Blog
OHRP Issues Guidance on COVID-19 for the Research Community
The Office for Human Research Protections (OHRP) has released guidance regarding how the Common Rule regulations should be applied in response to the COVID-19 outbreak. Given the current circumstances, “the research community is encouraged to prioritize...
COVID-19 Clinical Trials
With the pandemic of COVID-19 affecting the way of life across the globe, companies continue to accelerate the clinical development of a vaccine or a therapeutic. The number of Covid-19 clinical trials has been steadily growing because of the increases in...
Pearl IRB COVID-19 Response
The Centers for Disease Control and Prevention (CDC) has recommended the implementation of several community actions in an effort to reduce people’s risk of being exposed to COVID-19. These actions slow the spread, reduce the impact of disease (i.e.,...
Single IRB – A Guide for the Common Rule sIRB Mandate
The revised Federal Policy for the Protection of Human Subjects (the “Common Rule”) collaborative (multi-site) research provision requires that U.S. institutions engaged in cooperative research conducted or supported by a Common Rule agency must rely on a single IRB...
Acting with integrity within the sometimes-unethical pharmaceutical industry
Book: Bottle of Lies: The Inside Story of the Generic Drug Boom, by Katherine Eban Good read. I honestly forgot about the phone call I had with Katherine Eban more than 5 years ago, so it took me by surprise to see my name in her book. Yes, right there on page 224 in...