Clinical research is based on foundational principles that include respect for persons–a concept that implies individuals will be able to understand and make an informed choice about whether to participate in a research study. To help support participant understanding through clear communications across the entire clinical research life cycle, The Multi-Regional Clinical Trials (MRCT) Center is thrilled to announce the availability of a comprehensive, publicly-available resource. Read more
Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” [46.116(a)(5)(i)]—the “key information requirement,” for short. I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. Read more
PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an interesting learning opportunity, wherein I noted a common theme of this conference was to highlight the changes in the revised Common Rule and its practical implementation. Read more
I am a researcher working in an inner-city neighborhood serving a disadvantaged population. As such, I found the session “Navigating uncertainty: Research with Undocumented Immigrants” at the 2018 Advancing Ethical Research Conference quite relevant to my practice. This presentation helped me to understand the vulnerability of undocumented individuals involved in research. A person's documentation status may be a risk factor for health disparities; however, undocumented individuals should not be automatically excluded from research. Read more
Despite their significant importance in society and communities, there is a scarcity of research on the undocumented immigrant population. In addition, only a handful of studies address the social and emotional concerns of undocumented immigrants and students. At AER18, panelists Gene Gloeckner, PhD; Elizabeth Jach, MA; and Colleen Kohashi, MA, CIP, presented ways to ethically and sensitively conduct research with undocumented immigrants. Read more
