Dr. Angela Bowen: Pioneer of Research Ethics, and Founder of the Western Institutional Review Board

Clinical Researcher—December 2018 (Volume 32, Issue 10) IRBs IN FOCUS Lindsay McNair, MD, MPH, MSB; David Forster, JD, MA, CIP   This year marks the 50th anniversary of the founding of Western Institutional Review Board (WIRB), the first established independent ethical review board in the United States. WIRB’s parent company, WIRB-Copernicus Group, has spent this […]

Naila Ganatra

Addressing Compliance Gaps with Focused Training Programs

SPECIAL ADVERTISING SUPPLEMENT Rather consistently over the years, several general areas have comprised the most usual areas of clinical investigator noncompliance, although there are emerging signs that CDER is finding more cases of significant noncompliance today.[1] Overall, the following five areas represented the most frequent citations in CDER-issued Form 483-Domestic Inspectional Observations in FY2017:

Edwina McNeill-Simaan, MSHS, CCRP, CCRC, Vanderbilt University Medical Center

PIs Struggle to Meet Daunting Expectations

“All things begin and end with the investigator,” says Edwina McNeill-Simaan, MSHS, CCRP, CCRC, a clinical and translational research coordinator in obstetrics and gynecology at Vanderbilt University Medical Center. However, that doesn’t mean principal investigators (PIs) always know what’s expected of them. Far from it, in fact. “They’re expected to hit the ground running,” McNeill-Simaan […]