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, ...

New guidelines emphasize the need for clarity in consent agreements for clinical trials and aim to broaden participation in ...

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 ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Background: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...

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 ...

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.

When submitting a project through the eIRB system, researchers can request either a waiver of the need for signatures/documentation, or a waiver to alter or omit the entire consent process. In either ...

The Florida Boards of Medicine and Osteopathic Medicine recently released six new informed consent forms that will now be required for transgender youth and adults to sign in the next six months to ...

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.