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Information For Research Participants

 

UCLA is committed to protecting the rights, safety, and welfare of people who volunteer for research. Volunteers are also known as "subjects" or "participants." This page has basic information about research and about the rights of research participants.

 

 We hope this information will help you make informed choices if:

  • someone from UCLA asks you to participate in research,
  • you see or hear advertisements for UCLA research and think about volunteering, or
  • you want to volunteer for research, but you do not know where to start.

 

 

 


Table of Contents

 

General Information about Research

 

What to Know Before Volunteering to Participate in Research

 

 Rights of Research Participants

 

Whom to Contact with Complaints or Concerns

 

What is research?

 

Research is an organized way of collecting information to help understand problems and test ideas for the benefit of society. UCLA faculty, students and staff do research in many different areas.

 

People might participate in research about things like:

  • how or why an illness occurs or spreads
  • what treatments might work best for an illness
  • how safe and effective an experimental drug or device is
  • 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

 

Research may take place in a variety of locations, including hospitals, doctor offices, nursing homes, classrooms, over the Internet or by phone.

 

Clinical Trials:

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. You can find more information about "clinical trials" and other definitions at ClinicalTrials.gov.

 

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 condition that is being studied.

 

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Who reviews and approves research at UCLA?

 

One way that UCLA protects participants is by having special committees review most research involving people. These committees are called Institutional Review Boards, or IRBs. UCLA has several IRBs covering different areas of research. UCLA sometimes relies on the IRB reviews of other organizations or institutions.

 

UCLA IRBs include both scientists and people who are not scientists. Most of the members are UCLA faculty and staff. There are also members from the community who do not have any ties to UCLA. This helps ensure inclusion of different perspectives. University leadership appoints IRB members based on their expertise and protects them from undue influence.

 

IRB review and approval must happen before the research starts. An IRB generally must make sure that:

  • the risks of research are managed
  • the risks are reasonable compared to the possible benefits (an IRB looks at possible benefits to both participants and to society)
  • participants will be fully informed before, during and after the research (with some limited exceptions)
  • participants will be selected and treated fairly
  • privacy and confidentiality are protected
  • extra protection is provided to vulnerable people, such as children

 

An IRB may require changes to research, or even not allow research to take place, in order to protect participants. When an IRB approves a researcher's plan (called a protocol), the researcher must follow that plan.

 

UCLA also has other committees, besides the IRBs, to review specific issues. Examples of these issues include financial conflicts of interest, cancer research, the safe use of x-rays and other radiation, and the use of stem cells. The IRBs work closely with these other committees to help protect participants.

 

If you are asked to join research, but you are not sure if it is approved, you may contact the UCLA Office of the Human Research Protection Program (OHRPP) to check. OHRPP is an office that helps the IRBs.

 

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Who watches over research while it is being done?

 

The UCLA Office of the Human Research Protection Program (OHRPP) remains involved throughout the course of the research project.

 

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). If unexpected problems come up, researchers must report those problems to the IRB.

 

Depending on the level of risk, the IRB might also need to review the research from time to time to make sure that it is going as planned.

 

OHRPP and other offices inspect some UCLA research studies. Some sponsors (organizations that cover the costs of research) inspect the research they support. The government may also inspect researchers and IRBs to make sure that participants are being protected and that regulations are being followed.

 

Sometimes medical research studies use special committees to look at detailed information about the research while the research is going on. These committees follow special rules for changing or stopping a study. A study might be stopped if it meets its goals early or if it looks like the study will not meet its goals. This might also happen if safety problems come up more often than expected or if problems are more serious than expected.

 

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Where can I find more general information about research?

 

The websites listed below include general information about research:

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How can I find a research study to participate in?

