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Thank you for your interest in the Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) Study! We are conducting a research study beginning in Fall 2023. The purpose of this study is to compare how well two different COVID-19 boosters work to protect people 18 years of age and older against COVID-19.

The two types of COVID-19 boosters used in this study are the Novavax 2023-2024 updated COVID-19 vaccine and the Pfizer 2023-2024 updated mRNA COVID-19 vaccine. The Novavax vaccine has received Emergency Use Authorization* by the Food and Drug Administration (FDA) for safe use in individuals aged 12 years and older. The Pfizer vaccine has received FDA approval for safe use in individuals aged 12 years and older.

Thank you for your interest in the BEEHIVE Study. We are no longer enrolling participants. If you are interested in participating in future research, please call or message (801) 203-0320 or email BEEHIVEstudy@utah.edu.

If you would like to learn more about this study, select Frequently Asked Questions.

What is involved?

You will choose whether or not to receive an FDA-authorized COVID-19 booster.
If you choose to get a booster, you will receive one of two FDA-authorized COVID-19 boosters.
You will respond to short online surveys about how you feel each week and when you are sick.
You will complete weekly at-home rapid tests for COVID-19 and upload the results to the study portal or email/text the results to us.
If you experience any COVID-like symptoms or test positive on your weekly test, we will ask you to complete two more COVID-19 rapid at-home tests during the illness to confirm the result and to provide the results to us.
You could receive up to $550 for completing study activities from Fall 2023 to Spring 2024.

University of Utah

  • Sarang K. Yoon, DO

    Principal Investigator
  • Matt S. Thiese, PhD

    Co-Principal Investigator
  • Andy L Phillips, MD

    Co-Investigator
  • German Ellsworth, MD

    Co-Investigator
  • Yuanhang Zhao

    CRC
  • Jake McKell

    Senior CRC II
  • Amber Rhodes

    Vaccinator
  • Sydney Taylor

    Vaccinator
  • Walaa Abdelmoaty, MD

    Vaccinator
  • Susan Jackson, PA-C

    Vaccinator
  • Nicole Green

    Vaccinator
  • Valerie Zwonitzer, RN

    Vaccinator
  • Quinn Strenn, MD

    Vaccinator
  • Emily McCurdy

    Vaccinator
  • Jessica Woeppel, PA-C

    Vaccinator
  • Luisanaly Parada

    Vaccinator
  • Judie Guzman, PA-C

    Vaccinator
  • Riley Campbell

    Junior CRC
  • Jesse Williams

    Junior CRC
  • Marcus Stucki

    Data Manager
  • Tyler Allison

    Data Support RA
  • Rachel Brown, PhD

    Senior Program Manager
  • Megan Wilson

    Chief Program Assistant
  • Swarnam Pandey

    Program Assistant
  • Ashmita Shanthakumar

    Program Assistant
  • Josh Griffin

    Associate Program Manager
  • Adriele Fugal

    Program Assistant
  • Uchenna Ogbonnaya

    Lead Research Assistant
  • Audrey Cannon

    Research Assistant
  • Christian Guzman

    Research Assistant
  • Kabita Chhetri

    Research Assistant
  • Katarina Cook

    Research Assistant
  • Lu Thomas

    Research Assistant
  • Naveen Naveed

    Research Assistant
  • Suma Patha

    Research Assistant
University of Utah Study staff standing in two rows
Health - University of Utah

Contact Us

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Frequently Asked Questions (FAQs)

