For Participants in Human Subject Research

Research participants contribute greatly to society through taking part in studies. UCI's Human Research Protections (HRP) and Institutional Review Board (IRB) exist to ensure the rights and welfare of research participants. Please see the below resources we curated to help answer common questions from participants:

Have a Concern or Complaint?

HRP is concerned about the safety, rights and welfare of all individuals participating in UCI research studies.

All reported concerns or complaints to the HRP are handled with care and taken seriously.

Reporting a Concern or Complaint

Human Research Protections (HRP) is concerned about the safety, rights and welfare of all individuals participating in research studies conducted by UCI personnel and/or at UCI, UCI Medical Center, or affiliated sites. All research concerns or complaints reported to the HRP are taken seriously.

The Consent form or Information Letter that you receive when you are invited to be a research participant includes the contact information of the researcher. We recommend that you contact the researcher if you have questions, concerns, or complaints about the research study, especially if you are experiencing medical problems.

If you have general research questions, concerns, or complaints about the research that we may be able to help resolve, or questions about your rights as a research subject, we encourage you to contact our office.

General Questions:
General IRB Phone Number: (949) 824-8170

Human Research Protections
160 Aldrich Hall
Irvine, CA 92697

If you contact our office, every precaution will be taken to maintain your confidentiality. If you report a problem, we might need to reveal your name or other information about you in order to investigate the problem. A representative from our office will contact you before revealing information about you.

Frequently Asked Questions

Research is an organized way of collecting information to help understand problems and test ideas for the benefit of society. UCI faculty, students and staff do research in many areas. Humans might participate in research about things like:

  • how or why an illness occurs or spreads
  • what treatments work best for an illness
  • how people behave or make decisions
  • the ways groups and societies are organized
  • what people think or believe
  • how people learn
  • the best ways to provide social services or healthcare

You may have heard the phrase "clinical trial." That is a name for research about health and illness in people, especially when the research compares treatments or uses experimental drugs or devices.  A drug or device is called "experimental" when the U.S. Food and Drug Administration (FDA) has not approved it for any use. A drug or device is also "experimental" when the FDA has not approved it to treat the illness that is being studied.

Participants help researchers in many ways. Depending on the goals of the research, participants might be asked to do things like:

  • Take part in interviews (sometimes as part of a group)
  • Complete questionnaires, tests or special tasks
  • Allow access to private information (such as medical records or school records)
  • Let researchers observe behavior
  • Complete physical, psychological or other kinds of examinations
  • Give samples of blood, saliva, urine or other materials
  • Take experimental drugs or use experimental medical devices

UCI’s Institutional Review Board (IRB)is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted by UCI faculty, staff, or students. UCI’s IRB is composed of more than 50 members representing University faculty and staff, as well as the local community. The IRB reviews research which involves human subjects to ensure that two broad standards are upheld: first, participants are not unnecessarily exposed to risk; second, they willingly give, without undue influence or coercion, informed consent to participate in the research. A project is first reviewed in its proposal stage - even before participants are recruited. An IRB can require changes to research, or even not allow research, to protect participants. When an IRB approves a researcher's plan (called a protocol), the researcher must follow that plan exactly. If a researcher wants to change the plan, an IRB has to review and approve the changes first (unless changes are needed right away to protect participants from harm). When issues arise, researchers must report those problems to the IRB. Each approved study is re-evaluated at least annually. The Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP) oversees the operation of the IRB, and the Food and Drug Administration (FDA) enforces regulations for the use of experimental drugs and devices.

Anyone can volunteer. People who volunteer for research come from all walks of life. Volunteers can be healthy or they may have a specific disease or condition. Volunteers can be younger or older adults as well as children. Everyone, regardless or gender, age, or ethnicity may volunteer for research.

Yes, children can participate in research studies. However, there are additional protections for children. For example, the parent(s) or legal guardian(s) must provide their permission for the child to participate. In addition, if a child is old enough to understand what the study is about, the child may also be asked to give his/her agreement or assent to participant in the research.

It is your decision whether or not you want to participate. In most cases you do not have to decide right away. You have the right to make this decision without any pressure. There will not be any consequences if you refuse. You do not have to participate in any research offered by your doctor.

To help you make an informed decision, you have the right to receive information about the study. Information will almost always be given to you in writing (written study information is called an "informed consent form" or "study information sheet"). The information must always be in a language you can understand. If you do not understand something, the study team must explain it for you in a way that you can understand. You have the right to ask questions at any time and to have your questions answered. If you decide to participate, you will be asked to sign and date the informed consent form. You have the right to receive a copy of the signed and dated written consent form.

You also have the right to leave the research at any time. If you leave the research, your decision will not affect your relationship with UCI or UCI Medical Center, or any rights or benefits to which you are entitled. You simply need to tell your study doctor or research staff that you have changed your mind. Depending on the study, the study doctor may ask you to come back for a final visit. This information should be included in the consent form or information letter provided to you.

The researcher will usually give you the information listed below. Some of the information below will only be given to you for medical studies.

