For Research Participants

So, you're considering taking part in a clinical trial. The members of ACRP & APCR want you to be as informed as possible, so that you can make up your mind one way or the other. Like anything else, there is never a “one size fits all” in medical research, and we want you to be able to judge whether you think you should, or should not, take part in the clinical trial that you are considering. Before you get involved, we want you to know exactly what your participation may involve – including the possible risks. Equally important, we want you to fully understand your rights and responsibilities in the clinical trial process.

Why Participate in a Clinical Trial?
Why would you consider taking part in a clinical trial? The answer to this question is as individual as you are. Some participate because they simply want to help advance our medical knowledge. They recognize that we need clinical trials to improve our standards of medical care. Others are drawn to the clinical research process because they suffer from a disease for which there is still no effective treatment, or because they’ve tried all approved treatments without success. By getting involved in a study they hope to gain access to cutting-edge discoveries. It is commonly believed that people volunteer for clinical trials for financial reasons, but this is not a good reason to participate. Sure, some trials will provide money to cover the cost of your time and transportation, but the amount paid is never very large. It must not be your primary reason for enrolling in a trial.

And keep in mind that you may be disappointed if you’re volunteering with the hope you’ll receive some new, experimental treatment. There is no guarantee that you’ll actually receive it. Clinical trials are not the same thing as regular medical treatment. They are experiments, designed to test new ideas about medicines, devices, or other therapies. The benefit of the experiment is to science and to society---there’s no guarantee that you’ll receive any personal benefit from participating in the trial.

Whatever your motivation, it is important for you to know in advance exactly what will be expected of you.

Rights of Clinical Trial Particpants
The IRBs and medical monitors that oversee experimental testing on human beings are the chief protectors of your rights in a clinical trial. Here’s what they say you should expect:

• The right to have your exposure to risk minimized. IRBs demand that the procedures used must be consistent with good research design and that every effort be made to ensure that your participation does not pose an undue risk to your health.
• The right of informed consent. Your study designers must get your consent in writing and must make you aware of any changes in the risks you face. Both you and the IRB(s) must get a copy of the document.
• The right to be assured that your participation is truly voluntary. If you are recruited to participate in a study, there should be not even a hint of force or pressure to get you to agree.
• The right to assume that any risks you may be exposed to are balanced by the societal benefits expected to result from the research and the importance of the knowledge that is to be gained by the study.
• The right to privacy. This means that the study must protect your privacy, even after the data has been published. The sponsor and FDA have access to the information collected from you, but they will not know you by name or who you are.

The IRBs must see to it that children, or people who are poorly educated, economically disadvantaged, or mentally or physically disabled do not get included in studies without their fully and freely given consent---or, in the case of children and the mentally disabled, without the full and freely given consent of their parents or legally authorized representative. The IRBs also safeguard the rights of institutionalized populations---prison inmates, people who are in institutional care, members of the military — to make sure that these people are not forced to participate in a study against their will.

Important Questions to Ask
Once you've carefully read your informed consent document, you will no doubt still have some questions about the study your getting involved in. Some people, however, may find it useful to prepare themselves with a checklist of basic questions beforehand, so that when they're in the doctor's office they can be sure they've covered the important points. Here's a list of basic questions that you should have answered before you sign your consent form:

• What is the purpose of the study? In Phase II, III and IV studies, which rely on patient-participants, it's easy to confuse your involvement in the study with your treatment. The purpose of treatment is to alleviate your disease, but the purpose of the study may be quite different. For example, the study may involve you in a group that receives no medication, in order to provide a baseline of comparison for another group that receives the drug being tested. You should know this before agreeing to participate.
• Who is sponsoring the study? You need to find out who is paying for this experiment. This will tell you if your principal investigator stands to directly profit from your participation in the study. Is he or she rewarded specifically for recruiting participants to the study?
• Exactly what does the study involve? You want to ask just what will be performed on you. Make sure you understand how much time you'll be expected to spend during the course of the study, whether or not you'll have to be hospitalized for testing, and other such details.
• What could happen with — and without — this experimental drug or device? This is the risk/benefit question. You want to get a full explanation of both any improvements you may gain and the possible bad effects you may suffer.
• What are the alternatives? Here you want to know the advantages and disadvantages of treatments other than those provided in the trial. You'll also want to know how these compare to the results you might expect from the treatment that is being tested.
• Are there side effects? For experimental drugs, some side effects are unknown. Still, you should ask if side effects are likely, and what they are. You should also ask how these potential side effects would compare to those that you might encounter if you followed a more standard course of treatment, or no treatment at all.
• How long is the study expected to last? While you're free to withdraw from a trial at any time and for any reason, it's best to start out with the intention of staying with the program to the end. To make that commitment, you need to know up-front just how long the study is expected to run.
• What will it cost to participate? Are those costs (if any) covered by insurance? Some studies are free of charge to participants, others involve a fee. In addition, experimental treatment may not be covered by your insurance, so you'll want to know in advance if you’re going to have to pay any out-of-pocket costs.
• What happens if I'm harmed by participation in the study? You need to know in advance just what provisions have been made for dealing with such problems.  These provisions will vary from one study to the next. You also need to know exactly what you have to do to get this help.
• Is there any follow-up care after the trial, and how do I get it? Trials eventually end, but in many cases the disease for which the experimental treatment is intended will remain uncured. Find out if there is any long-term care or monitoring available after the study is over.
• Will I have any pain or discomfort? Some trials involve simple tests and monitoring, others may call for more complicated procedures, some of which may cause pain or discomfort.
• Can I see my regular physician while I'm in the trial? The answer is always “Yes”! However, your regular doctor should not normally interfere with the study itself. Some trials will require that you be treated by one of their own team of doctors.  It is important that your own doctor understands the clinical trial, because he or she will not want to accidentally interfere with the study unless absolutely necessary.  The Informed Consent document is probably the best thing to use for this.
• Is there any post-trial risk? You will want to know if your participation in the trial may put you at risk for complications or problems once the trial is over.
• How can I be sure that I can trust my investigator? This is a good question. The clinical trials procedure exists to protect you, but some studies still fail to meet the standards. That’s why the FDA maintains a list of disqualified or restricted investigators. These lists can be found on the Internet. Their web site addresses are listed on the inside back cover of this booklet.
• Is the FDA aware of this study? And has it received the approval of an IRB? This is important. The FDA’s involvement is not required for every study, but an IRB certainly should have reviewed and approved the protocol. If the answer to either of these questions is “no,” ask why not.
• Is there a safety committee involved in reviewing the data and the study protocol during the trial? If not, ask why not.

How to Get Involved in a Clinical Trial
For more information on participating in clinical trials, please visit the Center for Information & Study on Clinical Research Participation.