Does Research Involve Special Risk?

Clinical trials and other research into mental illness is important to help forward our knowledge about these conditions, and the most effective treatments to help people who have them. You may sometimes have the opportunity to participate in this kind of research, which is overseen by researchers at a university or college. But you may ask — does my participation in this kind of research involve any kind of special risk? What do I do if I have a problem while in the study?

Well before a clinical research 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 pre-clinical, 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.

What Is the Investigator’s Responsibility if a Patient Has a Problem?

In most research, an investigator will try to follow the research design. This generally involves following a research plan that has met professional and ethical conditions to ensure that any proposed clinical research has scientific merit. This is also done to be fully attentive to participants’ well-being, which takes precedence over “tailoring” treatments to a patient’s unique needs.

However, a patient who becomes much worse during a study will be withdrawn from the project and given immediate personal care, even though the worsening may not be related to the treatment being given.

You and or your legal representative should discuss with the investigator the possibility that your illness could worsen during the research study. Then you can decide how to handle any emergencies that might arise during the study.

Among the issues you may wish to discuss is how the researcher will judge the nature and severity of your symptoms. Another issue could be that, under certain conditions such as a medication washout or a pharmacologic challenge, you might decide to reject all treatment. If you are seriously ill, you might not recognize how dangerous that decision could be. Thus, you should agree in advance on how to handle this situation.