Sandra Maddock, President & CEO, IMARC Research

Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.

The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection.

In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent.

What is the Belmont Report?

The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with the disease, and passed congenital syphilis onto their children.

Following the Tuskegee study, Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission met regularly for nearly four years, culminating in a four-day discussion at the Smithsonian Institution’s Belmont Conference Center in February 1976.

The resulting Belmont Report summarized the three ethical principles the commission concluded should guide human research:

• Respect for persons: All individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection
• Beneficence: Researchers should maximize possible benefits and minimize possible harm
• Justice – All persons should be treated equally, and the selection of research subjects should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class or other factors

The Belmont Report remains a primary ethical framework for researchers today.

How the Belmont Report defines informed consent

The Belmont Report addresses informed consent as a necessary part of showing respect for all persons. It states that all subjects, to the degree that they are capable, should be given the opportunity to choose what shall or shall not happen to them.

According to the report, informed consent requires three elements: information, comprehension and voluntariness.

Information

Research subjects “must be given sufficient information about the research procedure, their purposes, risks and anticipated benefits and alternative procedures (where therapy is involved).” They should be given the opportunity to ask questions and have the right to withdraw from the research at any time.

In cases where informing subjects about some pertinent aspect of the research is likely to impair the validity of the research, the Belmont Report states withholding information is justified only if the following three criteria apply:

1. Incomplete disclosure is truly necessary to accomplish the goals of the research
2. There are no undisclosed risks to subjects that are more than minimal
3. There is an adequate plan for debriefing subjects, when appropriate, and for disseminating research results to them

Researchers should never withhold information about risks for the purpose of getting a subject to cooperate.

Comprehension

The Belmont Report states that “the manner and context in which information is conveyed is as important as the information itself.” For instance, allowing too little time for the subject to consider the information could affect their ability to make an informed choice.

That means researchers need to consider a subject’s maturity, capacity for understanding, language and literacy when presenting information to obtain informed consent. In some cases, the report states, it may be appropriate to give oral or written tests of comprehension.

Related: What Does “Understandable Language” Mean In Informed Consent?

When a subject’s comprehension is severely limited due to age, disability or other factors, researchers need to seek the permission of other parties to protect them from harm.

Voluntariness

Informed consent means there is no coercion or undue influence. In other words, researchers cannot threaten harm or offer an “excessive, unwarranted, inappropriate or improper reward” to obtain compliance.

That means researchers need to take special care when conducting clinical trials involving vulnerable people who are under the authority of someone else, such as inmates or people who are ill.

Other considerations involving informed consent

On the surface, informed consent seems like a straightforward concept. However, the evolution of clinical research and the introduction of new technologies continue to raise new questions about its application.

For instance:

• What additional considerations apply when informed consent is obtained electronically?
• How can researchers avoid overstating the potential benefits of a medical device?
• How can researchers avoid undue influence when enrolling employees in a clinical trial?

The FDA released its latest guidance on informed consent in 1998 and has drafted an update to that document that has yet to be finalized. While it’s not likely we’ll ever see the “last word” on informed consent, the Belmont Report serves as an important and timeless reminder of the fundamentals of informed consent.

Curious to learn more about the origins of informed consent, Good Clinical Practice and other research guidelines? Explore the history of clinical research in this interactive timeline.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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