Protection Of Research Participants Research Articles

Monitoring committees for research participant protection

Resumo O tema segurança tem sido intensamente discutido, mostrando-se cada vez mais relevante na saúde pública e em projetos de pesquisa envolvendo seres humanos. Participantes de estudos clínicos estão sujeitos a riscos, físicos ou não, que impactam em sua integridade, direitos ou autonomia. Este trabalho apresenta e discute a atuação do Comitê de Monitoramento de Dados e de Segurança para a proteção do participante de pesquisa e minimização de riscos em pesquisa clínica. A metodologia consiste em revisão integrativa da literatura, realizada com o propósito de identificar as funções dos comitês e seu papel na proteção dos participantes. Identificou-se que grande parte das publicações analisadas confirmam que os comitês de monitoramento têm como responsabilidade principal a proteção do participante de pesquisa, além da garantia de integridade e credibilidade da pesquisa.

The role of nursing members in research ethics committees in Japan.

The International Council of Nurses (2012) and the Council for International Organizations of Medical Sciences (2016) determined and published ethical standards relevant to nursing researchers and practitioners; based on these standards, nurses are expected to participate in committees where decisions on ethical issues are made. While clinical practitioners and nursing educators actively serve on research ethics committees, their precise role in these platforms has yet to be elucidated. In this study, medical, humanities/social science, lay, and nursing members in research ethics committees across Japan were invited to participate in a semi-structured interview; data were analyzed through a qualitative analysis method. Specifically, we interviewed 23 research ethics committee members in Japan to clarify the role of nursing members in the committee. Our qualitative analysis yielded six themes: share perspectives and experiences in nursing, protect research participants, evaluate the research design, represent the voice of research participants, confirm the informed consent documents and ascertain research participants' free will. The analyses revealed a slight difference between what other committee members expected of the role of nursing members and nursing members' recognition of their own role. Nursing members make an important and independent contribution to ethics committees on deliberations and decision-making regarding research ethics. Within the context of research ethics committees, member selection and training are essential issues, and this study contributes to the literature by showing how these topics relate to the role of the research ethics committees and of their members.

The Post-Roe Political Landscape Demands a Morality of Caution for Women's Health.

The recent Supreme Court decision (ie, Dobbs v. Jackson Women's Health Organization), revoking the constitutional right to abortion in the United States, has the potential to dramatically disrupt progress in women's health research. The typical safeguards to ensure confidentiality and privacy of research participants in studies that collect certain types of personal health information may not hold against criminal investigations surrounding suspected pregnancy terminations. There are additional risks to participants in digital health research studies involving the use of wearable devices capable of tracking physiological measures, such as body temperature and heart rate, as these have shown promise for tracking conception and could be used to identify pregnancy termination signatures. There are strategies researchers can use to protect the safety of participants in health research who could get pregnant, while also maintaining integrity of research methods. The objective of this viewpoint is to discuss potential strategies to protect research participants' privacy that include the minimization of nonessential sensitive personal health information and anonymization protocols in the event of miscarriage or termination of pregnancy. We invite others to join this discussion so as to not let the current political landscape impede progress in women's health and reproductive research, while also protecting research participants.

International Research and Philanthropy

International Research and Philanthropy

Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi.

Pragmatic clinical trials generally rely on real world data and have the potential to generate real world evidence. This approach arose from concerns that many trial results did not adequately inform real world practice. However, maintaining the real world setting during the conduct of a trial and ensuring adequate protection for research participants can be challenging. Best practices in research oversight for pragmatic clinical trials are nascent and underdeveloped, especially in developing countries. We use the PRECIS-2 tool to present a case study from Lilongwe in Malawi to describe ethical and regulatory challenges encountered during the conduct of a pragmatic trial and suggest possible solutions. In this article, we highlight the following six issues: (1) one public facility hosting several pragmatic trials within the same period; (2) research participants refusing financial incentives; (3) inadequate infrastructure and high workload to conduct research; (4) silos among partner organisations involved in delivery of health care; (5) individuals influencing the implementation of revised national guidelines; (6) difficulties with access to electronic medical records. Multiple stakeholder engagement is critical to the conduct of pragmatic trials, and even with careful stakeholder engagement, continuous monitoring by gatekeepers is essential. In the Malawian context, active engagement of the district research committees can complement the work of the research ethics committees (RECs).

Training needs of health researchers in research ethics in Cameroon: a cross-sectional study

BackgroundResearchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon.MethodsIt was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants’ exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants.ResultsOf 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants’ protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31–7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant’s protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles.ConclusionThe coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Boosting ethics review capacity in public health emergency situations: Co-creation of a training model for French-speaking research ethics committees.

