Here’s What We Know: How Clinical Trials Are Monitored for Safety

Clinical trials give you access to the next generation of medical breakthroughs. If you choose to participate in a clinical trial, many checkpoints are in place to ensure clinical trial safety every step of the way. 

Here are a few ways we work with you to ensure clinical trials remain safe for you, your loved ones and other people who take part in clinical research studies. 

Your Role in Clinical Trial Safety 

When you sign up for medical care in a clinical trial, you play a role in your safety. Your role depends on your age or the age of the child enrolled as a participant in a clinical trial. 

For You: Informed Consent 

Before signing up for a clinical trial, it is essential to learn as much as possible about it. This way, you can enter the trial with clarity and confidence. This educational process is part of giving informed consent.  

A few pieces of information you’ll learn before giving consent include: 

As the trial moves forward, you may change your mind about participating. If you become uncomfortable with the benefits and risks, you can withdraw from the study at any time, for any reason. 

For Your Child: Legal Consent 

Children under 18 years of age cannot sign themselves up to participate in research. At least one legal guardian, such as a parent, must provide permission. This is known as legal consent. 

The process for giving legal consent is similar to informed consent. You learn about the benefits and risks of the trial, clinical trial safety measures and more. If you feel comfortable with the purpose and potential risks, you grant your child legal permission to participate in the trial. 

Some pediatric trials require special consent, such as: 

Outside Agencies That Protect Clinical Trial Safety 

Professional organizations also help promote and protect the safety of clinical trials. Every study at Weill Cornell Medicine depends on such oversight to protect your health and wellbeing.  

Organizations that provide scientific oversight of clinical trials include: 

• Data and Safety Monitoring Board (DSMB). Research and specialty experts review clinical trial data to detect safety issues and other potential problems. They also review data from previous trials and stop current trials if the research isn’t needed or puts participants at unnecessary risk. 
• Institutional Review Boards (IRB). Physicians, community members and statisticians evaluate a study’s purpose and safety measures. Members of the IRB then ensure potential benefits outweigh potential risks, patients are protected and the trial has ethical means and goals. 
• Office for Human Research Protections (OHRP). When the U.S. Department of Health and Human Services performs or supports research, the OHRP oversees the study. A major goal of the OHRP is to protect patients’ rights and welfare. 
• U.S. Food and Drug Administration (FDA). Any research trial involving new medication or medical devices requires FDA oversight. The FDA checks for informed or legal consent, ensures proper safety procedures are followed and provides guidance to protect patients and lead to the most beneficial outcomes. 

Conclusion  

Today, clinical trial safety is guarded by multiple organizations and individuals. This helps you engage in clinical research trials with confidence. 

Visit the Joint Clinical Trials Office at Weill Cornell Medicine to learn about ongoing clinical trials.