TAG ARCHIVES FOR vulnerable populations

6
Aug2018

In April, the EPA published a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” The due date for comments on this rule is August 16. As a nonpartisan organization dedicated to advancing the highest ethical standards in the conduct of research that advances human health and well-being, PRIM&R decided it was important to comment on this proposed rule, detailing two main concerns. First, we believe that the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants. We urge EPA to withdraw this misguided rule immediately. Read more

12
Sep2017

In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018. One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more

25
Aug2017

This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments. Read more

11
Aug2017

PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work. Read more

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