Before entering a clinical trial, you must give what is termed informed consent. This means that the researchers must explain
exactly what will happen during the trial, and goal of the clinical trial. The patient can ask questions at that time, and decide
whether or not they want to be a part of the trial.
Often trials are “blinded” meaning, some people get the experimental treatment, and others might get the standard treatment or
a placebo (“sugar pill”). It is called blinded because neither the patients nor the doctor know which of these the patient is
getting. That is important so that people and their doctors don’t have imagined benefits which has been known to make a
treatment seem more effective then it really is.
Some of the Risks of Participating in Clinical Research
Some clinical research has very little risk: it simply may involve a physical examination, or filling out a survey. Other studies,
especially those that test a treatment, may have risks that you will be informed of during the consent process. These include:
You might not receive the therapy under investigation (you may receive a placebo instead).
New therapy may have unexpected, possibly severe side effects or may be less effective than your current care.
Some of the Benefits of Participating in Clinical Research
People who participate in research aren't always simply making a contribution to others. There are many possible benefits.
Firstly, you may benefit from the treatment being tested. Secondly, you may get additional monitoring for your condition which
you might not otherwise get. Additionally, you may get additional diagnostic or other testing that you would not get otherwise,
which could lead to subsequent treatments. Finally, people who are in trials often receive extended treatment, even after the
trial is over, and sometimes, that treatment continues to be free (check to find out if this is true in the case of any trial you are
considering).
The following are some additional questions that you should ask before participating in clinical research:
risks and determine which are more important to you. However, any person who participates in a clinical trial has done
something good for all the rest of us by allowing new treatments to be evaluated.
exactly what will happen during the trial, and goal of the clinical trial. The patient can ask questions at that time, and decide
whether or not they want to be a part of the trial.
Often trials are “blinded” meaning, some people get the experimental treatment, and others might get the standard treatment or
a placebo (“sugar pill”). It is called blinded because neither the patients nor the doctor know which of these the patient is
getting. That is important so that people and their doctors don’t have imagined benefits which has been known to make a
treatment seem more effective then it really is.
Some of the Risks of Participating in Clinical Research
Some clinical research has very little risk: it simply may involve a physical examination, or filling out a survey. Other studies,
especially those that test a treatment, may have risks that you will be informed of during the consent process. These include:
You might not receive the therapy under investigation (you may receive a placebo instead).
New therapy may have unexpected, possibly severe side effects or may be less effective than your current care.
Some of the Benefits of Participating in Clinical Research
People who participate in research aren't always simply making a contribution to others. There are many possible benefits.
Firstly, you may benefit from the treatment being tested. Secondly, you may get additional monitoring for your condition which
you might not otherwise get. Additionally, you may get additional diagnostic or other testing that you would not get otherwise,
which could lead to subsequent treatments. Finally, people who are in trials often receive extended treatment, even after the
trial is over, and sometimes, that treatment continues to be free (check to find out if this is true in the case of any trial you are
considering).
The following are some additional questions that you should ask before participating in clinical research:
- Am I comfortable with the idea of being the subject of an experiment?
- What are researchers trying to learn in this study?
- What treatments and tests will I get during this study?
- What are the differences between what I would get in this study and my current care?
- Are there different side effects? What are the risks and benefits?
- How will this trial affect my daily life?
- How long will this trial last?
- Who will pay for my medical care if I am injured during the study?
- How will I know if the trial was successful? Will I get the results?
- How much time will I need to spend as part of the trial?
- How many visits will I need to make, and how long will those visits last?
- What expenses will the study have? Will I miss time from work? Will I have to pay for travel, parking, and meals?
- What private information about me do the study researchers need to know? How will they protect that information?
- Who will be in charge of my care during the study?
- Who do I contact if there are problems?
risks and determine which are more important to you. However, any person who participates in a clinical trial has done
something good for all the rest of us by allowing new treatments to be evaluated.
Before You Volunteer to be in a Research Study
From Living Older, Living Better! by Katrina Gwinn, MD
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