Researchers at the University of Pennsylvania Law School and Columbia University examined 215 research protocols and their accompanying consent forms from the years of 1977 to 2002.

A study in IRB: Ethics & Human Research examined the changes over a quarter century in the accuracy and length of research consent forms used for 215 studies by one department in a major academic ...

Exempt (level 1) Research Exempt (level 1) Research correlates to activities listed in one of the "exempt" categories in the federal regulations (45 CFR 46). Exempt (level 1) Applications are reviewed ...

To the Editor: 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 ...

It is recommended that forms for adult subjects be written at a 6 th -grade reading level or lower, information should be accurate, precise, in sufficient detail, and organized in a way that ...

When applicable, one or more of the following elements of information shall also be provided to each participant: Disclosure or non-disclosure of particular studies presented in the planned project.

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 ...

FDA and OHRP included several recommendations on how consent forms can be organized and presented in a way to facilitate potential subjects’ understanding of the research, including: ...

The new consent requirement applies to “applicable clinical trials” or trials initiated on or after March 7, 2012, of drugs, biological products or devices that are subject to FDA regulation.

The consent forms reviewed in the study were approved by university panels called institutional review boards, or IRB’s, which are required under federal regulations to protect research volunteers.

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 ...

The survey was the work of the Research on Medical Practices project, or ROMP, which was launched in the aftermath of a controversial research-consent form used in a study that compared two oxygen ...