The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A ("The Common Rule") is the baseline standard of ethics by which any government-funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding.
This subject is very complicated so instead of reading voluminous pages, I am including charts and a PPT which are easier to read.
RESEARCH INVOLVING HUMAN SUBJECTS NIH REGIONAL SEMINAR
ETHICAL PRINCIPLES OF HUMAN SUBJECT PROTECTION
DATA SECURITY AND RESEARCH-COMPLETING REQUIRED FORMS
HIPPA PRIVACY AND CONFIDENTIALITY
DRAWING THE LINES-WHAT NEEDS IRB REVIEW
ETHICAL ISSUES IN TRANSLATIONAL RESEARCH
BASICS OF HUMAN AND ANIMAL RESEARCH REGULATIONS
NEW MODELS FOR DATA SHARING AND COLLABORATION TO IMPROVE HEALTH AND HEALTHCARE
They are using people they designate as Non-Humans - Targeted Individuals.
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.
RESEARCH ETHICS TRAINING CURRICULUM
45 CFR 46
Complete document available on line at Protection of Human Subjects. This is only Title 45 Part 46. Public Welfare and the Protection of Human Subjects, as it pertains to the subject matter.
Operational Guidelines for Ethics Committees That Review Biomedical ResearchWorld Health Organization, Geneva 2000
Nuremberg Code - Permissible Medical Experiments
Nuffield Council on Bioethics - The ethics of research related to healthcare in developing countries
Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human Subjects
RULES FOR HUMAN SUBJECTS RESEARCH REGULATIONS
FUTURE STRATEGIC ISSUES FUTURE WARFARE 2025
U.S. “HUMAN BRAIN PROJECT”
Begun in early 90’s, funded by 16 organizations across 5 agencies (NIH, NSF, DOD, NASA, DOE)
AKA “ Neuroinformatics” (intersection of neuroscience and informatics)
“Exploding field;” 10,000 individual presentations at annual meeting of Society for Neuroscience (from
molecular geneticists to cognitive psychologists)
Determining detailed neuroanatomy of human brain (“digital brain atlas”)
Use of IT to study brain, use of brain info to aid IT/AI
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