STUDY BACKGROUND

  • The purpose of this research study is:
    • To find out how well two different COVID-19 booster vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus); and
    • To determine if getting a booster provides better protection from COVID-19 than not getting a booster.
  • The University of Utah is conducting this study along with Novavax Inc. and Westat Inc.
  • Novavax Inc. is a vaccine company based in Gaithersburg, Maryland that is supporting and funding the study. Novavax will also be contributing the Novavax 2023-2024 updated COVID-19 vaccine to the study.
  • Westat Inc. is a research company based in Rockville, Maryland that is working with University of Utah to carry out the study.
  • If you decide to join this study, you will be asked to complete the following activities:
    • An online enrollment survey about yourself, your work and health, and COVID-19 and flu vaccinations you may have received.
    • An in-person enrollment visit where:
      • You will receive a supply of COVID-19 test kits.
      • If you choose to get a COVID-19 booster, you will receive one COVID-19 booster.
      • On the 1st, 2nd and 7th day afterwards, you will be asked to complete an online post-vaccination survey about any reactions you may have experienced.
      • If you choose not to get a booster, you will not receive one.
    • Weekly online surveys about whether you have any COVID-19 symptoms, beginning after the enrollment visit for 24 weeks.
    • Weekly COVID-19 tests starting after the enrollment visit for 24 weeks. You will need to upload a photo of the results to your own portal account that you will create on the study website.
    • Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19.
    • An online survey in the middle and at the end of the study about your work, health, thoughts about COVID-19, and any COVID-19 and flu vaccinations received.
    • An online survey in the middle and at the end of the study about COVID-19 symptoms if you tested positive or had symptoms but did not test positive.
  • You could receive up to $550 in electronic Amazon gift cards to thank you for your time and efforts. Exactly how much depends on the number of study activities that you complete.
  • If you report having COVID-19 symptoms:
    • You will receive a link to complete additional short online surveys about how you feel.
    • You may have symptoms without testing positive for COVID-19.
    • You will be asked to do a COVID-19 test on the 1st and 3rd day after the original test and upload a photo of each result to the study portal.
    • Getting test results does not replace medical care, and you should seek medical care if you need it.
  • If your test result is positive:
    • You will receive a link to complete additional short online surveys about how you feel.
    • You will be asked to do another COVID-19 test on the 1st and 3rd day after the original positive test and upload a photo of each result to the study portal.
    • Getting test results does not replace medical care, and you should seek medical care if you need it.

COVID-19

  • Coronavirus disease 2019 (COVID-19) is the name of the illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • Common COVID-19 symptoms include: fever, chills, malaise, fatigue, headache, cough, shortness of breath, sore throat, runny nose or nasal congestion, nausea or vomiting, diarrhea, muscle or body aches, or change in smell or taste. COVID-19 symptoms may range from mild to very severe, and some people may have no symptoms at all.
  • Older adults and people of any age who have underlying medical conditions are at higher risk for severe illness from COVID-19.
  • COVID-19 vaccines are an important way to prevent COVID-19.

COVID-19 BOOSTER

  • A COVID-19 booster is an additional dose of the COVID-19 vaccine that is given after the protection provided by the original COVID-19 vaccine has begun to decrease over time.
  • The two types of COVID-19 boosters used in this study are the Novavax COVID-19 booster vaccine and the Pfizer mRNA COVID-19 booster vaccine.
  • The booster vaccines used in this study have received Emergency Use Authorization by the Food and Drug Administration (FDA) for safe use in adults.
  • None of the study boosters contain live virus.
  • No. You have the choice whether or not to receive a COVID-19 booster.
  • You can get a COVID-19 booster or not and still be in this study.
  • You will have a 50/50 chance of receiving either the Novavax COVID-19 booster or mRNA COVID-19 booster.
  • A computer program will decide which booster you will get by a random process that is like pulling a name out of a hat.
  • Yes. You will receive proof that you got a COVID-19 booster, but you will not know which one you got until after the study is over.

