Frequently Asked Questions About Clinical Trials and Health Research
Search the topics below to find answers to frequently asked questions about clinical trials and health research.
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Who oversees health research to make sure it’s safe and fair?
All clinical trials and health research studies that involve human volunteers are reviewed by an Institutional Review Board (IRB), primarily the one at Indiana University Purdue University of Indianapolis (IUPUI) located on the IU Medical School campus. The IRB’s primary concern is to make sure that volunteers are safe and that the study is fair and ethical. The IRB actively monitors each research study until the study is complete.
Any changes to the study must be approved by the IRB before they can take effect, and any new information about risks of the study are required to be reported to the IRB by the researchers.
Why is health research important?
Why should I participate in a clinical trial or research study?
There are many reasons why people volunteer for clinical trials and research studies. The following are examples of some reasons people participate:
- To help others,
- To help advance science or knowledge about a particular health condition,
- To possibly improve their own health,
- To benefit from having a research team involved in their care,
- To receive more treatment options or work with a specific physician that might not otherwise have been available to them outside the research study
Do all clinical trials involve giving blood or other samples?
No, not all clinical trials or health research studies involved giving blood, or other biological samples (such as urine or saliva). Any study that requests biological samples from a volunteer is required to explain this in the Informed Consent document.
Who can participate in a clinical trial or research study?
Anyone can participate in research studies, including people that are healthy or sick, children and dependent individuals. Each study has requirements that must be met before a volunteer can take part. These requirements are called “inclusion criteria” and the requirements that prevent volunteers from participating are called “exclusion criteria.” These criteria may pertain to age, gender, the type and progression of a health condition, previous treatment history, and other medical diagnoses.
What is Informed Consent?
The informed consent is a printed or web-based form that explains the purpose of the study, any risks, any potential benefits and your rights regarding the research so that you can be informed before agreeing to participate in a study. It also lists the study procedures so you know what to expect. You will be asked to read this form prior to participating in any study. You should receive a copy of this consent form for your records.
What questions should I ask before consenting to participate?
- What kind of study is this?
- Why are you conducting this study?
- Where does the study take place (ex. by phone, via mobile app, at a medical clinic)?
- What will I have to do (ex. fill out a survey, donate biological samples such as blood or saliva, participate in a focus group, try a new medical treatment)?
- Does this study involve a new medication or medical device?
- If so, are there any side effects?
- Is the treatment available outside of the study?
Normally these types of questions are already addressed in the Informed Consent but do not be afraid to ask if the answers are not immediately clear.
Even if you consent to participate in a clinical trial, you always have the right to withdraw. By asking the right questions and talking with the research team, you can find out if a clinical trial is a good fit for you before agreeing to be part of the study.
How much time will I have to commit if I decide to be in a research study?
“My experience in three clinical trials has been phenomenal. Although not cured, my quality of life for the nearly four years since diagnosis has been excellent. The professionalism and compassion of my [physician], the nurses, and staff have been truly exceptional.”
“Research studies not only offer the potential for improved treatment to the individual clinical trial participant, but very importantly, provide the means for development of improved and safe therapies.”