Ethics Committee Members Research Articles

What are the bottlenecks to health data sharing in Switzerland? An interview study.

While health data sharing for research purposes is strongly supported in principle, it can be challenging to implement in practice. Little is known about the actual bottlenecks to health data sharing in Switzerland. This study aimed to assess the obstacles to Swiss health data sharing, including legal, ethical and logistical bottlenecks. We identified 37 key stakeholders in data sharing via the Swiss Personalised Health Network ecosystem, defined as being an expert on sharing sensitive health data for research purposes at a Swiss university hospital (or a Swiss disease cohort) or being a stakeholder in data sharing at a public or private institution that uses such data. We conducted semi-structured interviews, which were transcribed, translated when necessary, and de-identified. The entire research team discussed the transcripts and notes taken during each interview before an inductive coding process occurred. Eleven semi-structured interviews were conducted (primarily in English) with 17 individuals representing lawyers, data protection officers, ethics committee members, scientists, project managers, bioinformaticians, clinical trials unit members, and biobank stakeholders. Most respondents felt that it was not the actual data transfer that was the bottleneck but rather the processes and systems around it, which were considered time-intensive and confusing. The templates developed by the Swiss Personalised Health Network and the Swiss General Consent process were generally felt to have streamlined processes significantly. However, these logistics and data quality issues remain practical bottlenecks in Swiss health data sharing. Areas of legal uncertainty include privacy laws when sharing data internationally, questions of "who owns the data", inconsistencies created because the Swiss general consent is perceived as being implemented differently across different institutions, and definitions and operationalisation of anonymisation and pseudo-anonymisation. Many participants desired to create a "culture of data sharing" and to recognise that data sharing is a process with many steps, not an event, that requires sustainability efforts and personnel. Some participants also stressed a desire to move away from data sharing and the current privacy focus towards processes that facilitate data access. Facilitating a data access culture in Switzerland may require legal clarifications, further education about the process and resources to support data sharing, and further investment in sustainable infrastructureby funders and institutions.

Ethical Considerations and Checklist for Affective Research With Wearables

As the popularity of wearables increases, so does their utility for studying emotions. Using new technologies points to several ethical challenges to be considered to improve research designs. There are several ethical recommendations for utilizing wearables to study human emotions, but they focus on emotion recognition systems applications rather than research design and implementation. To address this gap, we have developed a perspective on wearables, especially in daily life, adapting the ReCODE Health - Digital Health Framework and companion checklist. Therefore, our framework consists of four domains: (1) participation experience, (2) privacy, (3) data management, and (4) access and usability. We identified 33 primary risks of using wearables to study emotions, including research-related negative emotions, collecting, processing, storing, sharing personal and biological information, commercial technology validity and reliability, and exclusivity issues. We also proposed possible strategies for minimizing risks. We consulted the new ethical guidelines with members of ethics committees and relevant researchers. The judges ( <italic xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">N</i> = 26) positively rated our solutions and provided useful feedback that helped us refine our guidance. Finally, we summarized our proposals with a checklist for researchers' convenience. Our guidelines contribute to future research by providing improved protection of participants' and scientists' interests.

Letting Go of the Status Quo: One Program's Experience Discontinuing Ethics Committees and Creating Alternative Structures for Engagement.

AbstractThe authors describe their Ethics Program's transition from utilizing ethics committees to instead implementing a three-initiative structure consisting of Ethics Grand Rounds, an Ethics Liaison Network, and an Ethics Advisory Group. They first outline the history of ethics committees. Then, they discuss the history of their Ethics Program and the challenges that ethics committees posed. Next, they describe their approach to developing new initiatives for non-ethicist healthcare professionals to engage in ethics work and what these initiatives specifically entail. They then describe how they worked to secure buy-in for dissolving their ethics committees and, based on pre- and post-implementation surveys, how this transition has been received by former ethics committee members. Finally, the authors reflect on what has been gained and lost through these changes and offer insights and recommendations for other ethics programs thinking about discontinuing their own ethics committees in favor of more innovative models.