STUDY PARTICIPATION

  • You may qualify to be in this study if:
    • You are at least 18 years of age.
    • You already received at least 2 doses of Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines, such as the Pfizer-BioNTech or Moderna COVID-19 vaccine.
    • You live and plan to remain living in the greater Salt Lake City area for the next 12 months.
    • You are comfortable reading and responding to text messages and emails sent in English or have an interpreter to assist you
    • You have daily access to the internet (via cell phone, laptop, desktop, or tablet) and a phone to receive text messages.
    • You are willing to complete the study activities.
  • Some reasons you may not qualify to take part in this study are:
    • You live with another person who is already taking part in this study.
    • You had a severe allergic reaction to COVID-19 vaccines in the past.
    • You had COVID-19 within the past 90 days.
    • You received a COVID-19 vaccine within the past 90 days.
    • You are taking part in another vaccine trial now.
    • You have a medical condition or take medicine that lowers your body's ability to fight infection.
    • You received the Johnson & Johnson COVID-19 vaccine.
    • You received a monoclonal antibody COVID-19 treatment such as EVUSHELD or REGEN-COV.
  • If you agree to participate, you will be in the study from when you enroll until Summer 2024.
  • No. Taking part in this research study is your choice. This means you can choose to be in the study or not.
  • This document may contain words and information that you do not understand. Before deciding whether to take part in this research study, please ask the study staff to explain anything that is not clear to you. Please take time to read the following information carefully and discuss it with friends and relatives if you wish.
  • You can also choose to stop participating at any time for any reason. Choosing to stop your participation will not result in any penalties and will not affect any care or services you may receive in the future
  • You may change your mind and revoke (take back) your consent and HIPAA authorization by writing to Dr. Sarang Yoon, the study principal investigator, at: BEEHIVEstudy@utah.edu or by calling the study phone number 801-203-0320. If you revoke your consent and authorization, you will not be allowed to continue taking part in this study and no additional information about you will be collected. However, the study staff may still use information already collected from you for this study.
  • The study staff have the right to stop your participation at any time. Examples of why this could happen include because you failed to follow study instructions, you moved out of the greater Salt Lake City area, or because the study has stopped.
  • If you agree to participate in the study, you will need to sign an online consent and HIPAA authorization form. The consent form describes the study and asks for permission to check your vaccine records to confirm what kind and how much of the COVID-19 and flu vaccine you received in the past. These details may come from state and/or city vaccine registries or from past records if you took part in other COVID-19 or flu vaccine studies. You can choose not to give permission to confirm your COVID-19 and flu vaccine history and still be in the study.
  • After you agree to join the study by signing the online consent and HIPAA authorization form, study staff will provide you with instructions for creating a portal account on the study website, completing an online enrollment survey, and scheduling an enrollment visit.
  • The online enrollment survey will take about 20 minutes and will ask questions about yourself, your work and health, and COVID-19 and flu vaccinations you may have received.
  • The enrollment visit is required whether or not you choose to get a COVID-19 booster. The visit will take place at the University of Utah Health. The main clinic is located at 250 East 200 South, Suite 100, Salt Lake City, UT 84111.
  • If you choose to get a COVID-19 booster as part of this study, at the enrollment visit study staff will ask you some questions to make sure you are feeling well enough to receive the booster. If you are not feeling well, you will need to reschedule the visit.
  • A study health care professional will inject one dose of study COVID-19 booster in your upper arm.
  • Study staff will show you how to complete the online study surveys in the study portal.
  • Study staff with give you a supply of COVID-19 test kits, explain how to use them, and show you how to upload a photo of the results to the study portal.
  • Study staff will give you proof that you received a COVID-19 booster but will not be able to tell you which one you received until after the study is over.
  • On the first, second, and seventh day after getting the booster, you will receive a link to an online post-vaccination survey. This survey will take about 2-3 minutes and will ask about any reactions.
  • If you decide not to get a COVID-19 booster, at the enrollment visit study staff will show you how to complete the online study surveys in the study portal.
  • Study staff with give you a supply of COVID-19 test kits, explain how to use them, and show you how to upload a photo of the results to the study portal.
  • Should you receive a booster outside of the study during your participation, you will be allowed to remain in the study; however, we will ask you to provide information about the booster you received in online survey questions at the middle and end of the study.
  • Weekly Surveys and COVID-19 Testing:
    • Once a week for 24 weeks you will receive a link to an online survey that will take about 5 minutes. This survey will ask about any symptoms related to COVID-19. Between surveys, you can also go to the study portal to report symptoms.
    • Beginning after the enrollment visit, you will also be asked to start doing a weekly COVID-19 test for 24 weeks. You will need to upload a photo of each result to the study portal.
    • If you report COVID-19 symptoms or show a positive test:
      • You will receive a link to complete additional short online surveys about how you feel.
      • You will be asked to do a COVID-19 test on the 1st and 3rd day after the original positive test and upload a photo of each result to the study portal. Getting these results does not replace medical care, and you should seek medical care if you need it.
    • By Summer 2024, study staff will tell you when the weekly surveys end and when you can stop testing.
  • Mid-Study and End-of-Study Surveys:
    • In the middle and at the end of the study, you will receive a link to an online survey that will take about 20 minutes. The survey will ask about your work, health, thoughts about COVID-19, and any COVID-19 and flu vaccinations received.
    • If you tested positive or reported symptoms but did not test positive, in the middle and at the end of the study you will also receive a link to an online “Long COVID Survey” that will take about 15 minutes. The survey will ask how long your symptoms lasted and how they affected your health.

