Abstract
BackgroundEvolving research practices and new forms of research enabled by technological advances require a redesigned research oversight system that respects and protects human research participants.ObjectiveOur objective was to generate creative ideas for redesigning our current human research oversight system.MethodsA total of 11 researchers and institutional review board (IRB) professionals participated in a January 2015 design thinking workshop to develop ideas for redesigning the IRB system.ResultsIdeas in 5 major domains were generated. The areas of focus were (1) improving the consent form and process, (2) empowering researchers to protect their participants, (3) creating a system to learn from mistakes, (4) improving IRB efficiency, and (5) facilitating review of research that leverages technological advances.ConclusionsWe describe the impetus for and results of a design thinking workshop to reimagine a human research protections system that is responsive to 21st century science.
Highlights
Over half a century ago, in response to egregious cases of research participant mistreatment, the US government proposed prospective review of research involving human participants
We describe the impetus for and results of a design thinking workshop to reimagine a human research protections system that is responsive to 21st century science. (J Med Internet Res 2016;18(12):e329) doi:10.2196/jmir
institutional review board (IRB) are firmly entrenched within the fabric of academic research institution, with estimates putting the number of IRBs in the United States at around 6000 (I Prichard, Senior Advisor to the Director of the Office for Human Research Protections, Department of Health and Human Services; oral communication, September 2014)
Summary
Over half a century ago, in response to egregious cases of research participant mistreatment, the US government proposed prospective review of research involving human participants. We propose that the time has come to reimagine and work toward redesigning our human research protections system so that it is responsive to both the evolution of general research practices and new forms of research enabled by technological advances—what we refer to here as 21st century science. This is critical for the proper protection of research participants, ethical and efficient use of research resources, and facilitation of research insights important for human health and knowledge production more generally. Evolving research practices and new forms of research enabled by technological advances require a redesigned research oversight system that respects and protects human research participants
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