Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

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 ...

In most cases, no protocol, consent process, or consent form may be changed without prior approval from the IRB, except to eliminate an apparent, immediate hazard to one or more subjects. Also, the ...

Research that is exempt under 45CFR46.104 is also exempt from Department of Health and Human Services (DHHS) requirements for informed consent as described under §46.116 and for documentation of ...

Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete ...