Are Clinical Trials Safe? Understanding Participant Protections
If you’ve ever considered joining a clinical trial, you may have questions about your safety and what protections are in place.
Participant safety and well-being are a priority throughout the clinical trial process. Clinical trials include safeguards designed to protect participants and help ensure you have the information you need before and during a study.
While every clinical trial may involve potential risks and benefits, understanding what to expect and how participants are protected can help you feel more informed and confident when deciding whether participation is right for you.
Clinical Trials Undergo Review Before They Begin
Before participants enroll, clinical trials undergo a review process based on the type of research being conducted and applicable regulatory requirements.
A clinical trial follows a detailed research plan called a protocol. The protocol describes how the study will be conducted, who may be eligible to participate, what procedures will take place, how participants will be monitored, and how safety information will be collected and evaluated.
Depending on the study, clinical research in the United States may also be subject to oversight by the U.S. Food and Drug Administration (FDA) and other federal requirements.
These processes are intended to help identify and manage potential risks, but they do not eliminate all risk or guarantee a particular outcome.
Informed Consent Helps You Make an Informed Decision
One of the most important protections for clinical trial participants is the informed consent process.
Before deciding whether to participate, you’ll receive information about the study that may include:
- The purpose of the clinical trial
- What procedures and visits are involved
- Known or reasonably foreseeable risks and discomforts
- Potential benefits, if any
- Available alternatives to participation, when applicable
- Costs and compensation, if applicable
- Your rights as a research participant
- Who to contact with questions or concerns
Informed consent is more than signing a form. It is a process that gives you the opportunity to review information about the study, ask questions, discuss concerns with the research team, and decide whether you want to participate.
Participation in a clinical trial is voluntary, and you should have the opportunity to make your decision without coercion or undue influence.
An Institutional Review Board Reviews the Research
Clinical trials involving human participants generally undergo review by an Institutional Review Board (IRB) as required by applicable regulations.
An IRB is a committee that reviews research involving people with the goal of helping protect participants’ rights and welfare. IRBs include members with different professional and community perspectives, including members whose primary concerns are in scientific areas, members whose primary concerns are in nonscientific areas, and at least one member who is not affiliated with the institution.
As part of its review, an IRB may evaluate:
- The study design and research procedures
- Potential risks and anticipated benefits
- The informed consent process and documents
- Participant protections
- Recruitment and advertising materials
IRB oversight may continue throughout the study as required. An IRB may require changes to research or take other actions when necessary to protect research participants.
Participants Are Monitored During the Trial
Participant monitoring continues after enrollment.
Depending on the clinical trial, participants may attend scheduled visits, complete health assessments, undergo laboratory testing, or report symptoms and side effects. The research team collects and evaluates safety information according to the study protocol.
Researchers are also required to follow procedures for documenting and reporting certain adverse events and safety information.
If important new information becomes available that may affect a participant’s willingness to remain in the study, participants may be provided with updated information.
Some clinical trials also use an independent Data and Safety Monitoring Board (DSMB) or similar monitoring committee to periodically review accumulating study data and make recommendations about whether the study should continue, be modified, or stop.
You Can Choose to Leave a Clinical Trial At Any Time
Participating in a clinical trial is voluntary.
You can choose not to participate, and if you do enroll, you generally have the right to withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled.
If you decide to withdraw, the research team may discuss recommended follow-up procedures and explain what happens to information or samples already collected as part of the study.
Understanding Risk Is Part of the Decision
Clinical trials play an important role in evaluating potential new treatments, medications, devices, and approaches to medical care. However, because clinical research is designed to answer questions that may not yet have complete answers, participation can involve uncertainty.
Protections such as informed consent, IRB review, study protocols, regulatory oversight when applicable, and ongoing monitoring are intended to help protect participants and identify or manage potential risks.
They do not mean that a clinical trial is risk-free or guarantee that an investigational treatment will be safe, effective, or beneficial for an individual participant.
Before joining a study, consider asking the research team about the specific risks, potential benefits, alternatives, procedures, and time commitments involved. Taking the time to understand the study can help you decide whether participation is right for you.
Interested in Learning More?
If you’re considering clinical research and want to better understand what participation may involve, the Equity Medical team is available to answer questions about our current studies and the research process.
We believe prospective participants should have clear information about a study so they can make an informed and voluntary decision about participation.
Visit the Equity Medical “Why Participate?” page to learn more about clinical research opportunities and what you may be able to expect as a participant.
