Research and Economic Development

Resources

Some of our research committees are transitioning to Kuali's online applications to help streamline the management of research protocols. For details and training resources related to Kuali, visit UCR's Kuali Research Page.

Resources Related to Specific Research


Resources for Research Participants

Are you considering becoming a research participant? This page provides important information to keep in mind.

Spanish language videos about research participation

Printable copy of the Frequently Asked Questions below

  • Who are we?

    Research Compliance provides broad oversight, resources and education for integrity and compliance issues relating to the conduct of research at UCR. We strive to promote excellence in research while ensuring compliance with federal and state regulations. Research Compliance has oversight and responsibility over the research compliance committees on campus. For the purposes of this page, we will be discussing human subjects research.

  • What is an Institutional Review Board (IRB)?

    The Institutional Review Board- Socio-behavioral (IRB-SB) and the Institutional Review Board-Clinical (IRB-Clin) review and approve studies that involve human research participants. These committees are independent from the studies they review. The membership of the committees include faculty, medical personnel, scientists, and people from the community. They review human research to make sure it is well-planned and that the study has a favorable risk-benefit ratio. The IRBs serve to protect your rights and your welfare prior to the initiation of the research. The IRBs may also review studies while they are ongoing to make sure volunteers are protected.

    The IRBs do not decide for you nor endorse any particular study. Whether or not you should participate in a research study is a decision for you to make after contemplation of the risks involved. You are encouraged to compile a list of questions and call the study coordinator or principal investigator for answers (see ‘What questions should I ask?’ below) before enrolling in the research.

    If you have questions, concerns, or complaints about your involvement in the research, you should talk to the research team. If the issue is still unresolved or you had an unpleasant experience or have questions about your rights, please contact the IRB at (951) 827 - 4802 or irb@ucr.edu. You can also send a letter to 900 University Ave, UOB 216, Riverside, CA; 92521. Please provide as much information as possible (dates, names, location, study title, etc.).

    We will review your comments/concerns/questions and then best determine how to assist you.

    Additional general information regarding human participant research protections can be obtained from the U.S. Department of Health and Human Services Office for Human Research Protections:

    Office for Human Research Protections
    (866) 447-4777
    1101 Wootton Parkway, Suite 200
    Rockville, MD. 20852
    ohrp@osophs.dhhs.gov
    fax: (240) 453-6909

    (You should contact the IRB, not OHRP, regarding complaints or issues regarding participation in a specific study)

  • What is a research study?

    A research study collects information to learn more about a problem, answer questions and/or test ideas for the benefit of society. Faculty, students and staff conduct different kinds of studies in various fields. For example, a research study may test whether a treatment is safe and effective, attempt to find out what health care practices work best, or seek the best way to prevent an illness. A research study may use a survey or an interview to understand feelings people have about their health. People 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

    Another type of research study is called a “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 clinical trial is a research study that will try to decide whether new treatments are safe and effective. In clinical trials, treatments may be compared with placebos to check the effectiveness of those treatments. A placebo is an inactive substance which may resemble an active substance (often it’s a sugar pill that has no value to treat or prevent an illness). Also, a drug or device is called "experimental" when the U.S. Food and Drug Administration (FDA) has not approved it for that particular use or indication. Clinical trials are usually divided into different phases which range from Phase I to Phase IV.

    Please be aware that the ORI does not maintain a list of UCR research studies.

  • Who can be a study participant?

    Study participants can be healthy volunteers, or they can be people who have specific diseases or conditions. They may test a drug or treatment, or they may serve as a control population which does not get either the drug or treatment being tested or a placebo. The participant may be compensated or not, depending on the research design.

    Children can also participate in research studies. However, there are additional protections for children. For example, the parents or legal guardians must provide permission for the children 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.

  • What does a study participant do?

    By volunteering to participate in the research, 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 samples of blood, saliva, urine or other materials
    • Take experimental drugs or use experimental medical devices

    If anyone asks you to take part in a research study, you always have the right to refuse.

