Evaluating the Impact and Effectiveness of Flint's Community Ethics Review Board (CBOP-CERB): A Pilot Study.

In recognition of the importance of evaluation for funding, research, and quality improvement, a longstanding Community Advisory Board in Flint Michigan embarked on a process to evaluate their impact. The Community-Based Organization Partners (CBOP)-Community Ethics Review Board (CERB) engaged a research team composed of an academic researcher (Solomon Cargill) and a community partner (Spencer) to obtain funding, design and implement an evaluation of the CBOP-CERB. This evaluation study yielded two evaluations of the CBOP-CERB, one with researchers who had engaged with the CBOP-CERB and the other with Flint area community residents. The results of these two evaluations can serve to show other Community Advisory Boards how to establish and expand their impact, establish their worth for future funding, and how to articulate, evaluate, and achieve their goals.

Participatory monitoring in community-based fisheries management through a gender lens.

In small-scale fisheries management, the significance of participation is widely recognised but we are still learning how this can be better operationalised to include different groups, such as women or Indigenous peoples. Participatory monitoring is one tool which has been used to increase participation in fisheries management. The aim of this review is to use critical interpretive synthesis to examine the literature on participatory monitoring within community-based fisheries management from a gender perspective. The synthesis identified and discussed several key areas: reasons presented in the literature for engaging with the themes of gender or participatory monitoring, gendered aspects of participatory monitoring, knowledge valuation and prioritisation in management, replicability and transparency of programme or research methods, and marginalisation narratives. Our findings show the complexities of conducting gender-aware participatory monitoring. Participatory monitoring has the potential to be a transformative and empowering process if the power dynamics involved are considered and addressed.

"Community 101 for researchers": an online training program to build capacity for ethical community-engaged research with Native Hawaiians and Pacific Islanders.

To address the history of unethical research and community distrust in research among Native Hawaiian and Pacific Islander communities, we developed the "Community 101 for Researchers" training program, which was launched in 2014 to enhance the capacity of researchers to engage in ethical community-engaged research. The purpose of this paper is to describe the development of this training program as well as its reach and feedback from participants. The Community 101 training program is a self-paced, 2-h online training program featuring community-engaged researchers from the University of Hawai'i and their longstanding community partners. Throughout the five modules, we highlight the historical context of Native Hawaiians and Pacific Islander populations in Hawai'i related to research ethics and use examples from the community as well as our own research projects that integrate community ethics, relevance, benefits, and input. To determine reach and gather participant feedback on the training, we extracted data from the user accounts. The training has been completed by 697 users to-date since its launch. Despite very little advertisement, an average of nearly 70 users have completed the Community 101 Program each year. The majority of the participants were located in Hawai'i though participants were also from other states and territories in the US, and international locations. The majority of participants were from universities in Hawai'i in 51 different departments demonstrating multidisciplinary relevance of the program's training. The general feedback from the 96 participants who completed an optional anonymous evaluation survey given at the end of the training was positive. The "Community 101 for Researchers" Training program is an accessible and relevant tool that can be used to advance ethical community engaged research, specifically with Native Hawaiian and Pacific Islander communities.

A marathon, not a sprint - neuroimaging, Open Science and ethics.

Open Science is calling for a radical re-thinking of existing scientific practices. Within the neuroimaging community, Open Science practices are taking the form of open data repositories and open lab notebooks. The broad sharing of data that accompanies Open Science, however, raises some difficult ethical and legal issues. With neuroethics as a focusing lens, we explore eight central concerns posed by open data with regard to human brain imaging studies: respect for individuals and communities, concern for marginalized communities, consent, privacy protections, participatory research designs, contextual integrity, fusions of clinical and research goals, and incidental findings. Each consideration assists in bringing nuance to the potential benefits for open data sharing against associated challenges. We combine current understandings with forward-looking solutions to key issues. We conclude by underscoring the need for new policy tools to enhance the potential for responsible open data.