 

  • Advertising appears on television, radio, public transportation, social media, and the Internet. Advertising also appears in community newspapers and public areas (bulletin boards, clinic waiting rooms, telephone poles, etc.). Advertising always includes a way to contact the researchers for more information.
  • Ask your healthcare providers if they are doing research, or if they might be able to refer you to a researcher or to other sources of information.
  • Advocacy groups, interest groups or social organizations often work with researchers who are looking for people with certain characteristics, with a particular disease or from a specific community or group of people.
  • Clinicaltrials.gov (a federal government-run registry that lists many clinical trials conducted in the US and around the world)
  • Searchclinicaltrials.org (a website run by a non-profit organization called CISCRP)
  • AIDSinfo (a government-run website that lists HIV/AIDS research)
  • The clinical trials website of the National Cancer Institute (listings and information)
  • Contact a UCLA Department, Division or Research Center directly:
    • A list of departments and divisions of the David Geffen School of Medicine at UCLA
    • The clinical trials website of the UCLA Jonsson Comprehensive Cancer Center

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What are participants commonly asked to do?

 

Participants help researchers in many different 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 blood, saliva, urine or other samples
  • take experimental drugs or use experimental medical devices

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What information should the researcher give to me?

 

The researcher will usually give you the information listed below. The information that is followed by an asterisk (*) will be given to you only 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 may experience
  • how information about you will be protected
  • any potential benefits
  • any expected costs to you or your insurance provider*
  • other choices you have if you don’t want to participate. This includes other treatment options that may help you*
  • medical treatment you will receive in case of a bad reaction or unwanted response related to the research*
  • reasons you might be asked to leave the research
  • if any of the researchers have conflicts of interest
  • what the researchers will do with genetic testing results
  • what will happen to any samples provided (such as blood or urine) after the study is complete
  • who can help you with problems or give you more information about the study or your rights

 

If you are being asked to participate in medical research, California Law requires that you are informed of and provided a copy of the "Subject's Bill of Rights" (Research Participant's Bill of Rights). The Research Participant's Bill of Rights lists your rights as a research participant.


If you are concerned about any issue or you do not feel like you have enough information, ask the researcher questions 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 participate in the research.

 

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What questions might I want to ask before agreeing to participate?

 

Your participation in a research study is voluntary. It is your decision whether or not you want to participate. It is important that you have the information needed to make such a decision. To help you prepare questions you may want to ask the researcher, click here for a list of commonly asked questions.

 

Remember: You have the right to get all of your questions answered. If you do not understand the answer or would like further clarification, ask the question again.

 

For additional information to help you decide if you want to participate in research, please visit the U.S. Office for Human Research Protections (OHRP) website for a series of short videos about research participation.

 

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What will happen if I decide to volunteer for research at UCLA?

 

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 (or in some cases give verbal or online consent). You might also be asked to sign other documents, such as a form giving permission to collect data from your medical records.

 

The researchers may need to ask some basic questions or perform procedures to make sure you qualify for participation. If you participate in medical research, this may include a physical examination, blood tests or other procedures. This part of the research is called "screening.”

 

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 in the research plan.

 

If you do not qualify, it does not mean something is wrong with you. It just means that the study was not right for you. There might be other studies that you qualify for.

 

If you qualify for a study, you will go through the steps of the approved research plan. What you undergo during the research should be 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.

 

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What are the benefits of participating?

 

Researchers are searching for new information and new answers to societal or health-related problems. With these answers they hope to design solutions or programs, but these solutions take time. Most research is not intended to provide you with direct benefits. However, when you participate in research, you are 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) and there is no guarantee that your condition will get better. There may also be both serious and unknown risks. Some medical research, however, may result in improved health.

 

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Will I be paid for participating?

 

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 possibly 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 the portion of the research you completed.

 

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Who else will know that I am participating in research?

 

Members of the study team, and when appropriate, others who are involved with your medical care or who have permission to see your records, will know that you are participating in research.

 

Other authorized people involved in running the study or making sure that it is done properly and that your rights are protected may see information about you.

 

The consent process should include more details about privacy and confidentiality.

 

If you are participating in medical research, it is a good idea to let your primary healthcare provider know. S/he will want to know how this might affect your medical care.

 

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Can I be removed from the research study?

 

The study team may choose to remove you from a study, even if you want to continue. This may happen for a number of reasons. For example, if you miss too many study visits, if the study closes because there are not enough people interested in participating, or because of concerns for your safety.

 

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What happens if I leave a research study?