    Remember:

    • Your decision not to participate will not affect how the service providers treat you
    • You need to weigh both the risks and the potential benefits of the research study
    • It may be helpful to talk with family members, friends, or your health care providers about participating in the study
    • If you decide to volunteer for a research study, you can change your mind and stop or leave the research study at any time
  • How do I start?

    There are various ways: If you see an advertisement, you can call the number listed, a service provider may tell you that you qualify for a study and ask you to contact the researchers directly, you may hear about the study by word of mouth or you may see a study advertised on social media. These are just a few options.

  • How do I stop?

    You always have the right to stop being a participant. Just tell the researcher you want to stop participating and withdraw from the study. In some cases, you may also ask to have your data withdrawn from the research and in other instances this may not be possible.

    You do not have to explain your decision to anyone. 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 participate.

    You do not have to, but you might want to discuss any problems with the researchers before leaving. They might not be able to do anything if the research plan is not flexible, but it might be helpful for them to know why you cannot continue.

    If you leave a medical study, you might 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 often important for your safety.

  • What is Informed Consent?

    Informed Consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study. The research staff will go over the "informed consent form" that explains these facts so you can decide whether or not you want to take part in the research study. These facts include details about the research study, tests or procedures you may get as part of the study, the benefits and risks that could result, and your rights as a research volunteer.

    While Informed Consent is the default mechanism for securing consent from participants, in rare cases Passive Consent can also be used. Passive consent means participants are informed of the study, and are considered to agree to participate unless they specifically decline to be included in the study. There are some instances where consent can be waived by the IRB.

    This is a list of different variations of consent:

    Implied consent - Participation in the study is proof of consent. This is acceptable for studies that provide anonymity, such as opinion surveys.

    Explicit consent - Participants give consent by answering a specific question about their willingness to participate. This may be done verbally or in writing (consent form).

    Active consent - Participants indicate their willingness to participate by agreeing to a specific statement, and then are included in the study. This is the most common, and recommended, form of consent for research.

    Written - Participants give their consent by filling out a consent form. Written consent guarantees active and explicit consent, thus offering the highest guarantees to the participants.

    Oral/verbal - Oral consent should be considered when obtaining explicit, active consent is essential, but the risk or discomfort involved in the process is too great to make just written consent a valid option. This information is generally provided in conversations with the researcher and in written Consent Forms.

    The Consent Form should be written so it can be easily understood. If you don't understand part of it, be sure to ask the researcher, doctor, or other study person to explain it. Make sure you understand all of the information in the consent form before you agree to be in the study. See “What questions Should I Ask” below.

  • What are the risks and benefits of participating?

    Risks – Sometimes research procedures and treatments may cause discomfort and side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research study may not be known completely when you start the research study. The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the research study for as long as you take part in the research study.

    Benefits - There may or may not be direct benefits to you if you take part in a research study. For example, your health or a health condition you have may get better as a result of your participation in the research study. It may stay the same. It may get worse. No one can predict what will happen with a research study or how it might affect you. Or the research study may not help you personally but it may provide information that will help others in the future.

    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 may have not been proven to work. There may be unknown risks, as well. Although being in a medical study might help you, nobody can guarantee a direct benefit for you. Most often the benefit is to future patients.

  • What are my rights as a research participant?

    It is your decision whether or not you want to participate. In most cases, you do not have to decide right away if you wish to participate. You have the right to make this decision and be informed of the nature and reason for the study. There will not be any negative 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 ("informed consent form" or "study information sheet"). The information should 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. You should be informed regarding what will happen during the study and what risks, benefits or discomforts there may be. If you decide to participate, you will be asked to sign and date the informed consent form.

    You also have the right to leave a study at any time. If you leave the study, your decision will not affect your relationship with University, 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.

    UCR also suggests that the Experimental Subject’s Bill of Rights or its Spanish equivalent be made available for all studies conducted at UCR. This document, according to California law, requires that anyone who is asked to be in a research study (specifically those in what are defined as ‘medical experiments’), and anyone who is asked to agree for someone else to be in a research study, has the right to be informed regarding their rights in a language in which the person is fluent.

