Pennsylvania Supreme Court Ruling Requires Physicians to Personally Obtain Informed Consent

9/12/2017

What does that mean for the informed consent process for clinical trials?

Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard.

Update to "Is it SRS, cIRB or sIRB? A guide to understanding the June 2016 NIH Single IRB Policy" – NOW Effective January 25, 2018

7/13/2017

**UPDATED EFFECTIVE DATE** The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.