Reasonable Research Oversight: A Work in Progress.

Abstract

On January 19, 2017, the Office for Human Research Protections, released an updated "Common Rule" that was the product of a six-year administrative odyssey to modernize and improve the regulations that had been in place for more than thirty years.  Although the impulse to update the regulatory landscape for human research is laudable, some of the changes proposed appear reactive and focused on making misconduct more difficult, rather than facilitating important science with reasonable safeguards. Instead of making research more difficult for all scientists across the board, a more sensible approach would involve better education of the public about the ways their specimens and data may be used to advance important scientific discoveries coupled with a legitimate method for holding bad actors accountable for deliberate violations of the rules. Regardless of what happens with the Common Rule, we need a reframing of research as a social good that requires reasonable oversight, not reactive rule making.