TAG ARCHIVES FOR human subjects protections

31
May2019

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report. Read more

8
May2019

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

22
Apr2019

Twenty years ago in 1999 I attended my first annual PRIM&R conference. I did so in the aftermath of then OPRR (now OHRP)’s shutdown of human subjects research that year of three federally funded institutions. At the time, there was a feeling of “there go I but for the grace of god;” if it could happen at these institutions, it could happen anywhere. Here we are in 2019, and there are once again scandals grabbing the research compliance headlines—this time involving scientific misconduct and questions of research integrity. And I cannot help but step back 20 years to that pivotal moment for IRBs and human subjects protections programs across the United States and ask again, what does a strong and robust Research Integrity program look like? Read more

8
Apr2019

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