While IRB members are not expected to be scientific experts, especially given the broad range of protocols they review, they do need to assess the scientific merits of a protocol to evaluate its suitability for human subjects. The... more
While IRB members are not expected to be scientific experts, especially given the broad range of protocols they review, they do need to assess the scientific merits of a protocol to evaluate its suitability for human subjects. The following 10 questions can assist IRBs in determining whether a study has the scientific merit to justify participation by human subjects:
A therapeutic misconception occurs when a patient mistakes participation in a clinical study for clinical care. IRBs can ask the following questions to assess the risk of therapeutic misconception. By scoring the answers, the risk can be... more
A therapeutic misconception occurs when a patient mistakes participation in a clinical study for clinical care. IRBs can ask the following questions to assess the risk of therapeutic misconception. By scoring the answers, the risk can be characterized and mitigated. These questions do not apply to a study that constitutes standard of care. They require interpretation for a study that has aspects of clinical care. For example, if a study medication has no chance of improving a patient's health but participation in the study gives a patient access to procedures and assessment that would, otherwise, be unavailable to him or her, it is reasonable for the patient to conclude that the study has a reasonable chance of providing health benefits, even though they are not due to the study medication.
