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Articles & Interviews

Broad Consent for Biobanks Will be an Enigma

The Revised Common Rule includes two new exemption categories intended to facilitate the creation of biobanks for future research. Many institutions will struggle with how to implement these exemption categories, and will likely give up or encounter difficulties with compliance.

These new exemption categories allow an investigator to obtain “broad consent” from a subject for […]

By |December 21st, 2017|Articles & Interviews|

Single IRB Review for All Multicenter Clinical Trials

Authors:
Stuart Horowitz, PhD
President, Institutions and Institutional Services
WIRB-Copernicus Group

Dawn M. Furey
Executive Director, Head of Global Operations, Global Clinical Trial Operations
Merck & Co.

Publication:
Applied Clinical Trials

Newest Oncology Studies Considerations for IRB Review

Author:
Lindsay McNair, MD, MPH, MSBioethics
Chief Medical Officer
WIRB-Copernicus Group 

Publication:
IRB Advisor

Assessing Research Benefits

Authors:
Jeffrey Cooper, MD, MMM
Vice President, Process and Strategic Improvement
WIRB-Copernicus Group 

Lindsay McNair, MD, MPH, MSBioethics
Chief Medical Officer
WIRB-Copernicus Group 

Publication:
Journal of Empirical Research on Human Research Ethics (JERHRE)

Myths and Realities of Placebo Response: A 21st Century Prescription

Author:
Mark Opler, PhD, MPH
Chief Scientific Officer
ProPhase

Publication:
Clinical Researcher

Applying ISO 9001 to the IRB Process

Authors:
David Borasky, MPH, CIP
Vice President, Quality Management
WIRB-Copernicus Group

Heather Kim, MS, RAC, CIP
Quality Assurance Manager
Copernicus Group IRB

Publication:
Clinical Researcher

Message from the Guest Editor

Author:
Jeffrey A. Cooper, MD, MMM
Vice President for Process and Strategic Improvement
WIRB-Copernicus Group (WCG)

Publication:
Clinical Researcher

Future World Without Paper Consent Could Be Here Sooner Than Imagined

Authors:
David Forster, JD, MA, CIP
Chief Compliance Officer
WIRB-Copernicus Group (WCG)

Publication:
IRB Advisor

The Clinical Trials Technology Ecosystem

Authors:
Suzanne Caruso
VP, Clinical Solutions
WIRB-Copernicus Group (WCG)

Dawn Furey
Executive Director and Head of Global Clinical Trial Operations
Merck

Publication:
PharmaVoice

Three Tips for Reaching Your Study Enrollment Goals

Author:
Suzanne Caruso
VP, Clinical Solutions
WIRB-Copernicus Group (WCG)

Publication:
PharmaVoice