Questions and Answers for Research Participants

Many people volunteer for a clinical study because the current treatment available for their condition is not effective or is partially effective, and participation in a clinical study might offer them a new alternative to standard therapy before it is available to the general public. Another reason people volunteer is to contribute to research efforts that may help patients in the future.

There may be risks associated with any clinical study. The principal investigator or study coordinator must explain all risks and potential risks, along with the potential benefits to the patient before they consent to become a participant in a clinical study. Also, since the drug or therapy is investigative (experimental), there are no guarantees that the drug or device being studied will be effective. Only the patient can decide whether or not it is appropriate to participate.

At the Minneapolis Heart Institute Foundation we follow Allina’s guidelines for research subjects.

Research Subject's Bill of Rights

People who volunteer to participate in an experiment (also called a research study or clinical trial) need to understand what is expected of them and why the research is being done. As you think about whether or not to volunteer, it is important that you know that you have rights in place to help protect you. These rights, listed below, will be further explained as you undergo the informed consent process.

If you are asked to participate in a research study, you have the right to:

• Be told the purpose and details of the research study.
• Have the drugs or devices (tools or pieces of equipment) used in the research study described.
• Have the procedures of the research study and what is expected of you explained.
• Have the risks, dangers, and discomforts of the research study described.
• Have the benefits and advantages of the research study described.
• Be told of other drugs, devices or procedures (and their risks and benefits) that may be helpful to you.
• Be told of medical treatment available to you should you be injured because of the research study.
• Have a chance to ask questions about the research study.
• Quit the research study at any time without it affecting your future treatment.
• Have enough time to decide whether or not to take part in this research study and to make that decision without feeling forced or required to participate.
• Be given a copy of the signed and dated informed consent form.

The informed consent process is required for participation in all clinical studies involving human subjects. Individuals are given information about what is involved in the study, including procedures, possible benefits and risks. The physician or study coordinator encourages questions. After this information is presented, individuals can make a decision whether or not to participate. The individual's consent to participate is documented in their medical record.

The following are some questions to consider before giving consent to become a research volunteer:

• What is the purpose of the study?
• What tests and treatments are involved this study?
• How could this study affect daily life?
• What is likely to happen with, or without, this new research treatment?
• What are the other choices and their advantages and disadvantages?
• What are the potential side effects?
• How long will this study last?
• Is hospitalization involved? If so, how often and for how long?
• Are there any costs involved? Will any of the treatments be free? The answers to these questions should be in the consent document and can be explained more fully by the investigator or study coordinator.

Each study is different in what will and will not be paid for during the course of the clinical study. For example, some studies pay for all medications, doctor visits, tests, and treatments. Other studies will only provide the study drug at no cost to the patient and will submit the cost of other procedures and tests to the patient or their insurance company. Patients should freely discuss with their physician what costs are involved in their cases prior to participating in the study. This should also be outlined in the informed consent document. The general guideline is that those tests or procedures, done solely for the purpose of research, unless clinically indicated, are paid for by the study. Some studies provide a stipend for incidental costs incurred during the course of the study.

The Minneapolis Heart Institute Foundation sponsors certain clinical studies initiated by the physicians as part of its ongoing commitment to clinical research. Additional funding may come from the federal government (via the National Institute of Health), voluntary health agencies such as the American Heart Association, private industry (pharmaceutical and/or biotechnology companies), or from philanthropic private donations to the Minneapolis Heart Institute Foundation that are set aside for research.