Camille Nebeker

Reimagining Human Research Protections for 21st Century Science.

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.

Smart Teaching Matters! Applying the Research on Learning to Teaching RCR

Requirements for educating the next generation of scientists in the responsible conduct of research (RCR) were published approximately 25 years ago. Over the years, an extensive collection of research ethics educational resources have been developed, most of which are available to the scientific community. We can use these resources to effect change in student learning about responsible and ethical research practices; however, research on RCR educational effectiveness reveals mixed results. Rather than assume ethics education is ineffective, perhaps we should examine whether we are making the best use of these training tools and resources when teaching RCR. Connecting the body of knowledge on how people learn with how we teach research ethics may be a solution to improving student-learning outcomes associated with research ethics education. This essay provides a brief review of the research on human learning and introduces practical tips for connecting evidence-based principles to RCR teaching. Next steps involve RCR educators planning empirical research to support the application of research-informed practices to teaching research ethics.

Using social media for health research: Methodological and ethical considerations for recruitment and intervention delivery:

As the popularity and diversity of social media platforms increases so does their utility for health research. Using social media for recruitment into clinical studies and/or delivering health behavior interventions may increase reach to a broader audience. However, evidence supporting the efficacy of these approaches is limited, and key questions remain with respect to optimal benchmarks, intervention development and methodology, participant engagement, informed consent, privacy, and data management. Little methodological guidance is available to researchers interested in using social media for health research. In this Tutorial, we summarize the content of the 2017 Society for Behavioral Medicine Pre-Conference Course entitled ‘Using Social Media for Research,’ at which the authors presented their experiences with methodological and ethical issues relating to social media-enabled research recruitment and intervention delivery. We identify common pitfalls and provide recommendations for recruitment and intervention via social media. We also discuss the ethical and responsible conduct of research using social media for each of these purposes.

NIH support of mobile, imaging, pervasive sensing, social media and location tracking (MISST) research: laying the foundation to examine research ethics in the digital age

Mobile Imaging, pervasive Sensing, Social media and location Tracking (MISST) tools used in research are raising new ethical challenges for scientists and the Institutional Review Boards (IRBs) charged with protecting human participants. Yet, little guidance exists to inform the ethical design and the IRB’s regulatory review of MISST research. MISST tools/methods produce personal health data that is voluminous and granular and, which may not be subject to policies like the Health Information Portability and Accessibility Act (HIPAA). The NIH Research Portfolio Online Reporting Tools (RePORTER) database was used to identify the number, nature and scope of MISST-related studies supported by the NIH at three time points: 2005, 2010 and 2015. The goal was to: 1-examine the extent to which the NIH is supporting this research and, 2-identify how these tools are being used in research. The number of funded MISST research projects increased 384% from 2005 to 2015. Results revealed that while funding of MISST research is growing, it only represented about 1% of the total NIH budget in 2015. However, the number of institutes, agencies, and centers supporting MISST research increased by roughly 50%. Additionally, the scope of MISST research is diverse ranging from use of social media to track disease transmission to personalized interventions delivered through mobile health applications. Given that MISST research represents about 1% of the NIH budget and is on an increasing upward trajectory, support for research that can inform the ethical, legal and social issues associated with this research is critical.Funding: support for mobile technologies on the riseThe number of US government-backed biomedical research projects that involved mobile and digital technologies rose 384% from 2005 to 2015. Camille Nebeker and colleagues from the University of California, San Diego, USA, tabulated how much grant money the US National Institutes of Health was allocating to research projects in which these new kinds of imaging, sensing and tracking tools played an integral role. They found that the agency spent

Building Research Integrity and Capacity (BRIC): An Educational Initiative to Increase Research Literacy among Community Health Workers and Promotores.

47 million on 134 relevant projects in 2005;

Don’t quote me: reverse identification of research participants in social media studies

137 million for 338 projects in 2010; and

Technology Innovations in Dietary Intake and Physical Activity Assessment: Challenges and Recommendations for Future Directions

293 million for 649 projects in 2015. Although these studies in 2015 represented only about 1% of the agency’s total budget, the authors conclude that the growing popularity of the technologies necessitates giving more consideration to the ethical, legal and social issues associated with their use with human research subjects.

Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives

While citizen science is gaining attention of late, for those of us involved in community-based public health research, community/citizen involvement in research has steadily increased over the past 50 years. Community Health Workers (CHWs), also known as Promotores de Salud in the Latino community, are critical to reaching underserved populations, where health disparities are more prevalent. CHWs/Promotores provide health education and services and may also assist with the development and implementation of community- and clinic-based research studies. Recognizing that CHWs typically have no formal academic training in research design or methods, and considering that rigor in research is critical to obtaining meaningful results, we designed instruction to fill this gap. We call this educational initiative “Building Research Integrity and Capacity” or BRIC. The BRIC training consists of eight modules that can be administered as a self-paced training or incorporated into in-person, professional development geared to a specific health intervention study. While we initially designed this culturally-grounded, applied ethics training for Latino/Hispanic community research facilitators, BRIC training modules have been adapted for and tested with non-Latino novice research facilitators. This paper describes the BRIC core content and instructional design process.

A Proposal for Thinking Strategically About Ethics Education: Applying the Principles of Andragogy to Enhance Teaching and Learning About Responsible Conduct of Research (RCR)

We investigated if participants in social media surveillance studies could be reverse identified by reviewing all articles published on PubMed in 2015 or 2016 with the words “Twitter” and either “read,” “coded,” or “content” in the title or abstract. Seventy-two percent (95% CI: 63–80) of articles quoted at least one participant’s tweet and searching for the quoted content led to the participant 84% (95% CI: 74–91) of the time. Twenty-one percent (95% CI: 13–29) of articles disclosed a participant’s Twitter username thereby making the participant immediately identifiable. Only one article reported obtaining consent to disclose identifying information and institutional review board (IRB) involvement was mentioned in only 40% (95% CI: 31–50) of articles, of which 17% (95% CI: 10–25) received IRB-approval and 23% (95% CI:16–32) were deemed exempt. Biomedical publications are routinely including identifiable information by quoting tweets or revealing usernames which, in turn, violates ICMJE ethical standards governing scientific ethics, even though said content is scientifically unnecessary. We propose that authors convey aggregate findings without revealing participants’ identities, editors refuse to publish reports that reveal a participant’s identity, and IRBs attend to these privacy issues when reviewing studies involving social media data. These strategies together will ensure participants are protected going forward.

371. Connected and Open Research Ethics (CORE) Initiative: Engaging Stakeholders to Shape Ethics in the Digital Age

Dietary intake (DI) and physical activity (PA) data are used in a variety of ways, including to determine nutrient adequacy and deficiency; to assess nutritional, fitness, and health status; to develop health promotion and behavioral interventions; and to understand food chemical and microbiological exposure, food!drug interactions, and pharmacokinetic effects.1!3 Methods used to capture these data must therefore be reliable and accurate to ensure confidence when determining quantitative DI and energy intake (EI), food behaviors, and energy expenditure (EE), especially for real-time monitoring and interventions. Moreover, because the underlying pathways and mechanisms regulating energy homeostasis are not fully understood, improved measures can help address challenges in understanding interrelationships between DI and PA. The increased prevalence of diet-related chronic diseases, obesity, and sedentary behavior has intensified interest to understand the long-term effects of diet and PA on aging and health. Although the use of biomarkers and new “omics” technologies has enhanced understanding of genotypic and biological effects, assessment of DI and PA has not progressed as rapidly. Current DI and PA assessments are typically based on self-report and thus have inherent biases.5!9 New technology-enabled methods designed to objectively measure DI and PA hold promise in addressing these shortcomings. In 2016, NIH and the Interagency Committee on Human Nutrition Research intensified support to develop new objective tools to improve the accuracy and reliability of DI and PA measures. An expert forum (Tech Summit: Innovative Tools for Assessing Diet and Physical Activity for Health Promotion) was convened at the University of California, San Diego (UCSD) in December 2016 to address the state of the science and technology innovations in DI and PA assessment across the life span. Scientists from the U.S. Department of Agriculture Agricultural Research Service, American College of Sports Medicine, and NIH helped plan the program, and a multidisciplinary group of experts in the field discussed the current state of technology-enabled tools and methods for DI and PA assessment and identified challenges and future needs. Attendees comprised researchers, technology developers, commercial applicators, practitioners, ethics professionals, and policy makers from multiple disciplines, including statistical modeling, device development, software and biomedical engineering, nutrition and food sciences, behavioral sciences, psychology, sports medicine, biology, regulatory science, law, and ethics.