The Clinical Trial Participant Bill of Rights
15 Essential Protections You Should Know
When you consider joining a clinical trial, there is a lot of information to absorb—study visits, eligibility criteria, specialized procedures, potential risks, and the medical discoveries researchers hope to unlock.
While learning about the science is important, there is another part of the conversation that deserves equal priority: your fundamental rights as a participant.
At Kalo Clinical Research, we prioritize transparency, respect, and patient safety above all else. Derived from the Center for Information and Study on Clinical Research Participation (CISCRP) guidelines, this Participant Bill of Rights outlines what you can expect, what you can request, and the choices that remain entirely yours—before, during, and after a study.
Your 15 Core Participant Rights
1. The Right to Know the Purpose
Before deciding whether to participate, you have the right to fully understand why the study is being conducted, what researchers hope to discover, and how the clinical trial fits into broader medical advancements.
2. The Right to Understand Potential Risks
Clinical trials can involve risks, discomforts, or unexpected side effects. You have the right to a clear, honest explanation of all known potential risks before making any decisions.
3. The Right to Learn About Potential Benefits
You should receive balanced information about potential benefits linked to participation. Because benefits are potential outcomes rather than guarantees, understanding both risks and benefits is key to making an informed choice.
4. The Right to Know What Participation Entails
You have the right to a full picture of what day-to-day participation involves—including the frequency of study visits, specific medical procedures, health monitoring, and any study medications or devices.
5. The Right to Know How the Study Differs from Standard Care
If a study treatment, procedure, or protocol differs from standard medical care you would normally receive, those differences should be clearly outlined for you.
6. The Right to Clear Expectations on Time Commitments
Some studies require a couple of site visits over a few weeks, while others span several months or years. You have the right to know the precise duration expected of you before agreeing to join.
7. The Right to Explore Your Alternative Options
A clinical trial is never your only path. You have the right to hear about alternative treatment options—including standard therapies—so you can compare choices objectively.
8. The Right to Information in Your Preferred Language
Language should never be a barrier to informed choices. You have the right to receive study materials in your preferred language and to request a professional medical interpreter when discussing participation.
9. The Right to Keep Asking Questions
Your right to ask questions doesn't expire when you sign a form. You have the right to ask questions before enrolling, throughout the trial, and whenever a new concern arises. Our clinical site team is always here to listen and answer.
10. The Right to Medical Care Plan Information
Before enrolling, you have the right to know what medical care or provisions will be made available to you if a study-related medical problem or adverse event occurs during the trial.
11. The Right to Full Financial Transparency
You have the right to clear, upfront information regarding all potential costs, insurance coverage expectations, and any compensation or stipend provided for your time and travel.
12. The Right to Bring a Support Person
You don't have to navigate clinical research decisions alone. You are always welcome to bring a trusted friend, family member, or care partner to your appointments to listen, take notes, and help you evaluate options.
13. The Right to Your Own Signed Consent Form
After completing the informed consent process, you have the right to receive a signed and dated copy of your Informed Consent Form to keep in your personal records for reference at any time.
14. The Right to Say No or Stop at Any Time
Participation is entirely voluntary. You have the absolute right to decline participation before a study starts, or to withdraw from a trial at any point, for any reason, without losing access to your routine standard healthcare.
15. The Right to Take Your Time Deciding
You will never be rushed into a decision. You have the right to take study documents home, consult with your personal physician or loved ones, write down questions, and make your decision when you feel completely comfortable.
Oversight & Protection: Your Rights Continue After You Say "Yes"
An Informed Consent Form isn't a contract that binds you—it's an ongoing dialogue.
Clinical research at Kalo Clinical Research adheres strictly to federal regulatory standards and ethical guidelines. Every study protocol is independently reviewed and monitored by an Institutional Review Board (IRB)—an independent committee dedicated solely to protecting participant safety, rights, and welfare.
Agreeing to participate never means waiving your rights. If concerns arise at any point during a study, you always maintain direct access to both our clinical trial staff and the presiding IRB.
Empowering Patients Through Informed Choices
At Kalo Clinical Research, we view clinical trial participants as true partners in scientific discovery. Providing clear information, honoring your decisions, and respecting your health journey are the foundation of everything we do.
Knowing your rights isn't just an extra feature of clinical research—it is the cornerstone of safe, ethical, patient-first care.
Resource Note:
This guide was adapted using educational guidelines from the Center for Information and Study on Clinical Research Participation (CISCRP) Participant Bill of Rights. CISCRP is an independent, non-profit organization dedicated to educating and engaging the public and patients as partners in clinical research. For additional educational resources, visit the CISCRP Education Center.
