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Psychedelic Breakthroughs: Key Considerations for Clinical Trials

Healthcare Law Insights blog

Informed Consent: Ongoing and Essential Respecting patient rights is central to any clinical trial. Essential to this is ensuring ongoing informed consent from participants. The principle of informed consent extends to the practice of therapeutic touch, a component particularly relevant to psychedelic-mediated therapy.

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Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Healthcare Law Insights blog

On June 23, 2023 the U.S. Informed consent is recommended to include notice that subjects may experience changes in perception, cognition, and judgment that persist for many hours, as well as increased vulnerability and suggestibility during the treatment session. Comments can be submitted to Regulations.gov.

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Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges

Healthcare Law Insights blog

In August 2023, a new crop of cases began appearing in federal courts, this time challenging public or private healthcare employer mandates under the Fourteenth Amendment’s due process and equal protection clauses, certain federal statutes, and numerous other purported “laws.” granted Wash. Governor Jay Inslee’s Motion to Dismiss.

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Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

Randy died February 26, 2023. And so Ruth highlighted one of the features of this pragmatic trial that was different than the outpatient trial was that we didn’t need to consent patients and families for participation in this study. And so that’s how we were able to proceed with the study under this waiver of consent.

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