On June 30, 2020, OHRP posted new decision charts for the revised Common Rule (2018 Requirements) on their website. These charts are intended to help decision-makers determine if research is considered human subjects research, if exemption categories apply, if...
Investigators may have noticed that there seems to be a high degree of variability in Institutional review board (IRB) reviews, both in review type and approval requirements.Several regulations must be considered when reviewing a study. IRBs are given discretion to...
The COVID-19 pandemic has brought up questions regarding the emergency use of drugs, devices, and/or biologics. What issues must investigators understand prior to submission of a study to the Institutional Review Board (IRB) for review? Below is a brief description of...
At PRIM&R’s 2014 Advancing Ethical Research Conference, Dr. Anthony Fauci gave a keynote address where he shared his personal account of the ethical challenges of research during the HIV/AIDS epidemic. The urgency and fear that surround an outbreak like...
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 public health...
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 incidence...