COVID-19 TESTING

  • Beginning after the enrollment visit, study staff will ask you to start doing a COVID-19 test at home every week using the supply of test kits that you received.
  • You will need to take a photo of each test result and upload it to the study portal.
  • If you have COVID-19 symptoms or show a positive test:
    • You will receive a link to complete additional short online surveys about how you feel.
    • You will be asked to do a COVID-19 test on the 1st and 3rd day after the original positive test and upload a photo of each result to the study portal. Getting these results does not replace medical care, and you should seek medical care if you need it.
  • By Summer 2024, study staff will tell you when the weekly surveys end and when you can stop testing.
  • The supply of COVID-19 tests that study staff will give you at the enrollment visit are at-home, rapid antigen tests for SARS-CoV-2 infection.
  • At the enrollment visit study staff will give you instructions, explain how to do the test, and show you how to upload a photo of the results to the study portal.
  • A video with instructions for how to do the COVID-19 test is available at: Here
  • The COVID-19 test will provide your results in about 15-20 minutes.
  • All COVID-19 testing will be done for study purposes only. These results are part of this research study and are not medical results.
  • You will need to follow up with a medical provider if you want to be tested for any health problem or if you have questions about your health or whether you should stay home and/or separate yourself from others.
  • If you feel sick at any time during the study, you should consult with your medical provider as you normally would for symptoms of illness.
  • The tests for COVID-19 used in this study are accurate but they are not perfect. It is unlikely, but a negative test result can happen even if you are infected.
  • COVID-19 results may be reported to the local health department as required by local, state or federal disease reporting laws.
  • You will need to label your test using one of the stickers provided to label your test in the top space on the test cassette. The stickers do not have to be used in a certain order.
  • Take a digital photo of your test result making sure that the test cassette and sticker can be seen clearly in the photo.
  • Upload this photo to your own portal account that you will have created on the study website and input your test results and the sticker number you used.
  • image of phone with the open survey button highlighted for the COVID-19 Test Photo option in the active week
    screenshowing upload image option, for uploading a picture of your COVID-19 test result image
    Picture showing option to select the test result of your COVID-19 home test
  • At the enrollment visit study staff will give you instructions, explain how to do the test, and show you how to upload a photo of the results to the study portal.
  • A video with instructions for how to do the COVID-19 test and how to upload the results is available at: Here
  • After you upload the photo of your test result to the study portal, you can discard the used test materials.
  • If you have questions about doing the COVID-19 tests, need another test kit, or have any other concerns, please call 801-203-0320 or send an email to BEEHIVEstudy@utah.edu.

BENEFITS

  • If you decide to get a COVID-19 booster as part of this study, this booster may protect you against COVID-19 by preventing or lessening the effects of severe infection from the SARS-CoV-2 virus.
  • Whether or not you choose to get the booster, your participation in this study will provide helpful information about which booster provides better protection against COVID-19, and if getting a booster provides more protection than not getting a booster.
  • By taking part in this study, you may benefit from knowing if you test positive for COVID-19. With this information, you can seek treatment early or make choices to help protect other people from getting infected.
  • Your participation also has a chance to provide more information about COVID-19 and the SARS-CoV-2 virus. This could benefit you or other people in the future.

