clinical research studies in utah

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• Clinical Trials at Huntsman Cancer Institute

As the only academic medical center in the Mountain West , our physicians provide not only exceptional patient care, they also teach and perform research in a continuous effort to bring the latest medical advancements to the bedside.

Clinical trials help physicians and researchers prevent, diagnose, and treat diseases. You can search by keyword or specialty to locate a trial of interest. Learn more about how you can participate.

What Is Clinical Research

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Clinical Trials

Clinical research at utah cancer specialists.

OUR MISSION: To bring new, or novel medications to the patients of Utah.

For over 25 years now, Utah Cancer Specialists, has been deeply committed to advancing the science of oncology. Clinical trials are a critical component in expanding treatment options for people with all types of cancer. Because all new treatments and therapies must be evaluated through clinical trials, the greater the number of participants, the faster emerging therapies can be brought to patients. Participants expand their own treatment options by accessing promising new therapies that are currently only available through clinical trials – and contribute to the advancement of medical knowledge that may help other patients in the future.

Utah Cancer Specialists offers participation all phases of clinical trials.

Phase I – A phase of research to describe clinical trials that focus on the safety of a drug.

Phase II – A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease.

Phase III – A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase IV – A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing.

Utah Cancer Specialist has dedicated staff to streamlining your experience in any of our clinical trials.

Our late phase program offer participation in phase 2 and 3 trials.  These trials are conveniently offered at all Utah Cancer Specialist locations.

Considering participation in a clinical trial?

All clinical trials have guidelines about who can participate. The criteria-based evaluations consider such factors as age, gender, the type and stage of disease, previous treatment history and other medical conditions.

Patients considering participation in a clinical trial will receive important facts about the study’s purpose and what is involved, such as the tests and other procedures used, possible risks and benefits. Participants will be asked to sign a written consent form outlining the details of the study prior to beginning treatment, however, the trial is completely voluntary and patients may stop at any time.

Justin Call, MD

DiSean Kendall, MD

William B. McKean, PhD, MD

Julie Luckart DNP, AOCNP, FNP

To contact Phase 1  START Mountain Region call 801-907-4750

To contact Utah Cancer Specialist late phase research call 801-281-6864

Or Email us at: [email protected]

Frequently Asked Questions

What are clinical trials.

Clinical trials are research studies conducted with people who volunteer to participate in the testing of new therapies. The purpose of these studies is to find better therapies for cancer treatment.

How are cancer clinical trials conducted?

Clinical research trials are one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis and treatment are safe and effective.

What are the benefits of participating in a clinical trial?

• You may have access to promising new therapies that doctors hope will be more effective or less toxic than the standard treatment. These therapies are not yet available to patients outside the study.
• You can play an active role in your cancer care by expanding your treatment options.
• You will receive expert medical care during the trial and throughout your treatment.
• Your overall health is closely monitored throughout the trial.
• You will be contributing to greater knowledge that may help other cancer patients in the future.

What are some of the possible risks of participating in a clinical trial?

• Participants in randomized studies will not be able to choose the approach they receive.
• Health insurance and managed care providers may not cover all patient care costs in a study, in which case the patient would be responsible for those costs.
• Therapies under study are not always better than the standard care.
• New treatments may have unknown side effects or risks.

How are my rights protected during a clinical trial?

Clinical research trials are conducted according to strict scientific and ethical principles and groups of experts at the national and local levels approve research studies before they begin. One important group who evaluates clinical trials is the Institutional Review Board (IRB) of the research organization implementing the trial. An IRB is made up of doctors, researchers, community leaders and other members of the community. This board is focused on protecting the safety of participants by reviewing the protocol to make sure the study is conducted fairly and participants are well-informed of their rights during the study.

When considering if I want to participate in a study, what type of information will be available?

A physician, nurse or someone from the research team will give you the important facts about the study, including the purpose of the study and what is involved such as the tests and other procedures used, possible risks and benefits. You will also receive a written consent form explaining the study, which you will be asked to sign should you decide to participate. However, even if you sign the consent form, you may stop participating in the study at any time.

Do I have to participate in a clinical trial?

No. Your participation in a clinical trial is completely voluntary at all times. It is important to ask a lot of questions and consider all of your treatment options before you decide if taking part in a study is right for you.

Salt Lake City (West Jordan), Utah

Velocity clinical research, salt lake city.

Velocity's Salt Lake City research site was founded in 1984 by Werner Huck as Advanced Clinical Research, the first community based clinical research center in Idaho and Utah, and acquired by Velocity in 2019. Mr. Huck was an early advocate of community-based outpatient studies. An initial model of embedding research staff in local practices evolved to stand alone research facilities. Mr. Huck and his research team participated in a large number of antibiotic trials from the 1980s until the early 2000s, addressing many unmet needs in infectious disease indications. This experience led to development of significant expertise in conduction of vaccine studies which remains a key therapeutic focus. Over the years, the Salt Lake City site has expanded its clinical research expertise into Dermatology, Gastroenterology, Cardiology, Women’s Health, and a variety of Family Medicine indications. By working collaboratively and developing strong relationships with area physicians and patients, this site has a broad network of study participants ranging from pediatric to geriatric demographics. In addition, this site also has access to Samoan and Latinx populations.

