On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance ...

Background: The patient’s consent to a medical procedure must be preceded by a pre-procedure discussion with the physician that is documented on a standardized form. Evidence suggests that these forms ...

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 ...

An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks and benefits has found that the forms were extremely long ...

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.

(Reuters Health) - Cancer patients usually get written consent forms to sign before radiation that are supposed to clearly spell out the treatment risks, but a new U.S. study suggests these forms are ...

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