What should an informed consent document contain?

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

Does chart review require informed consent?

application, and HIPAA waiver, if applicable. identifiers are needed or if a linking list is desired. will apply to the project. In that case, informed consent of the participant is the default requirement.

Who is responsible for obtaining the informed consent?

physician’s
Obtaining patients’ informed consent is the physician’s responsibility, but the process is more than just a signature on a page. Surgery center staff are witnesses who confirm the informed consent form has been signed.

When do you need to revise an informed consent document?

Revision of Consent Documents during the study Study protocols are often changed during the course of the study. When these changes require revision of the informed consent document, the IRB should have a system that identifies the revised consent document, in order to preclude continued use of the older version and to identify file copies.

Who is responsible for obtaining informed consent for research?

The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before that subject participates in the research study. FDA does not require the investigator to personally conduct the consent interview.

What should be included on a medical record review form?

The consent form should include a statement disclosing that medical records review is part of the study procedures. Informed Consent Requirements: Research involving subject contact requires informed consent, no matter the level of review your study requires. The consent form should include the following information:

What’s the difference between informed consent and oral consent?

To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form. FDA believes that obtaining a subject’s oral or written informed consent is only part of the consent process.