Hello!
If you’re thinking about participating in a research study, you may have a lot of questions.
Informed consent is the process researchers use to give you the information you need about
the study and to answer your questions so you can decide if you want to participate.
The Federal Office for Human Research Protections, or OHRP, made this video to explain the informed
consent process.
There are many reasons that might make you think about joining a research study.
Perhaps you want to help other patients or society, or maybe you hope that joining a
research study will allow you to try out a new medicine for your condition.
However, participating in research can have risks.
While you might receive benefits from being in the research, it is also possible that
you could be harmed or have other unwanted consequences.
For example, volunteers in a clinical trial testing a new drug might benefit from more
medical attention for their condition, but they might also experience harmful side effects
of the new drug that researchers didn’t know about.
So, before you decide to volunteer for research, you should have information about the study
so that you can consider the reasons for why you might or might not want to participate.
Informed consent is the process you go through to get this information and make your decision.
Through the consent process, researchers will explain the study to you in detail to help
you understand what they will do, and what you would need to do while participating in the study.
Sometimes researchers will explain the information to you orally, but they will usually also
give you the information in writing to review and keep.
This is called the consent form.
You should read it carefully.
If you don’t understand the information or if you have questions, ask the researchers
to explain it to you.
It is their job to answer all of your questions.
If you would feel more comfortable reading the consent form or asking questions in a
different language, ask for an interpreter or a translated version of the document.
It is important for you to understand how participating in the study might affect you.
The consent form should tell you why researchers are doing the study and what they are trying
to find out.
It should also tell you why they are asking you to participate.
For example, maybe researchers are testing a new therapy because they have reasons to
believe that this new therapy has fewer side effects.
Or perhaps they are studying a new way to provide assistance for people with the same illness.
So, they may be asking you to join because you have this illness.
Finally, the consent form should also tell you what you would have to do in the study
and how much time it would take.
The consent form should also tell you about the risks and benefits to you if you participate
in the study.
It is important that you know how being in the study could affect your health.
If there are risks to you, you should know how researchers will minimize these risks
and how they will monitor your health during the study.
Researchers should answer any questions you have.
Of course, risks from participating in research studies are not always just about your health.
For example, in a study about illegal drug use, there is a risk that sensitive information
about volunteers could get out.
This could damage their reputations or create legal problems for them.
The consent form should explain how researchers plan to keep your participation confidential
and protect the information you provide from getting out.
It should also say whether researchers plan to use the information you provide in other
research studies.
As for benefits, if you join a medical study, you might benefit from better monitoring of
your condition.
However, there may or may not be other medical benefits.
For clinical trials that test new medications or medical procedures, people sometimes think
that joining a trial means they will automatically get a new and better treatment.
But it is important to remember that the reason researchers are doing the research is to find
out if the new treatment is better—they don’t know yet.
The consent form should make it clear what benefits you might expect from participating
in the research, or if there are no benefits that you will receive directly.
For this kind of clinical trial, researchers should explain what they know so far about
the new treatment and how it is different from the regular medical care that you get.
The consent form should let you know if there are other treatment options for you without
joining the research.
You can discuss these options with your regular medical doctor as you consider whether to
participate in the study.
Considering these options and thinking about how being in the study might affect you will
help you make a decision about whether to participate.
The consent form should also tell you how researchers plan to do the study.
For example, in a clinical trial that is testing a new treatment, often times not all participants
will get the new treatment.
Clinical trials often assign volunteers to different treatment groups randomly—some
volunteers get the new treatment and others do not.
The decision about who is in each group is often done randomly, like flipping a coin.
This means that as a volunteer, you cannot choose which group you are in and you might
not get the treatment that you want.
You may not even find out which treatment you got until the study is over.
So, if you have a strong preference for one of the treatments, you might not want to join
this type of study.
The consent form should describe all of this clearly, so you can consider the reasons you
might or might not want to join.
Remember that participation in research is voluntary.
This means that if a researcher asks you to participate in a research study, it is up to you.
You can agree to participate, or you can say no.
You should face no negative consequences for saying no.
And if you say yes, you can still change your mind later, even after the study has started.
Informed consent is about giving you all the information you need to make a decision about
participating in a research study.
Use the information you get to think through how participating in the study or not would
affect you.
It is about helping you make a decision that works for you.
If you choose to participate, you can sign the consent form.
If you choose not to participate, you don’t have to sign the form or do anything else.
OHRP has created a website called About Research Participation to help you learn more about
participating in research.
The website has many helpful resources including videos that cover topics such as: what research
is, how research is different from medical care, and what clinical trials are.
You can also find a list of questions that you can print out and take with you to remember
what to ask the researchers when you meet with them.
To print this list of questions and see other information about research participation,
check out the OHRP website at
www.hhs.gov/about-research-participation