Clinical trials and research doctor looking at a sample.

Ascension Clinical Research Institute

We are committed to patients and the communities we serve through discovery, continuous improvement, and care transformation.
For investigators
For partners and sponsors
For patients
Our Annual Report

In collaboration with partners and in alignment with our clinical programs, the Ascension Clinical Research Institute (ACRI) is committed to equitably advancing the health and wellness of the patients and communities we serve through discovery, continuous improvement, and care transformation.

  • About ACRI

    Ascension has more than 2,600 sites of care in 19 states and the District of Columbia. With this size and scope, ACRI has nearly 3,000 active and/or approved studies at any given time. We provide clinical research support and oversight to all sites engaged in research, including:

    • A multi-site clinical trials coordination center
    • A single, Ascension-wide Institutional Review Board
    • Longitudinal clinical database research support
    •  A centralized research business office
    • Therapeutic-area clinical research forums

    Read our FY 2024 Annual Report

  • Our leadership

     

    Frederick Masoudi, MD, MSPH, MACC, FAHA, Chief Science Officer and Vice President, Clinical Research and Analytics, Ascension

    Frederick Masoudi, MD, MSPH, MACC, FAHA

    Chief Science Officer and Vice President, Clinical Research and Analytics

    Dr. Masoudi joined Ascension in 2021 and previously served as professor with tenure in the Department of Medicine at the University of Colorado Anschutz Medical Campus and Chief Scientific Advisor of the American College of Cardiology’s NCDR, a suite of national quality assessment and improvement platforms for cardiovascular conditions and procedures. He is an internationally recognized clinical scientist who has spent his career dedicated to cardiovascular care in practice, research, and education. He has co-authored over 325 peer-reviewed articles and contributed to numerous national practice guidelines, scientific statements and policy documents.


    Ryan Leslie, PhD, Associate Vice President, Research, Ascension

    Ryan Leslie, PhD

    Associate Vice President, Research

    Dr. Leslie is Associate Vice President of Research for Ascension and is the business and administrative leader for the Ascension Clinical Research Institute. Prior to his national research leadership role, Ryan was a member of the executive leadership team of Ascension Texas, where his responsibilities included analytics, research, graduate medical education (GME), and the development and support of collaborative data, research, and analytics capabilities for Ascension’s partnership with The Dell Medical School at the University of Texas at Austin. Ryan holds three degrees from UT-Austin, including a BBA in management information systems and an MS and PhD in health economics and outcomes research.


    Tina Noonan, Senior Director of Human Research Protection

    Tina Noonan

    Senior Director of Human Research Protection

    Tina Noonan is Senior Director of Human Research Protection for Ascension. Prior to this role, she spent ten years as the Executive Director for Research for Ascension Indiana. Tina is also a member of Ascension Clinical Research Institute’s (ACRI) Research Advisory Council, where she functions as the subject matter expert for Human Research Protections and IRB operations. She has more than 30 years of experience in the administration regulatory compliance oversight of medical research, spanning basic science, translational, and clinical research. She holds an MBA in Finance, is certified in Healthcare Research Compliance (CHRC) through the Healthcare Compliance Association (HCCA) and is a Certified IRB Professional (CIP).

  • Research in our ministries

    Learn more about market-specific information and programs below.

 

For Ascension investigators

The Ascension Institutional Review Board (IRB) reviews study protocols to ensure the protection and ethical treatment of human subject research participants as well as the scientific integrity of the research. The Ascension IRB operates under a domestic Federal Wide Assurance for the Protection of Human Subjects (FWA00015877) granted by the U.S. Department of Health and Human Services.

As of October 1, 2022, Ascension has a single Institutional Review Board (IRB) with regional panels and an office focused on streamlining minimal risk studies. If you are participating in a study that already has a review by a central IRB, our reliance team can work with you and the central IRB.

In addition, Ascension uses an electronic IRB system called eIRB for all IRB submissions, including those that are requesting reliance on a central IRB. This system is accessible at: eirb.ascension.org. Ascension’s Human Research Protection Program (HRPP) Plan and its other associated HRPP and IRB policies are publicly available at the eIRB Home page.

Regional IRB teams

Regional IRB panels are overseen by three Ascension Regional IRB offices. If you have any questions, please contact your regional IRB director.

  • North Central (Michigan, Wisconsin, and Maryland): Lee Bowen, Regional IRB Director
  • Midlands (Indiana, Tennessee and Florida): Rebecka Snyder, Regional IRB Director
  • Southwest (Texas, Oklahoma, Kansas and Alabama): Esmeralda Galvan, Regional IRB Director

Minimal risk studies

For assistance with minimal risk studies (including QA/QI and EBP), please contact the Ascension Minimal Risk Office through its Director, Annette Latta.

Studies using a central IRB

For assistance with studies that will use a central IRB, contact the Ascension IRB Reliance Office through its Director, Brittany Keown.

 

For partners and sponsors

The Ascension Clinical Research Institute (ACRI) seeks to foster partnerships with all types of partners including federal, state, commercial and non-profit organizations.

