Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward
Dickinson Law Idea, 2022
Artificial intelligence (AI) and other digital health products, such as smart pills, are rapidly entering clinical practice. We live in the age of big data, where massive amounts of data are collected and used to develop or update digital health products and are shared with third parties for research or commercial purposes. Moreover, we can already see a shift in health care from hospitals to people’s homes, for example through the use of medical apps, Fitbits, and other wearables. This line between clinic and home will likely become more and more blurry in the near future. According to one estimate, the smart home health care market size is projected to grow from $6.1 billion in 2018 to over $30 billion in 2025. In particular, the COVID-19 pandemic has propelled the adoption of health AI and digital health across multiple applications. For example, the development and use of digital home health products have been expedited to reduce exposure to the coronavirus SARS-CoV-2, such as through remote patient monitoring, and to better control its spread, such as through exposure-notification apps. At the same time, the regulation of medical devices is more flexible during the public health emergency. However, the acceleration of launching new digital home health devices on the US market combined with less regulatory oversight also raises some challenges, including post-pandemic questions. In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.
A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule
Krista L. Snyder, Jon F. Merz
medRxiv, 24 August 2022
The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.
We conducted a multi-pronged search to try and identify all trials conducted under the EFIC rule, drawing on numerous reviews, Medline and Google searches (including of the clinicaltrials.gov registry), examination of the FDA’s docket, posting an inquiry on the IRB Forum, and email requests to lead authors of all published EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early.
We identified a total of 105 trials as of April 1, 2022: 77 complete, 10 recruiting, 10 registered on clinicaltrials.gov but not yet recruiting, 5 trials that were abandoned before enrolling any subjects, and 3 trials in early planning. Nine of the 77 completed trials were pilot or feasibility trials. Of 68 completed full trials, 30 (44.1%) were terminated early. The most common reason for early termination was futility or safety (17 trials, 25.0%) followed by poor recruitment (9 trials, 13.2%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period.
The rate of early termination of EFIC trials for futility or safety appears higher than for other kinds of clinical research. We provide the list of trials in a Supplement for further in-depth data collection and analysis of this set of trials.
Use Of Teach-Back During Informed Consent In Cancer Clinical Trials
Yale School of Nursing Digital Theses, 2022
Five percent of the 1.8 million patients diagnosed with cancer in the United States (US) enroll annually in a clinical trial (American Cancer Society, 2021; Institute of Medicine Committee on Cancer Clinical Trials; National Cancer Institute Cooperative Group Program, 2010). Flawed research consent practices are detrimental to patient safety and costly to the US Healthcare system (Eisenberg et al., 2012; Unger et al., 2019). Well trained nurses are imperative to conducting rigorous, reproducible, and quality research (Brandt et al., 2011). Programs designed to educate nurses on how to implement comprehensive communication strategies confidently during the Cancer Clinical Trials (CCT) consent process remain scarce (Nusbaum et al, 2019; Purdom et al., 2017). The purpose of this quality improvement project was to develop, implement, and evaluate the effects of an evidenced-based education program on nurse confidence with use of the teach-back method during the CCT consent process. An evidenced based education program was developed. It was implemented as a synchronous webinar to members of the International Association of Clinical Research Nurses. Pre and post test program surveys measuring confidence levels were disseminated. There was an overall increase in postsurvey responses suggesting an improvement in confidence levels with use of the teach-back method during the CCT IC process. Further study can explore if patient understanding of CCTs during the IC process is developed proportionally to levels of nurse confidence with use of the teach-back method.
Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials
Tiffany Bellomo, Jennifer Fokas, Noah Tsao, Clare Anderson, Christopher Becker, Rachel Gioscia-Ryan, William Meurer
Ethics & Human Research, 8 July 2022; 44(4) pp 14-25
We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.
Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Julie R. Bromberg, Evelyn Nimaja, Andrew W. Kiragu, Karla A. Lawson, Lois Lee, Isam W. Nasr, Charles Pruitt, Stephanie M. Ruest, Michael J. Mello
Ethics & Human Research, 8 July 2022; 44(4) pp 34-38
The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.
Issues About Digital Informed Consent in Clinical Research
Freade Akbar, Ray Wagiu Basrowi
Indonesian Journal of Community and Occupational Medicine, July 2022; 2(1) pp 40-7
Informed consent is a concrete form of moral and ethical values that urgently needs to be emphasized, especially in research that requires the role of humans as subjects and is commonly associated with experimental research. Informed consent itself consists of two forms of print and digital, along with the times many parties began to examine how the role of informed consent, the advantages and disadvantages between print and digital, the application of good digital informed consent, and how information about research should be conveyed to the research subject so that it is easy to understand and in accordance with moral and ethical standards. The purpose of this article is to address issues related to digital informed consent in clinical research.
We conducted a search on the SpingerLink database in March 2022 to see various publications in the last 2 years related to electronic informed consent using keywords: digital, informed consent, research.
