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Federal Legislation and Regulations for Research with HumansPublic Health Services (PHS) Act: The PHS Act forms the statutory basis for the DHHS regulations codified at 45 CFR 46 The Belmont Report -- Report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research, drafted by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979, provided the framework for ensuing federal regulations. The Privacy Rule - The privacy provisions of the federal law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses. The Department of Health and Human Services (HHS) has issued the regulation, "Standards for Privacy of Individually Identifiable Health Information," applicable to entities covered by HIPAA. HIPAA Frequently Asked Questions Department of Health and Human Services (DHHS) 45 CFR 46: Regulations on the Protection of Human Subjects published by DHHS. This code has four (4) subparts: Subpart A, often referred to as The Common Rule, or the Federal Policy for the Protection of Human Subjects covers all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency (with noted exceptions). Subparts B –D comprise additional DHHS protections special populations including (i) pregnant women, human fetuses and neonates, (ii) prisoners, and (iii) children, respectively. Food and Drug Administration (FDA) 21 CFR Parts 50 and 56: While the HHS regulations [45 CFR Part 46] apply to research involving human subjects conducted by, or funded in whole or in part by the DHHS the FDA regulations apply to research involving products regulated by the FDA. Federal support is not necessary for the FDA regulations to be applicable. Department of Education 34 CFR Parts 97, 98, and 99: Basic Department of Education policy for Protection of Human Research Subjects, Protection of Pupil Rights Amendment (PPRA), and Family Education Rights and Protection Act (FERPA), respectively.
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