Reports, Declarations, Codes & Guidelines

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research: Respect for persons, Beneficence, and Justice. The Belmont Report explains how these principles apply to research practices. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.

• Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Belmont Report Educational Video
• History of the Belmont Report and the Federal Regulations 

At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), 1989 (Hong Kong), 1996 (Somerset West, Republic of South Africa) and 2000 (Edinburgh, Scotland).

• World Medical Association Declaration of Helsinki 

Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the Code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if participants are given the opportunity to consent; they are free from coercion (i.e., outside pressure); and they comprehend the risks and benefits involved. The Code also states that researchers should minimize risk and harm, make sure that risks do not significantly outweigh potential benefits, use appropriate study designs, and guarantee participants′ freedom to withdraw at any time.

• Nuremberg Code 

The Presidential Commission for the Study of Bioethical Issues advises the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology. The Commission works with the goal of identifying and promoting policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner.

• Presidential Commission for the Study of Bioethical Issues 

The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949.  CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research, among other activities. CIOMS promulgated guidelines in 1993 entitled “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” These 15 guidelines, later revised to 21 in 2002, address issues including informed consent, standards for external review, recruitment of participants, and more. The Guidelines, informally referred to as CIOMS Guidelines, are general instructions and principles of ethical biomedical research.

• International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • International Ethical Guidelines PDF

  TUSKEGEE CENTER FOR BIOETHICS AND HEALTHCARE

The Tuskegee University National Center for Bioethics in Research and Health Care was established in January 1999. The Bioethics Center was developed as a partial response to the apology of President William J. Clinton for the United States Public Health Service Study on Syphilis conducted at Tuskegee, in Macon County, Alabama from 1932 to 1972. The negative legacy of this study has been cited as a contributing hindrance to the full participation of African Americans and others in taking advantage of medical care and scientific research. It is the aim of the Tuskegee University National Center to transform the burden of this negative legacy. The Tuskegee University National Center for Bioethics in Research and Health Care works with local, regional, national and international communities, to address ethical and human rights issues in science, technology and health, particularly as they impact people of color. The Center's goals are to:

National Center for Bioethics in Research and Health Care
Tuskegee University 

PROFESSIONAL ORGANIZATIONS STATEMENTS OF ETHICS