Located just south of Salt Lake City, this site serves the greater Jordan Valley area. It is within walking distance from Jordan Valley Medical Center and has ample parking for study volunteers. Several hub sites are available as well. This main location has capabilities for overnight stays and extended day visits. All trials are performed in accordance with ICH and FDA guidelines, and in compliance with GCP. The Velocity Salt Lake City team is committed to being a resource for study volunteers, to providing the highest quality of patient care with compassion and kindness and to advancing medicine through research.

Velocity Clinical Research, Salt Lake City 3590 West 9000 South, Suite 300, West Jordan, UT 84088

Phone: (801) 542-8190

Email: [email protected]

Find a Clinical Trial in Salt Lake City (West Jordan) Visit VelocityClinicalTrials.com or follow us on Facebook for study updates and more.

Improve lives by making clinical research accessible to all.

Our Mission

Improve the clinical research process to accelerate the delivery of new therapies and provide exceptional care to our community.

Our experienced research team in Salt Lake City (West Jordan)

The Velocity Salt Lake City (West Jordan) team of physician investigators and clinical research professionals are experienced clinical researchers. All physicians are board certified in their specialty area(s) and all research staff is trained in clinical research regulations, including GCP and HIPAA. Training records and certifications are maintained. Our clinical team is dedicated to conducting quality research in a professional and caring environment and strives on collecting quality data.

Barbara Rizzardi, MD

Principal Investigator Barbara Rizzardi, MD attended the University of Nevada School of Medicine and completed a residency and internship in internal medicine at LDS Hospital in Salt Lake City, UT. Dr. Rizzardi has research experience in broad range of therapeutic areas including vaccines. In addition to research, she is an independent practitioner with a private clinic. In her spare time, Dr. Rizzardi also enjoys rafting and kayaking wild rivers of the western US.

Salt Lake City (West Jordan) facility features

The Velocity Clinical Research, Salt Lake City facility is designed for the ease and comfort of study participants and to allow optimal efficiencies in performing clinical trials. Features at this site include:

• Private examination/consultation rooms
• Comfortable patient reception areas
• Facilities for extended-stay pharmacokinetic studies
• Nursing station
• Secure monitoring rooms or workstations with phone & high-speed internet access
• Multiple individual & secure workstations for research staff
• Regulatory document processing area
• Electronic data capture (EDC) capabilities
• Secure record storage
• CLIA certified research laboratory or clinical laboratory with CLIA waiver
• Ambient and refrigerated centrifuge
• Secured & temperature controlled investigational product storage with pharmaceutical refrigerator & freezer
• Freezers equipped for laboratory specimens at -20 & -70 degrees Celsius
• Backup generator/power source in the event of site power loss
• Standard medical equipment, including ECG and Holter machines, digital and analog scales

Quality. Continuity. Velocity.

Studies For You

Office of research participant advocacy, main navigation, u can help shape a stronger future..

Your participation in research studies helps create a healthier community.

for a healthier you; for a healthier us

Research studies and clinical trials have the potential to change lives in a meaningful way. Not only do you gain personal benefits through your participation, but you make it possible for these studies and research to help others. 

Participate - for a healthier you; for a healthier us together. 

• Get compensated
• Access medication opportunities
• See better health outcomes for you and others
• Contribute to meaningful research
• Offer your voices and views to make research more impactful and increase its reach

Explore Study Topics

Our studies cover a broad spectrum of health, from diabetes to cancer, that impact people from all walks of life..

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That change lives..

Our researchers are looking to improve health outcomes for people. People are at the heart of what we do. Yes, there is science, which is sometimes complicated and hard to understand. Complex problems often require complex solutions. We seek people-oriented solutions to these problems.

Ivy's Story

Volunteering in research is a gift you can give to your family, community and the world.

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Have you been diagnosed with COVID-19 in the last 3 days?

Join a remote COVID-19 study using a digital wristband. Researchers at the National Institute of Health (NIH) are recruiting for a COVID-19 study.

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Participate in COVID-19 Plasma Trials

Sponsored by Johns Hopkins University, this clinical trial is helping patients avoid hospitalization.

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"Why should I participate?"

Participate in clinical trials and help researchers discover better ways to treat, prevent, diagnose and understand human disease.

Paid Studies in Your Area

Help us bring new and beneficial medications to the market through the FDA's drug approval process.

Clinical Studies and Trials in Utah

Highland Clinical Research has 19 years of experience conducting clinical research trials in Utah. Our growing office is dedicated to collecting reliable data for medical professionals and heath care decision makers to give them the best information with which to treat patients and allocate resources for the clinics and hospitals they manage, respectively. Our clinical studies in Utah involve people from all over the state, as well as many of our participants who live in Idaho, Wyoming, and other surrounding states. The quality of our research and methods attracts many people from disparate backgrounds to participate in our clinical trials in Utah.

