title: Human Subjects Protection and Technology in Prevention Science: Selected Opportunities and Challenges.
abstract: Internet-connected devices are changing the way people live, work, and relate to one another. For prevention scientists, technological advances create opportunities to promote the welfare of human subjects and society. The challenge is to obtain the benefits while minimizing risks. In this article, we use the guiding principles for ethical human subjects research and proposed changes to the Common Rule regulations, as a basis for discussing selected opportunities and challenges that new technologies present for prevention science. The benefits of conducting research with new populations, and at new levels of integration into participants' daily lives, are presented along with five challenges along with technological and other solutions to strengthen the protections that we provide: (1) achieving adequate informed consent with procedures that are acceptable to participants in a digital age; (2) balancing opportunities for rapid development and broad reach, with gaining adequate understanding of population needs; (3) integrating data collection and intervention into participants' lives while minimizing intrusiveness and fatigue; (4) setting appropriate expectations for responding to safety and suicide concerns; and (5) safeguarding newly available streams of sensitive data. Our goal is to promote collaboration between prevention scientists, institutional review boards, and community members to safely and ethically harness advancing technologies to strengthen impact of prevention science.
authors.affiliation: University of Rochester, Rochester, NY, USA. anthony_pisani@urmc.rochester.edu.
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Pisani
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Wyman
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Mohr
authors.affiliation: University of Miami, Coral Gables, FL, USA.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Perrino
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Gallo
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Juan
authors.initials: J
authors.lastname: Villamar
authors.affiliation: American Institutes for Research, Washington, DC, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Kendziora
authors.affiliation: George Washington University, Washington, DC, USA.
authors.forename: George W
authors.initials: GW
authors.lastname: Howe
authors.affiliation: Applied Prevention Science International, Inc., Ontario, OH, USA.
authors.forename: Zili
authors.initials: Z
authors.lastname: Sloboda
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: C Hendricks
authors.initials: CH
authors.lastname: Brown
mesh_terms: D017408:Guidelines as Topic; D006291:Health Policy; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D020407:Internet; D011315:Preventive Medicine; D012449:Safety; D013672:Technology
keywords: Common rule regulations; Ethics; Human subjects; IRB; Prevention; Technology