship of funds and materiel. • Government culture and academic culture are less than perfectly compatible

  5. Breaking the Vicious Cycle • Facility directors • Don’t really have the flexibility to limit risk by setting research agenda • Are not researchers, and must depend on others for knowledge of resource requirements • Are resource challenged • Are the “Captain of the Ship” • Research offices • May not feel adequately staffed to support “bureaucratic needs.” • Not staffed to provide compliance training • Investigators • Overwhelmed by the number of rules • Cannot seem to find time to manage both the bureaucracy and clinical commitments • Often bite off more than they can chew.

  6. Suggestions to Investigators • Carefully assess your own research. • Do you really have the time necessary to do the research you have planned? • Can you get where you want to go without using human subjects, animals, select agents, hazardous chemicals. • Is a lack of resources to do the right things going to risk your scientific career. • If the answers are something other than “yes, yes, no,” then either change your research direction or find another job.

  7. Suggestions to Research Offices • Remember that you are staff, and serve the facility director. • You MUST be crystal clear about the required resources, basing your recommendations upon hard benchmarks and comparables. • You SHOULD advise investigators about regulatory hurdles, when possible, BEFORE they write the applications! • Remember that you are not the University, you are the government. The US government cannot and should not defer to the University.

  8. Suggestions to Directors • Be certain that you understand your responsibilities for human subjects protection and animal welfare. Read the rules yourself. • Be sure that your facility is adequately resourced to deal with the areas of vulnerability. • Don’t let your fiscal officer put you at risk by telling you that Research VERA cannot support regulatory compliance activities. Research VERA is a part of the budget request to Congress. Congress expects the budget to be used this way.

  9. Challenge to the Program • How do we make compliance with regulation and policy easier than non-compliance? • How do we build a culture in which human subject protection and animal welfare are second nature, rather than obstacles to overcome?

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