Reimagining Human Research Protections for 21st Century Science.

ABSTRACT

BACKGROUND: 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. OBJECTIVE: Our objective was to generate creative ideas for redesigning our current human research oversight system. METHODS: A 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. RESULTS: Ideas 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. CONCLUSIONS: 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.