  • What questions should I ask?

    Before you decide to volunteer to take part in a research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down in advance or take this document with you. The following is a list of sample questions. Not every question will apply to all various research studies out there.

    • Who is doing this research study and what question might it answer?
    • Will this research study help in understanding my condition? If so, how?
    • What tests or procedures will be done?
    • Is it possible that I will receive a placebo (inactive substance)?
    • Will I have to make extra trips?
    • What could happen to me, good and bad, if I take part in the research study?
    • How long will this research study last?
    • What will happen to any specimens that I give?
    • Who has reviewed and approved this research study?
    • Could my condition get worse during the research study?
    • What will happen if it does?
    • What other options or choices do I have if I decide not to take part in this research study?
    • Who will be in charge of my care?
    • Will I be able to continue to see my own doctor?
    • Will I be charged anything or paid anything to be in this research study?
    • If I decide to participate in this research study, how will it affect my daily life?
    • What will happen to me at the end of the research study?
    • Will I be told the results of the research study?
    • Who will find out that I am taking part in this research study?
    • How do I end my participation in this research study if I change my mind?
    • Whom do I contact for questions and information about the research study?
    • Whom can I complain to if I feel that I have been mistreated or my rights have been violated?

    Remember, if you do not understand the answer to any of your questions, ask again. Ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the research study, just ask them again.

  • What information should the researcher give me?

    The research team will explain the research study to you, and they will review any forms including the informed consent form with you. You should take your time during this process. The researchers 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 I am being asked to participate
    • How long my 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
      (For example, Your information will be given only to the people who need it, which can include the researchers and staff who carry out the study, the IRB, the company or group funding the study and various government oversight agencies)
    • Whether there are any expected direct or indirect benefits
    • Whether there are any expected costs to me or my 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
    • Who can help you with problems or give you more information about the study or your rights

    You can take the information home. You can discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the research study. If you decide to take part in the research study, you will be asked to provide your informed consent.

    If you are concerned about any issues, 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 any 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.

  • What is the takeaway?

    Questions, questions, questions! Make sure you ask questions until you are completely satisfied with the answers, and then ask more if another question comes to mind. There is never a ‘dumb question’ when you are participating as a research participant/subject. Do not forget that you are a volunteer helping the researchers and their job is to make this experience as comfortable as possible.

    The most important thing to do is to 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!

    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 have certain procedures performed for you to safely withdraw from medical studies.

    The following pages provide additional information.


Statement of Privacy Practices: GDPR - Research

Effective Date: This statement is effective as of June, 2020.

  • Transparency Regarding the Use of Your Personal Data

    As part of our commitment to protecting your privacy, this statement is designed to provide you with information regarding how UC Riverside (UCR) researchers, research administrators and research departments of may collect, receive, use and share information about you when you agree to participate as a research subject, when existing information about you is used, or when you agree to be a researcher at UC, as a fellow or student. This statement is applicable to any individuals who are located in the European Economic Area (EEA).

    For purposes of the General Data Protection Regulation (GDPR), the data controller is the Regents of the University of California, with a location at 900 University Ave. Riverside, CA 92521.

  • Your Personal Data We Use

    Information you provide directly to UC:

    UC Riverside researchers and research staff collect personal information about you called Personal Data. Most often, before any Personal Data are collected for research purposes, you will be provided a consent and/or authorization form relating to the specific research project that explains the types of data collected and for the purposes for which such data are processed and shared. In such a case, the description of the collection and use of your Personal Data provided in the consent and/or authorization form will replace the information provided here. The Personal Data collected by our researchers is collected for the primary purpose of furthering research and understanding in various fields of academic study. Examples of Personal Data that may be collected for research purposes are listed below. Not every research study will collect each of these types of data. If you have questions about the processing of your data in connection with a research study, you should contact the UC personnel who are conducting the research or the contact persons named in any consent form you signed when you joined the study.

