The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

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 ...

The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

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 ...

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 ...

A successful consent process presents detailed information which is organized and presented in a way that helps the prospective subject understand why a person might or might not want to participate.

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 ...

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 represents one of the most important ethical aspects of clinical treatments and scientific research involving humans. This article will discuss the key elements of informed consent ...

Clinical research on Alzheimer disease (AD) is much needed but requires the participation of patients with substantial cognitive impairment who have difficulty providing informed consent. Despite ...

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 ...

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 ...