The principle of respect for persons demands that participants enter the research voluntarily and with adequate information. When deceptive methodologies are used, participants are given incomplete or ...

Because treating a child who has a life-threatening injury must be done immediately, there will not be time to ask parents/guardians for permission. Parents/guardians will be notified after their ...

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 ...

This type of review is intended to support researchers in assuring that adequate informed consent is obtained from individuals participating in their studies. The review is performed at the request of ...

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 ...

Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and ...

Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

Human clinical trials are the final stage of research for any new medical treatment. Medical breakthroughs rely on willing participation from people who agree to be part of the studies. Joining a ...

Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent. “Informed ...

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 ...

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 ...