When you choose to participate in a clinical trial, you’re volunteering for interventions for the advancement of science and medicine. You deserve to have your rights respected and be treated with the utmost care during the process. While in the U.S., the Food and Drug Administration (FDA) sets rules and regulations for such research studies, there are also ethical codes that help guide clinical trial setup.
In this article, we’ll discuss a few of these codes and principles in greater detail to understand how they help guide research study design and operations toward safeguarding participant rights and safety.
Codes of Ethics and Regulations
Ethics are moral principles that help guide behavior or activities. For example, in medicine, doctors, nurses, and other healthcare providers follow principles based on the Hippocratic Oath, summarized as to “do no harm.”1 Similarly, clinical trials are designed to minimize any harm to participants when the investigation team is learning about new treatments and advancing medicine.
There are several ethical codes and documents that have laid the groundwork for patients’ rights and provided guidance for doctors and researchers.2 The Nuremberg Code is an ethical code that was recognized after World War II in response to highly unethical clinical trials performed by Nazi scientists and doctors. Today, the Nuremberg Code is used as a standard ethical code for clinical research around the world.
The Nuremberg Code set out several principles, including:3
- The participant must give voluntary consent — they can’t be forced against their will to participate in research, and their consent must be given without deceit, fraud, or use of force
- Clinical trials and experiments must be designed to avoid any unnecessary injury or suffering
- The clinical trial should be able to yield useful results that will benefit medicine and society as a whole
Other ethical codes later developed to further protect clinical trial participants include:
- The Declaration of Helsinki: An international agreement passed in 1964 presented by the World Medical Association; it’s updated as needed to address new ethical concerns as they arise.4
- The Belmont Report: A report written by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, released in 1976.5
- The Common Rule: A rule of ethics created in 1981 that applies to all government-funded biomedical and behavioral research in the United States.6
- The International Conference of Harmonization Good Clinical Practices (ICH GCP), an international ethical standard for scientific research.7
The National Institutes of Health (NIH) follow seven principles that guide ethical research in the United States:8
- Scientific validity: A clinical trial should be designed to answer a valid scientific question so that participants are not put at risk for no reason and resources are not wasted.
- Social and clinical value: A clinical trial should be designed to answer a specific question that’s important or valuable to improve medicine and, as a result, society.
- Independent review: There should be no conflicts of interest during a study to prevent bias and protect the integrity of the data collected.
- Informed consent: Individuals must be able to make their own decisions to participate and continue in clinical trials based on information provided to them.
- Favorable risk-benefit ratio: The benefits of a clinical trial should, as much as they can, outweigh the risks they pose to participants.
- Fair subject selection: Clinical trial participants should be recruited to answer the specific question being asked for the study; they should not be recruited for convenience or taken advantage of due to their vulnerability. Those who bear the burdens of the research should enjoy its benefits.
- Respect for potential and enrolled subjects: The privacy and rights of individuals should be protected at all times during the recruitment and clinical trials process.
Informed Consent
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Informed consent is based on ethical principles from the Nuremberg Code, stating that clinical trial participants must give their voluntary consent. However, informed consent also requires that participants receive information on all aspects of the clinical trial, including the purpose of the study, what will be done to them throughout the study, and any benefits and risks.9
It’s also important to note that as a participant, you have the right to refuse and/or leave a clinical trial at any time. Investigators can’t force you to take a treatment you don’t want or force you to stay in a study. Clinical trial staff are required to discuss all forms and information regarding the clinical trial to make sure you understand everything that’s being asked of you. Only then can you give your informed and voluntary consent to participate.
Upholding Ethical Codes and Agreements
With all of these ethical codes in place, you may be wondering — who enforces them? The FDA requires that any clinical trials that receive government funding must have an institutional review board (IRB).10,11
An IRB is made up of doctors, scientists, and community members to ensure that participants’ rights and best interests are protected during studies. This board is responsible for reviewing several aspects of clinical trials, including:
- How investigators recruit participants
- Any surveys, questionnaires, or tests that participants will take during the trials
- How the participants’ confidentiality will be protected during the trial
- The informed consent forms that participants will read and sign before joining a clinical trial
