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 ...

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 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.

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 ...

Informed consent involves a subject being given information that a reasonable person would want to have to make an informed decision about whether to participate in research, and the chance to discuss ...

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 ...

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 ...

Robbee Wedow is a research fellow at AnalytiXIN, which is a consortium of health-data organizations, industry partners and university partners in Indiana primarily funded through the Lilly Endowment, ...