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 ...

These files may be useful to you if you are submitting a proposal to the IRB or developing written material for your project. Unless otherwise indicated, all files are Microsoft Word documents (.docx) ...

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 ...

Research activities involving in-person interactions that would take place even if the research was not being performed (e.g., classroom-based research, research that is part of routine clinic visits) ...

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