Recognising values and engaging communities across cultures: towards developing a cultural protocol for researchers.

Efforts to build research capacity and capability in low and middle income countries (LMIC) has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/AIDS, even culturally specific codes for recruiting vulnerable populations such as the San or Maori people. However, the same cannot be said for implementing research in global health. In an effort to build on this work, the Pakistan Institute of Living and Learning and University College London in the UK sought to better understand differences in beliefs, values and norms of local communities in Pakistan. In particular, they have sought to help researchers from high income countries (HIC) understand how their values are perceived and understood by the local indigenous researchers in Pakistan. To achieve this end, a group discussion was organised with indigenous researchers at Pakistan Institute of Living and Learning. The discussion will ultimately help inform the development of a cultural protocol for researchers from HIC engaging with communities in LMIC. This discussion revealed five common themes; (1) religious principles and rules, (2) differing concepts of and moral emphasis on autonomy and privacy, (3) importance of respect and trust; (4) cultural differences (etiquette); (5) custom and tradition (gift giving and hospitality). Based on the above themes, we present a preliminary cultural analysis to raise awareness and to prepare researchers from HIC conducting cross cultural research in Pakistan. This is likely to be particularly relevant in collectivistic cultures where social interconnectedness, family and community is valued above individual autonomy and the self is not considered central to moral thinking. In certain cultures, HIC ideas of individual autonomy, the notion of informed consent may be regarded as a collective family decision. In addition, there may still be acceptance of traditional professional roles such as 'doctor knows best', while respect and privacy may have very different meanings.

Solidarity and Community Engagement in Global Health Research.

Community engagement (CE) is gaining prominence in global health research. A number of ethical goals-spanning the instrumental, intrinsic, and transformative-have been ascribed to CE in global health research. This paper draws attention to an additional transformative value that CE is not typically linked to but that seems very relevant: solidarity. Both are concerned with building relationships and connecting parties that are distant from one another. This paper first argues that furthering solidarity should be recognized as another ethical goal for CE in global health research. It contends that, over time, CE can build the bases of solidaristic relationships-moral imagination, recognition, understanding, empathy-between researchers and community members. Applying concepts from existing accounts of solidarity, the paper develops preliminary ideas about who should be engaged and how to advance solidarity. The proposed approach is compared to current CE practice in global health research. Finally, the paper briefly considers how solidaristic CE could affect how global health research is performed.

Community-Engaged Approaches to Address the Ethical Concerns of Maternal Mental Health Disparities Research.

Participatory research approaches have brought to the forefront the ethical obligations that researchers have towards underserved communities. We describe how a community-academic partnership used community-based participatory research principles and structure to develop a human subjects research protocol and to address the ethical concerns community stakeholders had regarding maternal mental health research with Black women.

Utilizing Community-based Participatory Research Principles in a Safety-Net Hospital to Develop a Research Partnership.

Research at safety-net hospitals may require additional planning to ensure the ethical conduct of research with vulnerable populations. This report discusses application of the principles of community-based participatory research and bioethics to establish a research partnership with a safety-net hospital in the southern U.S.

Translational Research-For the Individual and the Community.

The potential for translational research to improve human health is unprecedented, as the integration of genetic health risks with other data influencing health provides substantial opportunities for improvement. However, how integrating these data sources in a fair, unbiased and appropriate way without reinforcing pre-existing assumptions requires thoughtful implementation. Furthermore, integration of new technologies requires assessment of needs and benefits for the individual balanced with community needs and goals. Thus, examination of values, goals and implicit assumptions through transparent, authentic engagement of individuals and communities is essential.

Framework for Ethical Community Engagement (ECE) with Underserved Populations in the Rural South: A Help for Bioethics and Healthcare Promotion.

