Office of Research Support Services

Several documents have established the ethical standards for human subjects research. The principal document is the Belmont Report, formally titled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” which was drafted in 1979 by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It is widely accepted as the foundation for ethical human subjects, and was followed by the Declaration of Helsinki, which was developed by the World Medical Association.

In addition to the foundational documents setting forth basic principles of ethical research, there are federal regulations and rules, as well as state and local laws, that institutions and investigators must abide by when conducting human subjects research. Applicable regulations include Department of Health and Human Services regulations at 45 CFR 46, Food and Drug Administration regulations at 21 CFR Parts 50 and 56, and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) at 45 CFR Part 160 and Part 164. Federal agencies also issue guidance documents. Moreover, every institution engaged in federally supported human subjects research must file a Federal Wide Assurance with the DHHS Office for Human Research Protection (OHRP) of protection for human subjects. Marshfield Clinic has filed an approved FWA (FWA00000873) and is responsible for ensuring compliance with the assurance. The FDA also has Good Clinical Practices (GPC) guidelines that establish minimum requirements that must be met for FDA-regulated research. Marshfield Clinic is also committed to ensuring compliance with all applicable state and local laws.

Ethical Principles

Belmont Report

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The charges to the Commission included identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines which should be followed to assure that such research is conducted in accordance with those principles.

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Declaration of Helsinki

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

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Oversight Agencies and Regulations

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have passed regulations regarding human subjects research (45 CFR Part 46 and 21 CFR Parts 50 and 56). DHHS, through its Office for Human Research Protections (OHRP), and the FDA also issue periodic guidance documents for institutions and investigators. Sections of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Part 160 and Part 164 are also relevant to Institutional Review Board (IRB) review of research. Questions regarding the regulations or guidance documents may be directed to ORIP at (715) 389-3022.

Department of Health and Human Services Office for Human Research Protections (OHRP)

The Office for Human Research Protections provides leadership and oversight on all matters related to the protection of human subjects participating in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure that such research is carried out in accordance with the highest ethical standards and in an environment where all who are involved in the conduct or oversight of the research understand their primary responsibility for protecting the rights, welfare and well-being of human subjects.

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Food and Drug Administration (FDA)

The FDA is responsible for protecting public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for improving public health by helping to speed innovations to make medicines and foods more effective, safer and more affordable and by helping the public obtain the accurate, science-based information they need to use medicines and foods to improve their health.

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Federal-Wide Assurance

Marshfield Clinic Health System has negotiated a document with the U.S. Department of Health and Human Services in regard to the protection of human research subjects. This document, called a Federal-Wide Assurance (FWA), assures that all of the institutional activities related to human subject research will be guided by the ethical principles set forth in The Belmont Report and that the institution will comply with the regulatory standards set forth in 45 CFR 46. The FWA requires that the institution have a formal mechanism for monitoring compliance. The FWA names the Marshfield Clinic Health System Institutional Review Board (MCHS IRB) as the IRB responsible for the review, approval, and ongoing monitoring of human subject research activities conducted at Marshfield Clinic Health Systems sites or by its staff. The FWA number is FWA00000873.

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