Harvard Law Today Reports on ANPRM Conference

Harvard Law Today, published by Harvard Law School, reports on May's conference on the ANPRM, held at the school's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

["The Future of Human Subjects Research Regulation," Harvard Law Today, July 2012.]

The article highlights the plenary address by Greg Koski, former director of OHRP.

Koski said regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.

He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”