Navigating the ethics of remote research data collection.

COVID-19 has accelerated broad trends already in place toward remote research data collection and monitoring. This move implicates novel ethical and regulatory challenges which have not yet received due attention. Existing work is preliminary and does not seek to identify or grapple with the issues in a rigorous and sophisticated way. Here, we provide a framework for identifying and addressing challenges that we believe can help the research community realize the benefits of remote technologies while preserving ethical ideals and public trust. We organize issues into several distinct categories and provide points to consider in a table that can help facilitate ethical design and review of research studies using remote health instruments.

Consumer Views on Health Applications of Consumer Digital Data and Health Privacy Among US Adults: Qualitative Interview Study.

BACKGROUND: In 2020, the number of internet users surpassed 4.6 billion. Individuals who create and share digital data can leave a trail of information about their habits and preferences that collectively generate a digital footprint. Studies have shown that digital footprints can reveal important information regarding an individual's health status, ranging from diet and exercise to depression. Uses of digital applications have accelerated during the COVID-19 pandemic where public health organizations have utilized technology to reduce the burden of transmission, ultimately leading to policy discussions about digital health privacy. Though US consumers report feeling concerned about the way their personal data is used, they continue to use digital technologies. OBJECTIVE: This study aimed to understand the extent to which consumers recognize possible health applications of their digital data and identify their most salient concerns around digital health privacy. METHODS: We conducted semistructured interviews with a diverse national sample of US adults from November 2018 to January 2019. Participants were recruited from the Ipsos KnowledgePanel, a nationally representative panel. Participants were asked to reflect on their own use of digital technology, rate various sources of digital information, and consider several hypothetical scenarios with varying sources and health-related applications of personal digital information. RESULTS: The final cohort included a diverse national sample of 45 US consumers. Participants were generally unaware what consumer digital data might reveal about their health. They also revealed limited knowledge of current data collection and aggregation practices. When responding to specific scenarios with health-related applications of data, they had difficulty weighing the benefits and harms but expressed a desire for privacy protection. They saw benefits in using digital data to improve health, but wanted limits to health programs' use of consumer digital data. CONCLUSIONS: Current privacy restrictions on health-related data are premised on the notion that these data are derived only from medical encounters. Given that an increasing amount of health-related data is derived from digital footprints in consumer settings, our findings suggest the need for greater transparency of data collection and uses, and broader health privacy protections.

Adjusting the focus: A public health ethics approach to data research.

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population-level research and big data because it results in a primary focus on consent (meta-, broad, dynamic and/or specific consent). Two recent guidelines - the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health-related research involving humans - both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision-making capacity? I propose that a public health ethics framework - based on public benefit, proportionality, equity, trust and accountability - provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.

Genetic research and consent: On the crossroads of human and data research.

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to using an individual's biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio-samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research.

Responsible data sharing in international health research: a systematic review of principles and norms.

BACKGROUND: Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation (GDPR), the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we set out to explore relevant ethical principles and norms. METHODS: We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. RESULTS: We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. CONCLUSIONS: While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust.

Using Drones to Study Human Beings: Ethical and Regulatory Issues.

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research (HSR), exempt HSR, or non-exempt HSR. In the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research.

Challenges in Collecting Big Data in A Clinical Environment with Vulnerable Population: Lessons Learned from A Study Using A Multi-modal Sensors Platform.

Agitation is one of the most common behavioural and psychological symptoms in people living with dementia (PLwD). This behaviour can cause tremendous stress and anxiety on family caregivers and healthcare providers. Direct observation of PLwD is the traditional way to measure episodes of agitation. However, this method is subjective, bias-prone and timeconsuming. Importantly, it does not predict the onset of the agitation. Therefore, there is a need to develop a continuous monitoring system that can detect and/or predict the onset of agitation. In this study, a multi-modal sensor platform with video cameras, motion and door sensors, wristbands and pressure mats were set up in a hospital-based dementia behavioural care unit to develop a predictive system to identify the onset of agitation. The research team faced several barriers in the development and initiation of the study, namely addressing concerns about the study ethics, logistics and costs of study activities, device design for PLwD and limitations of its use in the hospital. In this paper, the strategies and methodologies that were implemented to address these challenges are discussed for consideration by future researchers who will conduct similar studies in a hospital setting.

Promises and Pitfalls of Using Digital Traces for Demographic Research.

The digital traces that we leave online are increasingly fruitful sources of data for social scientists, including those interested in demographic research. The collection and use of digital data also presents numerous statistical, computational, and ethical challenges, motivating the development of new research approaches to address these burgeoning issues. In this article, we argue that researchers with formal training in demography-those who have a history of developing innovative approaches to using challenging data-are well positioned to contribute to this area of work. We discuss the benefits and challenges of using digital trace data for social and demographic research, and we review examples of current demographic literature that creatively use digital trace data to study processes related to fertility, mortality, and migration. Focusing on Facebook data for advertisers-a novel "digital census" that has largely been untapped by demographers-we provide illustrative and empirical examples of how demographic researchers can manage issues such as bias and representation when using digital trace data. We conclude by offering our perspective on the road ahead regarding demography and its role in the data revolution.

Consent and the ethical duty to participate in health data research.

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency.

Ethical and Practical Considerations for Collecting Research-Related Data from Commercially Sexually Exploited Children.

