BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is (...) engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes. (shrink)

Mobile health research involving pervasive sensors, mobile apps and other novel data collection tools and methods present new ethical, legal, and social challenges specific to informed consent, data management and bystander rights. To address these challenges, a participatory design approach was deployed whereby stakeholders contributed to the development of a web-based commons to support the mHealth research community including researchers and ethics board members. The CORE platform now features a community forum, a resource library and a network of nearly 600 (...) global members. The utility of the participatory design process was evaluated by analyzing activities carried out over an 8-month design phase consisting of 86 distinct events including iterative design deliberations and social media engagement. This article describes how participatory design yielded 55 new features directly mapped to community needs and discusses relationships to user engagement as demonstrated by a steady increase in CORE member activity and followers on Twitter. (shrink)

Shen et al. (2024) have articulated the many opportunities as well as notable challenges associated with the emerging practice of returning individual research results (IRR) specific to digital phe...

A model frequently used to implement community‐based research involves engaging local community health workers who are trusted members of the community and familiar with local customs, language, and culture. In Spanish‐speaking communities, the CHWs are also known as promotores de salud (“health promoters”). Depending on the study design and nature of the research, promotores facilitate research through community outreach, instrument design, participant recruitment, intervention delivery, data collection, and other research‐related tasks. In 2000, the National Institutes of Health published a regulation (...) requiring training of “key personnel” named on NIH‐supported research involving human subjects. Regardless of whether promotores are technically designated as key personnel on a particular study, they may benefit from training in research ethics. Unfortunately, the educational programs designed for academic researchers in response to the NIH mandate were poorly aligned with the needs of promotores and not suited for learning about human research ethics applied to the community health setting. For example, many promotores in our California‐Mexico border region are monolingual Spanish speakers who have no formal academic research training. Therefore, we set out to develop a training alternative appropriate to our local CHWs. In this essay, we provide overviews of the relevant instructional design principles and our formative research process, including examples of key findings. (shrink)

Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.

Despite the potential value of graduate-level research ethics training, most Middle East countries, including Jordan, do not routinely offer formal research ethics training. In students enrolled in Jordanian master’s level graduate program in pharmacy, the current study assessed: 1- differences in pre- and post-enrollment exposure to research ethics core themes, 2- whether this exposure was through a formal course or in an informal setting, and 3- student attitudes towards research ethics education and the need for integrating a dedicated research ethics (...) course into pharmacy graduate programs. A 12-item on-line survey was developed by the authors and disseminated to a convenience sample of current and former master-level pharmacy students in Jordan. A total of 61 eligible respondents completed the survey. A minority of respondents (38%) acknowledged receiving research ethics training prior to enrollment into a postgraduate pharmacy program with nearly half (16%) describing this training as informal. In comparison, a larger percentage of the total respondents (56%) had received research ethics training during their postgraduate program enrollment, with nearly half of those (25%) indicating that this training was informal. A majority of respondents reported a strong need for integrating a formal research ethics course into postgraduate pharmacy curriculum (90%) to support their research training and thesis writing (89%). Overall, the study revealed a notable lack of research ethics education for graduate-level pharmacy students in Jordan. (shrink)

Training in the responsible conduct of research (RCR) is mandated for select trainees supported by federal funds. RCR Instructors typically address standards and accepted practices for the planning, conduct and reporting of academic research. While this focus may be relevant to future academic scientists, the majority of science graduate students pursue careers in non-academic employment sectors (e.g., government, non-profit, industry). The ethical and regulatory conventions, norms and expectations of the academic setting may not always transfer to other work environments. As (...) such, educators should focus less on answering specific questions about standards and practices in academia, and instead design ethics education to actively engage students in a learning process that prepares them with the skills to identify and navigate ethical dimensions in a wide range of possible science professions. This paper introduces the principles of andragogy and provides recommendations for educators to consider when designing research ethics education for graduate students seeking cross-sector science careers. By applying principles that resonate with adult learning and integrating strategies that promote self-directed and life-long learning (e.g., reflective practice and collaborative projects), professional and research ethics instructional effectiveness may be enhanced. (shrink)

The speed and scale of the COVID‐19 pandemic has highlighted the limits of current health systems and the potential promise of non‐establishment research such as “DIY” research. We consider one example of how DIY research is responding to the pandemic, discuss the challenges faced by DIY research more generally, and suggest that a “trust architecture” should be developed now to contribute to successful future DIY efforts.