What are my rights as a participant?

Here's how we protect you every step of the way.

  1. Informed consent: Before joining a trial, you will receive detailed information about its purpose, potential risks, and benefits. You can ask questions and discuss any concerns with the physician and study team before you decide.
  2. UCI Health Experimental Subject's Bill of Rights: The State of California requires that any person participating in a clinical trial is entitled to a bill of rights.

    Read the Experimental Research Subject’s Bill of Rights
  3. Ethical review: An independent ethics committee (Institutional Review Board) carefully reviews and approves each trial to ensure it meets ethical standards and poses minimal risks to you.
  4. Safety monitoring: We have a comprehensive plan in place to monitor and manage any adverse events or side effects that may occur during the study.
  5. Data confidentiality: Your privacy is paramount. All your personal information and study data are kept strictly confidential and secure.
  6. Patient withdrawal: You have the right to withdraw from the trial at any time, without facing any penalties or losing any benefits.
  7. Medical care: Regardless of whether you receive the experimental treatment, you will receive the highest standard of medical care and treatment throughout the trial.
  8. Compensation: We understand that participating in a trial may involve time and expenses. While compensation may be provided, it's important to note that it's never used as a coercive factor for participation.

Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that your rights, safety, and well-being are protected and that the clinical trial data are credible.

Regulatory groups

Regulatory groups help ensure researchers conduct clinical trials safely and ethically, and that new therapies are safe and effective. These include, but are not limited to:

FDA: The U.S. Food and Drug Administration sets high standards for the safety and effectiveness of drugs, biologics, and medical devices. It carefully reviews and approves new therapies to ensure they meet these standards.

ICH: The International Council for Harmonisation develops guidelines for the pharmaceutical industry, including those for clinical trials. These guidelines, followed by regulatory bodies worldwide, help ensure the safety and effectiveness of new therapies.

IRB: Institutional Review Boards are independent committees made up of diverse experts, including scientists, physicians, and community representatives. They help protect your rights and welfare. Before a study begins, the IRB reviews and approves the study protocol, informed consent process, and other documents to minimize risks and ensure your full understanding of the study. Throughout the study, the IRB monitors progress and addresses any concerns that may arise. If you'd like to learn more, visit UCI's IRB website.

These measures ensure that your participation in clinical trials is treated with respect and care, protecting your rights, dignity, and well-being throughout the process.

Contact Our Recruitment Team

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI