Ethical Principles | Oversight Agencies | Regulations | Federal Wide Assurance | Other Links


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, the 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 a 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

ethics, integrity, trustOn 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 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects, and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.

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.

Top of Page


Oversight Agencies

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

The Office for Human Research Protections (OHRP) 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.

Food and Drug Adminstration (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 that they need to use medicines and foods to improve their health.

Top of Page


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 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)

Food and Drug Adminstration (FDA) 

Top of Page


Federal Wide Assurance

Marshfield Clinic 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 ethic 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 Research Institute Institutional Review Board (MCRI IRB) as the IRB responsible for the review, approval, and ongoing monitoring of human subject research activities conducted at Marshfield Clinic, or by its staff. Terms of the FWA can be found at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html


The FWA number is FWA00000873.

Top of Page


Other Links

Public Responsibility in Medicine and Research (PRIMR) is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. PRIMR's conferences, educational programs, and training resources serve individuals and organizations involved in biomedical and social science/ behavioral research.

National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). The NCI is the Federal Government's principal agency for cancer research and training.

Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.

Office of Human Subjects Research (OHSR) operates within the Office of the Deputy Director for Intramural Research (DDIR), National Institutes of Health (NIH). The NIH is part of the U.S. Public Health Service (PHS) which is an agency within the Department of Health and Human Services (DHHS).

National Institutes of Health (NIH) is one of the world's foremost medical research centers, and the Federal focal point for medical research in the United States. The NIH, comprising 27 separate Institutes and Centers, is one of eight health agencies of the Public Health Service which, in turn, is part of the U.S. Department of Health and Human Services.

National Institute for Health (NIH) Online Human Subject Protection Training

NIH Videocasting & Podcasting (Bioethics, Research, IRB Training)

Secretary's Advisory Committee on Human Research Protections (SACHRP) The Secretary's Advisory Committee on Human Research Protections (formerly known as the National Human Research Protections Advisory Committee) provides expert advice and recommendations to the Secretary of Health and Human Services on issues and topics pertaining to or associated with the protection of human research subjects.

Presidents Council on Bioethics was created in 2001 to advise the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology.

Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.

Agency for Healthcare Research & Quality (AHRQ) mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.  AHRQ priorities are described.

Regulatory Affairs Professional Society (RAPS)

Health Care Compliance Association (HCCA) - Research

Society of Clinical Research Associates (SoCRA)

Association of Clinical Research Professionals (ACRP)

Society of Research Administrators - International (SRA)

First Clinical Research (source of clinical research information)

Journal of Clinical Research Best Practices - Hundreds of free articles

Top of Page