title: Reimagining Human Research Protections for 21st Century Science.
abstract: 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.
  
  
  
  Our objective was to generate creative ideas for redesigning our current human research oversight system.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Center for Wireless and Population Health Systems, The Qualcomm Institute, Calit2, University of California, San Diego, La Jolla, CA, United States.|Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.|Department of Family Medicine and Public Health, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Cinnamon
authors.identifier: 0000-0003-1315-8387
authors.initials: C
authors.lastname: Bloss
authors.affiliation: Center for Wireless and Population Health Systems, The Qualcomm Institute, Calit2, University of California, San Diego, La Jolla, CA, United States.|Department of Family Medicine and Public Health, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Camille
authors.identifier: 0000-0001-6819-1796
authors.initials: C
authors.lastname: Nebeker
authors.affiliation: Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California, Irvine, Irvine, CA, United States.
authors.forename: Matthew
authors.identifier: 0000-0002-7782-3887
authors.initials: M
authors.lastname: Bietz
authors.affiliation: Robert Wood Johnson Foundation, Princeton, NJ, United States.
authors.forename: Deborah
authors.identifier: 0000-0002-9082-3574
authors.initials: D
authors.lastname: Bae
authors.affiliation: Scripps Human Research Protections Program, La Jolla, CA, United States.
authors.forename: Barbara
authors.identifier: 0000-0002-9175-112X
authors.initials: B
authors.lastname: Bigby
authors.affiliation: Department of Pathology, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Mary
authors.identifier: 0000-0002-3803-2396
authors.initials: M
authors.lastname: Devereaux
authors.affiliation: Department of Political Science, University of California, San Diego, La Jolla, CA, United States.|Department of Medicine, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
authors.forename: James
authors.identifier: 0000-0001-7795-1638
authors.initials: J
authors.lastname: Fowler
authors.affiliation: Waldo Law Offices, PLLC, Washington, DC, United States.
authors.forename: Ann
authors.identifier: 0000-0002-9783-070X
authors.initials: A
authors.lastname: Waldo
authors.affiliation: Center for Wireless and Population Health Systems, The Qualcomm Institute, Calit2, University of California, San Diego, La Jolla, CA, United States.|Department of Computer Science and Engineering, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Nadir
authors.identifier: 0000-0002-3457-4227
authors.initials: N
authors.lastname: Weibel
authors.affiliation: Center for Wireless and Population Health Systems, The Qualcomm Institute, Calit2, University of California, San Diego, La Jolla, CA, United States.|Department of Family Medicine and Public Health, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Kevin
authors.identifier: 0000-0002-7334-3042
authors.initials: K
authors.lastname: Patrick
authors.affiliation: Department of Computer Science and Engineering, University of California, San Diego, La Jolla, CA, United States.|Department of Cognitive Science, University of California, San Diego, La Jolla, CA, United States.
authors.forename: Scott
authors.identifier: 0000-0001-9006-0805
authors.initials: S
authors.lastname: Klemmer
authors.affiliation: Robert Wood Johnson Foundation, Princeton, NJ, United States.
authors.forename: Lori
authors.identifier: 0000-0003-0926-8989
authors.initials: L
authors.lastname: Melichar
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000639:trends; D005544:Forecasting; D049674:History, 21st Century; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D017216:Telemedicine
keywords: behavioral research; biomedical research; ethics committees, research; informed consent; telemedicine