  • Why the research is being done
  • Why you are being asked to participate
  • How long your participation will last
  • What will happen during the research (what you will do, the drugs you will take, etc.)
  • How the research is different from your usual medical care (research is not the same as treatment)
  • Any expected risks or discomforts that you might experience
  • How information about you will be protected
  • Any expected benefits
  • Any expected costs to you or your insurance provider
  • What you can do instead of participating, such as what treatments you can take that might work for you, and how those treatments compare to the research procedures
  • What medical treatment you will get in case of problems
  • If there are any possible conflicts of interest, for example:
    • If your doctor is part of the study, you will be told that he or she is interested in both your health and in the success of the study
    • If a member of the study team has a financial interest in the study, such as an investment that might increase in value if the study is successful
  • Reasons you might be asked to leave the research
  • Who can help you with problems or give you more information about the study or your rights

If you are concerned about any issue or you do not feel like you have enough information, tell the researcher at any time before, during or after the research.

While you are participating, you also have the right to be given new information that comes up. This information might include changes to what you will be asked to do, new risks or new treatment options. If you are given new information, you will be asked if you are still willing to stay in the research.

You will be presented with information about the study. This is called the informed consent process. Members of the study team, including the researchers, will discuss this information with you. They will usually ask you questions to make sure that you understand the information.

Once you understand the information and decide to participate, you will be asked to sign the consent form. You might also be asked to sign other documents, such as a form giving permission to use your medical records.

Before you go through informed consent, the researchers might ask some basic questions about you. This is to see if you might qualify to participate.
If you answer questions before giving informed consent, the researchers might still need more information about you after you give informed consent. This will be done to make sure that you qualify. If you are in medical research, this might include a physical examination, blood tests or other procedures.

Even if you give informed consent, you are not guaranteed a place in the research. In some cases, researchers can accept anyone who volunteers. In other cases, researchers can accept only a certain number of people or only people who fit exactly what they are looking for. If you do not qualify, it does not mean something is wrong with you. It just means that the study was not for you. There might be other studies that you qualify for.

If you qualify for a study, you will go through the exact steps of the approved research plan. What you undergo during the research should be exactly what is described in the consent form.

What will happen (and for how long) depends on the goals of the research. Sometimes researchers will be able to work around your schedule. In other studies, visits might have to happen at very specific times. All of this should be explained to you during the informed consent process.

Researchers are searching for new information and new answers to problems. Because of this, most research is not intended to provide you with direct benefits. Research can also have serious risks. When you participate in research, you are mostly contributing to scientific progress and helping society.

Research is not the same as treatment. In medical research, many of the drugs, devices and procedures being tested are experimental. This means that they have not been proven to work. There may be unknown risks. Although being in a medical study might help you, nobody can guarantee a direct benefit for you.

Payment will be explained to you during the informed consent process. Some studies do not have the resources to pay you. Other studies might pay you for the time and effort it takes to participate. The money is usually only enough to cover expenses (parking, transportation, meals, etc.) and maybe for some of the time you spend away from work.

The payment should not be enough to convince you to take risks that you normally would not take.

If you leave before the end of the research, you will usually be paid for that portion of the research you complete.

The most important thing to do is take an active role and communicate with the study team before, during and after the research. You should always ask questions if you are not clear about something, if you are curious about something, or if it seems like the research plan is different from what you were told. You have a right to have your questions answered. Take your time making decisions about whether or not to participate. You should seek the advice of trusted family members, friends or healthcare professionals before and during the research.

If you feel uncomfortable with what you are doing, or if you think you might be experiencing changes in your health (whether good or bad), let the study team know so that they can help you. Always keep in mind that participation in research is voluntary. If you feel like you are being pressured to join or stay in a study, you can always say no. You can leave the research at any time for any reason, and you do not have to explain your decision.

You can also contact our office with questions about your rights, or any problems or complaints about your experience with research at UCI.

Regulations to Protect Volunteers in Research

Learn about the regulations that protect people who participate in research, why we have them, and who enforces them. (Courtesy of: U.S. Department of Health and Human Services (HHS)).

Recommended Resources on the Web

UCI Center for Clinical Research
Provides a link to the clinical research studies being conducted by UCI College of Medicine Faculty members.

OHRP Human Research Volunteer Informational Videos (in English and Spanish)
A service of the National Institutes of Health provides regularly updated information about federally and privately supported clinical research in human volunteers. gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.

Provides information about clinical research as well as clinical trial listings.

A service of the National Library of Medicine and the National Institutes of Health that provides information on over 650 diseases and conditions, on prescription and nonprescription drugs, health information from the media, and links to thousands of clinical trials.

The Food and Drug Administration’s webpage that provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

Provides health information in both English and Spanish.

National Cancer Institute
Provides information about all types of cancer, cancer treatment, coping with cancer and links to cancer clinical trials.

Medical Privacy - National Standards to Protect the Privacy of Personal Health Information
The Office for Civil Rights provides information about your health information privacy rights Under the Health Information Portability and Accountability Act (HIPAA)

Health Information | National Institute on Aging  
The National Institutes on Aging's website provides aging-related health information.

Center for Information & Study on Clinical Research Participation (CISCRP)
Provides potential clinical research participants with many facts and information about the clinical trial process, including information about subjects’ rights, benefits, and risks; including answers to key questions people have about research. The Center also includes a way for people to sign up if they’d like additional information, such as a quarterly update called "The Participant."

Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness (PDF)
A publication by America's Health Insurance Plans.

Pamphlet from the Office of Human Research Protections: Becoming a Research Volunteer: It's Your Decision (PDF)

Folleto de la Oficina para la Protección de Seres Humanos en Estudios de Investigación: Ser Voluntario en Estudios Clinicos: Es Su Decisión (PDF)