Language Interpretation Issues 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 ...

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 ...

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 ...

Unless the need for consent is waived by the IRB, the written consent form must be reviewed with the participant (or the participant's representative) and signed and dated by the participant or the ...

General Details of the Informed Consents All protocols must detail the informed consent process personnel will use if participants will be involved in the research study. Protocols must use the ...

FORMS The information and sample documents in the compliance form section are provided to help researchers develop consent and assent documents customized to the design of the individual research ...

For example, the informed consent for a research study might advise patients in the following way: Over the course of this trial, routine healthcare information, such as [name of test] results and ...

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.

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 ...

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information ...