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 –Something happens  New rule (more opportunities to fail) + more inspections (more opportunities to identify failures)  Demand for more rules

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

“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

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.

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.

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.

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.

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?