Blog
OHRP Issues Decision Charts for Current (2018) Requirements
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...
Levels of risk in human subjects research
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...
Emergency Use of a Test Article: Types and Regulations
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...
COVID-19 Clinical Trial Considerations
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...
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...