PartnerREC network: Result from a process of coconstruction with patient partners and researchers

The PartnerREC network at the Geneva University Hospitals aims to facilitate the collaboration between researchers and patient partners in any type of clinical research, mainly those led at the HUG. It is the result of a coconstruction process initiated in 2019 by physicians, research professionals, cantonal research ethics committee members, a lawyer, and patient partners. The network implemented four initiatives: a) a website providing information to researchers and patients participating to research projects; b) personalized counseling for researchers to explore partnership opportunities in their own research projects; c) a training program related to patient partnership in research developed together with different partners in French-speaking Switzerland and d) its own research program on partnership in clinical research.

ПРОЕКТ ЭТИЧЕСКОГО КОДЕКСА СУБЪЕКТОВ, ОСУЩЕСТВЛЯЮЩИХ ДЕЯТЕЛЬНОСТЬ ПО СОЗДАНИЮ, ПРИМЕНЕНИЮ И УТИЛИЗАЦИИ МЕДИЦИНСКИХ ИЗДЕЛИЙ НА ОСНОВЕ БИОПРИНТНЫХ ТЕХНОЛОГИЙ, ПО ВЗАИМОДЕЙСТВИЮ С ПАЦИЕНТАМИ И ДОНОРАМИ КЛЕТОК, ПО ОБОРОТУ ДОНОРСКИХ КЛЕТОК, БИОЧЕРНИЛ И БИОПРИНТНЫХ ТКАНЕВЫХ (ОРГАННЫХ) КОНСТРУКТОВ

The draft Code of Ethics of Entities Engaged in the Creation, Use and Disposal of Medical Devices Based on bioprint technologies, interaction with patients and cell donors, turnover of donor cells, biochernils and bioprint tissue (organ) constructs (hereinafter — The Code of Ethics), is a set of general principles of professional service ethics and basic rules of official conduct, which should guide the subjects engaged in the creation, use and disposal of medical devices based on bioprint technologies, interaction with patients and cell donors, turnover of donor cells, bio-ink and bioprint tissue (organ) constructs. The presented draft Code of Ethics is aimed at strengthening the authority of medical professionals, increasing patient confidence in bioprinting technologies and preventing potential negative consequences as a result of their use. The principles reflected in the Code of Ethics serve as the basis for improving the system of legal regulation of bioprint technologies. The digital development of the healthcare system will inevitably entail a change in the regulatory regulation of bioprint technologies, therefore, the proposed draft Code of Ethics is an attempt to form ethical foundations that can be laid in the basis of the law-making process of this digital technology and its practical implementation in clinical medicine. The ethical principles in the code are divided into information blocks formed based on the stages of the implementation of bioprint technology. The draft Code of Ethics is intended for lawyers, scientists and practitioners, medical professionals, members of clinical ethics committees, medical ethics specialists, representatives of law–making bodies, government departments, the business community and public organizations, patients, as well as a wide range of readers interested in the digital ransformation of the healthcare system

Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study.

Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving successful implementation. This study aims to identify insights for the design and implementation of a user-friendly, personalized, and long-term eIC application based on a usability study with (potential) research participants and semistructured interviews with stakeholders on the practical integration of such an application into their daily practice. An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the "think aloud" technique. In addition, usability tests involved completing the System Usability Scale questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives active in Belgium and involved in clinical research. Thematic analysis was undertaken using the NVivo software (Lumivero). In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD 8.35) and 71.3 (SD 16.1) out of 100, respectively, which represents above-average usability. Semistructured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders. This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems.

‘It is a complex process, but it’s very important to return these results to participants’. Stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified.

Ethical Considerations in Research With People From Refugee and Asylum Seeker Backgrounds: A Systematic Review of National and International Ethics Guidelines

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research.

Ranking Research Methodology by Risk — a cross-sectional study to determine the opinion of research ethics committee members

BackgroundWhen reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards — IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants’ time, researchers’ time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews.MethodWe conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey.ResultsWe collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky).ConclusionsWe discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.

Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs).

The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary 'nocebo' effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles. We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022. 25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles. We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved.

