It can be a rewarding experience to participate in research studies that offer many potential personal, medical, and financial benefits. However, if you are new to or are not entirely familiar with ...

The federal regulations for the protection of human subjects (Common Rule) were revised effective January 20, 2019 to reduce administrative burdens for low-risk research while enhancing protections ...

The goal of the informed consent process is to ensure that the research participant is treated with respect and human dignity. This is achieved by safeguarding and advocating for the participant's ...

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The FDA’s draft guidance proposes adding a requirement for informed consent forms used in connection with FDA-regulated clinical investigations to begin with a “key information” section. The FDA’s ...

Informed consent represents a crucial component in modern medical practice, ensuring that patients are fully apprised of the benefits, risks, and alternatives associated with medical procedures. This ...

Click here to watch a short video on what is Exception From Informed Consent research. Acute care research is sometimes conducted under Exception from Informed Consent regulations. In many ...

Artificial intelligence (AI) now enables researchers to analyze vast amounts of clinical data within seconds, unlocking possibilities for faster discoveries, personalized interventions and more ...

Acute care research is sometimes conducted under Exception from Informed Consent regulations. In many life-threatening illnesses, patients are unconscious or too sick to provide written or verbal ...