Frequently Asked Questions about health research and clinical studies
Search the topics below to find answers to frequently asked questions about health research and clinical studies.
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What is health research?
When people are asked about participating in a health research study, they often think of drug studies or other types of medical research, but not all research is to test new medicines or sick people. Some health research studies use questionnaires, interviews, or surveys to gather information on a wide range of subjects, including healthy people, to improve health care, change procedures, or to understand health from the patient’s perspective.
Why are clinical studies important?
Clinical studies and trials are important because medicine can’t advance without testing these new treatments to see if they work and are safe. They help physicians:
- Find new advances in medicine,
- Develop new ideas or approaches for treatment,
- Identify safe and effective treatments,
- Obtain FDA approval for use of new drugs or devices,
- Personalize medicine by determining which existing treatments are better for specific patients, and
- Determine which treatments are the most cost-effective.
Why is health research important?
I often hear the term”clinical trial.” What is a clinical trial?
The term “clinical trial” can refer to a general health research study but it often refers to a specific type of study. Usually when people use the term “clinical trial” they are referring to a drug or device study. However, this term has been used for both drug trials and non-drug trials, so it is important to find out what type of study it is before participating.
Who can participate in a 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.
Will I be paid to participate in research?
Some studies will pay you for your participation while others will not. Before you agree to participate, you will be told whether or not you will be paid, how much you will be paid, how you will be paid (i.e. check, gift card), and when you will be paid (i.e at each visit/session, at completion). Payment is not meant to convince you to participate but to thank you for giving up your time and to cover any costs you may have incurred by participating (i.e. travel, taking time off work).
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
How is my information protected?
There are guidelines put in place to protect your information. Information is stored on protected computers. Usually researchers will remove your name and other direct identifiers (like your date of birth) from your information and replace them with a code. There will be a master list linking the codes to names, but it will be kept separate and secure. They also limit and keep track of who sees your information. In order to work with your health information, researchers must promise not to try to find out who you are. Researchers will tell you if someone accesses your data who does not have permission to do so.
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.
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.
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.
How much time will I have to commit if I decide to be in a research study?
Does it cost anything to participate in a clinical trial?
Most clinical trials are funded by the government, pharmaceutical or device companies, or philanthropist, so there is no cost to participate. All research related visits, medications and tests are often provided free of charge. In addition, there may be reimbursement for your travel, parking and time. In some studies, researchers may be looking at how well the treatment compares to usual care or the care that is normally provided by your doctor. In these cases, researchers talk with you at your regular doctor office visits and your standard office co-pay may apply. Researchers will inform you before you participate what payment you will receive and what costs, if any, there are for participating.
What are the drawbacks of participating in a clinical study?
Some clinical studies include drug trials testing how well a new drug works on the condition it is designed for, while others may be testing a new therapy method. The medication or therapy being studied might cause side effects or might not work at all. You should talk with the study coordinator and physician about all the risks before participating in a study.
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.
Are there benefits to being in a clinical trial or health research study? Will I benefit from the research?
In some way, all of us have benefited from the knowledge gained from clinical trials and health research. Any medication you have taken when you’ve been sick was once part of a clinical trial. Vaccines which help prevent diseases and have even helped eliminate some disease are a result of health research. Victims of trauma and disaster receive psychological and social support services that were also developed from health research findings. By participating in a clinical trial or health research study you may not benefit personally, but your participation can benefit humanity by helping researchers to learn more about a certain disease or condition. However, for some studies, you may have access to experimental treatments you may not have been able to receive otherwise that may stop your disease’s progression or lessen its effects on you.
Are there risks to being in a health research study or clinical trial?
All clinical trials and health research studies may involve some degree of risk. For studies that just ask you to fill out a survey, the risks are minor, such as asking you questions that make you uncomfortable. For studies that ask you to take an experimental drug, the risks can be much greater; such as having a bad side effects.
The study coordinator will go over all of the risks and benefits of a study with you before you enroll. These will also be explained in the informed consent. Each individual must weigh the risks and benefits in order to decide for themselves if the study is something they want to be involved in. If you have any concerns about potential risks, make sure your ask the study team.
“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.”