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 ...

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 ...

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...

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

The European Union’s General Data Protection Regulation requires every organization that collects sensitive personal data from those residing in the EU to ask for clear and specific consent before ...

Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. Of 272 forms, 268 ...