Before participating in a research study, you may wish to find out some more information about clinical research studies and the role of research participants.
What is a clinical research study?
A clinical study is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments.
Clinical studies (also called medical research and clinical trials) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the fastest and safest way to find treatments that work.
Ideas for clinical studies usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials.
Clinical trials proceed through four phases of testing:
- In phase I clinical trials, researchers test a new drug or treatment in a small group of people (approximately 20 - 80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
- In phase II clinical trials, the study drug or treatment is given to a larger group of people (approximately 100 - 300) to see if it is effective and to further evaluate its safety.
- In phase III clinical trials, the study drug or treatment is given to large groups of people (approximately 1,000 - 3,000 or more) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
- Phase IV clinical trials are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
What are the pros and cons of participating in a clinical research study?
It's important to note that there are both benefits and drawbacks to participation in a clinical research study. It is good to weigh their significance before agreeing to participate.
The following are a few of the pros and cons of participation:
In addition to receiving high-quality care, there are many other benefits to participating in clinical research studies. Your participation could potentially benefit others by increasing knowledge about a disease and its potential treatments. Also, as a clinical study participant, you could be one of the first participants to experience positive results from a new therapy.
It is possible that new treatments may not be better than standard care, and may, in fact, be worse. Unknown side effects may be worse than those experienced with standard treatments. Also, you may be placed in a control group that receives the standard care instead of the study treatment. You may be placed in a control group and receive placebo (a sugar pill), which has no therapeutic benefit.
What is informed consent?
Prior to participating in a clinical research study, you will be asked to provide informed consent.
The following are some important notes about informed consent.
Informed consent is a process, not just a form. Complete and understandable information must be presented to research subjects in order for them to voluntarily decide whether or not to take part in a study. The informed consent document will explain the purpose of the study, the length of the study, experimental procedures involved in the study, alternative therapies that are available, risks and benefits of the study article and the confidentiality of your research record. The signed informed consent document provides the basis for consent and can be used by the subject for future reference. The informed consent document will be updated when additional information has been learned about the study article. Subjects will be asked to sign these revised informed consent documents.
While an informed consent document provides you with the information you need, one of the most vital parts of the informed consent process is the opportunity to discuss any questions or concerns that you may have with a knowledgeable member of the research team.
All research protocols and informed consent documents must be approved by an Institutional Review Committee or Board
. This group's primary function is to ensure that the possible benefits of the research article being studied outweigh the risks and that all known risks are stated in the informed consent document.
Where can I find more information?
There are many places online which provide information on clinical research studies and participation in them.
Office of Human Subjects Research
The Office of Human Subjects Research (OHSR) operates within the National Institutes of Health (NIH). View additional information.