Thank you for reminding the research and scholarly community of the fundamental importance of striving to obtain each subject’s true informed consent prior to her or his participation in research ...

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 ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

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 ...

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 ...

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 ...

Research that is exempt under 45CFR46.104 is also exempt from Department of Health and Human Services (DHHS) requirements for informed consent as described under §46.116 and for documentation of ...

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.

The FDA issued “Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors” that supersedes its 1998 guidance and finalizes its 2014 guidance. The guidance outlines the primary ...

Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not a document or single event.

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 ...