FAQs About Clinical Research Studies and Their Safety

Are clinical research studies safe?

There are protective measures in place to ensure that your safety is protected during the course of a clinical study.  Before people can enroll in a study funded by the federal government, the protocol and procedures involved in the study must be reviewed by a group of experts from the field associated with the disease (Institutional Review Board).^1-2 In addition, researchers doing the clinical studies on human participants are required to complete special training on clinical research regulations and processes before they can help with the study.

You, as the participant in the study, have rights to be informed of the purpose of the study, the procedures associated with the study, potential study risks and benefits. Informed consent is the process where you will learn about all of the study details before you enroll in the study.

As part of the informed consent process, you also have the right to leave the study at any time.

After the specifics of the clinical study have been explained to you by the research team, and you understand the study details, you will be asked to sign an informed consent form. Even after you sign the form, you can always ask for more information as the study progresses. You can also leave the clinical study at any time. Just because you have signed an informed consent form, you are not obligated to continue participating in a study if you are uncomfortable. 

There are newer measures being added to clinical study requirements to increase the inclusion of diverse participants. In 2024, the FDA released updated guidance for clinical studies to have greater diversity and inclusion in the studies, especially when studying diseases that disproportionately affect Black or underrepresented communities.

When more diverse populations participate in a clinical study, it allows researchers to observe how safe and effective the new drugs can be for more people.² Historically, pregnant women have been excluded from clinical studies because of the unknown risk to the unborn child. This has limited the availability of information about the effect of medications during pregnancy. In recent years, the FDA has issued guidelines for including pregnant women in clinical studies. In order for a pregnant woman to be included in a clinical study, researchers, manufacturing companies, the investigational review board are recommended to follow regulations and guidelines by the FDA and the Department of Health and Human Services to protect the mother and child.³ 

FAQs and Answers: 

What is informed consent?

Informed consent is the process where you learn about the study details before you enroll in a study. During this process a researcher will explain the specifics of the study to you and make sure you understand. You will sign an informed consent form stating that you understand the purpose of the study, the processes within the study, and you agree to participate.

If I feel uncomfortable during a clinical research study, am I obligated to participate?

The Informed consent process makes sure you understand the clinical study before you participate. After the specific details about the study have been explained to you, you will be asked to sign an informed consent form. You can leave the study at any time, even after you sign the form.

Are clinical research studies safe?

There are potential risks associated with each study, but there are measures in place to protect your safety when you participate in a clinical study. Before the study can begin, experts review the safety details of the study. Also, any potential risks associated with the study will be explained to you beforehand, and if you ever feel uncomfortable participating in the study at any time you can leave the study. 

Are clinical research studies available at no cost?

In most cases, your participation in the clinical study may be covered in multiple ways. The sponsoring company that is testing the drug may pay a portion for the study medication. Your insurance may pay another portion. Sometimes, you will have to pay some of the costs associated with the study drug. Because of frequent clinic visits during the study, you may also have additional costs for travel, housing, transportation, or child care. 

Are there benefits to participating in clinical research studies?

Participation in clinical studies may be beneficial. Depending on the study, you may have access to investigational medications before they are widely available to the public. You also will get study-related care from the physician and research team as a study participant. Lastly, your participation helps the development of treatments for your disease so by participating you may be helping yourself and helping others.

Interested in learning more?

Find out why clinical research is so important for Black people in particular and how they are designed to protect us.