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 ...

Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...

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 ...

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 ...

The primary purpose of informed consent is to protect the prospective human subject. Informed consent provides the individual with the pertinent information regarding the research in which s/he is ...

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 ...

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 Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...

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 ...

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 ...