Research Ethics Roundup: Real World Evidence and the FDA, New Report on Biosecurity Concerns and Research, All of Us Research Program Visits Low Income Communities, The Animal Welfare Act and Farm Research Animals

This week’s Research Ethics Roundup looks at a top Food and Drug Administration (FDA) official’s speech on real world evidence, a National Academies report that highlights the lack of guidance for the research community on the security concerns around dual-use research,  how and why the All of Us Research Program is working with traditionally marginalized communities, and the effectiveness of Animal and Plant Health Inspection Service (APHIS) inspections of Agricultural Research Service facilities.

FDA’s Woodcock: The Clinical Trials System is ‘Broken’
In this Regulatory Focus piece, Zachary Brennan highlights a recent speech by the director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, at a real world evidence workshop convened by the National Academies of Sciences, Engineering, and Medicine. Dr. Woodcock argued that there needs to be a better way to gather patient data and that clinical trial networks need to be revamped. The FDA Reauthorization Act of 2017 and the 21st Century Cures Act allow the FDA to more frequently take into account real world evidence, although Dr. Woodcock said “there has been ‘very little historical use of real world experience in drug regulatory decisions about effectiveness.”  

It’s Too Easy for Bioterrorists to Access Dangerous Research
Clare Wilson reports for New Scientist that a new National Academies of Sciences, Engineering, and Medicine report is raising the alarm about the lack of understanding of the biosecurity issues with dual-use research of concern, which involves certain agents and toxins that may cause severe harm to public safety if not conducted properly. The report’s authors argue the current governing policies and regulations that apply to this field are “fragmented.” Another area they also struggled with is how to balance making such research transparent in order to accelerate the identification of countermeasures with the need to limit the publication of findings in certain cases when the research might be misused for nefarious purposes.

To Advance Medicine’s Future, the NIH Tries to Win the Trust of Communities Mistreated in the Past
In this STAT  article, Lev Facher discusses how the National Institutes of Health is trying new recruitment methods to bolster enrollment for the All of Us Research program which seeks to enlist one million participants willing to share items such as electronic health records. Study authors see the large-scale study as an opportunity to advance personalized medicine and they want more than 50% of research participants to be from historically underrepresented research populations so that they too can benefit from the study. All of Us’ outreach efforts include an enrollment truck and working with federally qualified health centers to publicize the initiative though researchers acknowledge that they must address the long-standing concerns many marginalized communities have about biomedical research.

Local USDA Lab Cited After Federal Effort to Improve Animal Welfare
Sean Dolan reports for The Herald Journal on the citations issued to a US Department of Agriculture (USDA) research facility for the deaths of multiple birds; the problems were unearthed during an USDA Animal Plant Health Inspection Service inspection. Dolan also details how USDA changed its policies after a 2016 office of inspector general report in part by conducting more unannounced inspections of Agricultural Research Service facilities to look for Animal Welfare Act violations. However, since the Animal Welfare Act does not technically cover farm animals in certain kinds of government research labs, the effectiveness of APHIS’ enforcement inspections are questionable.