FAQs For Patients
What is research
Physicians, scientists and others called “investigators” conduct research to add to our general knowledge about the world. Research is completed because investigators and scientists don’t know for sure what will work best for you. You may see the following terms that describe research:
- Clinical trial
Research is not the same as treatment. If you agree to volunteer in research, you may find that volunteers in research are sometimes referred to as:
- Human subjects
Is there a difference between a clinical trial and research?People often think of research as medical research or “clinical trials.” However, there are different types of research including clinical trials.
A clinical trial is a research study with human volunteers to answer specific health questions. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics or other interventions on patients in strict scientifically controlled settings, and are required for U.S. Food and Drug Administration (FDA) approval.
However, research also includes research in non-medical departments such as psychology, business, anthropology and sociology. In these areas, investigators may not be evaluating drugs or devices but many be evaluating different approaches, methods or experiences to produce new knowledge about an area.
How is clinical research different from regular medical care?When you receive medical care from your own doctor, he or she develops a plan of care just for you.
When you take part in a clinical research study, you and the investigator must follow a set plan called the “study protocol.”
The investigator usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well.
How do I decide whether to take part in a research study?
If you are interested and seem to fit the study requirements, the research team will explain the research to you and give you a consent form to read. Then they will go over the consent form with you. They will describe what happens during the research study, the possible side effects and other information you need to know about the research study.
The research team will give you time to ask questions. You should ask as many questions as you want. Here are some questions you may want to ask:
- What will happen to me in the research?
- Are there any risks to me if I participate?
- Will the research help me personally?
- What are my other options if I do not want to participate?
- Can I leave the study at any time?
- Will it cost me to participate in the research
You usually don’t need to decide right away. You can take the consent form home, read it over and think about it. You can also talk to friends, family and your own doctor about the research.
The decision whether to take part is a voluntary decision that only you can make. You can decide not to take part in the research and your decision will not affect the care you receive at Ascension facilities.
If you have questions or concerns, you may speak with the investigator, research study team or you may contact the Ascension Genesys Hospital Institutional Review Board (IRB) at 810-606-7722.
What is an institutional review board or IRB?When investigators involve humans as subjects in their research, they must receive prior approval from an institutional review board (IRB). An IRB is a group of people who have authority to approve all research activities at an institution. The Ascension Genesys Hospital IRB is charged with assuring that all human subject research conducted at Ascension facilities, regardless of sponsorship, complies with the federal regulations (45 CFR 46) of the Department of Health and Human Services, FDA, the Belmont Report, state and local laws and MHC Human Research Protections Program policies and procedures.
According to federal regulations (45 CFR 46), IRBs must have at least five members, with at least one member who is not affiliated with the institution (a “community member”), and the board should represent varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
What happens if I decide to take part in the research study?You will be asked to sign the consent form. Your signature means that you volunteer to take part and understand what will happen. You will then be asked to do what is required for the study.
Remember, you can ask questions or change your mind at any time.
I was a volunteer in a research study and now I have questions about the research. Who should I contact?For questions about the research, we suggest that you contact the “responsible” or “principal investigator” whose contact information is listed on the consent document you received when you agreed to participate. If you do not have this information, contact the IRB office at 810-606-7722.
Where can I learn more about the protections in place for research volunteers?It is important that potential volunteers be fully informed about the research before they agree to participate (usually conveyed in the informed consent document). Research participants should know that participation is voluntary, and they may discontinue involvement at any time.
What Is A Clinical Trial?
A clinical trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical trials (also called research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work. The design of a trial is divided into several different steps called “phases":
- Phase I -- testing safety in healthy subjects
- Phase II -- testing safety and effectiveness in a small group of people with the condition
- Phase III -- confirming effectiveness in a large group of people with the condition
- Phase IV -- monitoring long-term safety and effectiveness in very large numbers of people with the condition
Ascension Genesys Hospital offers clinical trial opportunities for participating in Phase II through Phase IV studies.
Why Take Part In A Clinical Trial?
People take part in medical research through clinical trials for several reasons:
- To receive uniquely focused care from their healthcare team in addition to their standard care
- To receive medications or devices at reduced or no cost
- To benefit future generations from the knowledge gained
Taking part in a clinical trial is always your choice and is never a requirement for quality care. If someone from the Ascension Genesys Research Office talks to you about being in a research study, your involvement would be considered a partnership with us in making your medical care the best it can be.
For more information about clinical trials at Ascension, please call the Ascension Genesys Research Office at Tel: 810-606-7722.