 

You always have the right to leave the research study at any time and for any reason, and you do not have to explain your decision to anyone. For example, you might feel less comfortable than you thought you would, or maybe the research takes up too much of your time. Nobody should pressure you into staying in the research if you do not want to.

 

You do not have to, but you may discuss any problems with the researcher before leaving. They may not be able to resolve the problem, but it may be helpful for them to know why you cannot continue.

 

If you leave a medical study, you may be asked to come back once or twice for some extra safety tests. This is to make sure that you are not having any problems related to the study. You do not have to come back, but it is usually important for your safety that you do.

 

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What happens when the research study ends?

 

When you complete everything (or if you leave the study early), that is usually the end of your participation.

 

The consent form might describe extra contact with the study team after the study. The researcher might send you information about your participation, including any new information that might affect your health. If you were using an experimental drug or device, sometimes you may be able to continue using the drug or device. You might be asked if you are willing to be contacted about other research in the future.

 

At the end of the study, the researchers put together all the information they have collected. They will analyze that information. They may publish the results in scientific journals, present the results at conferences or use the results to develop more research.

 

Sometimes the study information from UCLA will be combined with information from other places doing the same study. If a company paid for the research, the company might use the information to help obtain an approval by the U.S. Food and Drug Administration (FDA).

 

Researchers may or may not be able to provide you study results at the end of the study. Sometimes it takes many years to achieve study results. You should ask the study investigator about this before you enroll.

 

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What rights do I have as a participant?

 

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 most likely be given to you in writing (written study information is called an “informed consent form” or “research information sheet”). The information must always be in a language you can understand. The type of information you will get is described in the “What information should the researcher give to me?” section of this page.

 

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 may be asked to sign and date an informed consent form. You have the right to receive a copy of the form to take home.

 

You also have the right to change your mind and leave the research at any time. If you leave the research, your decision will not affect your relationship with UCLA or UCLA Health, or any rights or benefits to which you are entitled. Sometimes, however, you will be asked to perform certain procedures in order to safely leave a medical study.

 

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How does UCLA protect participants?

 

It is a privilege for UCLA to involve people in research. UCLA takes this privilege very seriously. Federal regulations, state laws and University of California policies require that UCLA protect the rights, safety, and welfare of research participants.

 

Everyone at UCLA is responsible for following these requirements. Every participant receives the same high level of protection. This is true no matter who pays for the research or where the research actually takes place.

 

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How do I protect my rights if I volunteer?

 

The most important thing to do is to take an active role and communicate with the study team before, during and after the research. 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 the 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 may, however, be asked to perform certain procedures in order to safely withdraw you from a medical study.

 

You can also contact the UCLA Office of the Human Research Protection Program (OHRPP) with questions about your rights or any problems or complaints about your experience with research at UCLA.

 

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How can I get more information about my rights or if I have a problem?

 

If you are already participating in research, communicate with your study team first, especially if you are experiencing medical problems.

 

You can also contact the UCLA Office of the Human Research Protection Program (contact information below) for help if:

  • you want general information or have general questions about research or your rights
  • you wish to discuss problems, suggestions or concerns
  • you do not feel comfortable communicating with the study team
  • you want advice about how to communicate with the study team
  • you have communicated with the study team, but they have not been able to help you

 

If you contact OHRPP, 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 OHRPP will contact you before revealing information about you.

 

You may contact OHRPP by mail, phone, fax, or e-mail.

 

UCLA Office of the Human Research Protection Program (OHRPP) 
Box 951406
Los Angeles, CA 90095-1406

 

Telephone: (310) 206-2040
Fax: (310) 794-9565
E-Mail: participants@research.ucla.edu

 

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Whom can I contact if I have a complaint or concern about a study?

 

If you do not want to discuss your complaint or concern with the study team, you may contact the UCLA Office of the Human Research Protection Program (OHRPP) directly at the contact information above or by completing this form. The form itself contains instructions.

 

Thank you for considering participation in research at UCLA. It is an important decision and we hope that the information provided above will assist you in making that decision.

 

 

 

Page Last Updated: March 14, 2018