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
Today is the 40th anniversary of the Belmont Report, the foundational document on which our federal oversight system for human subjects research is based. This milestone warrants a pause in our busy day to reflect on its impact and its legacy. Read more
You are on a jury in a courtroom trial. The plaintiff is suing "everyone" for serious injuries received when she was hit by a car driven by the subject. The subject was in a clinical study of a medication that might cause drowsiness. A witness has testified that the subject appeared to be asleep at the time of the crash. 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
As genomics and personalized medicine advance, there is increased awareness that “race” is an inappropriate proxy for groups that may share a genetic background. However, proposals that assume that self-reported race correlates with biological/genetic difference are still being submitted and approved at institutions across the country—even as genetic evidence reveals that the difference between races is smaller than differences among individuals of any particular race. Such studies risk perpetuating racist stereotypes, inappropriately influencing clinical medicine, and reinforcing inaccurate ideas about biology and race. It’s important that research oversight professionals understand how to approach the continued wave of race-based research. On February 21, PRIM&R hosted a webinar to provide guidance for IRBs in this area. After the webinar, presenters responded to some of the attendee questions that time didn’t permit us to address live; we’re pleased to share those responses with the readers of Ampersand. Read more
Meet Noé Tirado-Muñiz DMV, DVM, MS, CPIA, who'll be covering the 2019 IACUC Conference (IACUC19) as a member of the Blog Squad. Members of PRIM&R's Conference Blog Squad provide an insider's view of the conferences by sharing their experience before, during, and after the meeting. Read more
