Question

How do you think two crucial research events—the creation of the Nuremberg Code and the U.S.
Public Health Service Syphilis study at Tuskegee—influenced the role of Institutional Review
Boards (IRBs) in the study design process?
how you think the Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research also influences IRBs.

Your textbook may be used as a reference.
 Jacobsen, K. H. (2017). Introduction to health research methods (2nd ed.). Burlington,
MA: Jones & Bartlett Learning.

Answer 1

Prior to the twentieth century, research ethics were primarily governed by individual conscience and professional codes of conduct. Whether and how humans might be investigated, however, has always been subject to the laws and customs of the society and government at the time. For many reasons, in the second half of the twentieth century, an elaborate set of rules and regulations about research were established by the American government to protect individual and public interests.

The modern history of human subjects protections began with the discovery after World War II of numerous atrocities committed by Nazi doctors in war-related research experiments. The Nuremberg Military Tribunal developed 10 principles, known as The Nuremberg Code, to judge the Nazi doctors.

The significance of the Code is that it addressed the necessity to require the voluntary consent of the human subject and that any individual "who initiates, directs, or engages in the experiment" must bear personal responsibility for the quality of consent.

Although it did not carry the force of law, the Nuremberg Code was a very complete statement about the use of humans in experiments which came at a moment in history which made it internationally visible.

Revelations about the 40-year-long U.S. Public Health Service Syphilis Study at Tuskegee — and other ethically questionable research — resulted in legislation calling for regulations to protect human subjects, and for a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research. The Commission's final and most influential report, The Belmont Report, elucidates three basic ethical principles that investigators must balance when conducting research with human subjects:

• Respect for persons. This principle includes both respect for the autonomy of human subjects and the importance of protecting vulnerable individuals.
• Beneficence. More than just promotion of well-being, the duty of beneficence requires that research maximize the benefit-to-harm ratio for individual subjects and for the research program as a whole.
• Justice. Justice in research focuses on the duty to assign the burden and benefits of research fairly.

Although not directly related to specific far-reaching government action, the issues involved in the Tuskegee syphilis experiment heightened awareness of the need to protect human subjects and to assure their informed voluntary consent to participate in human subjects research.

As a result of these events, it is now required that informed consent is taken from participants and it must include information, comprehension and completeness. The nature and scope of risks and benefits must be assessed in a systematic manner. Also, there must be fair procedures and outcomes in the selection of research subjects.

In 1981, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report. In 1991, the core DHHS regulations were formally adopted by more than a dozen other Departments and Agencies that conduct or fund research involving human subjects as the Federal Policy for the Protection of Human Subjects, or "Common Rule."

The main elements of the Common Rule include :

• requirements for assuring compliance by research institutions;
• requirements for researchers obtaining and documenting informed consent;
• requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
• additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children.