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Regulations and regulatory
“the most widely accepted guidance worldwide on medical
World Medical Association (WMA) policy statement
Declaration of Helsinki Extend Nuremberg code to include:
• Research combined with medical care
• Incompetent subjects and Vulnerable subjects
• Review by an independent review committee
• International research (research in developing countries)
Ethical principles for medical research involving human
subjects, material and confidential data resources.
Implementing National Health and Medical Research
National Health and
Medical Research
Develop and maintain health standards in Australia
This appendix contains the text of Part 46 Protection of Hu-
man Subjects of Title 45 Public Welfare of the Code of Fed-
eral Regulations (C.F.R.). Part 46 of the C.F.R.s were revised
June 23, 2005, and made effective that day.
Subpart A:Basic DHHS Policy for Protection of Human Re-
Code of Federal Regula-
search Subjects
tions Title 45: Public
Welfare Part 46: Protec-
Subpart B:Additional Protections for Pregnant Women, Hu-
tion of Human Subjects
man Fetuses, and Neonates Involved in Research
Subpart C:Additional Protections Pertaining to Biomedical
and Behavioral Research Involving Prisoners as Subjects
Subpart D:Additional Protections for Children Involved as
Subjects in Research