We perform a wide range of clinical trials in our Salt Lake City office, in all different therapeutic areas within the medical discipline. During our research studies, ensuring our participants’ safety is our top priority. We take care to find the right participants for each study so that we can guarantee the reliability of all the health care data we collect during our medical trials. We are always looking for people to participate in our ongoing and upcoming medical studies. The different areas of medicine we investigate allow people from all walks of life to participate in furthering scientific medical research to develop improved treatments and cures for current and future patients.

What is Highland Clinical Research?

Dr. Muse founded Highland Clinical Research in 1998 when he began to conduct medical research to provide doctors and other health care professionals with high-quality, actionable clinical data. Since its inception, HCR has performed countless clinical research studies in Utah. Many of these studies have been focused on the following medical disciplines and conditions, among others:

• Endocrinology
• Gastroenterology
• Healthy Patient Studies
• Osteoarthritis
• Otolaryngology
• Pain Management

We value the quality and integrity of our data as paramount to our work because of the immeasurable importance of the information we obtain during each of our medical studies in Utah to evaluate investigational medications, treatments, and procedures. This scientific medical information is invaluable for developing cutting-edge medical treatments for a wide variety of ailments and conditions and bringing new drugs to market safely.

Please don’t hesitate to contact us if you are interested in learning more about how to participate in or sponsor one of our medical research studies. We’ll be more than happy to discuss the details of the study that interests you to determine whether you qualify to participate. If you don’t meet the criteria to join one of our studies as a subject, we can help you find other ways to participate in studies that are important to you, such as sponsorship. Call today to learn more.

Areas of Ongoing Medical Research and Current Clinical Trials in Utah

We are always involved in numerous medical studies in Utah. Some of the studies we’re currently looking for participants for include the following:

-Endometriosis

-High Cholesterol

-Interstitial Cystitis/Bladder Pain Syndrome

-Pediatric Migraine

-Menstrual Migraine

Please feel free to click the Volunteer for Clinical Trials tab in our menu bar to register as a potential participant. We will contact you about any of Highland Clinical Research’s studies that you may qualify to participate in.

Get Involved In Clinical Research Trials

About Physicians’ Research Options

We are an experienced Clinical Research Company dedicated to the performance of Phase II, III and IV Pharmaceutical and Pilot/Pivotal Medical Device clinical trials. Our staff experience totals over 60 years in Clinical / Medical Research.

Our staff recruits for and manages studies, including paid clinical trials, in five (5) investigative clinics in Utah and Colorado.

PRO℠ has a mature network of Clinical Investigators whom conduct clinical trials. Our Investigators are dedicated and motivated to provide the highest level of patient care and quality study data. Our experienced staff includes Medical Directors, Administrative, Regulatory, Contract/Budget and Clinical Research Coordinators.

Why Join a Clinical Trial?

There are several reasons why people choose to participate in clinical trials. Learn why clinical trials may be a good choice for your situation.

Currently Enrolling Studies

Learn about some of the clinical research trials currently enrolling in Salt Lake City and in surrounding Utah areas.

Research Study

Participants Needed

Chronic Low Back Pain – Buprenorphine Injection Chronic Low Back Pain (Interview Questionnaires) High Cholesterol and Non-Alcoholic Liver Disease Low Back Pain Due to Degenerative Disc Disease (DDD) Sciatica Pain Males (age 45 to 80) with Low Testosterone Levels

Why Choose Pro?

PRO℠ provides comprehensive clinical research services for Pharmaceutical, Medical Device and other sponsor companies performing Phase II, III and IV trials. Clinical Trials are our business. Quality and efficiency are our goals. We are experienced in all phases of trials (Phase II through IV) and PRO℠ also conducts limited Phase I trials.

Our offices are located in modern, medical-office complexes that are conveniently located close to hotels, shopping and eating centers, and the incredible Wasatch Mountains and their ski resorts. Numerous medical offices and a modern Diagnostic Imaging Center are within our office buildings.

The affiliations we maintain with many local physicians, the close proximity to our affiliated Surgery Center, the local hospitals (4) and diagnostic Imaging Centers all benefit patient enrollment and our sponsors.

PRO℠ is affiliated with a Center of Excellence Surgery Center located in our building. Our experienced staff can support a wide array of medical device clinical trials.

We look forward to working with your company on your Clinical Trial endeavors.

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• Education at U of U Health
• Center for Health Ethics, Arts, and Humanities

CHEETAH Research

University of utah health, the center has a long standing history of multidisciplinary and collaborative research and scholarship, focused on exploration of timely topics using the most applicable methodologies., *make sure to check each tab for details, ethical end-of-life care, informed consent, professionalism and conflict of interest, disclosure of medical errors, ethical response to patients with infectious diseases, ethical implications of genetic testing, research ethics, pediatric ethics, theological ethics, literature and medicine, aids and the humanities, cultural and gender studies, methodologies, survey research, focus group discussions, in-depth interviews, healthcare record review, scholarly analysis of ethical problems, review and critique of relevant literature from healthcare, law, philosophy, the arts, and humanities, jeffrey botkin, md, mph, guru: graduate and undergraduate researchers of uceer.