Ethics review preparedness is a major foundation for national effective response to public health emergencies, because it promotes pertinent research and enhances the protection of research participants and communities. In low-income countries, it can also promote equitable research partnership. However, most relevant literature is in English and not easily accessible for the members of research ethics committees in French-speaking African countries. A training module in French, addressing the issue of research ethics review during outbreaks and other public health emergencies, was designed based on a non-systematic literature review, and in order to be complementary to the Democratic Republic of Congo (DRC) national guidelines for ethics review. The module was administered to 42 members of the five ethics committees in DRC that expressed their interest for the training. This training, co-designed with local stakeholders, in the local working language and taking into account local circumstances and regulation, provided participants with up-to-date insights of research ethics (and research ethics preparedness) in public health emergencies. It resulted in rich reflection and knowledge-sharing on good practices across the ethics committees. As most participating ethics committees do not have yet explicit standard operating procedures for expedited review of protocols submitted in emergency situations, this would be a next important step to facilitate emergency reviews in the most efficient way.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Legal Duties of Researchers to Protect Participants in Child Maltreatment Surveys: Advancing Legal Epidemiology

Legal Epidemiology Author Ben Mathews Studies of the prevalence of child maltreatment respond to a public policy imperative to better understand and prevent child abuse and neglect. These studies span domains of law, public health, and legal epidemiology. When conducting them, researchers must comply with legal duties to protect research participants. Australia has a complex legal environment, with additional challenges when participants are children, or are in danger. Duties arise in three bodies of law, vary across States and Territories, and require statutory interpretation, conceptual analysis, and operationalisation. This article conducts the first comprehensive analysis of researchers’ legal duties to protect participants in child maltreatment surveys. It contributes new understandings of the operation of mandatory reporting duties in child protection law, duties to report child abuse offences in criminal law, and the duty of care in negligence law. The analysis informs conclusions about the applicability of these duties, and indicates a legally compliant, ethically sound, and operationally practicable approach. Findings are relevant to multiple settings.

Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.

The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.

Reflections on research ethics in a public health emergency: Experiences of Brazilian women affected by Zika.

In Brazil, the epicenter of the Zika crisis, brown, black, and indigenous poor women living in municipalities with scarce resources were disproportionally affected. The gendered consequences of the epidemic exposed how intersectional lenses are central to understand the impact of public health emergencies in the lives of women and girls. The demand for Zika-affected children and women to be research participants is relevant for an ethical analysis of participant protection procedures during a crisis. We investigated how women experienced research participation by analyzing their narratives. Two-year-long longitudinal qualitative study in Brazilian sites located in the epidemic's epicenter was performed using mixed methods: ethnography with women from two distinct states and individual semi-structured interviews with five women in different Zika-affected states, four of which were community leaders. All women in the study were mothers or grandmothers of Zika-affected children. Thematic analysis was used for data evaluation. Women perceived being pressured to participate in research and a lack of benefit sharing. Structural determinants of gender inequality, such as its effect on power distribution, were found to impact research participant protection. Formal procedures for research protocols approvals were insufficient in protecting participants because these instruments were unable to account for structural aspects. Communitarian mobilization, through WhatsApp groups, was found to be an important mechanism to create conditions to challenge oppressive structures. Strengthening public health, effective community-based participation in research planning and implantation of ethical strategies that promotes gender equality can have transformative effect on unequal power structures and promote participant protection.

Regulamentação ética da pesquisa no Brasil: papel do controle social

Abstract This work presents historical facts that resulted in the first health research normalization in Brazil and seeks to highlight the importance of social participation in its control. Going through the Regulatory marks of the countries, the social movements were evidently responsible for changes in the system formed by the research ethics committees and by the National Committee of Research Ethics. However, there are hindrances regarding the standards of analysis in the diverse committees, the difficulties of following the projects in course, and the register on the Plataforma Brasil. The Brazilian system is, nonetheless, a referential for other countries regarding respect and protection of research participants and the insertion of society in the committees.

The importance of universal ethical standards in science

Long-standing ethical principles for genetics research help respect and protect research participants, and they are especially important for preventing harm to marginalized or vulnerable populations. Recent reports allege that several genetic studies conducted in China might not have secured individuals' consent for their participation freely and without coercion. These reports reinforce the need for ASHG to articulate expectations that scientists worldwide abide by universal ethical standards for biomedical research and to update our own policies and practices, including updating journal instructions to authors and expectations for content submitted to ASHG's Annual Meeting program.

Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: a qualitative study

BackgroundDelivering high quality, patient- and family-centered care depends upon high quality end-of-life and palliative care (EOLPC) research. Engaging patients and families as advisors, partners, or co-investigators throughout the research lifecycle is widely regarded as critical to ensuring high quality research. Engagement is not only an ethical obligation, it also raises ethical challenges of its own. We conducted a qualitative study to understand ethical challenges and potential solutions when engaging patients and families in EOLPC research.MethodsWe recruited and interviewed 20 clinical investigators and 22 patients or family caregivers through the Palliative Care Research Cooperative Group (PCRC). Interview transcripts were analyzed using constructivist grounded theory methodology. Analysis sought to identify ethical challenges and potential solutions, as well as to synthesize findings into practical recommendations tailored to engaging patients and families in EOLPC research.ResultsOur study identified 8 ethical challenges considered unique to the EOLPC research context and 11 potential solutions to these challenges. The most frequently described ethical challenges included the need to minimize burdens of engagement for patients and caregivers, challenges of dealing with death and illness, and paternalism or “gatekeeping” (i.e., withholding the opportunity to participate from patients or caregivers). Investigators and patients or family caregivers conceptualized ethics challenges differently; several issues appeared to fall outside a traditional research ethics paradigm and more into the ethics of relationships. We synthesized these findings into 4 practical recommendations hypothesized to support authentic engagement.ConclusionsEngaging patients and families in EOLPC research can raise unique ethical challenges. These challenges can be overcome to empower participation, minimize the unique burdens of EOLPC, and promote diversity. Whereas traditional research ethics tend to emphasize protecting research participants who may be vulnerable, an ethics approach based on authentic engagement that explores what it means for investigators and patients or family caregivers to be in a relationship may be needed. Future research is needed to explore this approach and test these recommendations in practice.

