The National Academies of Sciences, Engineering and Medicine released a new report in late June that looks at federally funded research and is now recommending an independent commission be established to take a close look at ethical and legal issues of human subjects research and update policies to address the new research landscape of today.
The report recommends that several gaps be addressed and that an independent commission look at how principles of human subjects research should be applied to:
- Research involving anonymous and de-identified human biospecimens
- Research involving large data sets
- Clinical trials where the unit of intervention is a cluster or group
- Clinical studies comparing the effectiveness of different accepted interventions for a disorder to determine whether one approach may be preferable
- Research aimed at clinical innovation and quality assurance and improvement
The Belmont Report, created years ago in the late 70’s, identifies the principles to guide research involving humans. With the advancements in knowledge and technology since that time, it is apparent that many questions arise about how those principles should be applied in today’s research environment.
“Congress and the administration have an opportunity for a course correction that can yield significantly greater value to the public from the nation’s investment in research, and we hope our recommendations will guide that effort,” said Larry Faulkner, chair of the committee that wrote the report and president emeritus at the University of Texas, Austin.
For more information, check out Melissa Fassbender’s article in Outsourcing Pharma. Follow this link to the press release from the National Academies of Sciences, Engineering and Medicine. Pearl IRB is dedicated to sharing informative issues in research.