WIRB-Copernicus Group Chief Medical Officer Guest Editor of Clinical Research Journal

Dr. Lindsay McNair guest edited the ethics issue of “Clinical Researcher”, published by the Association for Clinical Research Professionals (ACRP)

PRINCETON, N.J., Mar. 31, 2016 – WIRB-Copernicus Group® (WCG™), one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, announced that its Chief Medical Officer (CMO), Lindsay McNair, MD, MPH, MSBioethics, was the guest editor of the February-March issue of Clinical Researcher, the Association for Clinical Research Professionals (ACRP) peer-reviewed journal.

The theme of the issue is: Past, Present, and Future: Ethical Issues at Sites and Beyond. The issue takes a hard look at complex ethical clinical trials issues, including the latest informed consent challenges, the Food and Drug Administration’s tough new regulatory requirements, and how the promise of personalized medicine also raises the peril of unforeseen ethical dilemmas.

“Clinical research is constantly evolving,” said WCG Chairman and Chief Executive Officer (CEO) Donald A. Deieso, PhD. “Clinical trials are becoming increasingly complex, and the science that drives them is more nuanced than ever before. As the leader in ethical review, it is our responsibility to help the industry to rationalize the ethical implications inherent in today’s research.”

While focusing on the present and future of clinical research, including recent advances such as gene- and immune-therapy, Dr. McNair encourages readers not to forget the lessons learned from the past, and maintain a focus on the protection of human subjects. The authors featured in this issue of Clinical Researcher, many of them experts in specific areas of clinical research ethics, have contributed their thoughts on where we are today, and the changes we can look forward to in this field.

Dr. McNair writes in her guest editor message, “…while some ethical issues remain constant, advances in technology and medicine, and even whole new approaches to the design and conduct of clinical trials, can raise unexpected and sometimes challenging ethical considerations.”

The following articles are included in this issue:

Proposed Revisions to the Informed Consent and IRB Regulations

David Forster, JD, MA, CIP and David Borasky, MPH, CIP

Informed Consent: Improving the Process

Elizabeth Bankert, MA and Judith L. Forman, MPH

The Ethics of Targeted Oncological Trials

Cecilia Nardini, PhD

Designing Clinical Trials for New Drugs: Ethics, Governance, and Reputational Challenges

Jennifer Miller, PhD; Arthur Caplan, PhD; Alessandro Blasimme, PhD

New Opportunities and Threats in the Realm of Informed Consent

James Michael Causey

Therapeutic Innovations in Oncology: What Ethical Challenges Does Gene Therapy Bring?

Chris Jenkins, PhD, MPH and George D. Demetri, MD

Serious Adverse Events: How to Interact with Clinical Trial Participants When They Need You the Most

Michael Noss, MD

Is Your CAPA System Effective?

Susan Muhr Leister, BS, MBA, PhD, CQA, CSSBB

The February-March issue of Clinical Researcher is available to members of ACRP as a benefit of their membership. For non-ACRP members who would like to receive a print copy of this issue, please email your mailing address to WCG: (info@wcgclinical.com).

About WIRB-Copernicus Group

WIRB-Copernicus Group (WCG) is one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research. The industry’s first Clinical Services Organization (CSO), WCG enables biopharmaceutical companies, contract research organizations and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.

WCG solutions include contract and budget negotiation, study start-up acceleration, regulatory and ethical review services, oversight of research involving gene therapy, and lab safety consulting. Powered by a suite of proprietary technologies, WCG solutions help clients to increase regulatory compliance and support the digital management of clinical trials. For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.

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