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Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype

Bill of Health

Previously, its authors had contributed to a related piece in this Bill of Health blog, which argued for a precautionary approach to touch in psychedelic-assisted therapy.) As each contribution emphasizes, these oversights have ethical implications for research design, informed consent processes, and public communication.

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Judging in the Pandemic – A Malawian Perspective

Bill of Health

In Nyirenda v Ministry of Health , the applicants sought to review the of the imposition of mandatory vaccination, arguing that it amounted to a violation of human rights including the right of bodily integrity, as part of the right to private life and the right to free and informed consent.

COVID-19 307
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Legal Responsibilities of Nurses in Medication Administration 

American Medical Compliance

Informed Consent Before giving any medication, patients have the legal right to understand what theyre receiving. While it may appear as simple as handing over a pill or administering an injection, the reality is far more complex. Not knowing the law isnt an excuse.

Nurses 98
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CMS Releases New Guidance Regarding Informed Consent for Sensitive Exams

Hall Render

Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum to state survey agency directors highlighting revisions and clarification to the Hospital Interpretive Guidelines for Informed Consent (the “Guidance”).

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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.

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A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

Bill of Health

Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.

Bioethics 359
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Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?

Bill of Health

While not exhaustive, this blog post explores some of the major legal issues likely to arise if a device like the Sarco were to be introduced into the United States. Under the U.S. system of health care federalism, the legal analysis of self-operated assisted suicide devices involves both federal and state considerations. FDA Approval.

FDA 245