Research at Aspirus Health

Participants gain satisfaction knowing that they are advancing healthcare for future generations through finding more effective treatments for a particular disease they themselves struggle with.

All medical research may involve some level of potential risk for the participant. The specific risks associated with any research are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. 

There is no cost to join a research trial. Each trial is different. If there are research costs associated with treatment, this will be discussed with you by the research staff.  

It’s very important to understand a trial before joining. Researchers are not allowed to give you treatment in a trial unless you fully understand what the trial is about, and what you can expect as a participant. 

Every clinical trial has a process where the trial doctor and research team go over what happens in the trial and reasons you may or may not want to join. The trial doctors and research team will explain what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the trial. This process is known as informed consent.

You must read and agree to an Informed Consent Form before you participate. You will get a copy of this form. As a potential participant, you can ask as many questions as you want before signing the Informed Consent Form.

All clinical trials must follow federal laws and ethical guidelines. Trials must also be approved by an expert group called an Institutional Review Board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.

Every trial must also have a protocol, which is the overall plan for the trial that includes instructions that the doctors and staff doing the trial must follow. This protocol must be approved by an IRB.

You can take as much time as you need before deciding. It is very important to understand a clinical trial and to be comfortable with what is planned to happen before you agree to participate.

Being in a trial is optional. Agreeing to be in a trial does not take away any of your rights. You can stop being in a trial at any time and for any reason. The trial staff will help you do this safely. You can talk to the trial staff or the IRB anytime you have concerns about being harmed.

Fact: Although a clinical trial cannot guarantee better outcomes for every individual, participant safety is a top priority in all clinical trials and participants have rights that protect them.

One of the most important goals of researchers is protecting the well-being of clinical trial participants. There are several steps that researchers must follow to ensure the safety of participants.

One of these is informed consent — a process required by the Food and Drug Administration (FDA) that makes sure participants are given complete information about the clinical trial. Each participant must read and sign an informed consent form before any investigational treatment or testing related to a clinical trial can begin.

Additionally, each research institution or hospital has an independent committee, called an Institutional Review Board (IRB), that reviews and monitors clinical trials, for patient safety.

Fact: A clinical trial is often an option, regardless of when the participant was diagnosed or what treatments they received. By enrolling onto a trial, participants may have access to new research options before they are widely available.

Clinical trials enable each patient to play an active role in his or her healthcare.

Fact: Placebos are never used in place of standard of care. A participant who enrolls in a clinical trial will always receive either standard of care or the investigational treatment.

With each treatment a patient receives in a clinical trial, whether standard of care or an investigational therapy, they will always be closely monitored.

Yes, in clinical trials, patients may receive a placebo (an inactive substance like a sugar pill) instead of the actual new treatment to help researchers determine if the new drug is truly effective, by comparing outcomes between groups getting the real treatment and those getting the placebo, often in a blinded way where neither patient nor doctor knows who gets what. As part of the informed consent process, patients are informed they might get a placebo and can decline participating. While participating in a clinical trial all patients will always receive standard of care treatment or the new investigational treatment. 

Fact: There are two types of costs associated with clinical trials – routine medical care costs and research costs. Routine medical care costs, or patient care costs, include any treatment, test or procedure that participant would typically receive whether or not they enroll in a clinical trial. Federal law requires most health insurance plans cover the routine care costs of a clinical trial. Research costs are those related to taking part in a trial, which are covered by the trial sponsor.

Participants  are strongly encouraged to discuss costs with their research team before enrolling in a trial.

Fact: Participation in clinical trials is crucial. Every treatment available today was approved through a clinical trial. Clinical trials give us insight and lead us to better ways to prevent, detect and understand the disease. Most important, they can help others and future generations of individuals with the same disease.