Reimagining Human Research Protections for 21st Century Science

Cinnamon Bloss; Camille Nebeker; Matthew Bietz; Deborah Bae; Barbara Bigby; Mary Devereaux; James Fowler; Ann Waldo; Nadir Weibel; Kevin Patrick; Scott Klemmer; Lori Melichar

doi:10.2196/jmir.6634

Reimagining Human Research Protections for 21st Century Science

J Med Internet Res. 2016 Dec 22;18(12):e329. doi: 10.2196/jmir.6634.

Authors

Cinnamon Bloss^{1

2

3}, Camille Nebeker^{1

3}, Matthew Bietz⁴, Deborah Bae⁵, Barbara Bigby⁶, Mary Devereaux⁷, James Fowler^{8

9}, Ann Waldo¹⁰, Nadir Weibel^{1

11}, Kevin Patrick^{1

3}, Scott Klemmer^{11

12}, Lori Melichar⁵

Affiliations

¹ Center for Wireless and Population Health Systems, The Qualcomm Institute, Calit2, University of California, San Diego, La Jolla, CA, United States.
² Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.
³ Department of Family Medicine and Public Health, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
⁴ Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California, Irvine, Irvine, CA, United States.
⁵ Robert Wood Johnson Foundation, Princeton, NJ, United States.
⁶ Scripps Human Research Protections Program, La Jolla, CA, United States.
⁷ Department of Pathology, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
⁸ Department of Political Science, University of California, San Diego, La Jolla, CA, United States.
⁹ Department of Medicine, School of Medicine, University of California, San Diego, La Jolla, CA, United States.
¹⁰ Waldo Law Offices, PLLC, Washington, DC, United States.
¹¹ Department of Computer Science and Engineering, University of California, San Diego, La Jolla, CA, United States.
¹² Department of Cognitive Science, University of California, San Diego, La Jolla, CA, United States.

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.

Keywords: behavioral research; biomedical research; ethics committees, research; informed consent; telemedicine.

©Cinnamon Bloss, Camille Nebeker, Matthew Bietz, Deborah Bae, Barbara Bigby, Mary Devereaux, James Fowler, Ann Waldo, Nadir Weibel, Kevin Patrick, Scott Klemmer, Lori Melichar. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 22.12.2016.

Publication types

Historical Article

MeSH terms

Biomedical Research / ethics*
Biomedical Research / trends
Forecasting
History, 21st Century
Human Experimentation / ethics*
Humans
Informed Consent
Telemedicine

Grants and funding

R01 HG008753/HG/NHGRI NIH HHS/United States