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.

Recruiting to preclinical Alzheimer's disease clinical trials through registries

“…Altered methods may ensure practicability while still adhering to the requirements of ethical research [29]. Internet-based registries, for example, may represent a realistic means to establish adequately large populations of willing participants, though there may be risks associated with electronic consent such as participants rapidly scrolling or clicking through consent documents and blithely clicking “enroll,” as they might with a new smart phone application [30]. Comprehension and retention of consent information may differ for screen-based, compared to paper-based, learning [31].…”

“…The opportunity to have questions answered may be reduced or delayed. Alternatively, electronic consent is likely to enhance opportunities to utilize videos, graphics, and other multimedia approaches for more concise and creative means to enhance participant understanding while simultaneously reducing participant burden [30]. Automated quizzes may enable assessment of participant understanding.…”

Challenges for Preventive Digital Stress Management Systems - Identifying Requirements by Conducting Qualitative Interviews

“…According to estimates of the World Health Organization, mental illness will be one of the leading causes of disease in industrialized countries by 2030 [16]. Participation in conventional preventive services is low, while the technological capability to mine, interpret and respond to a big amount of data for promoting the welfare of human subjects grows [14]. According to a study by Bitkom, 69% of all participants believe that digital technologies will improve prevention [2].…”

Navigating Ethics in the Digital Age: Introducing Connected and Open Research Ethics (CORE), a Tool for Researchers and Institutional Review Boards

“…Many researchers are eager to study the clinical potential of mobile and digital tools, but they may not be aware of all the potential risks to participants, or of means to mitigate them [ 6 , 7 ]. IRBs have thus been placed in the difficult role of evaluating these research proposals and ensuring they are both safe and ethical.…”