RISKS

  • What are the risks for me if I receive a booster?
    • If you choose to receive a booster, you may experience mild discomfort where the booster was injected into your arm muscle and possible reactions such as redness, swelling at the injection site, swelling of the lymph nodes, pain, or tenderness. Study staff will use sterile equipment and clean the injection site with alcohol to lower the chance of infection.
    • Some people who receive a COVID-19 booster may experience reactions such as fever, body aches, headache, malaise, myalgia, and/or nausea. These symptoms usually go away on their own in about 1-2 days.
    • Like any other COVID-19 vaccine, there is a risk of severe reactions including: shortness of breath, wheezing, hives, hoarseness, difficulty swallowing, swollen face/tongue/pharynx (muscles inside the neck), tachycardia (faster than normal heartbeat), paresthesia (tingling or crawling feeling), hypoesthesia (decreased feeling or sensitivity), dizziness, and/or weakness.
    • Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside of the heart) have occurred in some people who have received the Novavax or mRNA COVID-19 vaccines. Symptoms of myocarditis and pericarditis include chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart, with symptoms most commonly reported as beginning within 10 days after vaccination. These side effects were seen more often in male adolescents and young adults after the second dose of the vaccine. However, they were also seen in women and older adults after the first dose. The chance of having this occur is very low. In the rare case you experience myocarditis or pericarditis symptoms, you should seek immediate medical attention and notify the study staff.
  • Are there any other risks?
    • By taking part in this study, there is a risk that your personal information could be revealed. The study team will handle your personal information in a confidential manner to make this risk as low as possible. Study staff will follow strict guidelines to keep your information secure and will take steps to protect your privacy, such as:
      • A study number instead of your name will be used on study records wherever possible.
      • Study staff will protect information that is stored electronically by using secure passwords and will protect information stored on paper using a locked file cabinet in a locked office that only study staff can access.
      • Study results and reports that are presented or published will not use your name or any other personal information that could identify you.
    • It is also possible that you may feel sad or depressed while taking part in this study. If you experience a mental health crisis, please call or text 988 to reach a licensed mental health professional at the Suicide and Crisis Lifeline.

RESEARCH-RELATED INJURY

  • If you are injured from being in this study, medical care is available to you at the University of Utah, as it is to all sick or injured people.
  • The University of Utah has not set aside any money to pay the costs for such care. The University will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care that you receive.
  • Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research.
  • The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code.

ALTERNATIVE PROCEDURES

  • You do not have to be in this study to get a COVID-19 booster or test for COVID-19.
  • For information about where you can get the COVID-19 booster or obtain COVID-19 test outside of the study, you can contact your local health provider, clinic or pharmacy.

COST

  • There is no cost to you to take part in this study.
  • The study will provide the COVID-19 boosters and all of the test kits that will be given to you.
  • Standard message and data rates will apply for receiving and sending study text messages.

COMPENSATION

  • To thank you for your time and efforts, we will send you up to $550 in electronic Amazon gift cards.
  • Exactly how much you receive depends on the number of study activities that you complete:
Study Activity Amazon Gift Card Amount
Enrollment Survey
  • Answering questions about yourself, your work, health, and COVID-19 and flu vaccine history
$30
Enrollment Visit
  • Attending a visit in person at the University of Utah Health
  • Receiving a supply of COVID-19 test kits
  • Learning how to complete the study surveys in the study portal
  • Receiving a COVID-19 booster if you choose to get one
$50
Post-Vaccination Surveys (if applicable)
  • Answering questions about any reactions on Day 1, Day 2, and Day 7 post-vaccination, if you choose to get a booster
$12 per survey on Day 1 and Day 2,
$20 for completing a survey on Day 7
(Total amount up to $44)
Weekly and Illness Surveys and COVID-19 Test Photo Submission beginning after the enrollment visit for 24 weeks
  • Answering questions about how you feel
  • Uploading a photo of your test results to the study portal
$14 per survey with photo submission
(Total amount up to $336 for 24 weeks)
Mid-Study Survey and End-of-Study Survey
  • Answering questions about your work, health, thoughts about COVID-19, and COVID-19 and flu vaccinations received
$30 each
(Total amount up to $60)
Long COVID Surveys (if applicable)
  • Answering questions at mid-study and end-of-study about COVID-19 symptoms if you tested positive for COVID-19 or had symptoms without testing positive
$15 each
(Total amount up to $30)
Total Amount Up to $550 Total

