Research Ethics

Informed Consent is a collaborative process between the research team and the research participant. As a member of the RTM, you should have completed your core training in research ethics and be familiar with the Belmont principles of Respect for Persons, Beneficence, and Justice. [If you are not familiar with these principles, you should become so at http://www.fda.gov/oc/ohrt/IRBS/belmont.html

Beneficence and Justice are critical considerations in the design and execution of the research protocol, whereas Respect for Persons is primarily relevant to the IC process. The goal of IC is to ensure that the prospective research participant is (a) truly informed in order to (b) make a truly autonomous choice about participating in the research. This sounds very straight-forward; as is often the case with simple goals, however getting there can be quite torturous and contain many opportunities for failure and/or unintended consequences. A firm grounding in the ethics from which the IC process is derived is essential in avoiding and dealing with such problems.