Trials network

ACRI is your front door to performing clinical trials at Ascension. Our team provides:

  • Feasibility analysis of potential trial sites
  • Coordination of communications
  • Centralized budget and contract negotiations
  • A single Clinical Trials Management System
  • Centralized Accounts Receivable and Accounts Payable teams
  • A single IRB

In partnership with the Ascension Data Science Institute, we can help design and perform database research as well as quasi-experimental and real-world data research.

For more information, or to discuss a trial opportunity, please contact national_research@ascension.org.

 

For patients

Many Ascension sites of care offer patients a wide variety of clinical trials and research studies to answer specific research questions about health issues. These studies test new treatments for safety and effectiveness and search for ways to improve health or prevent illness.

Our researchers participate in clinical trials supported through the government and drug and device companies, as well as conduct independent research. Clinical research is necessary to improve care and treatment and these advancements are not possible without volunteers who participate in research studies. Your participation may or may not help you personally, but the results of the research could help other people in the future.

It is up to each person to decide if they want to be in a research study and participation is always voluntary and you can stop at any time. Your decision to participate in a study will not affect the care you receive.

Before you decide to participate in a research study, you should learn about research and be sure that you understand the research study, and the risks and responsibilities involved. Our researchers will provide you information and can answer your questions you may have.

Deciding to take part in a clinical trial is personal. There are many reasons you may choose to participate. For example, clinical trials can give you the opportunity to receive advanced treatments. During the trial, you are watched closely by your care team for side effects from the treatment or medicine being tested. Before taking part in a trial, you should fully understand the risks and benefits of participating in the research. Your doctor can help answer your questions and help you decide if a clinical trial is right for you. Common questions patients ask include: 

  • Who can participate in clinical trials?
    All clinical trials define a specific population that is studied, and participation is always optional. Factors that can be considered include age, gender, the type and stage of a disease, previous treatment history and other medical conditions. To determine if you can be in a clinical trial, researchers may have to review your medical record, ask you additional questions, or obtain tests to determine if you are a good candidate.
  • How can I decide if a trial is right for me?
    Many clinical trials and research studies may include unproven treatments that have not been proven to be effective or safe in treating your disease or condition. Volunteering is a personal choice and may not be right for everyone. The results of research can help advance medical science by helping researchers better understand possible treatments and their safety and effectiveness. Often, there is no cost to participate in trials and financial support may be provided for participants, but each trial is different.
  • What is a clinical trial?

    There are many kinds of research studies. Research that includes humans is clinical research. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. There are also different kinds of clinical research.

    A clinical trial tests new drugs, medical devices or treatments. Clinical trials might be testing new experimental drugs, or ways to use currently approved drugs in different ways. Clinical trials are also done to test new surgical techniques, medical devices or biological products. New treatments like these must be tested before they are approved for use by the U.S. Food and Drug Administration (FDA) and made available for commercial use. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory rules.

  • What is informed consent?

    Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. Details in this consent process include the purpose of the study, its duration, the required procedures, all safety monitoring and potential risks and potential benefits.

    A member of the research team reviews an informed consent document that includes details about the study, such as its purpose, duration, required procedures and names of key contact personnel. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

  • Is it safe for me to participate in a clinical trial?

    Clinical trials are strictly reviewed to make sure they are as safe as possible. In some cases, the U.S. Food and Drug Administration (FDA) must approve the trial plan before it is started. In every case, an Institutional Review Board (IRB), which is a group of people who reviews studies to make sure that human rights are protected, must approve the trial before it is started. The IRB also reviews the study throughout its course to protect the volunteers.

    There may be risks for taking part in a clinical trial. The research team will explain the study to you and help you understand the risks before you decide to participate. We encourage you to talk with the study doctor and ask your questions — big and small. We’re here to answer your questions and help you make an informed decision.

    Before you participate, you will be asked to sign an informed consent form. This form gives you information about the potential risks and benefits of participating in the study. Your participation in any clinical trial is completely voluntary. If it becomes unsafe for you to stay in the study for any reason or if you have changed your mind for whatever reason, you can stop your participation at any time. Your health and wellness is our priority.

  • What questions should I ask before I volunteer for a clinical trial?

    Learning more about the clinical trial you are considering can help you figure out if the study is right for you. Some questions to ask before you volunteer are:

    • What is the reason for the study?
    • What are the eligibility requirements for the trial?
    • How long is this trial? And how often will I have to come for visits?
    • How will this affect my daily life?
    • Does everyone in the study get the active treatment? Or do some people get a placebo (a control substance with no active product included) or usual care?
    • Who is the doctor that will take care of me during the trial or research? Can I see my own doctor during that time?
    • What are the risks, benefits and possible side effects?
    • What kinds of tests and procedures will I have during this research?
    • What happens if I get sick during the research study?
    • Do I get to have my personal results from the study?
  • What happens to the information from the study?
    Your personal and health information from the study is private and kept confidential. Researchers must follow strict federal regulations, codes of ethics, and other standards throughout the entire research process. The data collected about you will be shared with the sponsor of the study in order to answer the questions the study asks. You will need to ask the research team what results can be shared with you and what information you can share about your participation for each clinical trial.