The previous post described what clinical research is and gave a few examples. This post will focus on what to expect if you (or a family member) is approached and asked to participate in clinical research and why it is important to participate if you can.
There are several ways that researchers identify people who are eligible for a research study. Large studies might advertise in the newspaper or on television. Researchers from smaller studies typically identify patients from medical clinics, emergency rooms, or hospitals. Patients are individuals who have the disease or medical condition being studied. Healthy individuals also can be eligible for clinical research. There are several ways that a researcher might identify a group of healthy individuals for a study. Research eligibility means that an individual fulfills the specific study criteria for participation. For example, in a study of blood pressure changes with pregnancy, researchers might be looking for women (1) in the first trimester of pregnancy, (2) at least 18 years of age, (3) without prior high blood pressure, (4) and without other medical conditions. A woman meeting these criteria would be considered eligible for research.
Several rules are in place to ensure that humans who participate in clinical research are treated ethically. At the core of these ethical rules are two basic principles: researchers must (1) do good (known as beneficence) and (2) do no harm (known as non-malfeasance). There are research ethics boards that approve, review, and monitor human research to ensure that these principles are upheld. In the United States, they are called Institutional Review Boards (or IRBs).
Informed consent is part of the ethical approach to good clinical research. Informed consent means that research participants (1) should know that they are participating in research and (2) should be informed about what will be expected of them. Once researchers identify an individual who is eligible for their study, the process of informed consent follows. Informed consent should include a verbal description of the study, a written description of the study (that is signed by the participant), and an opportunity to ask questions. Researchers cannot force individuals to participate; access to medical care cannot be used to encourage participation; they must make an effort to keep participant information confidential; and they must inform the participant that he/she can stop participating at any time. Some (but not all) studies will offer money or some other incentive to participate.
There are several reasons why people choose to participate in research – the financial incentive, curiosity about research, and the desire to help others. Since the research participant does not always see the final result(s) of the research, it might not be obvious to them how helpful their participation was. When you review past posts and read future posts, keep in mind that we know what we know about a certain clinical topic because a group of people agreed to participate in clinical research. If you (or a family member) are asked to be in a study, please try to participate. Clinical research is how we learn more about human health and disease.