Dr. Joydeep Kaur Arneja*


The participation of human subjects in clinical trials is important for the purpose of measuring the efficacy of any health-related intervention on health outcomes.[1] Such health-related interventions may include investigation related to the improvement and development of medical devices, drugs and even the use of cells in humans(1). Depending on the prospective risk or the discomfort involved with the health-related intervention, clinical trials may be categorized as; minimal risk, or more than minimal risk. In the context of clinical research, minimal risk is defined as the harm or discomfort expected to occur to an individual, that is not greater than the risks of those aspects, in the daily life or routine examinations.[2] In contrast, any clinical trial with greater than minimal risk is considered as a more than minimal risk clinical trial.[2] This category of risky clinical trials require the participant to use his or her discretion and freedom to make mature, uncoerced and informed decisions, with regard to his or her involvement in the clinical research process. However, there are certain individuals who lack either the capability, and/or possess limited decision making capacity to protect their own interest in trials involving more than minimal risk.[3] Besides limited decision making capacity or inability to consent, a person may be unable to protect himself or herself in research due to poor economic background, limited intellectual ability or the presence of specific disease which is desirable in the research process.[4] These types of people are termed as “vulnerable” in the research context and are predisposed to harm by researchers, either “intentionally” or “negligently”.[5] Therefore, the concept of vulnerability in research setting calls into question, the participation of such subjects in more than minimal risk clinical trials, where the risk of injury is significantly higher than normal.

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