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Understanding Clinical Trials

Participant Safety in Clinical Trials

Are clinical trials safe? That's not a silly question. These advanced studies are critical to advancing science and ensuring that specific medications, devices, and therapies are safe and effective before they hit the market. But how can researchers do that without some risk to volunteers?

The simple truth is that they can't. Side effects may occur. Benefits aren't guaranteed. That said, clinical trials have some of the strictest safety guidelines out there.

In this article, we'll take a closer look at the risks you may face when you become a clinical trial participant. We'll examine the oversight process and the steps researchers take to protect your rights. In the end, you'll feel confident that you have the information needed to decide if signing up for a clinical trial is right for you.

Participant Safety in Clinical Trials

A Brief History of Clinical Trials and Safety Standards

In 1974, Congress passed the National Research Act, creating rules for research involving human subjects. Soon after, the Belmont Report outlined three guiding principles that still shape clinical research today:3

  • Respect for persons — recognizing autonomy and protecting vulnerable populations
  • Beneficence — maximizing benefits while minimizing harm
  • Justice — ensuring fair distribution of the burdens and benefits of research

Since then, the U.S. Food and Drug Administration (FDA) has continued to evaluate the regulation of clinical studies to strengthen participant safety.

Modern Protections for Clinical Trial Participants

In recognition of past mistakes, today's safeguards work together to protect people who join clinical trials. They include independent review by Institutional Review Boards (IRBs), the informed consent process, and oversight from Data and Safety Monitoring Boards (DSMBs). Together, these measures ensure that modern clinical trials are conducted with both scientific integrity and participant well-being in mind.4

Researchers must clearly outline how they will protect the human rights of participants before they begin recruiting people. They must also demonstrate to the oversight boards that they adhere to the established safeguards throughout the study.

If anything is amiss, the study is promptly shut down.

What Are the Risks of Participating in Clinical Trials?

Clinical studies happen in phases, with each phase of research carrying its own level of uncertainty. What's more, experiences can differ from one participant to the next.

The following is a general guide to these risks; you'll also want to review and ask questions about specific risks in any study you plan to join.

Side Effects

Starting in Phase 1 of a clinical study, researchers will observe and document the occurrence and severity of side effects. It's vital to note that they've already tested the device, medication, or therapy in animals and would not proceed to human studies if the results were concerning.

That said, humans have some different mechanisms, systems, and levels of awareness in comparison to lab animals. Therefore, unexpected side effects may become apparent during the first phase.

Side effects can certainly occur in subsequent phases. However, by then, researchers will be aware of most issues and have plans in place to minimize their impact.

Uncertainty of Benefit

Many people with health conditions join later-phase trials, hoping that an investigational treatment will help when standard care hasn’t worked. While this is possible, there’s no guarantee of improvement. Additionally, in blinded studies, you may not know whether you’re receiving the new drug, a placebo, or standard therapy until the trial ends.

Placebos (a fake version of the treatment) are critical to obtaining clean data. They can identify health improvements that occur by chance or due to the placebo effect.

The placebo effect is a natural human bias in which participants may think they're getting better or experiencing side effects because they believe that's what will happen. Participants and researchers alike can experience this bias.

Time Commitment

The time commitment will be outlined before you give your consent. It could include things like:

  • Keeping a symptom and side-effect diary
  • Attending regular meetings or consultations
  • Spending time in a hospital or lab
  • Undergoing medical tests

This time commitment can create inconvenience and stress that you agree to accept when you give your informed consent.

How Participant Safety Is Protected

Risk always exists. That's not a reason to ignore it. Researchers use certain procedures to both reduce the risk level and make sure you understand it.

Selective Recruiting in Phase 1

To reduce risk to participants during the first study on humans, researchers recruit generally healthy people for the initial phase. As healthy people, they are less likely to have a severe reaction. This provides researchers with an opportunity to pinpoint the dose size that delivers the most benefits with the fewest troubling side effects.

Protocol

A clinical trial protocol is a detailed plan outlining how research is conducted. This protocol is reviewed by independent experts (who don't benefit from the study's results). These individuals make sure the study is ethical, scientifically sound, and designed to minimize risks.

Federal regulations require that safety procedures be built into the design, such as monitoring for side effects at frequencies relative to the risk level, so more serious effects are caught quickly. They also provide participants with access to appropriate medical care if problems arise. If there's one risk you should not have to worry about, it's paying for care when you have a side effect that needs treatment. That's covered!

Participants also have the right to withdraw their consent at any time. This safeguard ensures that no one is forced to stay in a study against their will. If you choose to leave, your regular medical care and any treatment for side effects will continue without interruption.

Oversight

Oversight from an independent organization is essential to ensuring ethics and safety. Research teams collect and analyze safety data at every stage, and independent committees regularly review this information. If a treatment causes unexpected harm, the study can be modified or even stopped early.

Institutional Review Board (IRB)

In particular, the Institutional Review Board primarily works to safeguard the rights, safety, and well-being of participants.

By law, any clinical trial in the United States that involves FDA-regulated products must be approved by an IRB before it can begin. The board is made up of at least five members, including scientists, medical professionals, and at least one non-scientific community member. This mix of expertise ensures that decisions consider both scientific validity and the perspective of everyday participants.

Data and Safety Monitoring Committee (DSMC)

A Data and Safety Monitoring Committee, sometimes called a Data and Safety Monitoring Board (DSMB), is an independent group of experts that oversees the progress of a clinical trial while it is underway. The committee reviews safety data, monitors the quality of the study, and determines whether participants are being exposed to unnecessary risks. Its members typically include physicians, statisticians, and other specialists who are not part of the research team, ensuring their judgment is unbiased.

Informed Consent Process: What to Expect

Informed consent is more than just signing a form. It’s a process designed to make sure you fully understand what a clinical trial involves before agreeing to take part. Review the potential risks, requirements, and time commitments to make sure you can accept them. Ask questions if something is unclear.

Key points covered during the informed consent process include:

  • The fact that you can refuse or withdraw at any time
  • How your privacy and personal information will be protected
  • That the FDA or other regulators may review study records
  • Who to contact if you have any questions or concerns
  • The fact that you could get a placebo (when applicable)

Informed consent isn't always a one-time thing. If new information becomes known, such as unexpected side effects, you may be asked to sign a new consent form to continue participating in the study.

For children and certain adults, a guardian may be able to give consent.

Know the Risks to Join With Confidence

Clinical trials always carry some level of risk, but they are built on a framework of safeguards designed to protect participants. From informed consent and IRB review to oversight by independent safety committees, every step of the process is monitored to ensure that rights, safety, and well-being remain the highest priorities.

Learn about the risks and make sure you agree to accept them before giving consent. And if you choose to sign up, know that you're helping advance science one study at a time.

Sources

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