Research

While an exemption request may not be the most expeditious way to meet the requirements of this rule, the regulation for Protection of Human Subjects, 28 CFR Part 46 §46.101(b)(1)-(6), defines categories of research involving human subjects that are exempt from its provisions. It is important to note that these exemptions do not apply to studies involving incarcerated persons, fetuses, pregnant women, or human in...

• Overview of Human Subjects Protection
• Informed Consent
• When to Submit
• How to Submit
• Exemptions

Overview of Human Subjects Protection

To ensure that human subjects are adequately protected from unreasonable risks and properly informed of the potential...

Informed consent is a process in which the researcher provides sufficient information, in an understandable format, to the research subjects so that they can make a voluntary decision whether or not to participate in the study. The informed consent process is fundamental in ensuring respect for persons and should serve to educate the subject about the research, the benefits and risks, and the voluntary nature...