Research Studies: Should you participate?
You will probably be asked at some time to participate in a research project, especially if you are treated in an academic medical center. Your initial reaction might be, "Hey, I don't want to be a guinea pig." You also might think of press coverage of improprieties in research at some distinguished institutions. On the other hand, many other people respond with the sense that participating in research is a civic duty that also will help to ensure that they are receiving "the latest" in high-quality care from the nation's top doctors. In this article we will try to clarify many of the issues surrounding research participation and perhaps relieve some concerns, particularly with regard to behavioral research.
Why are there so many research projects?
Information obtained from medical research provides the basis for doctors to make decisions about diagnosis and treatment for their patients. This very important process occurs in nearly every hospital setting, though it is more common in medical centers affiliated with universities and medical schools. Only by continuing research can doctors achieve better understanding and more effective treatments for their patients.
Is it safe to participate in medical research?
Many people assume that participating in medical research automatically means that they will receive doses of some experimental drug or undergo some other unproven or dangerous treatment. Or you may be concerned that you will be given a placebo drug made up of sugar powder and therefore will receive no treatment at all. You also may be concerned about confidentiality, how the research information is used, and who will have access to it. Concerns about any one of these factors could make you hesitate to become involved.
In fact, all research institutions have strict guidelines to ensure that the potential benefits of research studies are greater than the risks. By law, academic medical centers are required to establish a panel to oversee research activities. These committees, usually called the Institutional Review Board (IRB) or the Human Subjects Research Committee (HSRC), are commonly composed of medical professionals and members of the lay public. Besides ensuring that research participants will be safe, they also review the scientific quality of research studies.
What are my rights if I participate?
By law, all patients have the right to know what is going to be done to them. You should be told that your participation is strictly voluntary and you can stop at any time without interfering with your care at that hospital. You must be informed of any potential harm. All information about your participation must be kept confidential. You also have the right to be informed about the final results of the research.
All of these things are spelled out in a form that you will be asked to sign, called "Informed Consent to Participate in Research." This form is required for every research study and must be presented to any patient who is considered to be a candidate for the study. Besides the information mentioned above, this form also briefly outlines the purpose of the study and both the benefits and risks of taking part. You will be told to review all this information and decide whether you are willing to participate in the study as described. You will then sign the form in the presence of an independent person who is not involved in the study. Although signing the form is a commitment to enter into the study, continued participation is voluntary. You have the right to drop out at any time.
What forms of research might I encounter?
Because medicine has many problems and questions to address, there are many different forms of medical research. Some do involve experimental treatments that could be risky. But many others involve very little active participation by the patient and present little or no risk. This kind of study may just look at results from tests such as EEG or MRI and compare them to other information, such as the nature or frequency of seizures. The design of this type of study is commonly called retrospective. This means that the research data were collected during routine clinical practice and the researchers are interested in studying how this existing information relates to current theory. Retrospective research does not require your active participation, but the purpose and design of the study will be reviewed by the institution anyway, to ensure that patient confidentiality and other important criteria are met.
Other forms of research do require more activity from you. Most studies of treatments follow a prospective research design. In this kind of study, the experimenter wants to acquire "baseline" data at the beginning of the study so it can be compared to other information, which will be obtained over time. The researchers will try to accumulate as much information as possible before the study begins. Then they will compare different treatment outcomes to a number of factors in the baseline data.