In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.
After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).
For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8, 2010 has been the go-to document for industry, FDA staff, clinicians/users, and IRBs to understand how to apply the regulations at 21 CFR 814.100, which govern the approval, use, and review of HUDs. Since then, amendments to the HUD program have been made by a variety of federal actions.
Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light on what an IRB considers during its review.
Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. In this blog, we’ll take a look at a unique type of ICF known as the study-specific screening consent.
The bad news is we cancelled our webinar on the revised Common Rule. The good news? We cancelled it because it seems the revised Common Rule implementation and transition have actually been relatively smooth.
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of
When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated.
The right to try movement and recent passage of the federal right to try law have renewed public interest in
Food and Drug Administration (FDA) regulations and the Common Rule require that the selection of participants in research is equitable.
Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies. Sec. 907
