Federal Policy for Protection of Human Subjects

The Common Rule Protects Us From Unethical Studies and Experiments

Nurse receiving information from patient before she donates blood
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The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, protects your rights if you participate in a clinical trial.

By law, Americans are guaranteed ethical treatment when they agree to participate in biomedical research, including clinical trials.

The policy is based on the Belmont Report, which was developed in the 1970s to guide medical researchers on the ethics of their work.

The Principles of the Federal Policy for the Protection of Human Subjects

There are three fundamental ethical considerations in the Common Rule:

  1. Respect through informed consent: Researchers must be truthful, helping their human subjects understand all aspects of any clinical trial or other research they will participate in. Subjects must volunteer on their own, then consent to participate.
  2. Beneficence: This is the "first, do no harm" aspect of research. Researchers must focus on minimized risk to their subjects.
  3. Fairness: There must be fair and equal distribution of costs and benefits among participants, reasonable and non-exploitive.

Oversight for the Federal Policy for the Protection of Human Subjects

There are two types of oversight to the Common Rule that you should be aware of:

  1. Any group, like an academic medical center or a pharmaceutical company, that runs clinical trials or other human experimentation must establish a relationship with an Institutional Review Board (IRB.) These boards are charged with overseeing all human research and are tasked with making sure the research adheres to the ethical principles as described above.
  1. IRB oversight comes from the Office for Human Research Protections (OHRP) which is part of the US Department of Health and Human Services. The OHRP is tasked with protecting the rights, welfare, and well-being of any person who chooses to become involved as a subject in biomedical research in the U.S.

    What the Policy Means for You

    Any person who is considering participation in a clinical trial or any other form of research should be familiar with these principles and their governance. While they guarantee subjects will be protected, it's possible that patients won't be protected if the biomedical researchers in charge of any given experiment do not adhere to the law.

    If you are involved in any form of research and feel that your needs or rights are being violated, ask questions and try to sort out the problems you perceive. If you still feel there are violations, you may want to get in touch with the OHRP.

    Why We Need the Federal Policy for the Protection of Human Subjects 

    It seems almost impossible today, but throughout medical research history, human subjects have been used in ethically reprehensible ways in an effort to - as those scientists would phrase it - further biomedical research. The key is that none of these subjects had any choice or gave consent. They were either duped or were being held prisoner and had no choice.

    You may be familiar with some of these examples:

    • The Tuskegee Syphilis Study conducted from 1932 to 1972 on poor black farmers in Alabama who had syphilis. Those farmers went untreated to see what would happen to them, even though penicillin was available. Not only did the farmers die from syphilis, but their wives were infected and died from it, too.
    • Beginning in the 1940s, prisoners in the Stateville Penitentiary in Illinois were intentionally infected with malaria so experimental malaria treatments could be tested on them.
    • Throughout American research history, subjects have been injected with or fed radioactive materials including uranium, plutonium, and iodine to see how their bodies would be affected. This included infants, children, prisoners and pregnant women. In none of these cases were the subjects aware they were being given radioactive material.
    • Research on Jews and other prisoners by Nazis during the 1930s and 1940s, such as experiments to change eye color by injecting chemicals into children's eyes, or using radiation as a sterilization treatment. Many of the Nazi experiments were considered to be "eugenics" — the practice of improving the human race by selective breeding and the use of sterilization.

      There are dozens of other examples of unethical human experimentation — some physical, some psychological — all conducted in the name of research on unsuspecting or unwilling participants.

      The Federal Policy for the Protection of Human Subjects, or the Common Rule, protects us against unethical experiments.

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