Participate in Research

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Information for Research Participants

Ascension Wisconsin is proud to 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 help or improve health, or prevent illness.

About Research

Clinical research is done to learn how to improve medical care and treatments. For example, research is done to develop new drugs to treat disease, new equipment to do diagnostic tests, improved medical procedures, and to find the best way to provide care.
At Ascension Wisconsin, our researchers work on clinical trials supported through the government and drug and device companies, as well as conduct independent research.Clinical research is necessary to improve the care and treatment, but these advancements are not possible without people to volunteer to participate in research studies. Being in a research study may or may not help you personally. The results of the research could help other people in the future.

Participating in Research

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.

Research participants roles can vary greatly, depending on the kind of research study. Participants might be asked to let researchers collect information from their record, or to complete questionnaires or surveys. Or, participants in a clinical trial for an experimental drug might take a new drug that has unknown risks.

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. The researcher will give you information and can answer your questions. You can also ask friends and family, or your other care providers before you decide to participate.

Frequently Asked Questions (FAQs) About Clinical Trial Participation

  • 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 is research to test new drugs, medical devices or treatments. Clinical trials might be testing new experimental drugs, or ways to use currently approved drugs in a different was. Clinical trials are also done to test new surgical techniques, 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.
  • Who can be in a clinical trial?
    All clinical trials have guidelines about who can participate, and participation in a trial is optional. Factors that can be considered are 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, you may have to allow researchers to review your medical record, answer question or agree to have some tests done.
  • 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.
  • What should I consider before agreeing to be in a clinical trial?
    You may consider taking part in a study because you could benefit from the new study treatment that would otherwise not be available to you, or because you want to help researchers to improve the treatments for future patients.

    You might consider not taking part in a study because:

    • The experimental treatment may not work for you, or it could make your condition worse.
    • The experimental treatment may cause side effects that no one anticipated.
    • Your health insurance may not cover research procedures.
    • If the trial is randomized and includes a placebo (an inactive, dummy pill), you may not be given the experimental treatment.
    • The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much time.
     

    Before you decide to participate, you should ask questions and you should feel comfortable with the answers. Much of this information can usually be found in the informed consent form the researcher will go over with you. Some questions to consider asking are:

    • What is the study about?
    • If I am ill, will this research help me?
    • How does the study differ from normal health care for the condition?
    • Is the study controversial?
    • What are the risks?
    • What is involved? What will I have to do?
    • Can I take my regular medication while I'm participating? Can I see my own doctor?
    • Will I have any extra cost? Will I be compensated for my participation?
    • How can I end my participation if I change my mind?
    • What will happen when the study is over? Will I be told the results?
    • Who can I contact to express concerns or get more information?

    The U.S. Office of Human Research Protection has A list of questions to ask before deciding if you what to participate in research available online  in English and Spanish.  


  • What are the risks and benefits of being in a clinical trial?

    Clinical trials are done to test new treatments. A clinical trial is done because researchers have an idea that the new treatment might work, but it is unknown during the trial. Therefore, while each study will have specific risks, the general risks of being in a clinical trial include the following:

    • It is not known if the new treatment will be more or less effective than the standard treatment
    • New treatments may have side effects that doctors do not expect or that are worse than standard treatment.
    • Health insurance and managed care providers do not always cover all patient care costs in a clinical trial.

     

    There can also be some benefits to you or others from participating in a clinical trial, including:

    • Participants play an active role in their own health care.
    • Participants may gain access to treatments before they are widely available.
    • Participants help others by contributing to medical research knowledge.
     
  • What are my rights and responsibilities as a research subject?

    If you decide to be a participant in a clinical trial, you will have some rights and responsibilities.

    • You have the right to not take part in a research study.
    • You have the right to drop out at anytime.
    • You have the right to be given new information about the study.
    • You have the right to ask questions at any time and have them answered as soon as possible.
    • Your decision about being in a clinical trial won't change how you are treated.

    If you decide to be in a study, you will have to agree to do certain tasks require by the protocol. this might include extra visits, taking a drug, recording symptoms or taking surveys. You also have the responsibility to stay informed during your participation in a study. You should ask questions about anything you do not understand or simply want to know.

  • Will it cost anything to be in a study?
    In many cases, taking part will not cost you or your insurance company anything more than your normal care would.

    In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. Sometimes insurance companies may not pay even costs related to your normal care if you are in a clinical trial.

    If you are injured as part of a study, you may or may not have additional costs. This depends on the specific study you are in.

    The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form. It might also be helpful to talk to your insurance company before deciding to participate.
  • Where can I get more resources and information about clinical
    research?
    • ClinicalTrials.gov Explore research studies in all 50 states and internationally on this database provided by the U.S. National Library of Medicine.
    • About Research Participation (Office of Human Research Protection(OHRP)) Review information about research and participating as a research subject.
    • Questions to Ask English, Spanish (OHRP) A list of questions to ask before deciding if you what to participate in research.
    • Clinical Trials: What Patients Need to Know (FDA) Specific information about participating in a Clinical Trial of a new drug or device.
    • Learn About Clinical Studies (ClinicalTrials.gov) Learn about types of clinical research, how research is conducted and participating in research.