What Is the Investigator’s Responsibility if a Patient Has a Clinical Crisis?
You read earlier about the differences between clinical research and the care you receive from your personal doctor. In most research, an investigator will try to follow the research design: Following a research plan that has met all of the conditions described in the next section of this pamphlet conditions meant to ensure that any proposed clinical research has scientific merit and is fully attentive to participants’ well-being 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 However, a patient who becomes much worse during a study will be withdrawn from the project and given immediate personal care, even though the worsening may not be related to the treatment being given.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, if it is appropriate, your legally authorized 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.
Psych Central. (2013). What Is the Investigator’s Responsibility if a Patient Has a Clinical Crisis?. Psych Central. Retrieved on April 27, 2015, from http://psychcentral.com/lib/what-is-the-investigators-responsibility-if-a-patient-has-a-clinical-crisis/000412