Compliance and Creativity

By Edward D. Miller, M.D.

By the time you read this column, Hopkins' herculean IRB re-review of more than 2,700 human subject investigation protocols—part of our action plan agreed to by the Office for Human Research Protections (OHRP) last summer—will have been completed.

That's the good news. The better news, from my perspective, is that this is not the end of a story. It's the beginning of a more important story of how Hopkins can muster its legendary creativity to meet the demands of a new era in the public's expectations. Put a different way, those who depend on us to develop better care, better doctors and new cures also depend on us to keep them safe while we're doing so. They, not we, are the end users of the "regulatory system." So our new and timely quest will be not just to comply with rules and forms governing research and patient care, but to help develop rules that are creative, meet the public's expectations, make sense and make us even better at what we already do well.

It might be useful to take a brief step back for some context. Five or 10 years ago, industries like banking, securities, airlines and pharmaceuticals had built government regulation into their cultures, because they had learned that without strict attention to standards, the public wouldn't trust them. But if academic medicine got out of compliance, the government expected only that a corrective action plan would be filed.

No more. Today, people expect medicine also to follow the rules, because standards are valuable. And so, everywhere we turn now, there are new regulations, many in confusing conflict with each other and with common sense. Too often in the past, our response to such a demand would have been that heavy regulation constricts innovation, that doctors and scientists with fertile minds don't go into medicine to be automatons or slaves to bureaucracies. Today, our quest must be to balance creativity with the need for compliance. We must learn to facilitate discovery by an extraordinary faculty while we comply with the regulatory demands pushing at us.

To strike such a balance, I believe that we must move beyond an adversarial process in which government regulators and academic medicine yell at each other across a no-man's land of red tape. We must reach a place where we comply because the rules make sense. And when they don't, there must be a process through which government regulators and medical researchers engage in meaningful exchange from which the public will benefit.

Let me give you an example of what I mean. For years, when the Joint Commission surveyed hospitals, they heard from surveyors that patients' pain control wasn't being adequately addressed. And so, these hospital regulators now require all patients to have a pain assessment. At first blush, that appears a good thing. Hopkins implemented that regulation, and so, when I took my annual physical recently, I was given a self-assessment pain threshold scale to fill out. My form will be filed and become part of the required JCAHO documentation regulations.

That rule is hugely well-intentioned. Pain assessment is vital. But this regulation does not assure improvement of patient care. Mandating that every person who has a routine physical take 30 seconds to fill out a form can't accomplish that. What is more likely to achieve the goal is working with JCAHO to define what we really need to find out from particular patients. That way, we can spend less time filing forms filled out by people who are healthy and more time identifying patients who need assessment and pain control.

Several industries that have developed a compliance culture have been innovative enough to use it to their advantage. Drug companies, for instance, that comply creatively and efficiently with FDA requirements to make their products safe and effective get their new drug approved and to market faster than their competitor. The FDA's regulations aren't perfect, but time has demonstrated the benefits of these rules to the public. Without credibility, without public trust, the mission fails utterly, and a company loses in the long run.

So where do we go from here? One thing we at Hopkins have learned is that to innovate we first must master our subject. We've found we need to do a better job of orienting researchers to the rules. This year, for the first time, we created a formal orientation for new faculty containing a segment on research review and protocols. We're also considering a course covering the half-dozen major areas in which regulatory compliance must be mastered. If we hope to continue to attract faculty who want to do research, the best thing Johns Hopkins can do is to make our culture parallel what the public expects: our best, our safest practices—all the time, every day.

In the end, Hopkins will get its gold stars for compliance. We'll make this part of our education mission and practice, because our best chance for meaningful regulatory reform rests inside the compliance circle, not outside yelling. Getting us inside that circle will mean keeping compliance high on our priority list—becoming a victim of noncompliance puts the biggest bite of all on creativity. The solution to the "problem" of compliance is to see compliance as a solution.