WIRB-Copernicus Group Compliance Experts Help to Rationalize Conflicting Federal Regulations Intended to Protect Clinical Trial Participants

PRINCETON, N.J., Nov. 25, 2014 – WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that David Forster, JD, MA, CIP, its chief compliance officer, and David Borasky, MPH, CIP, vice president of quality management at Copernicus Group IRB, have had a commentary published in the Hastings Center Report, which discusses the challenges that compliance professionals face when trying to reconcile varying human subject research regulations.

Forster’s and Borasky’s article, which is entitled: “The Irregular Terrain of Human Subjects Research Regulations,” focuses specifically on the different procedural requirements of the Office of Research Integrity (ORI) and Office for Human Research Protections (OHRP). Co-authored by Daniel Nelson, MS, CIP, formerly director of the Office of Human Research Ethics at the University of North Carolina Chapel Hill and now with the U.S. Environmental Protection Agency, and Jeffrey R. Botkin, MD, MPH, associate vice president for research integrity at the University of Utah, this commentary also highlights the confusion and potential for missteps that these variations in regulations can inadvertently create at institutions managing and overseeing clinical research trials.

As co-chair of the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) two main subcommittees, the Subpart A Subcommittee (Borasky) and the Subcommittee on Harmonization (Forster), Borasky and Forster are working diligently to fulfill the committee’s mission to enhance human subject protections while reducing unnecessary regulatory burden.

“The administrative structures for research and regulatory compliance oversight vary immensely among institutions,” said Forster. “We hope that this commentary and associated report inspire institutions and clinical research sites to establish appropriate policies, duties, and communication pathways to manage these regulations effectively.”

In the commentary, the authors dive into the core differences between these two sets of regulations, and discuss the importance of identifying the roles and obligations of individuals and organizations involved in oversight.

The Hastings Center Report, which is published six times a year, explores ethical, legal, and social issues in medicine, health care, public health, and the life sciences. The report contains an assortment of essays, columns on legal and policy development, and case studies on clinical care and institutional administration issues.


About The WIRB-­‐Copernicus Group
The WIRB-Copernicus Group (WCG) is the world’s largest and most trusted provider of regulatory and ethical review services for human research. The pioneer of independent ethical review, WCG continues to drive ingenuity in the clinical research space. Today, WCG’s solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials.

WCG is proud to serve the individuals on the frontlines of science and medicine, and the organizations that strive to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring that the risks of progress never outweigh the value of human life.

For more information, please visit www.wcgclinical.com.

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