Who is responsible for making the initial risk determination for a device being used in a study?

Question:- Who is responsible for making the initial risk determination for a device being used in a study?

Answer: the sponsors.

The sponsor has the responsibility of making the first risk analysis that relates to the use of a device in a study. The study sponsor, which may be a medical or surgical device manufacturer or a research organization, has the responsibility that the study is carried out compliant with relevant regulations about the rights and interests of the participating patients.

The first step is to determine if a particular device presents a risk that is reasonable about the intended use of the device, the population that will be studied, and possible adverse outcomes. For instance, where the device is a new implantable device, the sponsor would have to think about the fact that the study participants have to undergo surgery for implantation of the device or the possibility of the device’s failure within the study period; and the long-term effects on the participants.

The sponsor should also examine the labelling of the device, the instructions for using the device and any risk data from earlier related uses. Further, the sponsor may seek advice from other specialists, for example, engineers or specialists in security to have a wider view of the dangers that lurk in this device. This first risk assessment should then present the basis of the risk management Plan of the study, in terms of risk aversion and management structures of the device-related risks.