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, ...

Canadian researchers have published new guidelines intended to make consent forms used in clinical research easier for patients to understand. The guidelines describe 75 core elements for consent ...

Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

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.

A team of Northwestern Medicine investigators recently began developing a library of visual icons to support research participant comprehension of informed consent forms.

Journal of Empirical Research on Human Research Ethics: An International Journal, Vol. 16, No. 1/2 (February-April 2021), pp. 78-88 (10 pages) HIV cure research carries serious risks and negligible ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...

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 ...

Prior to completing an application, you will need to satisfy training requirements. The Human Subject Research Orientation on Canvas will ultimately save you time in ...