Approximately 80% of the US population has a social media account. Social media can be a powerful research tool for recruiting subjects and for conducting research. As regulatory professionals tasked with protecting research subjects, it’s important to understand the unique risks and benefits of social media use for research.Luckily, at PRIM&R’s 2018 Advancing Ethical Research Conference, there was a session devoted solely to the complex issues related to research on social media. Read more
For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” 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
Past disregard for human rights in studies such as the Tuskegee experiment, has left some individuals (rightly so) with an inherit distrust of the clinical research process. Over time, increased regulatory oversight of the clinical research environment was put into effect to protect those who participate in research, particularly those who might be more vulnerable. But sometimes the regulations don’t keep up with developments in the modern research enterprise. 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
