Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.

[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

Was OHRP Ever an Independent Watchdog?

Public Citizen is upset that NIH will get to write much of the NPRM. I don't understand why that matters.

Elliott Decries IRB Opacity

Writing for the Chronicle of Higher Education's Brainstorm Blog, Carl Elliott argues that the "by any reasonable estimate [the IRB] oversight system has been a failure . . . yet so many people are professionally invested in the current oversight system that they cannot imagine replacing it, only tinkering with it." He particularly condemns the secrecy of the system.

[Carl Elliott, “When Medical Muckraking Fails” Chronicle of Higher Education, Brainstorm, August 2, 2012.]

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.”