NHGRI 1R25HG010020-01 - 5R25HG010020-05

MULTIPLE PI: Botkin & Tabery

DURATION: 6/22/18-4/30/23

FUNDING: $108,000     TOTAL FUNDING: $540,000 (5 projects)      FUNDING IC: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

The phrase “nothing about us without us” has guided disability rights advocates for decades. The basic premise of the phrase is that conversations about disability, policy decisions affecting people with disabilities, and technological developments impacting disabled people should include members of the disability community, so that they can bring their lived experiences with disability to the table. “Nothing about us without us” is particularly relevant to the domain of genetic science and genetic medicine because it informs a range of disability-oriented criticisms aimed at those practices. Critics argue that prenatal genetic testing, used in part to facilitate decisions about bearing children with disabilities, endorses the idea that disability is something to be avoided rather than accommodated. A genetic policy that recommends testing or screening for certain conditions but not others is also judged suspect by some disability advocates because the list is an implicit endorsement of the idea that there are certain traits which make a life not worth living or excessively burdensome to families and society. Parents making decisions about the result of a genetic test, disability advocates also warn, are often given poor information about what it is like living with the disability in question. Attempts to involve people with disabilities in conversations about the ethical, legal, and social implications (ELSI) of genetic technologies, policies and practices are hindered by the fact that, while students with disabilities are enrolling in higher education at increasing rates, those students are also dropping out at higher rates. Long-term mentorship programs are one way to address this retention problem; in particular, programs that embed students with disabilities into a mentorship network with multiple mentors at the near-peer and faculty levels, and both with and without disabilities, have proven effective. These programs foster social integration, self-determination, and a sense of purpose. The goal of this project is to create a program that will equip undergraduate (2/year) and graduate (2/year) students with disabilities with mentoring, research, and curricular resources that facilitate their advancement towards becoming members of the professional community of ELSI scholars. Mentoring resources include a mentor network that incorporates a faculty research mentor, a mentor with a disability, a near-peer mentor, and an administrative mentor who monitors their overall progress. Research resources include the opportunity to participate in one or more ELSI research projects, and then support to present the results of that research at a local research symposium and at national academic conferences. And curricular resources include enrollment in an interdisciplinary ELSI course, a course on the responsible conduct of research, and a grant writing workshop (for graduate students) or a graduate record examination test preparatory course (for undergraduate students).

The purpose of this R25 Diversity Action Plan grant proposal is to create a program that will equip students with disabilities with mentoring, research, and curricular resources that facilitate their advancement towards becoming members of the ELSI community of scholars. Disability rights advocates argue conversations about disability, policy decisions affecting people with disabilities, and technological developments impacting disabled lives should include members of the disability community; however, this demand—“nothing about us without us”—is hindered by the fact that individuals with disabilities are underrepresented in academia. The proposed program is designed to embrace this demand by creating a future generation of ELSI scholars who have experience living with disability.

Utah Trial Innovation Center

NCATS 3U24TR001597-01S1

PI: Dean - .12

DURATION: 7/1/16-6/30/23

FUNDING: $3,622,562      TOTAL FUNDING: $39,582,153 (13 projects) FUNDING IC: National Center for Advancing Translational Sciences

The NIH established the Clinical and Translational Science Award (CTSA) program in 2006 to enhance translation of biomedical discoveries into therapeutic, diagnostic and preventive interventions to benefit patients and communities. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sciences (NCATS). Assessment by the Institute of Medicine (IOM) in 2013, and recommendations from the NCATS Advisory Council Working Group in May 2014, have contributed to the vision that the consortium of CTSA Programs should evolve into a collaborative national network to enable more efficient planning and implementation of high-quality multi-center research. NCATS began this evolution by requiring each CTSA Hub to actively participate in a developing national CTSA network (RFA-TR-14-009). NCATS is continuing the process by establishing Trial Innovation Centers (TICs) to accelerate implementation of multi-center studies by adding innovative network capacity to the existing strengths at the CTSA Hubs. The University of Utah proposes to be a TIC for the CTSA Network, with a focus on pediatrics, but capability across the lifespan. This proposal has three specific aims. Specific Aim 1. Provide immediate communication infrastructure for the TICs, RICs, NCATS, and CTSA investigators, and immediate capacity for NCATS to accept and assign trials on day 1, using our existing IT infrastructure, protocol development teams, functional reliance agreements and umbrella study contracts, central IRB procedures, budget templates, and capitation payment systems. Specific Aim 2. In the first six months, collaborate with the other TICs and the CTSA Network to standardize reliance agreement and contract language, consent templates, operating procedures, shared IT systems, innovative budgeting procedures, cIRB procedures, and performance measurement; and, subsequently implement a coordinated plan for securing agreements with all CTSA Hubs and their affiliates. Specific Aim 3. Using well-defined metrics to evaluate all trials supported by the three TICs and the two RICs, compare different strategies of trial planning, organization and implementation to identify and disseminate innovative ways to increase the quality and efficiency of multi-site clinical research. With our experience coordinating diverse multi-center trials across a broad range of diseases, the Trial Innovation Center at the University of Utah will provide immediate access to proven resources (electronic communications, cIRB, protocol assistance, streamlined contracting and budgeting expertise) to accelerate the evolution of the CTSA Network. We will share our existing resources, learning about and adopting better resources from other Network participants. We are excited to have the opportunity to help realize the potential of the CTSA program as a national laboratory for studying, understanding, and improving multi-site translational research.

