Why is this research study being done?
It’s important to understand the researcher’s plan and how the research might help answer questions about the problem being studied.
Who is doing the research?
Ask for the names of doctors involved, whether you will see a nurse or other health care provider, and who you should call if you have questions or concerns.
How many other people will be participating?
Sometimes the study will be held in more than one location. Sometimes it is done in other countries. Ask how many people will be in the study altogether, and how many will be participating at just this one location.
What will I have to do if I decide to participate?
The researcher will have a paper for you with a detailed list of activities and other important information about the study. This paper is called the Informed Consent Form. You will be asked to sign this paper to show you have read and discussed the study with the researcher. You should not sign this paper until you have asked all your questions and received satisfactory answers.
How long will I be expected to participate in the study?
Each person is only allowed to participate in a study for a set amount of time. The researcher is not allowed to change this time without first getting approval from the independent research review group called the Institutional Review Board, or IRB. Your researcher will tell you how long you will be in the study.
Why are volunteers needed for this research?
Some research is done without volunteers. Ask why this study needs volunteer participation.
Will my regular doctor be told that I am participating in research?
Most researchers have a process to notify your regular doctor that you are in a study. Ask your researcher about the process at their clinic.
How can I find out the results of the research?
The researcher can give you information on the results of the study. It often takes a very long time to complete a study, so it may take many years before you know the results.
Will I receive any money or other compensation for my participation?
Often you will receive money or other types of compensation, such as gift cards, for your time and travel expenses. Not all studies provide money or other compensation. The independent research review group called the IRB approves all compensation for study activities. You will be given a paper called the Informed Consent Form that lists the study compensation details.
Will I be expected to pay for anything I do in the study?
Usually all expenses related to the study are paid for by the researcher, but not all studies follow this standard guideline. Ask the researcher if you will need to pay for any part of the study.
Will my insurance be charged if I participate?
Usually all expenses related to the study are paid for by the researcher and not charged to your insurance, but not all studies follow this standard guideline. Ask the researcher if your insurance will be charged for any part of the study.
What are the risks or expected discomforts of participating in the study?
Some studies have expected discomforts such as the usual soreness if blood is drawn, etc. Other studies may have different risks, such as side effects from taking a medicine that has not been taken by very many people before. The researcher must inform you of all expected risks and also inform you of the possibility of any unexpected side effects. It is up to you to decide if those risks are worth helping improve your health or the health of others. If you have any hesitation, you may want to talk it over with trusted family and friends before making your decision.
What happens if I experience an injury related to my participation?
Researchers try their best to make a study as safe as possible. Occasionally, a volunteer may experience an unexpected injury or side effect from being in a study. The researcher will provide instructions on what to do if this happens. Ask the researcher about when care will be given and who will be expected to pay.
Will my medical information be secure?
Researchers take great care to keep your information private. All databases are built with security measures in place. Researchers do not discuss your medical history with anyone who is not involved in the study. Your medical information will be recorded for study purposes only.
What are the benefits of participating in the study?
Much of the time, it is community members or society in general that benefit from medical research. You may also receive individual benefits. For example, if you participate in a drug study to test a new medication, you may be one of the first persons to receive the new medication.
Will the study doctor provide medical care for me while I'm in the study?
Research doctors and nurses do not normally provide routine medical care for people while they are in a study. You should continue to see your regular doctor for routine medical care as usual. However, sometimes medical testing is provided that may be helpful for conditions requiring regular testing. Ask your researcher what type of care will be provided during the study.
Can I stop participating at any time for any reason?
Yes. All research participation is completely voluntary. No one can make you participate in a research study and you can stop participating at any time. Be sure to notify your researcher of your decision if you decide to stop. For your safety, your researcher may schedule a visit to do a final health checkup.
If I stop participating, will I be penalized?
If you decide not to be in a research study, you will not be denied care or benefits that you would otherwise receive.
Could I be asked to stop participating in the study?
A volunteer may be taken out of a study for many different reasons. Sometimes it is because the volunteer is not able to attend the clinic visits. Sometimes it is because they are not taking the medicine as often as they should. The researcher will provide details to you.
Could the research study be stopped suddenly?
A research study may be stopped for a number of reasons. Sometimes it is because a better medicine has been invented. Sometimes it is because the money for the study needs to be used for another purpose. Sometimes it has been decided that the study is more harmful than helpful. The researcher will provide details to you if that happens.