Mainstream bioethics has dealt inadequately with issues of race, gender, and class that intersect and shape the life experiences of vulnerable populations in the U.S., such as Black women in the rural South who have faced bioethical and public health challenges throughout U.S. history. They have suffered from health disparities, challenges to their autonomy, inadequate access to quality health care, biomedical violations, and a healthcare system that has implicit bias and discrimination. Thus, we propose a framework for biomedical and behavioral researchers and organizations who seek to engage, ethically, such vulnerable communities. The goal of this Ethical Community Engagement (ECE) framework is to empower communities, respect autonomy, and address needs of populations that suffer from health disparities. The Tuskegee/Macon County Diabetes Coalition, formed to coordinate and share information promoting healthy living and habits among citizens of this area, is a demonstration of this ECE framework.

Trust, Conflict, and Engagement in Occupational Health: North American Epidemiologists Conduct Occupational Study in Communities Affected by Chronic Kidney Disease of Unknown Origin (CKDu).

PURPOSE OF REVIEW: Science has been used as a tool of colonialism, and aspects of science privilege researchers in the global North (USA and Europe). The environmental justice and worker health movements in the USA and globally have influenced aspects of how occupational and environmental health research is conceived and conducted so that it is more equitable. This review provides a case example of research in the area of chronic kidney disease of unknown origin (CKDu). RECENT FINDINGS: In the present work, the author describes aspects of community-based participatory research and anti-colonial research that influence a current occupational epidemiology study of CKDu in Mesoamerica among workers in agriculture and non-agricultural industries. The research includes investigators from numerous countries in the global North and South and funding from the US government and corporations. The role of industry in science and the misuse of science by corporate interests remain substantial threats to research integrity. The ability of researchers to navigate potentially conflicting interests with industry and workers, and establish trust within and outside the scientific community, is essential for sustained engagement in longitudinal studies. Trust is about human relationships. It takes time and effort to build and is essential for creating equitable, empowering research relationships.

Tygerberg Research Ubuntu-Inspired Community Engagement Model: Integrating Community Engagement into Genomic Biobanking.

Introduction: Community engagement (CE) is an ethical imperative in research, but the knowledge base for what constitutes effective and ethically sound CE is limited. Ubuntu, as a component of responsive communitarianism where communal welfare is valued together with individual autonomy, is useful in furthering our understanding of effective CE and how it could best be achieved. Similarly, a relative solidarity model serves as a compromise between extreme individualism and extreme communalism and is more appropriate in a heterogenous African context. Approaching CE from an Ubuntu philosophical perspective in southern Africa is particularly important in genomic biobanking, given the implications for individuals, families, and communities. Discussion: CE is often implemented in a tokenistic manner as an ancillary component of research. Understanding consent information is challenging where genomic biobanking is concerned due to scientific complexity. We started a process of CE around genomic biobanking and conducted empirical research in an attempt to develop a model to promote effective and ethically sound CE, using relative solidarity to create a nuanced application of Ubuntu. The TRUCE model is an eight-step model that uses social mapping to identify potential communities, establishes the scope of CE, and requires that communities are approached early. Co-creation strategies for CE are encouraged and co-ownership of knowledge production is emphasized. Recruiting and engaging communities at each stage of research is necessary. Evaluation and adaptation of CE strategies are included. Discussion and dissemination of results after the research is completed are encouraged. Conclusions: There is a significant gap between the theory of CE and its authentic application to research in Africa. This Ubuntu-inspired model facilitates bridging that gap and is particularly suited to genomic biobanking. The CE model enhances and complements the consent process and should be integrated into research as a funding and regulatory requirement where applicable.

Best practice principles for research with Aboriginal and Torres Strait Islander communities in action: Case study of a safe infant sleep strategy.

