An Examination of Emerging Bioethical Issues in Biomedical Research Proceedings of a Workshop (2020) / Chapter Skim
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3 Ethical Questions Concerning Nontraditional Approaches for Data Collection and Use
3 Ethical Questions Concerning Nontraditional Approaches for Data Collection and Use
Pages 35-50
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From page 35... ...
1 • Personal science helps shed light on possible biases that exist and form within professional science. This allows for the opportunity to further address and improve awareness of the issues around biases in the scientific community.
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From page 36... ...
Over the past decade, many new tools for individuals to monitor their own health have emerged, and the public is increasingly engaging in scientific research activities, serving as advocates for their own health. Citizen science (also sometimes referred to as personal science, do-it- ourself science, patient y led research, or participant-led research)
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From page 37... ...
John Wilbanks, the chief commons officer at Sage Bionetworks, discussed the governance of unregulated research using mobile devices and how individuals engaging in self-study might be persuaded to do so ethically. CITIZEN AND PERSONAL SCIENCE Citizen science has been defined by the European Commission as "the general public engagement in scientific research activities," Hekler said (EC, 2014)
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From page 38... ...
There are now more than 2,000 people using similar devices they built using Lewis's open-source specifications. OpenAPS is an example of a personal science activity that has not only helped individual patients but has also contributed to scientific knowledge, spurring peer-reviewed publications and helping to increase the pace of development of artificial pancreas systems, Hekler said.
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From page 39... ...
If professional science is not hearing from the diversity of voices and methods that personal science brings, it is potentially ignoring valuable information that can promote scientific knowledge, Hekler said. Finally, personal science asks professional science to "go beyond pure science into ‘ought' thinking," Hekler said, drawing from the "is–ought framework" of philosopher David Hume.
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From page 40... ...
Open science enables personal science to build upon the work of professional science. For example, the OpenAPS algorithm was built on a commercial continuous glucose monitor and an insulin pump, Hekler explained.
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From page 41... ...
Due to the advantages in the affordability and availability of these types of materials and devices, the research capabilities in personal science are accelerating quickly. Wilbanks and colleagues set out to examine potential ethical and policy questions related to unregulated health research using mobile devices in the United States.
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From page 42... ...
. Preventing Harms from Unregulated Health Research Using Mobile Devices A range of options for preventing harms from unregulated health research using mobile devices were offered by the members of the working group.
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From page 43... ...
One recommendation from the study, Wilbanks said, is for NIH to establish an Office of Unregulated Health Research to provide more accessible information regarding ethical practices for self research. NIH cannot fund unregulated research studies, but it can fund studies about unregulated research to elucidate the actual risks and benefits.
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From page 44... ...
App stores could also prioritize where apps appear in search results based on adherence to certain norms, require that terms of service and privacy policies for health apps explicitly ban third-party data transfer, and require device devel opers to encrypt data both at rest and in transit. • Citizen science organizations reach unregulated researchers through social media, meet-ups, and mailing lists, and Wilbanks said these groups need to be better leveraged to promote ethical self-research.
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From page 45... ...
, the group "worked the system" and requested an IRB to declare the study as exempt from IRB review as it involved existing data, Nebeker said. This is not ideal, as the federal definitions within the Common Rule do not speak to self-study or self-experimentation, and yet journals are bound by the traditional conventions requiring research involving humans to obtain an IRB approval, which leads to the question of how to better support the responsible and ethical conduct of self-study.
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From page 46... ...
There are many examples of approaches to building the context and the capacity that can enable individuals to use research to support their personal needs, Hekler said (e.g., community-based participatory research partnerships, youth participatory action research networks, and initiatives such as the Patient-Centered Outcomes Research Institute)
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From page 47... ...
This example is indicative of the regulatory definitions found in the Common Rule limiting the ability of people doing self-study to seek an external review. With the growth of citizen science applied to health, this is an area that NIH could help to guide by supporting research on developing relevant infrastructures.
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From page 48... ...
He urged NIH to create opportunities for the institutional, citizen, and personal science communities to meet as equals and learn from each other. He suggested attending citizen science association meetings and hearing their critiques and concerns.
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From page 49... ...
He agreed with Nebeker that the principles are sound, but he said that specific institutional processes might not meaningfully reflect those principles. For example, the objectives of researchers have become to get IRB approval and then consent and enroll patients into a study, not necessarily to meaningfully think about the risks and benefits of a study and then to meaningfully inform potential participants about them.
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