NPRM Jumps White House Fence

Report on Research Compliance has spotted a notice on the Office of Information and Regulatory Affairs website suggesting that a proposed rule on "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" has reached OIRA and is awaiting EO 12866 Regulatory Review.

Don't ask me what this means in terms of a timetable, but it sounds as though the process is moving forward.

QI Focus Groups: Ditch Generalizability Criterion

Focus groups of professionals engaged in quality improvement (QI) or comparative effectiveness research (CER) report that the Common Rule's "generalizable knowledge" standard does not provide clear guidance.

[Whicher, Danielle, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis, and Peter Pronovost. “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight.” Journal of Empirical Research on Human Research Ethics, Published online before print, February 23, 2015, doi:10.1177/1556264615571558.]

IRB Asked, USB or FireWire. Silly, but Is It Bullying?

Caleb Carr, assistant professor of communication at Illinois State University, argues that abusive IRBs are best thought of as bullies.

Though IRBs are a legally required element of many higher education institutions and an important ethical part of all, their overextension of unchecked power is creating a hostile work environment for many social scientists, and calling them for what they are – systemic bullies – can empower administrators and faculties to finally respond to the increasing calls for IRB reform.

[Carr, Caleb T. “Spotlight on Ethics: Institutional Review Boards as Systemic Bullies.” Journal of Higher Education Policy and Management 37 (2015): 1–16. doi:10.1080/1360080X.2014.991530.]

University of Queensland Punishes Researchers, Won't Say Why

The University of Queensland demoted a professor and blocked him and another researcher from publishing findings, based on charges that they had not obtained necessary ethics clearances. But the university will not explain its conduct.

[Jorge Branco. “UQ Suppressed Bus Racism Study: Academics.” Brisbane Times, February 27, 2015. Thanks to Michelle Meyer for tweeting this to my attention.]