Foremost in everyone's mind is the safety of Research Subjects involved in clinical trials. Risks are an expected part of research experiments. Clinical trials have various degrees of risk of complications or side effects, some with little risk and some with large risk. For that reason, risk versus benefit is a concept of great importance in the approval of a clinical research study by the IRB. When the IRB reviews a research protocol, the members look closely at the risks involved for the Research Subjects and whether the expected benefits justify that risk. Also, during the informed consent process, each potential volunteer Research Subject must decide whether the possible personal risks are outweighed by the potential benefits.
Complications and drug side effects are commonly referred to in research studies as adverse events. Adverse events that are already known to occur from past experience with the treatment or drug under study are called anticipated adverse events. On the other hand, unexpected complications may still happen and they are called unanticipated adverse events. For example, complications and side effects that were discovered in Phase I and Phase II trials are already known before a Phase III trial is begun and are included in the informed consent by the PI as anticipated adverse events. Any new complications that appear during Phase III trials are considered unanticipated adverse events.
Adverse events, whether anticipated or unanticipated, are further classified as being mild, moderate, or serious. The definitions in these 3 categories of severity vary slightly among sponsors but all require that serious unanticipated adverse events are promptly reported to the IRB, the sponsor and often to federal agencies, such as the FDA. If a serious adverse event is very concerning, the clinical trial can be stopped immediately by the PI, or by the Program Director of the Clinical Research Unit, the IRB, the sponsor, or a responsible federal agency.
During the Informed Consent Process, adverse events can be discussed with the Research Subject Advocate, including how and when to contact someone about a complication.