BACKGROUND: Approaches to health promotion that are collaborative, support strengths inherent in Aboriginal and Torres Strait Islander culture, and demonstrate respect and understanding for individual communities, have achieved the most positive outcomes to date. AIM: To illustrate how the implementation and evaluation of a safe infant sleep health promotion strategy was facilitated by embedding recognised best practice principles for the conduct of research with Aboriginal and Torres Strait Islander peoples and communities. METHODS: The Pepi-Pod® Program was introduced across rural, remote and metropolitan locations in Queensland between 2013 and 2017. This case study discusses the partnership between the Pepi-Pod® Program and one community-controlled maternal and child health service that employed an Aboriginal Health Worker led model of maternal and child health care for remote regions of Queensland. FINDINGS: Best practice principles were embedded within the program design and adaptation, and in the approach to community consultation prior to program implementation. Collaborative partnerships based on trust, which established stakeholder expectations through transparent communication processes, together with effective engagement in achieving program goals, led to the implementation of this evidence-based health promotion initiative as intended. Consideration for locally relevant and culturally competent program delivery was key to success. The integrity of the program was maintained and embedded into ongoing service delivery. CONCLUSIONS: Through adherence to best practice principles for research with Aboriginal and Torres Strait Islander communities, implementation and evaluation of health promotion programs can be conducted in mutually acceptable, feasible and sustainable ways that develop capacity within participating health services.

Experiences from a community advisory Board in the Implementation of early access to ART for all in Eswatini: a qualitative study.

BACKGROUND: Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards (CABs) is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini (formerly known as Swaziland), which was implemented as part of the MaxART Early Access to ART for All study. METHODS: Trained Swazi research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. RESULTS: The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: (1) promoting ethical conduct, in particular privacy, consent and confidentiality; (2) communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and (3) liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. CONCLUSION: The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning.

Ethical Challenges in Participatory Research With Autistic Adults in Israel.

Contemporary calls for participatory research raise unique ethical questions. Our semi-participatory mixed-methodology study of the needs of autistic adults in Israel utilized an advisory committee of autistic persons. This article discusses three fundamental ethical issues that emerged in the study. First, employing formal diagnosis and legal guardian approval as inclusion criteria may result in the unjust exclusion of self-diagnosed autistics and those who are cognitively able to consent and participate. Second, adopting a participatory research approach does not in itself guarantee participatory justice; the representation of diverse groups from the community must be ensured. Finally, regarding autism spectrum disorder (ASD) as a medical diagnosis requires indisputable confidentiality which may conflict with the personal choice to waive anonymity and be recognized by name. Researchers and ethical committees should take these ethical challenges into account when conducting and reviewing studies with and about autistic adults.

Beyond the Belmont Principles: A Community-Based Approach to Developing an Indigenous Ethics Model and Curriculum for Training Health Researchers Working with American Indian and Alaska Native Communities.

Individuals responsible for carrying out research within their diverse communities experience a critical need for research ethics training materials that align with community values. To improve the capacity to meet local human subject protections, we created the research Ethics Training for Health in Indigenous Communities (rETHICS), a training curriculum aligned within American Indian and Alaska Native (AI/AN) context, culture, and community-level ethical values and principles. Beginning with the Belmont Report and the Common Rule that defines research with human subjects (46 CFR 45), the authors convened three different expert panels (N = 37) to identify Indigenous research values and principles common across tribal communities. The resulting culturally grounded curriculum was then tested with 48 AI/AN individuals, 39 who also had recorded debriefing interviews. Using a thematic analysis, we coded the qualitative feedback from the expert panel discussions and the participant debriefings to assess content validity. Participants identified five foundational constructs needed to ensure cultural-grounding of the AI/AN-specific research training curriculum. These included ensuring that the module was: (a) framed within an AI/AN historical context; (b) reflected Indigenous moral values; (c) specifically linked AI/AN cultural considerations to ethical procedures; (d) contributed to a growing Indigenous ethics; and (e) provided Indigenous-based ethics tools for decision making. Using community-based consultation and feedback from participants led to a culturally grounded training curriculum that teaches research ethical principles and procedures for conducting research with AI/ANs. The curriculum is available for free and the community-based process used can be adapted for other cultural groups.

Informed consent and community engagement in open field research: lessons for gene drive science.

BACKGROUND: The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. DISCUSSION: In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. CONCLUSIONS: While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.