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
TAG ARCHIVES FOR informed consent
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
“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
The 2018 Advancing Ethical Research Conference (AER18) was my second PRIM&R conference, and this year I came armed with questions for specific organizations and agencies. At the top of my list was a question regarding the 2015 NIH Genomic Data Sharing (GDS) Policy: When children’s data is submitted to a national genomic data sharing repository, such as the database of Genotypes and Phenotypes (dbGaP), what are the consent expectations when those subjects reach the age of majority? Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more