Conducting Empirical Research on Informed Consent: Challenges and Questions

She informed consent projects (ICPs) we describe here were designed to produce (1) new and improved methods for the informed consent process, (z) methods for confronting the challenges of obtaining consent for special or vulnerable populations, and (3) data to help inform and guide public policy development (Table 1). From the outset, the project investigators identified a number of conceptual and practical concerns and challenges in conducting empirical research on informed consent. These concerns and challenges were shared by all the investigators, despite the significant variability in the research methods used and the populations studied. Experienced researchers will recognize that some of these concerns and challenges are common to many kinds of research involving human subjects. Some, however, are unique to research on informed consent. We describe these matters for the purpose of fostering ongoing dialogue about the challenges researchers face in studying the informed consent process. Common Research Challenges