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 ...

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 ...

The plan for obtaining consent must be included in the Human Subjects Protocol. Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, ...

For children 7 to 11 years of age, the assent form should be simple enough for the child to understand what he/she is agreeing to do. In general, it should briefly explain in basic terms: For children ...

Informed consent is not just a form; it’s a process that respects patient autonomy and promotes trust between patients and ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s ... that involves the collection of identifiable private information or identifiable ...

6.3.6 We obtain informed consent from our contributors in a variety of ways depending on the circumstances of their contribution. Wherever practicable we should obtain consent in a form capable of ...

“So informed consent includes accurate and understandable ... The FDA has said the changes will have “benefits in the form of health care advances” because studies that would not have ...