The University of Utah Trial Innovation Center (TIC) works with the Clinical and Translational Science Award (CTSA) Hubs, other TICs, and the Recruitment Innovation Centers (RICs) to facilitate multi-center trials that will enable translation of biomedical discovery into therapeutic, diagnostic and preventive interventions to improve health across the human lifespan.

GENETIC TESTING & SCREENING FOR MENTAL HEALTH DISORDERS

NHGRI 1R13HG001285-01

Utah Center of Excellence in ELSI Research: UCEER

NHGRI 1RM1HG009037-01 - 2RM1HG009037-05

PI: Botkin - 4.32

DURATION: 5/16/16-5/31/21

FUNDING: $991,250    TOTAL FUNDING: $6,925,871 (8 projects)      FUNDING IC: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

CURRENT APPLICATION:

This application is for renewal of funding for the Utah Center of Excellence in ELSI Research (UCEER). Our Center has received funding under a P20 grant from 2014 – 2016 and under an RM1 grant from 2016 – 2020. UCEER is primarily focused on ELSI issues in population-based genetic testing and screening. For the current funding cycle, UCEER has had a strong emphasis on newborn screening, prenatal screening and carrier screening. For this renewal, we propose extending this focus to also address issues with genetic disabilities, including cost- effectiveness of treatments, adaptation and support within families and the community, and legal/policy issues. In addition, we propose to address issues arising from population-based heritage testing by direct to consumer genetic testing companies. We propose to maintain a robust set of efforts to involve faculty from a broad range of disciplines and students from the undergraduate to post-doc levels. UCEER has received a R25 award from  NHGRI , linked to our RM1 funding, that supports undergraduate and graduate students who identify with a disability. UCEER has developed an efficient administrative structure and processes and a strong group of staff to support our research and educational programs.

The University of Utah Center for Excellence in ELSI research explores issues relevant to population testing and screening for genetic conditions in the healthcare of women and children, as well as ELSI issues arising from testing and screening in the broader family context and responses to disabilities identified through genetic technologies. The Center supports cores in research, education and career advancement, and administration.

ORIGINAL APPLICATION:

To fund the University of Utah Center of Excellence in ELSI Research (UCEER). The University of Utah has a strong tradition in human genetics and ELSI research and this proposal will build on our successful development and management of a P20 funded CEER. The proposed UCEER will focus primarily, although not exclusively, on issues relevant to population screening for genetic conditions in the healthcare of women, children, and young families. Our primary emphasis will be on enhancing education and informed decision-making by patients and research participants with innovative approaches including multi-media and interactive computer platforms. Our overall goal is to create a "laboratory" for research and education with a diverse set of scholars and ideas in a creative, supportive academic environment. The CEER will support faculty across 6 colleges at the University of Utah including Medicine, Law, Nursing, Humanities, Engineering, and Fine Arts. Through our Research Core, we propose funding for 6 "Tier I" research projects that are of sufficient size and rigor to warrant publication but also will serve as pilot projects or future NIH grant applications. Through our Education and Career Advancement Core, we will support a variety of ELSI educational activities from across the spectrum from undergraduates to junior faculty and provide a strong mentorship program to foster the next generation of ELSI scholars. The UCEER Administrative Core will support an effective structure for the support, oversight, and integration of the research and educational activities across the University. Our proposed administrative structure includes strong, experienced leadership, communication tools, effective space, functional meeting schedules, and an advisory committee that will engage our CEER leadership, faculty, and trainees.

The proposal will fund a University of Utah Center for Excellence in ELSI research. The Center will support cores in research, education and career advancement, and administration. The primary focus of research will be population-based genetic screening.

The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research

NICHD 1R01HD082148-01A1 - 5R01HD082148-04

MULTIPLE PI: Rothwell & Botkin - 1.08

DURATION: 9/1/2015-5/31/20

FUNDING: $506,376      TOTAL FUNDING: $2,673,760 (5 projects) FUNDING IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT (NICHD)

Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs have chosen to store these specimens for several uses including biomedical research. (added to original)

Michigan BioTrust retains and catalogs newborn screening residual biospecimens for use in medical and public health research studies. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention.

The informed consent process for the retention and research use of biospecimens acquired through clinical care has serious limitations and may be a barrier to the effective use of biobanks as a resource for research. We will address this national problem within the context of residual newborn screening biospecimens in the Michigan BioTrust. We have not only a legal, but an ethical obligation, to assess novel multi-media approaches to improve the consent process.

