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Marley Berthound

Patients and Families

Are you considering being part of a research study?

Spectrum Health is dedicated to assuring the rights and welfare of all our research participants’ is respected and protected. These resources will tell you what to expect when taking part in research, what information can inform your choice to join a study and who to contact if you need more information.

What is “research”?

The medications, vaccines and therapies that we rely on today are all made possible because of years of careful research and volunteer participation. Research is a systematic gathering of information from volunteers to answer a specific question.

There are many types of research questions. Some are designed to find better ways of treating diseases, while others may concentrate on disease prevention, improving diagnosis or improving the quality of life for people with chronic illnesses.

Types of research studies:

  • Clinical Trials: A clinical trial is designed to learn if new treatments are safe and effective. These trials might test new drugs, devices, procedures or ways to use existing treatments. Researchers conduct clinical trials before any new treatment can be used by a doctor.
  • Observational Studies: In an observational study, researchers do not change your medical treatment. The researcher will only observe and collect information from you by interviews, surveys or from a medical chart.

Getting Involved in Research

Researchers need the help of volunteers to answer important medical questions.

There are many reasons to participate in research, including contributing to the advancement of health care. Before participating in a research study, you should evaluate all options to help make an informed decision. Use this website as a guide.

There are many ways to get involved with research at Spectrum Health:

  • Find an open research study: Check out the available research studies at Spectrum Health or click here to search for research studies available internationally.
  • Support research efforts at Spectrum Health: If you are interested in contributing to research, the Spectrum Health Foundation can help direct your donations to a cause close to your heart. For more information, email foundation@spectrumhealth.org or call 616.391.2000.
  • Share your personal research story: Have you or a loved one been impacted by clinical research? Share your story with the Spectrum Health and West Michigan community.
  • All of Us: We're calling on one million people across America to join researchers and advance how we prevent and treat diseases for generations to come. Join today!

Research is collaboration between researchers and patient volunteers. Participating in a research study gives you an opportunity to take an active role in your own health care and help others who may have similar health conditions.

The Informed Consent Process

Before you enroll in a research study, you will engage in the process of informed consent. The goal of this process is to provide potential participants with all the information they need to make the decision about whether to take part in the research.

During the consent process, you may be presented with a consent document to learn the purpose, risks and benefits of the research. Depending on the type of research it might also include expected length of time for participation and a description of all the procedures that will be completed during enrollment on the clinical trial.

Before making your decision, you will have an opportunity to ask the research team questions about anything you do not understand. If you agree to participate, you will sign the form before starting any study procedures.
Informed consent is a voluntary agreement to participate in research. Giving consent is not a contract; participants may leave a study at any time.

Screening Process

Every research study has guidelines for who can or cannot participate. These guidelines describe characteristics that must be shared by all who participate, such as disease type, age, gender, medical history and current health status. The research and their team will use a screening process to make sure these guidelines are followed.

The screening process could include a review of your medical record and you may be required to undergo additional testing. Screening potential participants helps us determine if this is the right study for you.

During the Study

When taking part in a research study, you may be asked to come to the clinic more often, do certain activities at home, complete surveys or answer phone calls from the study team, among other actions.

Before you decide to take part in a research study, ensure that you understand what you will be asked to do. Sometimes the research may have an impact on your daily life, and you may have extra costs, such as parking, childcare and taking time off work. It is important that you talk to the researcher about how this will impact your daily life and schedules before you volunteer. 
We encourage you to take all the time you need to share and review the study details with your family, friends and doctors to help you decide if you would like to volunteer.

Clinical research studies are conducted according to strict guidelines and regulations that are designed to protect participants’ rights and well-being.

When taking part in a research study, you have several rights as a participant:

  • You have the right to ask questions about the research study at any time.
  • You have the right to decide not to participate in the research without penalty or loss of benefits.
  • You have the right to make a choice that is free from coercion, undue influence or pressure.
  • You have the right to leave the study at any time, for any reason.
  • You have the right to get a copy of the consent form.
  • You have the right to know what other options are available to you and your family.
  • You do not waive any of your legal rights by joining a research study or signing a consent form.

The Institutional Review Board

Before research studies can start at Spectrum Health, steps are taken to ensure safety of all participants. All research conducted at Spectrum Health has been reviewed and approved by the Institutional Review Board (IRB). It is the responsibility of the IRB to make sure the trial is safe and that the benefits of participating in the trial outweigh any possible risks.

The Institutional Review Board is made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that study participation is equitable, that the risks are reasonable when compared to the possible benefits of the research, among other important factors. To learn more about what the IRB reviews, visit the Office for Human Research Protections website: Protecting Research Volunteers.

Benefits

Many studies hope to benefit the participants who enroll, but it cannot always be guaranteed. Sometimes, the benefits from taking part is to help researchers learn more that could help future patients.

Risks

Participating in clinical research may involve risks and those risks vary from study to study. Some studies might include a chance of higher risk than others and some may have little to no risk to you.

Details about specific benefits and risks involved in a study will always be explained in the informed consent process.

Staying Informed

It is important to become informed before you decide to join a study. Here are some examples of questions that you may want to ask the research staff about the study before you make your choice:

  • Why is the research being done?
  • What procedures, therapies or tests will I have as part of the research?
  • What will my responsibilities be if I participate?
  • Will the research help me personally?
  • What are the possible risks or side effects?
  • What other options do I have?
  • How long will the study last?
  • Will any costs of the research be billed to me or my insurance?

Resources

There are several additional resources available to help you find out more:
There are several common terms used by research study teams. These are some of the most common. If you have study-specific questions, contact the study team.