The rapid development of vaccines and other innovative medical technologies in response to the COVID-19 pandemic required streamlined and efficient ethics and governance processes. In the UK the Health Research Authority (HRA) oversees and coordinates a number of the relevant research governance processes including the independent ethics review of research projects. The HRA was instrumental in facilitating the rapid review and approval of COVID-19 projects, and following the end of the pandemic, have been keen to integrate new ways of working into the UK Health Departments' Research Ethics Service. In January 2022 the HRA commissioned a public consultation that identified strong public support for alternative ethics review processes. Here we report feedback from 151 current research ethics committee members conducted at three annual training events, where we asked members to critically reflect on their ethics review activities, and to share new ideas or ways of working. The results showed a high regard for good quality discussion among members with diverse experience. Good chairing, organisation, feedback and the opportunity for reflection on ways of working were considered key. Areas for improvement included the consistency of information provided to committees by researchers, and better structuring of discussions by allowing signposting of the key issues that ethics committee members might need to consider.

Post-approval process: A challenge for ethics committees.

Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight. The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges. We conducted a quantitative study contacting member secretaries of different ECs using an online Google Forms questionnaire. The questionnaire consisted of three domains and included questions about the description of the EC, conduct of post-approval activities, and challenges encountered during the post-approval process. We received responses from 61 member secretaries. We were able to identify challenges faced by the EC members in the post-approval process in the areas of site monitoring visit, review of post-approval submission (nonsubmission/incomplete submission/late submission of documents by PI, long time taken by reviewers, nonavailability of reviewers, nonadherence to timeline and too much paperwork), review of serious adverse events, and review of protocol deviations. Our study also noted the difference between accredited/assessed (National Accreditation Board for Hospitals and Healthcare Providers/Forum for Ethical Review Committees in the Asian and Western Pacific Region) ECs versus registered (Central Drugs Standard Control Organisation/Department of Health Research only) ECs by comparing the challenges.

Opinions and attitudes of research ethics committees in Arab countries in the Middle East and North African region toward ethical issues involving biobank research

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.

Research ethics committee members’ perspectives on paediatric research: a qualitative interview study

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs.

Exploring perspectives of research ethics committee members on the governance of big data in sub-Saharan Africa.

Interest in the governance of big data is growing exponentially. However, finding the right balance between making large volumes of data accessible, and safeguarding privacy, preventing data misuse, determining authorship and protecting intellectual property remain challenging. In sub-Saharan Africa (SSA), research ethics committees (RECs) play an important role in reviewing data-intense research protocols. However, this regulatory role must be embedded in a context of robust governance. There is currently a paucity of published literature on how big data are regulated in SSA and if the capacity to review protocols is sufficient. The aim of this study was to provide a broad overview of REC members' awareness and perceptions of big data governance in SSA. A descriptive cross-sectional survey was conducted from April to July 2022. We invited 300 REC members to participate in our online survey via Research Electronic Data Capture (REDCap). A total of 140 REC members, representing 34 SSA countries, completed the online survey. Awareness of data governance laws, policies and guidelines was variable across the subcontinent. A quarter of respondents (25%) indicated that national regulations on the trans-border flow of research data are inadequate. Institutional policies on research data protection were also regarded as being inadequate. Most respondents (64%) believed that they lacked experience in reviewing data-intense protocols. Data governance and regulation in SSA need to be strengthened at both national and institutional levels. There is a strong need for capacity development in the review of data-intense research protocols on the subcontinent.

Ethical Planning in Conducting a Research Project

Countries that still do not have a national normative document on research ethics, like most African and Latin American countries, have taken the Declaration of Helsinki as a reference for ethical guidance to researchers and members of ethics committees. However, the literature has shown that the latest revisions of this declaration have tended to favor the interests of central countries and their industries, mainly through the more flexible acceptance of greater risks and smaller benefits. Even when there are norms adequate to the reality of each country, the ethical planning of a research goes far beyond the simple bureaucratic fulfillment of the norms that guide the presentation of a protocol and a consent term to a research ethics committee. It presupposes an in-depth reflection on the methodological procedures themselves that will involve the participants and on the ways in which they interact with the socioeconomic and cultural contexts of these participants' daily lives. In developing countries, consideration of social vulnerability, especially with regard to poverty and low levels of education, is a central element in this planning. I intend to discuss this planning taking the three classic axes of research subject protection: obtaining consent, minimizing risks and maximizing benefits in their relationship with contexts of social vulnerability in three modalities of health research: those that handle information from identifiable subjects, such as clinical protocols; those using interviews and questionnaires; and clinical trials for new drugs.