University of Utah Center for Clinical and Translational Science (CTTS) Precision Medicine

NCATS 4UL1TR001067-04 - 5UL1TR001067-05

MULTIPLE PI: Dere & Hess - 1.8

DURATION: 9/26/16-4/30/18

FUNDING: $4,560,979      TOTAL FUNDING: $19,814,863 (9 projects) FUNDING IC: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

Our CCTS is built upon the UU's historic strengths in genetics and bioinformatics. Our vision for the next five years is to maintain and leverage the service cores of the CCTS and use that infrastructure as a springboard to launch new programs. With implementation of this vision we will fulfill the Aims of the CTSA described in the FOA by maintaining a home for translational research to: (1) Increase the quality, quantity, safety, efficiency, and impact of translational research for all conditions; (2) Provide resources and services to support and speed the planning and implementation of clinical and translational research across the entire range of research and communities; (3) Train, mentor, and support the next generation of translational investigators through the stage of becoming principal investigators and productive faculty members; (4) Maintain a governance structure that represents the full spectrum of translational science and all of its stakeholders to effectively fulfill the Aims; (5) Engage in a process of continuous evaluation, improvement, and innovation in all of these areas. The mission of the UU CCTS will be to provide support for all aspects of translational research. Even support that can be characterized as "service" will be used to inform innovation and catalyze new thinking. In addition, we will direct new resources toward providing special expertise to the CTSA consortium in specific areas, namely: Human genetics; genotype/phenotype correlation; health services research including comparative effectiveness; medical device innovation, and; taking the electronic medical record to the next level as a tool for medical care and medical research. We will continue to perform research aimed at re-engineering the process of translational investigation.

Providing resources and services to support and speed the planning and implementation of clinical and translational research across the entire range of research and communities.

BEHAVIORAL AND PSYCHOSOCIAL EFFECTS OF BRCA1 TESTING

NCI 1R01CA063681-01 - 5R01CA063681-04

DURATION: 9/1/94-3/31/00

FUNDING: $392,961     TOTAL FUNDING: $1,760,458 (6 projects)      FUNDING IC: NATIONAL CANCER INSTITUTE

Research in human genetics has permitted the localization of a number of genes that confer an increased risk of cancer. BRCA1 is a genetic locus that is associated with an increased risk of breast and ovarian cancer in some families. A large kindred residing in Utah and Idaho has been extensively studied at the University of Utah and found to have markers on chromosome 17q that are tightly linked with the BRCA1 gene. This kindred (K2082) is the largest 17q linked breast cancer family reported to date by any group. It is now possible to accurately test individuals in this kindred for the presence of this gene. For women, the presence of the gene substantially increases their lifetime risk of breast and ovarian cancer. Men who are gene carriers appear to have no associated health risks, but are at risk for transmitting the gene to their children. At the present time, knowledge of how individuals and families will respond to this type of information is limited. This research project will offer genetic testing to approximately 400 adult men and women in this kindred and provide them with individual results and counseling within a structured, multidisciplinary clinical environment. Women and men who are both gene positive and gene negative will be evaluated before testing and 1 week, 3 months, 1 year, and 2 years after testing to assess the psychosocial impact of the information on individuals and families. In addition, the use of preventive health services and individual health related behaviors will be evaluated pre and post genetic testing. The findings of this study will be important for our understanding of the psychological and behavioral responses to predictive testing for breast and ovarian cancer. Such an understanding is essential to the development of safe and effective genetic testing and counseling protocols for these forms of cancer. The results also may assist in the development of predictive genetic testing protocols for other serious, adult onset conditions.

SAMUEL BROWN, MD, MA

• 06/01/13 - 06/01/16 Improving Personalized Prognostication in Critical Illness. This project develops a novel method for automated calculation of APACHE IV and tests it against gold-standard APACHE IV as well as a Bayesian classifier. Principal Investigator: Samuel M. Brown Direct Costs: $39,854 Total Costs: $39,854 Intermountain Research and Medical Foundation Role: Principal Investigator
• 06/26/13 - Present Optimizing ICU Safety through Patient Engagement, System Science and Information Technology. This represents the BIDMC work within the Libretto Consortium; I work primarily on the electronic communication portal and measurement work. Principal Investigator(s): Ken Sands; Daniel Talmor Direct Costs: $4,500,000 Total Costs: $5,000,000 Gordon and Betty Moore Foundation Role: Co-investigator
• 09/18/13 - Present Value Personas and Decision-making Strategies in Life-threatening Illness: Methodological Studies. This project explores individual differences relevant to how individuals might experience the stresses of an ICU admission, using surveys, simulated decision making, and focus groups. I am senior investigator on this project. Principal Investigator: Eliotte L. Hirshberg Direct Costs: $60,000 Total Costs: $60,000 Intermountain Research and Medical Foundation Role: Co-investigator
• 07/01/14 - 07/01/16 R21HL123433 Discovery and Prediction of Novel Functional Outcome Phenotypes for ARDS. I am contact PI on this project employing "big data" clustering techniques to identify and develop prediction rules for long-term outcome phenotypes among survivors of ARDS. Principal Investigator(s): Samuel M. Brown; Dale Needham Direct Costs: $197,652 Total Costs: $218,434 National Heart, Lung, and Blood Institute Role: Principal Investigator
• 12/01/14 - 12/01/17 Physiology of Acute Stress among Family Members of ICU Patients (CORT-LT). A prospective observational study of autonomic nervous system function and salivary cortisol among family members of patients admitted to the ICU. Investigating the association between markers of acute stress and psychological distress 3 months after ICU admission. I am the senior investigator on this project. Principal Investigator: Eliotte L. Hirshberg Direct Costs: $60,000 Total Costs: $60,000 Intermountain Research and Medical Foundation Role: Co-investigator
• 10/01/14 - 04/30/21 1U01HL123018 The NHLBI Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL Network). I serve on the Long Term Outcome committee for PETAL, including writing standards and protocols. In addition I have led an effort in oxygenation imputation for overall protocols.Principal Investigator(s): Todd L. Allen; Colin K. Grissom; Alan H. Morris Direct Costs: $1,486,807 Total Costs: $2,052,071 National Heart, Lung, and Blood Institute Role: Co-investigator
• 11/01/14 - 12/01/17 Systems Biology of Cognitive function After Septic Shock (CASS). I lead this prospective observational study of septic patients, which employs deep RNA sequencing to interrogate the physiology of cognitive impairement after sepsis. This study is to generate preliminary data for an R01 submission to NIH. Principal Investigator: Samuel M. Brown Direct Costs: $60,000 Total Costs: $60,000 Intermountain Research and Medical Foundation Role: Principal Investigator
• 11/01/14 - 03/31/19 R01AG048022 Platelet Immune Responses in Aging and Influenza. This research explores aging related changes in immune and platelet responses to influenzavirues infection. I lead the long-term outcomes assessment and provide clinical methodological insight for this research.Principal Investigator: Matthew T. Rondina National Institute on Aging Role: Coinvestigator

