Reimagining Human Research Protections for 21st Century Science

Bloss, Cinnamon S.; Nebeker, Camille; Bietz, Matthew J.; Bae, Deborah; Bigby, Barbara G.; Devereaux, Mary; Fowler, James H.; Waldo, Ann; Weibel, Nadir; Patrick, Kevin; Klemmer, Scott R.; Melichar, Lori

doi:10.2196/jmir.6634

Cited by 33 publications

(19 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…16 Moreover, in addition to the growth of social media-enabled health research, the broader field of digital health research involving pervasive sensors and artificial intelligence carried out by researchers in both regulated and unregulated sectors, is outpacing what ethics boards are equipped to handle. 8,17 A slowly growing literature is developing on how to evaluate and mitigate potential harms involving social media research. 1,15,18,19 IRB's find it difficult to determine what risks and privacy expectations are unique to social media and what challenges can be addressed by modifications of known and understood risks inherent in research.…”

Section: Discussionmentioning

confidence: 99%

A retrospective analysis of NIH-funded digital health research using social media platforms

2020

Self Cite

View full text Add to dashboard Cite

Objective: Social network platforms are increasingly used in digital health research. Our study aimed to 1. qualify and quantify the use of social media platforms in health research supported by the National Institutes of Health (NIH) and document changes occurring between 2011 and 2017 and 2. examine whether institutions hosting these studies provided public-facing guidelines on how to conduct ethical social media health research. Methods: The NIH RePORTER (Research Portfolio Online Reporting Tools) database was searched to identify research utilizing Instagram, Pinterest, Facebook, or Twitter. Studies included used social media for observational research, recruitment, intervention delivery or to assess social media as an effective research tool. Abstracts were qualitatively analyzed to describe the population and health topic by year. Websites of organizations receiving funding for this research were searched to identify whether guidance or policy existed. Results: Studies (n ¼ 105) were organized by population targeted and health focus. Main "Health" themes were labeled: 1. substance use, 2. disease/diagnosis, 3. psychiatry/mental health, and 4. weight and physical activity. The populations most involved included adolescents and young adults, and men who have sex with men. The number of research studies using social media increased approximately 590% between 2011 and 2017. Studies were linked to 56 organizations of which 21% (n ¼ 12) provided some accessible guidance with 79% (n ¼ 44) offering no guidance specific to social media health research. Conclusions: Social media research is conducted with vulnerable populations that are traditionally difficult to reach. There is a compelling need for resources designed to support ethical and responsible social media-enabled research to enable this research to be carried out safely.

show abstract

Section: Discussionmentioning

confidence: 99%

A retrospective analysis of NIH-funded digital health research using social media platforms

2020

Self Cite

View full text Add to dashboard Cite

show abstract

“…While there are many new challenges in conducting technology-enhanced research, even navigating study approval via the institutional review board (IRB) ethical and regulatory evaluation process remains a primary challenge for many. Whether the existing IRB system is able to support the ethical review and subsequent advancement of research using these new and emerging technologies was recently questioned [ 1 ]. To address ethical challenges in this new age of technology-enhanced research, we outline a potential solution.…”

Section: Introductionmentioning

confidence: 99%

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

Torous

Nebeker

2017

J Med Internet Res

Self Cite

View full text Add to dashboard Cite

Research studies that leverage emerging technologies, such as passive sensing devices and mobile apps, have demonstrated encouraging potential with respect to favorably influencing the human condition. As a result, the nascent fields of mHealth and digital medicine have gained traction over the past decade as demonstrated in the United States by increased federal funding for research that cuts across a broad spectrum of health conditions. The existence of mHealth and digital medicine also introduced new ethical and regulatory challenges that both institutional review boards (IRBs) and researchers are struggling to navigate. In response, the Connected and Open Research Ethics (CORE) initiative was launched. The CORE initiative has employed a participatory research approach, whereby researchers and IRB affiliates are involved in identifying the priorities and functionality of a shared resource. The overarching goal of CORE is to develop dynamic and relevant ethical practices to guide mHealth and digital medicine research. In this Viewpoint paper, we describe the CORE initiative and call for readers to join the CORE Network and contribute to the bigger conversation on ethics in the digital age.

show abstract

“…In research supported by the US Department of Health and Human Services ( HHS ) or under FDA oversight, this review process is carried out by an Institutional Review Board ( IRB ) that is registered with the federal Office for Human Research Protections ( OHRP ) [54]. These regulations were initiated in 1974 as part of the National Research Act.…”

Section: Part Ii: Security Ethical Legal and Regulatory Consideratmentioning

confidence: 99%

Digital Medicine: A Primer on Measurement

et al. 2019

Self Cite

View full text Add to dashboard Cite

Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, requiring knowledge from many people across many fields. We aim to drive the field forward by unpacking that barrier, providing a brief introduction to core concepts and terms that define digital medicine. Specifically, we contrast “clinical research” versus routine “clinical care,” outlining the security, ethical, regulatory, and legal issues developers must consider as digital medicine products go to market. We classify types of digital measurements and how to use and validate these measures in different settings. To make this resource engaging and accessible, we have included illustrations and figures throughout that we hope readers will borrow from liberally. This primer is the first in a series that will accelerate the safe and effective advancement of the field of digital medicine.

show abstract

Reimagining Human Research Protections for 21st Century Science

Cited by 33 publications

References 18 publications

A retrospective analysis of NIH-funded digital health research using social media platforms

A retrospective analysis of NIH-funded digital health research using social media platforms

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

Digital Medicine: A Primer on Measurement

Contact Info

Product

Resources

About