Well before a clinical study begins, the researcher has attempted to reduce any risk of physical discomfort or harm to you and others who take part. The effort likely began with preclinical, or basic, laboratory research that probably included animal studies, for example, to test the safety of a new drug. Yet, for research to be absolutely “risk-free,” every possible outcome would have to be known and if it were, then the research would not be necessary.

In fact, various different causes or forms of discomfort could result from a particular research study. A patient/subject may have to take off from work, or pay for some of the treatment. These requirements could be inconvenient or expensive. As you will see in the next section describing informed consent, you will be told about any foreseeable risks or discomforts that may occur in the research before you agree to participate.

Naturally, the chance that there might be pain or harm worries most people who are thinking about joining a clinical research project. Some discomforts may be like what you are used to in routine health care, such as a needle prick when blood is drawn for testing purposes. However, sometimes a research design may call for more uncomfortable procedures, procedures with known risks, or procedures for which the risk may not be fully known. These could include, for example, being deprived of sleep, receiving injections, having a spinal tap, receiving a small dose of a radioactive substance needed for a brain scan, or treatment with an investigational drug.

Remember, nothing is without risks, including illness itself, and risks in clinical research are minimized as best as possible. Also remember that the research plan is reviewed by an IRB to insure the protection of people who participate in the research study, and any known risks should be described in the consent form.