191 Ethical Considerations of Decentralized Clinical Trials

OBJECTIVES/GOALS: Our goal is three-fold: (1) to enhance protections for research participants in decentralized clinical trials (DCT) by (2) identifying the ethical and regulatory challenges posed by DCT and (3) considering possible solutions to the ethical and regulatory challenges of DCT. METHODS/STUDY POPULATION: A literature review was conducted to identify the ethical and regulatory challenges of DCT. The review showed that, with few exceptions, the publications on DCT have been written by IT experts, researchers or representatives of the pharma industry. There are hardly any independent or multidisciplinary analyses of DCT, e.g., by ethicists, medical sociologists or patients. This suggests that, currently, the potential advantages of digitized clinical research are still to be tested empirically and confirmed independently. Ethical analyses of DCT are particularly scant, which points to a gap in the current understanding of the ethical and regulatory implications of DCT and the issues they raise. Our research used the method of ethical analysis to examine the ethical challenges and to consider possible solutions. RESULTS/ANTICIPATED RESULTS: We identify the following ethical challenges of DCT: (1) challenges related to modifications of research protocols to allow for decentralized activities; (2) lack of expertise for ethical review and approval of digital tools; (3) different regulatory standards of privacy for clinical trials and for commercial digital tools, (4) risks to participants privacy and confidentiality involving both data and physical privacy; (5) the impact of the digital divide on DCT, (6) technology-related subject selection bias and marginalization of vulnerable groups, (7) imposing new burdens on research subjects and caregivers due to technology needs and smaller research teams, (8) restricted access to the study team, and (9) impact of digital technology on informed consent and participant understanding. DISCUSSION/SIGNIFICANCE: DCT became the primary form of clinical research during the COVID-19 pandemic. DCT rely on a wide range of internet-based tools for recruitment, informed consent, data collection, health monitoring, and communication with participants. The tools pose ethical and regulatory challenges, which should be addressed to ensure participant well-being.

Institutional Review Board Use of Outside Experts: What Do We Know?

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.

Psychology, ethics, and research ethics boards

ABSTRACT Research Ethics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes of ethics by scrutinizing research proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes of ethics in the conducting of research, the evidence for risk to research participants as the basis for those codes, and the effectiveness of REBs in protecting research participants. We offer suggestions for how REB chairs, members, and researchers can improve the REB approval process so that it is fair and responsive.

Fostering research integrity in sub-Saharan Africa: challenges, opportunities, and recommendations.

Integrity and adherence to appropriate ethical standards are important elements of research. These standards are key to protecting research participants´ rights as well as ensuring the reliability and quality of research outputs. Although empirical evidence is scanty, several authors have alluded to the fact that violation of research integrity standards could be common in low- and middle-income countries including sub-Saharan Africa (SSA). Understanding the issues, challenges, and opportunities of research integrity and ethics in SSA is key to promoting the responsible conduct of research and the protection of research participants. This paper presents the authors´ critical views and recommendations on the current state of research integrity in SSA. We argue that understanding the current research integrity architecture in SSA has the potential to identify opportunities to promote responsible conduct of research in SSA. Such opportunities include, but are not limited to transparency, accountability, and reproducibility of research, which collectively lead to enhanced public trust in the research enterprise. We highlight the need to embrace equity, fairness, diversity, and inclusivity in the research cycle from conception (priority setting), funding, implementation, dissemination of findings, and scale up. We move on to provide a rationale for understanding the differences and similarities between research ethics and research integrity. Governments, research, and academic institutions must develop multifaceted approaches to promote compliance with principles of research integrity by developing and implementing clear research integrity policies and guidelines that foster responsible conduct of research and prioritize capacity building and empowerment of early career researchers, students, and other targeted key stakeholders.

Reform of research funding processes could pave the way for progress in global health

Reform of research funding processes could pave the way for progress in global health

Ethics of Outsourcing Drug Trials

With rising costs of drug testing and more stringent requirements, Western countries have been increasingly outsourcing their drug trials. While such actions make sense from a cost-benefit point of view, can we conclude the same from a marketing-ethics perspective? Are these lesser-developed countries being held to the same ethical standards and practices as expected in the Western countries? Are the drug companies' actions somehow influencing the research participants' decision to partake in such trials? The author applies the theory of reasoned action and ethical marketing underpinnings to develop relevant propositions. Consequently, drug testing companies, research participants, and marketing agencies can utilize these propositions to investigate whether more rigorous oversight is required to protect research participants.