    Information from Other Sources:

    UC Riverside researchers and research staff may also receive information about you from other sources and may combine that information with information we collect from you directly. Examples of Personal Data that may be collected from research organizations or other third parties are listed below. Not every research study will use each of these types of data.

    Examples of Personal Data:

    Examples of Personal Data that we or third-party vendors may collect and use for research purposes include the following. Please note that in most cases these data, if identifiable, would initially be provided voluntarily by you:

    • Contact Information: for example, your name, home address, email address and phone number;
    • Tax Information: for example, government identification number if you are being paid in connection with the research;
    • Demographic Information: for example, race, ethnicity, gender, age, education, profession, occupation, income level and marital status;
    • Personal Information and History: for example, personal interests, profession, and other information about your background;
    • Family Information: for example, family members, ages, occupations and health;
    • Employment History: for example, prior employers, titles, wages, work experience, trade union membership and disciplinary record;
    • Education History: for example, prior schools, transcripts, awards, honors and disciplinary records;
    • Health and Dietary Information: for example, doctor’s records, surgical records, immunizations and medications, allergies and dietary preferences;
    • Biometric Data: for example, facial measurements, finger prints and retinal scans;
    • Genetic Data: for example, genetic information obtained from your biological samples;
    • Course Engagement and Assessment Data: for example, assignment responses, test scores and course interactions (including, for example, the ways in which you move through and interact with the course materials);
    • Log Files: for example, IP address, browser type, internet service provider, pages visited (including referring/exit pages), operating system, date/time stamp and/or clickstream data;
    • Cookies and Similar Technologies: Information collected automatically through cookies and similar technologies. For more information regarding our use of cookies and similar technologies, consult the UC Privacy Official identified below; and
    • Location Information: for example, latitude, longitude, date and time (the precision of these data varies greatly and is determined by factors controlled by your device or mobile service provider); and
    • Mobile Device Sensor Information: for example, health-related information that may be available through an application using a sensor or component of your mobile device.
  • How We Use Your Personal Data and the Lawful Basis for Such Processing

    UC Riverside researchers and research staff process your Personal Data for the following purposes and bases:

    • To further research and understanding in fields of academic study. It is in our legitimate interests as a research institution to conduct such research;
    • To enroll you in a particular research study as a research subject or to administer the study if you are a researcher. This is generally required to process a transaction requested by you;
    • To satisfy legal, regulatory, and contractual obligations for conducting research. It is in our legitimate interests as a research institution to conduct such research in a compliant manner;
    • Processing and addressing any complaints or inquiries made by you or legally on your behalf. We do this because it is in our legitimate interest as part of the services UC offers to you; or
    • Utilizing sensitive Personal Data in connection with research, with your consent.

    In certain instances, UC may be required to obtain your consent to collect and process your Personal Data for a research study. This depends on the specific category of data collected and the intended use of the data, as well as when automated processing was used to assign you to receive a certain treatment that may be required by the research study. For more information on automated decisions, please see below. In these instances, we will ask for your consent to the intended collection of your Personal Data, prior to collecting the data.

  • Recipients of Your Personal Data

    UC Riverside researchers and research staff may share your Personal Data with the following recipients:

    • Other UC locations or departments: Other UC locations or departments in order to provide you with a UC service requested by you or where it is in UC’s legitimate interests.
    • Service Providers: Vendors that need access to your Personal Data in order to assist in UC in conducting and administering research.
    • UC Partners and Collaborators: When permitted by law, UC may share Personal Data with researchers at other institutions or research sponsors in order to support UC’s research mission.
    • Public and Governmental Authorities: Entities that regulate or have jurisdiction over UC’s research program including for example federal agencies involved in the oversight of research, such as the Office of Human Research Protection and the Food and Drug Administration, and state agencies, such as the California Department of Public Health.

    If your Personal Data is shared with a third party, UC will require that the third party use appropriate measures to protect the confidentiality and security of your Personal Data.

    We may also need to share your Personal Data as required to respond to lawful requests and legal process; to protect our rights and property and those of our agents, customers and others, including to enforce our agreements and policies; and in an emergency, to protect UC and the safety of our students, faculty and staff or any third party.

