Statement of Dr. Edward McCabe, Chief Medical Officer, March Of Dimes On Publication Of The Final Rule On Human Subjects In Research

January 25, 2017

The March of Dimes released today the following statement from Chief Medical Officer Edward R.B. McCabe, MD, Ph.D, regarding the publication of the final rule making changes to the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” as published in the Federal Register on January 19:

“Today’s final rule takes important steps to ensure that federal protections for people participating in medical research keep pace with the rapid rate of change in science and technology. The final rule institutes a number of useful changes that will ensure that research involving higher levels of risk receives appropriate scrutiny, while low-risk research may proceed with fewer barriers.

“Just as importantly, however, the final rule does not incorporate certain controversial proposals that were part of the Notice of Proposed Rulemaking. In particular, the final rule does not require research involving de-identified biospecimens to comply with the stringent requirements imposed on studies involving people. The March of Dimes, along with many other organizations, expressed serious concern that restrictions on the use of biospecimens would significantly hamper vital research while failing to provide an appreciable increase in privacy for research participants.

“The March of Dimes commends the Office of Human Research Protection and all the agencies involved for taking seriously the extensive public comment they received, particularly around the more controversial portions of the proposed rule. We are gratified that the concerns expressed by our organization and others were clearly heard, and that changes were made accordingly. We look forward to working with OHRP, other federal agencies, and interested stakeholders to ensure that lifesaving medical research can move forward while the privacy and rights of those generously participating are protected.”