Human Subjects

Introduction

The use of human subjects in research benefits society in many ways, from contributing to the development of new drugs and medical procedures to understanding how we think and act. It also can and has imposed unacceptable risks on research subjects. To help ensure that the risks do not outweigh the benefits, human subjects research is carefully regulated by society. Investigators who conduct research involving humans that is subject to regulation must comply with all relevant Federal regulations as well as any applicable state and local laws, regulations, and policies related to the protection of hu­man subjects.

 

Background

Society protects the welfare of individuals in many ways, but it did not specifically address the issue of the welfare of research subjects until after World War II. Following the War, widespread concerns about atrocities committed during the War in the name of research led to the formulation of a code for human subjects research known as the Nuremberg Code (1947) . Although not binding on researchers, the Nuremberg Code and the later Declaration of Helsinki (1964) , provided the first explicit international guidelines for the ethical treatment of human subjects in research.

The Nuremberg Code and Declaration of Helsinki did not put an end to unethical human subjects research. During the Cold War, U.S. researchers tested the effects of radiation on hospital patients, children, and soldiers without obtaining informed consent or permission to do so. From 1932 until 1972, well after antibiotics effective for the treatment of syphilis were discovered, scores of African-American males in a long-term syphilis study (conducted by the U.S. Public Health Service in Tuskegee, Alabama) were not offered treatment with the new drugs so that researchers could continue to track the course of the disease. These and other questionable practices raised serious public concern and led eventually to government regulation.

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was 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. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. In 1979, the resulting report, the Belmont Report , established ethical principles for the protection of human subjects in research: respect for persons (voluntary informed consent), beneficence (minimize risks, maximize benefits), and justice (fair and equitable selection of subjects and special care with vulnerable populations, such as children).

The federal policy for human subjects protection is known as the Common Rule (1991) . The Common Rule includes requirements for assuring compliance by research institutions, for researchers’ obtaining and documenting informed consent and for the Institutional Review Board (IRB) membership, review of research and record keeping. The Common rule also includes extra protection for vulnerable research subjects.

 

Human Subjects Research at Florida State University

Any member of the Florida State faculty, staff, post-doctoral and student body who plans to initiate research involving human subjects must submit a protocol application for review and approval by the Human Subjects Committee (Institutional Review Board) PRIOR to beginning the project.

For additional information about federal regulations, definitions, examples of human subjects research, FSU’s assurance with the federal government, the Human Subjects Committee’s (Institutional Review Board)responsibility and membership, the review process and types of reviews, the privacy rule, reporting adverse events, changes to the research protocol, renewing protocols, and closing a research study may be found on the FSU Office of Research’s Human Subjects Committee web page .