December 14, 2015

Review of Protections of Human Subjects Used For Research

Current laughable procedure of the Office for Human Research Protection at HHS requires human subjects without consent, to provide evidence of wrongdoing, and to identify the lead researcher. How is the human subject without consent to know and do that? Within a university setting the IRB can withhold funding without informed consent. But if funding is non institutional and researchers do not obtain consent there are no protections from egregious abuse by miscreant researchers. 

Even if performed on university property which violates the Common Rule (Title 45 CFR Section 46). There are no penalties for non compliance with the Common Rule. Psychiatrists are readily available to cover-up illegal abuses designating the victim insane. Then there is the lack of oversight by state authorities when deaths occur in research. MA law requires notice to the Medical Examiner or the District Attorney. But police conveniently allow researchers to investigate deaths occurring under their procedures. Thus negligence becomes pre-existing conditions.

Harvard Will Submit Comments on Changes to Research Approval Process
December 13, 2015

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