Clinical Researcher—February 2019 (Volume 33, Issue 2) SPECIAL FEATURE Robert Barton The U.S. Food and Drug Administration’s (FDA’s) proposed rule to allow an institutional review board (IRB) to waive or alter informed consent requirements in low-risk clinical trials is a good step toward streamlining the approvals process for drugs and medical devices, […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) DATA-TECH CONNECT Esther Daemen, MBA; Tine Wouters, MSc The General Data Protection Regulation (GDPR) (2016/679) brought about the greatest change to European data security in 20 years. Applicable since May 2018 and repealing the Directive 95/46/EC, GDPR intends to strengthen and unify data protection for […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas Clinical research is a valuable profession, and it deserves to be treated as such. Whether the members of its workforce are saving lives, alleviating suffering, or helping people live healthier, more active lives, it is difficult to think of a […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) CHAIR’S MESSAGE John P. Neal, CRCP We’ve had a strong start out of the gate for 2019, and the year ahead looks good for ACRP. In January, we held the year’s first ACRP Association Board of Trustees (ABoT) meeting at ACRP headquarters in Alexandria, Va. After […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) SCIENCE & SOCIETY Daniel Kavanagh, PhD This article will provide a brief overview of the state of genome-editing technologies as they relate to human genetic modifications that can be passed from parent to offspring (called “germline” genetic modifications). We will first look at what we […]