PRIVACY

  • The Health Insurance Portability and Accountability Act (HIPAA) of 1996, is a federal law that put safeguards in place to protect the privacy of patient's health information, known as protected health information (PHI), from being shared without the patient's consent or knowledge.
  • HIPAA gives patients control over who their information is shared with and for what purpose.
  • If you give your consent to take part in this study, you are giving your authorization (permission) for study staff to use your PHI and information collected during the study that may identify you, such as your name, address, phone number, and email address.
  • Study staff will not ask for your social security number or other government ID number.
  • The health information collected and used for this study includes information about past or current medical conditions, medications or treatments, and family medical history.
  • The authorization to use and share your health information does not have an expiration (ending) date.
  • The permission that you give allows study staff to look at your PHI and information collected that may identify you and share it with the University of Utah and Westat for analysis.
  • The research records may be also be used and reviewed by the University of Utah Institutional Review Board (IRB), which reviews research involving people to make sure the study protects your rights; the University of Utah Clinical Research Support Office Monitoring and Quality Assurance group, which helps oversee how the study is carried out; the FDA; and Novavax, the study sponsor. Novavax will not receive any information from this study that could identify you. In other words, they will only receive de-identified information. Novavax may keep the de-identified information from this study indefinitely.
  • If required by local, state, or federal reporting laws, your COVID-19 test result and personal information, such as your name, telephone number, age, and gender, may be shared with the local health department.
  • Study staff may also share your PHI with review boards and other persons who watch over the safety, effectiveness, and conduct of research, such as authorized persons from the Office of Human Research Protections (OHRP). However, study staff will not share with these review boards or persons any information that could identify you, such as your name or contact information.
  • If you do not want your health information used, you should not be part of this research. If you choose not to participate, you can still receive health care services at University of Utah Health Sciences Center.
  • You will also be asked for permission to check vaccine records to confirm what kind and how much of the COVID-19 and flu vaccine you received in the past. This history may come from state and/or city vaccine registries or from past records if you took part in other COVID-19 or flu vaccine studies.
  • You can choose not to give permission to confirm your COVID-19 and flu vaccine history and still take part in this study.
  • Yes. You can stop participating in the study at any time for any reason.
  • You can tell us anytime that you do not want to be in this study and do not want us to use your health information.
  • You may change your mind and revoke (take back) your consent and HIPAA authorization by writing to Dr. Sarang Yoon, the study principal investigator, at: BEEHIVEstudy@utah.edu or by calling the study phone number 801-203-0320.
  • If you revoke your consent and authorization, you will not be allowed to continue taking part in this study and no additional information about you will be collected. However, the information you provided while on the study may continue to be used in the final study reports.
  • The study staff also have the right to stop your participation at any time. Examples of why this could happen include because you failed to follow study instructions, you moved out of the greater Salt Lake City area, or because the study has stopped.

WHO TO CONTACT

  • For general questions or concerns about the study, call or text 801-203-0320 or send an email to BEEHIVEstudy@utah.edu.
  • You may also contact Dr. Sarang Yoon, the study principal investigator, at (801) 581-3626.
  • If your call is missed, please leave a voicemail with your name and a phone number beginning with an area code, and your call will be returned as soon as possible.
  • A description of this research study will be available at http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that could identify you. At most, the website will include a summary of the results. You can search this website at any time.
  • For questions about your rights and welfare as a research participant or for a research-related injury, please contact the University of Utah Institutional Review Board (IRB) or by email at irb@hsc.utah.edu. at (801) 581-3655. You can also contact the IRB if you have questions, complaints, or concerns that you do not feel comfortable discussing with study staff.
  • Another resource for people who volunteer to participate in research studies at the University of Utah is the Office for Research Participant Advocacy (ORPA). You can contact your Research Participant Advocate by phone at (801) 581-3803 or by email at participant.advocate@hsc.utah.edu.