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 ...

Warning! Sweeping changes in public health are on the rise. The latest word, according to Stat, is that the Department of ...

Our new Secretary of Health and Human Services wants to change CDC messaging about vaccines to emphasize "informed consent." ...

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.

Management strategy: Disclose your relationship / financial interest to research participants in the informed consent document(s) of the study under management. Management strategy: Disclose ...

Informed consent documents explain to potential participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Using this ...

There is sea change in America’s framework for conducting experiments on humans, involving a provision quietly implemented by the FDA.

PIC advocates for strong First Amendment protection of doctor-patient speech without fear of prosecution by medical boards ...

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 ...

Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form template (pdf) for more help and sample language. 1. Title of the Study 2. Names and Affiliations ...