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

ObjectivesWe aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying...

Ethics Expertise between Imagined Publics and Imagined Scientists

The notion of value-neutral or at least independent scientific expertise is mainly based on the distinction between statements of facts and value judgement. The functioning of ethics committees, in particular bioethics committees, demonstrates that this separation is doomed to fail. These committees are supposed to regulate the production of new scientific knowledge through appeal to extra-scientific, non-epistemic values. In making regulatory judgments, the committees find themselves on the edge of a tension between `cognitive democracy' and epistemic inequality. Сommittees have a duty to represent the interests of the public, protecting its dignity and freedoms from possible abuse from researchers. At the same time, the committees, by conducting an “internal” judgment on the ethical permissibility of research projects, remain part of scientific groups and institutions. However, members of ethics committees often imagine academic colleagues as having an incomplete, deficient view of the public good. The committees find themselves in a field of conflict between the epistemic deficits of the imagined public and the ethical deficits of imagined scientists. However, counteracting this double deficit logic can take the form of an ethical abstinence that shuts down the possibilities of value-laden imagination. Moreover, such withdrawal itself is ideologically engaged. The program of `critique of forms of life' can be seen as setting the overall perspective of combining representation with the possibilities of normative judgment. This combination is particularly relevant in light of the ongoing debates about moral enhancement and human genome editing, since both areas of biomedical inquiry involve biotechnological and social transformation of human forms of life.

The application of data altruism in clinical research through empirical and legal analysis lenses.

The legal framework for clinical research in the EU is complex and the lack of harmonization of the relevant legal and ethical rules remains one of the main challenges for stakeholders in the field. The recently adopted Data Governance Act (DGA) and the proposal for a European Health Data Space (EHDS) promise to solve the existing challenges with respect to access to and (re)use of personal data for research, but also risk to further complexify the field. The DGA introduced a novel mechanism - data altruism. Data altruism is understood as the voluntary sharing of personal and non-personal data, based on the consent of data subjects or the permission of natural and legal persons, without seeking a reward and for objectives of general interest. This study aimed to gain insights into the opinion of clinical research stakeholders on data altruism, and to critically discuss key issues pertaining to the application of data altruism from a legal point of view. Semi-structured interviews with (1) data protection officers (DPOs) and legal experts working with commercial and academic sponsors of clinical trials, (2) investigators, and (3) members of research ethics committees. Data underwent framework analysis. The legal discussion was comprised of legal doctrinal research with focus on the DGA, EHDS proposal, and the interplay with the EU General Data Protection Regulation (GDPR). Fourteen experts took part in the interviews, more than half of which were DPOs/legal experts. Interviewees were based in seven EU Member states and the United Kingdom. The majority of participants were critical towards the data altruism mechanism and pointed out challenges and risks associated with its application. Although data altruism holds the potential to facilitate data sharing, its application in clinical research at the moment is still riddled with uncertainties. The interplay of the DGA rules with the provisions of the GDPR and the EHDS proposal are insufficiently clear and further efforts from the legislator are required to build a working, patient-centered, and research fostering data altruism system.

URECA – the Research Ethics and Data Protection Online Review Platform used by the University of Malta Authors

Nowadays, research ethics and data protection are given very high importance, and research organizations, including universities, need to safeguard their level of professionalism and integrity by providing the necessary guidelines. Moreover, they need to ensure that these guidelines are being adhered to by their affiliated researchers, including students. This is needed for protection of the research subjects, researchers, and the organization (university) itself. However, care must be taken so that the research ethics review process is streamlined as much as possible to minimize bureaucracy, as such guidelines would then be viewed as a research barrier. This study describes URECA, the online review platform developed in-house by the University of Malta to streamline its research ethics review process, thus simplifying matters for the researchers/students, reviewers, and auditing committees. This platform is utilized by researchers and students to submit information regarding their research and related data collection, by supervisors to endorse their students’ research, by Faculty Research Ethics Committee members to review research proposals as required, and by the University Research Ethics Committee to manage and audit the overall process.