The Institutional Review Boards 101

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New discoveries of therapies and drug mechanisms are not always the daily news headline, but today ethical guidelines exist to continue to keep a standard of the production of any new medication or treatment. However, the history of clinical research has not always been so ethical. For instance, the PHS Syphilis Study in Tuskegee, AL and the Willowbrook Hepatitis Experiments, are only two of many notorious examples of horrifically unethical clinical trials. The purpose of this article is to bring light into the role of the Institutional Review Boards (IRB) in relationship to on ongoing  clinical trials today to ensure safety for human participants.

In 1974, Richard Nixon passed the National Research Act. This act was created to ensure excellence of biomedical and behavioral research within the United States. These guidelines within the National Research Act emphasized a respect for autonomy, beneficence, and justice for research participants. As a result, the Institutional Review Boards (IRB) was formalized, for all DHHS-funded research, as a Committee. This committee would reside either within the research institution or be external (e.g., commercial IRB’s); and would be an ethical review board designated to protect the rights and well-being of human research participants.

The IRB must be independent from the institution for which it reviews research to avoid any inherent bias within the study, though it is often made up of faculty and staff of the institution. The IRB functions to review and monitor research involving any human subjects. This board has the power to approve, enforce any change, or reject research of a clinical trial. Moreover, patient safety is a priority in clinical trials and the IRB plays a fundamental role in this. Thus, the board will review the protocols and progress throughout the study. The main goal of the IRB is to confirm that the right steps are taken to protect the welfare and the rights of participants. The IRB also operates to verify the integrity and quality of the data being collected. IRB is also required by the Federal Drug Administration (FDA) regulations and may perform audits of the clinical trial study records.

Prior to a patient being recruited for a clinical trial, there must be both legal and ethical steps to ensure the patient fully understands what their part in the clinical trial will entail. The IRB will review documentation presented to participants to ensure procedures, risks, and benefits are discussed. This process is known as informed consent. Informed consent consists of verbal and written documentation that confirms the participants acknowledge and understand their part in the clinical trial in its entirety. A signed informed consent document is part of the process for ensuring that the institution is compliant. This process is designed to help patients thoroughly understand what to expect as well as the risks and benefits of participating. It’s important to note that the informed consent form is only one part of the informed consent process; there must also be an ongoing process, including updating the participant of any new information throughout the study.

In conclusion, while some of the history of clinical trials is disheartening, today the IRB continues to provide advocacy and protection for any participant within in a clinical trial and remains to be an integral component to the welfare and safety of human participants within clinical trials.

Resources:

The History and Role of Institutional Review Boards: A Useful Tension:  https://journalofethics.ama-assn.org/article/history-and-role-institutional-review-boards-useful-tension/2009-04

Being in a Clinical Trial: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/what-does-a-clinical-trial-involve.html

Clinical Trials: What Patients Need to Know: https://www.fda.gov/patients/clinical-trials-what-patients-need-know

Thinking about joining a clinical trial? Here’s what you need to know:  https://www.health.harvard.edu/blog/thinking-joining-clinical-trial-heres-need-know-2016090110187