The IRB Office published an updated version of the informed consent template. The template and instructions for uploading this form in eRA have been posted to the Forms & Templates page. For your ...

Expedited studies are research projects that meet one of the categories under 46.110 and involve minimal risk. Full board studies are those the IRB determines does not fall under exempt or expedited ...

The goal of the informed consent process is to ensure that the research subject is treated with respect and human dignity. The process does this by safeguarding and advocating for the subject's right ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, ...

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

Achieving informed consent requires a potential contributor to be in possession of sufficient knowledge about our plans for a reasoned decision to take part in our content. The Editorial Guidelines ...