June 7, 2018
If you provide patients with stem cell therapies, new legislation may affect how you obtain informed consent from your patients, beginning today, June 7.
The new law, ESHB (Engrossed Substitute House Bill) 2356, applies to licensed healthcare providers who perform therapies using human cells, tissues, or cellular or tissue-based products that haven’t been approved by the United States Food and Drug Administration (FDA). You’ll need to inform your patient that the treatment hasn’t been approved by the FDA and obtain your patient’s written, informed consent before performing the therapy.
The consent form must be signed by the patient, or, if the patient isn’t legally competent, the patient’s representative. The form should be written in language the patient could reasonably be expected to understand, and should describe:
- The nature and character of the proposed treatment, including the treatment’s FDA approval status
- The anticipated results of the proposed treatment
- The anticipated possible alternative forms of treatment; and
- The recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including non-treatment
If you’re advertising your therapy services, you should include this notice.