09/01/16 - Present Translational Approaches to the Mechanisms of Septic Cardiomyopathy The major goal of this project is to define the intersections between dysadrenergia, dysregulated inflammation, and individual susceptibility, using a prospective observational echocardiography-based cohort of patients with and without septic cardiomyopathy, from whom cardiomyocytes will be derived from inducible pluripotent stem cells. I am co-PI, responsible for the CCC and echocardiographic analyses. Principal Investigator(s): Euan Ashley; Samuel M. Brown Direct Costs: $75,000 Total Costs: $85,000 Stanford University/Intermountain Healthcare Role: Principal Investigator

LESLIE FRANCIS, PHD, JD

• Agency: NHGRI 1RM1HG009037-01 Duration: 4/1/16-03/31/20 Funding:   $3,882,490   Utah Center for Excellence in Ethical, Legal and Social Implication Research (UCEER)     The University of Utah Center for Excellence in ELSI Research (UCEER) focuses primarily on issues relevant to population screening for genetic conditions in the healthcare of women and children. The specific focus is ELSI issues in prenatal screening, carrier screening and newborn screening .
• National Science Foundation, Law & Social Sciences Program, postdoctoral fellowship to study legal issues facing adults with autism ($200,000; 2013-2015) NSF SES-1228503
• Office of the National Coordinator for Health Information Technology, “Non HIPAA Covered Entities,” principal investigator on subcontract for study, 2010.
• University of Utah Seed Grant (co-principal investigator with Margaret P. Battin), “Ethics and Infectious Disease,” 2005, $40,000.

BRENT KIOUS, MD, PHD

• Young Investigator Grant, 01/15/17 - 01/14/19, Creatine and 5-HTP for antidepressant-resistant depression in women National Alliance for Research on Schizophrenia and Depression, Direct Costs: $70,000 Total Costs: $70,000, Role: Principle Investigator
• Research Grant, 08/01/2012-01/01/16, Pilot study of sertraline for the prevention of PTSD in burn victims,R. Harold Burton Foundation, Role: Principal Investigator

ERIN ROTHWELL, PhD

University of utah center for excellence in elsi research (uceer).

NHGRI 5RM1HG009037-07

MULTIPLE PI: Rothwell & Tabery

DURATION: 5/16/16-5/31/24

FUNDING: $991,250

This application is for renewal of funding for the Utah Center of Excellence in ELSI Research (UCEER). Our Center has received funding under a P20 grant from 2014 – 2016 and under an RM1 grant from 2016 – 2020. UCEER is primarily focused on ELSI issues in population-based genetic testing and screening. For the current funding cycle, UCEER has had a strong emphasis on newborn screening, prenatal screening and carrier screening. For this renewal, we propose extending this focus to also address issues with genetic disabilities, including cost- effectiveness of treatments, adaptation and support within families and the community, and legal/policy issues. In addition, we propose to address issues arising from population-based heritage testing by direct to consumer genetic testing companies. We propose to maintain a robust set of efforts to involve faculty from a broad range of disciplines and students from the undergraduate to post-doc levels. UCEER has received a R25 award from NHGRI, linked to our RM1 funding, that supports undergraduate and graduate students who identify with a disability. UCEER has developed an efficient administrative structure and processes and a strong group of staff to support our research and educational programs.

