Informed Consent is Contrary to Your Best Interest, It's the Law

Vanity | 10/14/2021 | Vanity

[Fitzy_888]

H.R.34 - 21st Century Cures Act 114th Congress (2015-2016) Public Law 114-255 114th Congress

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SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS.

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(b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where it is not feasible or it is contrary to the best interests of such human beings'' and inserting ``except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings''.

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TITLE 21 - FOOD AND DRUGS

21 U.S. Code § 355 - New drugs

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(i) Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary

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(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs.

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[Fitzy_888]

"...experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives , except where it is not feasible, it is contrary to the best interests of such human beings,..."

=> Explains a lot in retrospect.

[Jim W N]

St. Augustine: “an unjust law is no law at all.”