Total 4 articles as source of literature review. Recent research shows the tendency of research subjects to choose digital informed consent because content is easier to personalize, makes it easier to understand content that is only needed by the subject, and the ease of adding digital content in certain forms of media such as audio, and video into digital formats. From the researcher’s side will increase the active participation and number of study subjects, making it easier for long-term interaction, especially follow-up research. There are 4 types of informed consent based on utilization for research and 5 informed consent processes that must be carried out in clinical research, which is attempted using language that is easily understood by the research subject and dynamic for further research.
Informed consent in any form constitutes the autonomy right of the subject. Digital formats provide better prospects in facilitating communication to research subjects. But this ease must be accompanied by the consistency of the application of the standard informed consent process, even in intervention studies with biological samples this is more stringent. Informed consent given to the subject must use language that is easy to understand, and transparent. The subject of the study is given the right at any time to exit the research. In the future, the issue of morals and ethics of research will grow, and more dynamic informed consent is needed, especially for interventional clinical research.
‘Scraping’ Reddit posts for academic research? Addressing some blurred lines of consent in growing internet-based research trend during the time of Covid-19
Nicholas Norman Adams
International Journal of Social Research Methodology, 18 August 2022
The global scale of Covid-19 has constrained academics from conducting much person-facing research. Reactively, trend is increasing for digital-based methodologies capturing already existing online data. Scholars often ‘scrape’ user-postings from internet forums using coding algorithms and text capture tools, before analysing data, drawing conclusions and publishing findings. The online social news aggregation and discussion website Reddit is a particularly rich source of data for researchers. The public nature of Reddit materials may suggest rationale for user-data to be replicated, analysed and archived; indefinitely and in multiple locations, for scholarly research. However, this position overlooks several key ethical considerations. This paper presents an overview and explanation of Reddit, followed by an exploration of studies that use Reddit-acquired data. Arising ethical issues are discussed, and solutions to salient dilemmas presented. This is to enhance awareness of potential problems and improve protections for those whose data is unknowingly used for research.
Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic
Andrea Shin, Huiping Xu
Ethics & Human Research, 8 July 2022; 44(4) pp 26-33
We assessed public perspectives of microbiome research privacy risks before and after a nationwide emergency was declared in the United States regarding the Covid-19 pandemic. From January to July of 2020, we conducted an online survey of perceived privacy risks of microbiome research among U.S. adults. Among 3,106 participants (the preemergency group), most expressed that the microbiome posed privacy risks similar to those associated with DNA (60.3%) or medical records (50.6%) and that they would prefer detailed explanations (70.2%) of risk in consent materials. Only 8.9% reported moderate to high familiarity with microbiome privacy risks. In adjusted analyses, individuals who participated in the study after the Covid-19 emergency was declared (the Covid-19 emergency group) were less likely to express that microbiome privacy risks were similar to those of DNA or medical records and more likely to report familiarity with the privacy risks of microbiomes. There was a trend toward increased concern after the Covid-19 emergency was declared (p = 0.053). Overall, the study revealed that many U.S. adults believe that microbiome privacy risks are similar to those associated with DNA or medical records, and they prefer detailed explanations in consent documents. Individuals who participated after the Covid-19 emergency was declared reported greater knowledge of microbiome privacy risks but had more concern.
Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer
Anja Köngeter, Christoph Schickhardt, Martin Jungkunz, Susanne Bergbold, Katja Mehlis, Eva C Winkler
Journal of Medical Internet Research, 25 August 2022
Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients’ willingness to support research with their clinical data is a crucial prerequisite for research progress.
The aim of the study was to learn about patients’ attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes.
A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census.
In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%).
Although patients’ general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.
Digital Transformation of Big Data
Po-Chang Lee, Chih-Hsing Ho, Joyce Tsung-Hsi Wang
Digital Health Care in Taiwan, 14 August 2022; pp 219–228 [Springer]
The virtual National Health Insurance (NHI) card not only represents digitization but also enables contactless health care during the pandemic. Under the process of full-scale digitization, the National Health Insurance Administration (NHIA) continues to refine the health service delivery measures, especially in the field of home-based medical care and telemedicine.
Under the personal data protection regulation, the NHI data are opened for academic research purposes. More than 6550 published journal articles have utilized the NHI data, and these articles are made searchable online to support health policy management and clinical research. The NHI medical images combined with the application of artificial intelligence (AI) are the cornerstones of Taiwan’s smart health care. Domestic research teams are eligible to use the NHI database to verify or build their AI models after their research proposals are approved by the Management Council of the AI Application of NHI Data. The NHIA also plans to use NHI big data to develop digital patient decision aids by establishing a two-way digital interaction model to address the concerns of the healthcare providers and the public. By comparing the secondary use of health data in different countries, Taiwan is seeking a balance between innovation and conservative policies and is creating an environment that ensures the well-being of the next generation.