Before participating in a clinical research study, it is important to understand the possibility of any benefit or risks involved. Many studies hope to benefit the participants who enroll, but it cannot be guaranteed. It is important to remember that the main goal of research is to collect information that may help you and future patients.
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 risks or benefits involved in a study will always be explained in the informed consent form (ICF).
How Spectrum Health Protects YouBefore research studies can start at Spectrum Health, steps are taken to ensure safety to participants. All research conducted at Spectrum Health has been reviewed and approved by the Institutional Review Board (IRB) before participants can enroll. It is the responsibility of the review board to make sure the trial is safe and that the benefits of participating in the trial outweigh any possible risks. IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the study's consent form to make sure that it is accurate. The IRB continues to review approved research to ensure that it is properly conducted.
It is important to know that IRB approval does not mean that a research project is right for everyone. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to participants for consideration. You need to carefully look at the details of the research and decide whether it is right for your particular needs.
Get the FactsBefore you decide to become a research volunteer, get the facts. Know what you're getting into and the pros and cons. Here are some examples of questions that you may want to ask the research staff about the study:
- 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?