Implementing a Novel Consent Process for Biospecimen Research after Newborn Screening in Hospitals Serving Diverse Patients

NICHD 1R01HD082148-01A1 -

MULTIPLE PI: Rothwell & Goldenberg (original: w/Botkin - The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research)

DURATION: 9/15/22-6/30/27 (original: 9/1/2015-5/31/19)

FUNDING: $693,250      TOTAL FUNDING: $2,673,760 (5 projects) FUNDING IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT (NICHD)

Biobanks are an enormously valuable resource for genomic research. However, inadequate diversity among specimen donors limits their generalization for translational research. The lack of representativeness of biosamples has the potential to limit the application of precision medicine within underrepresented communities and may inadvertently exacerbate health disparities. Biobanks created using stored newborn screening bloodspots can be particularly valuable resources in efforts aimed at addressing the need for samples from diverse populations: they represent virtually the whole population of infants in a given state, and can be accessed by a wider range of researchers and institutions than smaller repositories with narrower research goals. However, the storage and future research use of newborn bloodspots has itself experienced a long history of national controversy given that state newborn screening programs do not obtain informed consent for collection and testing, and only a few states have subsequently added consent for the research use of leftover bloodspots. Ongoing lawsuits among some state programs and policy debates at both the state and federal levels have further mired any progress to promote the use of newborn screening bloodspots for important health research, including studies that assess health disparities. The implementation of consent processes at the state level may become necessary for the continued utilization of this important resource. The proposed renewal of our R01 will address these concerns by: identifying determinants, strategies, mechanisms, barriers, and facilitators of consenting quality across hospitals serving diverse and underserved populations for the retention and research use of residual dried bloodspots for the Michigan Biotrust of Health (Aim 1); engaging members of underrepresented and non-English speaking communities in Michigan to support implementation of an electronic informed consent intervention (EICI) in diverse hospital settings (Aim 2); and implementing and evaluating the EICI consent approach within four major hospitals across the state of Michigan serving underrepresented persons, Spanish and Arabic speaking participants, and the general population (Aim 3).

The storage and future research use of newborn bloodspots has itself experienced a long history of national controversy given that state newborn screening programs do not obtain informed consent for collection and testing, and only a few states have subsequently added consent for the research use of leftover bloodspots. Ongoing lawsuits among some state programs and policy debates at both the state and federal levels have further mired any progress to promote the use of newborn screening bloodspots for important health research, including studies that assess health disparities. We will address this national problem using an implementation science framework to assess consenting quality and implement an electronic consent progress within hospitals serving diverse and underserved populations for the retention and research use of residual dried bloodspots.

The Effect of Electronic Informed Consent Information on Residual Newborn Specimen Research

NIH NICHD 1R01 HD082148-01

MULTIPLE PI: Rothwell/Botkin - 1.08

DURATION: 7/1/2015-5/31/2019

FUNDING: $2,403,087

The purpose of this study is to 1) Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual DBS; 2) create a state-of-the-art electronic informed consent information (EICI) presentation for use in the clinical setting; 3) Evaluate the EICI consent approach by comparing it to traditional consent delivered on an electronic tablet and the current paper-based consent approach; and 4) Assess feasibility of the EICI through focus groups and interviews before and after the intervention.

ROLE: PI - Dean  .12

DURATION: 4/20/16-6/30/18

FUNDING: $14,999,940

The NIH established the Clinical and Translational Science Award (CTSA) program in 2006 to enhance translation of biomedical discoveries into therapeutic, diagnostic and preventive interventions to benefit patients and communities. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sciences (NCATS). Assessment by the Institute of Medicine (IOM) in 2013, and recommendations from the NCATS Advisory Council Working Group in May 2014, have contributed to the vision that the consortium of CTSA Programs should evolve into a collaborative national network to enable more efficient planning and implementation of high-quality multi-center research. NCATS began this evolution by requiring each CTSAHub to actively participate in a developing national CTSA network (RFA-TR-14-009). NCATS is continuing the process by establishing Trial Innovation Centers (TICs) to accelerate implementation of multi-center studies by adding innovative network capacity to the existing strengths at the CTSAHubs. The University of Utah proposes to be a TIC for the CTSA Network, with a focus on pediatrics, but capability across the lifespan.

University of Utah Center for Clinical and Translational Science Precision Medicine

NIH/NCATS 4UL1TR001067-04

PI: Dere - 1.8

DURATION: 5/1/16-06/30/18

FUNDING: $4,187,697

The Utah CCTS serves as the major infrastructure and home for clinical and translational research in the state of Utah and aims to: 1) establish an academic home, located in a dedicated space, to support clinical and translational research by consolidating resources, promoting interdepartmental and interdisciplinary research and facilitating increased interactions between basic scientists and clinical investigators; 2) develop new and innovative health services and research programs in the community and provide the infrastructure required to elevate the disciplines of clinical and translational research to the highest possible level; 3) develop services to support the broadest possible spectrum of clinical and translational investigators; 4) provide seed funds to new investigators and established interdisciplinary teams to initiate clinical and translational research projects that have a high likelihood of achieving extramural funding; and 5) promote the development of a new generation of clinical and translational investigators through a variety of educational programs and, most importantly, through a mentoring program to provide support and promote recognition of these investigators.

JAMES TABERY, PHD

PI: Tabery  (Multiple PI: Tabery & Botkin, 2018-2021)

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