Clinical Trials Laws and Test Subjects, 0221 RIBJ, RIBJ, 69 RI Bar J., No. 4, Pg. 13

PositionVol. 69 4 Pg. 13

Clinical Trials Laws and Test Subjects

Vol. 69 No. 4 Pg. 13

Rhode Island Bar Journal

February, 2021

January, 2021

William J. Connell, Esq. M.Ed. Attorney at Law North Smithfield

Introduction and Overview

The COVD-19 pandemic has generated much discussion regarding vaccines. Clinical trials, also known as clinical investigations, which use live human beings as test subjects, are a critical part of the process to find a vaccine. This article will discuss the federal laws governing clinical trials, with a focus on the regulations protecting the health and safety of test subjects.

What are Clinical Trials?

Clinical trials are a form of medical research studies that often involve human beings as subjects. These studies are ways to evaluate the effectiveness of medicines, vaccines, surgeries, therapies, and other medical intervention. Clinical trials can help researchers learn if a drug or therapy is both safe and effective.1 To say that someone is a "human subject" is to say the person can be a recipient of a test article, such as a drug, medical device, or food article (as examples), or that the person participates in the research as a control or part of a control group? The control group does not receive the test article, but is given either a standard treatment or a placebo. Results from the control group are compared to results from the group receiving the drug or other treatment being studied, and these are compared for efficacy.3

There are other types of medical research that are less invasive than clinical trials known as observational studies; however, according to the National Institutes of Health ("NIH"), which is an agency of the U.S. Dept. of Health and Human Services, "a well-designed clinical trial is the gold standard for proving that a treatment or medical approach works..."4 When it comes to viruses such as the flu, a vaccine is essentially a weakened or dead infectious agent - i.e. with influenza, a small dose of the virus. If it works, it produces a weak instance of the disease in the body, which leads to the person developing immunity. For a vaccine to be effective, it is crucial that the infectious agent be identified with great precision.5 This is where clinical trials are essential.

Ethical issues can arise with many clinical trials because the goal of the clinical trial is research, to gain information. While the ultimate goal may be to find a cure, a treatment, or some other response to help humanity, research may not provide or even be intended to provide the individual test subject with a particular health benefit.6

In the United States, much of the law at the federal level which governs clinical trials is found in the regulations of federal departments and agencies. The Department of Health and Human Services ("HHS" or "Department") and in particular the Food and Drug Administration ("FDA"), another agency within the Department, are prominently involved in overseeing many clinical trials and have regulations giving protections to human subjects.7The FDA jurisdiction includes, but is not limited to, drugs for human use, medical devices, and biological products.8The Health and Human Services section is written a little more broadly to cover most research involving human subjects that is supported by a federal agency.9

To start an FDA clinical trial, a sponsor applies to the FDA for permission to conduct a clinical trial using human subjects. Under the FDA's policy, tests must first be performed on animals to test safety and effectiveness of a proposed intervention prior to the authorization of clinical trials using humans. If the FDA approves the study for human participation, there follow four phases of a clinical trial. A drug or therapy or intervention must show sufficient success in the test groups before moving on to the next phase. In each phase, more subjects tend to be included, so that a Phase 1 trial may have as few as twenty participants, whereas a Phase 4 trial may have several thousand participants, and potentially can go on for years.10

A Brief History

Since the middle of the twentieth century, a fundamental guiding principle with clinical trials has been that the test subject must give informed consent prior to participating in the trial. Prior to World War II, some commentators mentioned this, but informed consent was not always sought. The Nuremberg War Crimes trials following World War II brought to light the issue of mistreatment of clinical trial subjects in a dramatic way. At the Nuremberg trials, Nazi and other German doctors and scientists were accused of conducting gruesome experiments on persons being held in concentration camps. One tactic adopted by some defendants was to identify medical trials that had been done by other countries, including the United States, which purportedly mistreated some subjects. In 1947, the Nuremberg International Medical Tribunal (the "Tribunal") issued a decision finding many of the Nuremberg defendants guilty of war crimes and crimes against humanity for their experiments. In their decision, the Tribunal included ten points or rules for conducting experiments on human beings, which became known as the Nuremberg Code.11 The Code addressed experimentation on human subjects. The opening sentence in the Code is "The voluntary consent of the human subject is essential." According to the Code, voluntary consent means the subject person gives consent without any form of coercion, and only after being appraised of all aspects of the experiment.12 This idea of voluntary consent would appear again in later laws.

In 1947, the World Medical Association adopted the Declaration of Geneva, which has been described as an updated and modernized version of the Hippocratic Oath.[13] On December 10,1948, the United Nations issued the Universal Declaration of Human Rights, a document signed by forty-eight countries or states, including the United States, which addressed fundamental rights as a human being.[14] In 1964, the World Medical Association adopted the Declaration of Helsinki, which contained specific recommendations to doctors in regard to humans in clinical trials. This Declaration emphasized the need for free consent of the subject and the duty to inform the subject of the nature, purpose, and risk of the clinical research.15

While the United States generally supported the Declarations and Codes set forth above, effective regulations in the U.S. did not really emerge until the 1970s. Congress passed the National Research Act in 1974 (the "Research Act").16 The Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979, this Commission released The Belmont Report, which discussed basic principles for the treatment of subjects in clinical research. The Report also identified ethical principles for research involving human subjects.17 In 1981, both the U.S. Dept. of Health and Human Services and the Food and Drug Administration revised their human subject regulations and incorporated many of the recommendations of the Belmont Report.18

Specific Rules and Regulations Governing and Protecting Human Subjects

Many federal departments and agencies which regulate clinical trials with human subjects have adopted what is known as "the Common Rule."19 Key provisions of the Common Rule include: that institutions doing research under a Federal department or agency comply with the regulations;20 that all human...

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