The Informed Consent Form should be in the primary language of the research participant, or at least in a language in which the participant is considered fluent. The investigator should submit a ...

When using an informed consent form, a final version, as it will appear to your subjects (e.g., on letterhead), must be included in the protocol. If no informed consent form will be used, a waiver for ...

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.

Informed consent is one of the primary ethical requirements of research with human subjects as it reflects the basic principle from the Belmont Report of respect for persons. Federal regulations (45 ...

Department of Health and Human Services (DHHS) regulations for the protection of human participants require that informed consent information be presented in language understandable to the participant ...

The Forms and Templates page includes templates for informed consent documents.. However, because each human participants research (HSR) proposal is different and carries unique risks to participants, ...

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

The informed consent form must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by ...

The debate about the need for and form of informed consent for research with stored biospecimens was revived by recent international discussions and proposed changes to the U.S. Common Rule ...

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”), ... or develop a separate form, to document the informed consent process and discussion with the patient, ...