  • Security

    UC is committed to protecting your Personal Data that are consistent with applicable privacy and data security laws and regulations. For more information about how UC protects data, refer to Systemwide Information Security Polices and Standards.

  • Retaining and Deleting Your Personal Data

    Where UC is processing your Personal Data based on our legitimate interests, UC generally will retain the data for the time needed for those interests. Where UC is processing your Personal Data based on your consent, UC generally will retain the information for the period of time necessary to carry out the processing activities to which you consented unless there is a legal requirement to maintain it for a longer period.

    International Transfer of Your Personal Data

    In order to fulfill the intended processing purposes described above, your Personal Data will be transferred outside of the European Economic Area (EEA), specifically to the United States, which does not protect Personal Data in the same way that it is protected in the EEA. UC will undertake appropriate measures to ensure adequate protection of Personal Data, including utilizing appropriate physical, administrative, and technical safeguards to protect Personal Data, as well as executing Standard Contractual Clauses approved by the European Commission or a supervisory authority under GDPR, or obtaining your consent, where appropriate. If your Personal Data is affected, you may contact the UC Privacy Official below to obtain a copy of the Standard Contractual Clauses.

  • Automated Decision-Making

    Automated decisions are defined as decisions about individuals that are based solely on the automated processing of data and that may produce legal effects that could significantly affect the individuals involved or that have similarly significant impact. For example, assigning clinical trial subjects to receive an intervention or placebo based solely upon each subject’s diagnostic data, where the assignment is done without any meaningful input from a physician or the research team, could be regulated by GDPR. Depending upon the type of research study you consent to, UC researchers may make automated decisions in conducting the specific research study.

    In these instances, UC will inform you of the automated decision-making and will request that you affirmatively indicate that you consent to the intended use of your Personal Data for that purpose, prior to the automated decision-making. Where automated decisions are made, research subjects may contact the UC research team with any questions. In most cases, because the research study requires the use of automated decisions, if the person objects to, or opts out of such processing, the person will not be able to participate in the research study.

  • Your Rights

    As required by the General Data Protection Regulation and applicable EU Member State and EEA state law, if you are located in the European Economic Area, you have a right to:

    • Access your Personal Data, as well as information relating to the recipients of your Personal Data, the purposes of processing your Personal Data, the duration for which the Personal Data will be stored, and the source of Personal Data that has not been provided by you;
    • Rectify or correct inaccurate or incomplete Personal Data concerning you, taking into account the purposes of the processing, and the right to have incomplete Personal Data completed;
    • Move your Personal Data to another controller or processor. UC will facilitate the lawful transfer of your data to the extent possible;
    • Have your Personal Data erased in certain circumstances;
    • Restrict the processing of your Personal Data in certain circumstances;
    • Object to the processing of Personal Data in certain circumstances;
    • Withdraw your consent to the processing of your Personal Data, should UC ask for your consent for the processing of your Personal Data. The withdrawal does not affect the lawfulness of processing based on your consent before its withdrawal.
    • Know whether your Personal Data is being used for automated decision-making in a research study. In those cases, UC will give you meaningful information about the decision, the significance and the envisaged consequences of such processing of your data, and the right to withdraw from the research study; and
    • Lodge a complaint with a supervisory authority.

    UC may be obligated to retain your Personal Data as required by U.S. federal or state law.

    If you wish to exercise your rights, you can contact the UC Privacy Official identified below.

    You may choose not to share your Personal Data with UC or UC-approved third parties for UC’s research activities. If you choose not to share your Personal Data with UC for research purposes, you will not be able to participate in UC research.

  • Questions and Complaints; UC Privacy Official

    If you have questions or complaints about our treatment of your Personal Data, or about our privacy practices more generally, please feel free to contact the UCR Compliance Analyst & Privacy Officer: Mr. Ian Hazrduk at ianh@ucr.edu or the UC Office of the President interim Privacy Official: Ms. Nicole Delange, Healthcare Compliance Manager, at nicole.delange@ucop.edu.