I could never have guessed just how large and life changing a venture creating a two-way, system-wide IRB infrastructure would be when I received exactly that project in late 2010. Now, as we approach the single IRB mandate, I wanted to share a little bit about the efforts that I was fortunate to lead and participate in for the benefit of all the organizations not only contemplating this step, but being required to implement it at this juncture. I can only hope this brief effort to capitulate our successes and failures will lead you and your organization to even grander aspirations and achievements than my own. Read more
TAG ARCHIVES FOR IRB
To kick off Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Carlotta Rodriguez, MS, CIP, CHRC, who works as the IRB Director at Rutgers University, the State University of New Jersey. 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
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
“One person’s flexibility is another person’s ambiguity.”
I kept going back to this comment, articulated by Carrie Wolinetz (NIH), as I helped my HRPP prepare for the revised Common Rule implementation in January. Although Dr. Wolinetz was referring to the NIH’s Genomic Data Sharing Policy, the phrase is a perfect expression of my thoughts on the “concise and focused presentation of the key information” that now must appear at the beginning of consent forms.
This topic was addressed at the AER18 plenary session “To Participate or Not to Participate, that Is the Question.” Moderated by Ivor Pritchard (OHRP), panelists Celia Fisher (Fordham University), Jonathan [...] Read more