This article presents seven challenges of collecting primary (i.e., firsthand) data from commercially sexually exploited children (CSEC). We drew on our research team's experience collecting longitudinal data from 28 CSEC survivors with a 12-month follow-up period. We used both face-to-face and electronic group brainstorming methods to nominate a list of research-related challenges. The two main themes that were identified were challenges that can limit data quality and concerns about the impact of research on participants, researchers, and others. The three challenges related to data quality are (1) the age of the research participants; (2) questions about obtaining informed consent from parents or guardians; and (3) the over-interrogation of CSEC youth. The four challenges related to concerns about the impact of research were (4) concerns that research participation may further exploit youth; (5) staying in the role of researcher and refraining from providing advocacy; (6) secondary trauma and burnout experienced by research staff; and (7) the additional burden that research and data collection may place on the advocates and direct service providers. Because the process of collecting data from CSEC youth can be complicated, and rife with ethical and practical challenges, we have relayed our experiences with seven specific research-related challenges in order to stimulate discourse and further progress in the field.

Ethical considerations when conducting joint interviews with close relatives or family: an integrative review.

BACKGROUND: Researchers are obligated to do no harm to participants of research. Conflicts in relationships can cause negative well-being; therefore, insight is needed into the particular ethical considerations that arise when conducting joint interviews with close relatives or family members simultaneously in the healthcare setting. AIM: To collect and share knowledge related to ethical considerations conducting joint interviews. DESIGN AND METHODS: A literature review inspired by the integrative review method was performed. Data were retrieved through a structured search in PubMed, CINAHL and the Philosopher's Index and Academic Search Premier for articles published in English from 1980 to 2016 and included 18 articles, of a possible 2153. Article content was assessed line-by-line, and ethical considerations were extracted and organized in three subgroups regarding: Planning joint interviews; Conduction joint interviews and Reporting on joint interviews Findings: Participants should be offered the best terms for a constructive, on-going relationship after the joint interview has ended. This obligates the researcher to ensure a safe environment during the joint interview and create a delicate balance between the needs of the participants, using nonconfrontational techniques that foster equal and neutral but dedicated attention to all parties, before, during and after the joint interviews. CONCLUSION: Specific ethical considerations should be taken into account before, during and after joint interviewing. Further research is needed before a final conclusion can be drawn.

Should Internet Researchers Use Ill-Gotten Information?

This paper describes how the ethical problems raised by scientific data obtained through harmful and immoral conduct (which, following Stan Godlovitch, is called ill-gotten information) may also emerge in cases where data is collected from the Internet. It describes the major arguments for and against using ill-gotten information in research, and shows how they may be applied to research that either collects information about the Internet itself or which uses data from questionable or unknown sources on the Internet. Three examples (the Internet Census 2012, the PharmaLeaks study, and research into keylogger dropzones) demonstrate how researchers address the ethical issues raised by the sources of data that they use and how the existing arguments concerning the use of ill-gotten information apply to Internet research. The problems faced by researchers who collect or use data from the Internet are shown to be the same problems faced by researchers in other fields who may obtain or use ill-gotten information.

Respecting Context to Protect Privacy: Why Meaning Matters.

In February 2012, the Obama White House endorsed a Privacy Bill of Rights, comprising seven principles. The third, "Respect for Context," is explained as the expectation that "companies will collect, use, and disclose personal data in ways that are consistent with the context in which consumers provide the data." One can anticipate the contested interpretations of this principle as parties representing diverse interests vie to make theirs the authoritative one. In the paper I will discuss three possibilities and explain why each does not take us far beyond the status quo, which, regulators in the United States, Europe, and beyond have found problematic. I will argue that contextual integrity offers the best way forward for protecting privacy in a world where information increasingly mediates our significant activities and relationships. Although an important goal is to influence policy, this paper aims less to stipulate explicit rules than to present an underlying justificatory, or normative rationale. Along the way, it will review key ideas in the theory of contextual integrity, its differences from existing approaches, and its harmony with basic intuition about information sharing practices and norms.

Ethical Design in the Internet of Things.

Even though public awareness about privacy risks in the Internet is increasing, in the evolution of the Internet to the Internet of Things (IoT) these risks are likely to become more relevant due to the large amount of data collected and processed by the "Things". The business drivers for exploring ways to monetize such data are one of the challenges identified in this paper for the protection of Privacy in the IoT. Beyond the protection of privacy, this paper highlights the need for new approaches, which grant a more active role to the users of the IoT and which address other potential issues such as the Digital Divide or safety risks. A key facet in ethical design is the transparency of the technology and services in how that technology handles data, as well as providing choice for the user. This paper presents a new approach for users' interaction with the IoT, which is based on the concept of Ethical Design implemented through a policy-based framework. In the proposed framework, users are provided with wider controls over personal data or the IoT services by selecting specific sets of policies, which can be tailored according to users' capabilities and to the contexts where they operate. The potential deployment of the framework in a typical IoT context is described with the identification of the main stakeholders and the processes that should be put in place.

Developing a System for Processing Health Data of Children Using Digitalized Toys: Ethical and Privacy Concerns for the Internet of Things Paradigm.

EDUCERE (Ubiquitous Detection Ecosystem to Care and Early Stimulation for Children with Developmental Disorders) is a government funded research and development project. EDUCERE objectives are to investigate, develop, and evaluate innovative solutions for society to detect changes in psychomotor development through the natural interaction of children with toys and everyday objects, and perform stimulation and early attention activities in real environments such as home and school. In the EDUCERE project, an ethical impact assessment is carried out linked to a minors' data protection rights. Using a specific methodology, the project has achieved some promising results. These include use of a prototype of smart toys to detect development difficulties in children. In addition, privacy protection measures which take into account the security concerns of health data, have been proposed and applied. This latter security framework could be useful in other Internet of Things related projects. It consists of legal and technical measures. Special attention has been placed in the transformation of bulk data such as acceleration and jitter of toys into health data when patterns of atypical development are found. The article describes the different security profiles in which users are classified.

Engaging use of social media as a research tool to capture the daily life experiences of young people with chronic pain.

EBN engages readers through a range of online social media activities to debate issues important to nurses and nursing. EBN Opinion papers highlight and expand on these debates.