"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.

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

BACKGROUND: Researchers 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. METHODS: It 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. RESULTS: Of 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. CONCLUSION: The 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.

Construção e aplicabilidade de um termo de assentimento em pesquisa em nutrição com crianças hospitalizadas em tratamento oncológico / Construction and applicability of a term of consent in nutrition research with children hospitalized for oncological treatment

Objetivo: relatar a experiência na construção e aplicabilidade de um termo de assentimento livre esclarecido em uma pesquisa com crianças pré-escolares e escolares hospitalizadas para tratamento oncológico. Material e método: trata-se de um relato de experiência sobre a construção e aplicabilidade de um Termo de Assentimento Livre e Esclarecido lúdico para realização de um estudo sobre perfil nutricional e educação alimentar e nutricional de crianças em tratamento oncológico de um hospital público infantil em Santa Catarina-Brasil. Resultados: a construção e aplicabilidade do Termo de Assentimento Livre Esclarecido permitiu melhor compreensão da criança anterior à realização da pesquisa referente às etapas e fases da coleta dos dados do estudo, assim como os riscos e benefícios do mesmo. Foi possível à criança esclarecer suas dúvidas e participar ativamente do estudo. Foram convidadas para participar do estudo 13 crianças de ambos os sexos entre 5 ­ 12 anos de idade que estavam internadas no ambulatório de oncologia. Considerações Finais: adoção do Termo de Assentimento Livre Esclarecido Lúdico construído mostrou-se efetivo ao alcance do objetivo de sua utilização no contexto ético em pesquisa e avançou no sentido de despertar sobre potencialidade para além da pesquisa e, também, como recurso fundamental para o assentimento das crianças em situações específicas no processo de adoecimento e internação, possibilitando o exercício de direito e compreensão do que está sendo realizado durante seu tratamento.

Objective: report the experience in the construction and applicability of an informed term of consent in a survey of children hospitalized for cancer treatment. Material and method: experience report on the construction and applicability of a free and informed term of consent for conducting a study on the nutritional profile and food and nutrition education of children and adolescents undergoing cancer treatment at a public hospital in Santa Catarina, Brazil. Results: the construction and applicability of the informed term of consent allowed a better understanding of the child prior to conducting the research regarding the steps and phases of data collection, as well as its risks and benefits. It was possible for the child to clarify their doubts and actively participate in the study. Thirteen children of both sexes, aged between 5 - 12 years, hospitalized and in the oncology outpatient clinic, were invited to participate. Final considerations: adoption of the playful free and informed term of consent proved to be effective in reaching the objective of its use in the ethical research context and it has advanced in the sense of raising awareness of the potentiality beyond research, and also as a fundamental resource for the consent of children in specific situations in the illness and hospitalization process, enabling them to exercise their rights and understand what is happening during their treatment.

Anti-Asian American Racism: A Wake-Up Call for Population-Based Cancer Research.

Since the start of the COVID-19 pandemic, Asian Americans have been subjected to rising overt discrimination and violent hate crimes, highlighting the health implications of racism toward Asian Americans. As Asian Americans are the only group for whom cancer is the leading cause of death, these manifestations of anti-Asian racism provoke the question of the impact of racism across the cancer continuum for Asian Americans. In this Commentary, we describe how the myth of the "model minority" overlooks the diversity of Asian Americans. Ignoring such diversity in sociocultural trends, immigration patterns, socioeconomic status, health behaviors, and barriers to care masks disparities in cancer risk, access to care, and outcomes across Asian American populations. We recommend cancer epidemiologists, population science researchers, and oncology providers direct attention toward: (i) studying the impacts of structural and personally mediated racism on cancer risk and outcomes; (ii) ensuring studies reflect the uniqueness of individual ethnic groups, including intersectionality, and uncover underlying disparities; and (iii) applying a critical race theory approach that considers the unique lived experiences of each group. A more nuanced understanding of cancer health disparities, and how drivers of these disparities are associated with race and differ across Asian American ethnicities, may elucidate means through which these disparities can be alleviated.

Looking back on a life of unacknowledged privilege and a call to action.

The year 2020 provided a wake-up call about the role systemic racism plays in shaping our nation and shaping science. While hard work and great mentors helped bring me a long way from a farm in Minnesota, it's become much clearer that the privilege of being white and male and the accumulated advantages that began there played powerful roles. It's time for white scientists like me to listen, think, and take action.

Assessment of research ethics education offerings of pharmacy master programs in an Arab nation relative to top programs worldwide: A qualitative content analysis.

The importance of research ethics (RE) training has led academic and funding institutions to require that students, trainees, and faculty obtain such training at various stages of their careers. Despite the increasing awareness of the value RE education offers, this training requirement is absent in Jordan. We aimed to assess RE education offerings of pharmacy master programs in Jordan and compare with the top-ranked pharmacy graduate programs globally. Therefore, a list of universities that offer research-based pharmacy master programs was created. Each program was evaluated for the inclusion of RE education. A qualitative content analysis approach based on inductive reasoning and latent analysis was followed to analyze the data. Results of the study showed a lack of appropriate RE education for graduate-level pharmacy programs in Jordan with only 40% of the programs partially discuss selected topics related to RE. Regarding pharmacy graduate programs globally, 10% offer a standalone RE course, 40% offer some discussions related to RE, another 10% do not offer RE education in any form, and the remaining 40% of the programs were difficult to assess due to lack of sufficient information available online. Based on the findings of this study, training in RE is tends to be lacking in pharmacy graduate programs in Jordan and globally, with a greater lack in Jordan than globally. There is a need to incorporate formal RE education into programs that do not offer this type of instruction. Programs that formally touch on some aspects of RE need to expand the scope of topics to include more RE-related themes. Integrating a standalone RE course into pharmacy graduate programs is highly encouraged.

Collecting and characterizing existing and freely accessible research integrity educational resources.

In addition to effective training practices, well-structured educational resources are important for developing successful research integrity training programs. A considerable amount of educational material has been developed in the last years, but there is a necessity to find better ways to assess and categorize the already existing resources. We collected 237 freely available online RI educational resources with the aim to describe them in as much detail as possible using a set of well-defined criteria. We developed a grid that gives a full description, based on our 21 criteria, for each collected resource. Mainly videos and online RI training are present in our collection. Worldwide, resources are mainly from the US, whereas in Europe mainly from the UK. In the majority of the cases, the educational resources are not customized, presenting the big three (falsification, fabrication, and plagiarism) as the most addressed topics. Making RI educational resources easily accessible might help to increase awareness about the topic. Moreover, the characterization we provide might help researchers and students to deal with daily RI-related issues, to look for the right tool at the right time, and might help institutions and trainers to develop new trainings without the need to develop new tools.Abbreviations: CITI: Collaborative Institutional Training Initiative; COPE: Committee on Publication Ethics; ENERI: European Network of Research Ethics and Research Integrity; ENRIO: the European Network of Research Integrity Offices; EU: European Union; NIH: National Institutes of Health; NSF: National Science Foundation; NRIN: the Netherlands Research Integrity Network; ORI: the Office of Research Integrity; PPT: powerpoint; QRP: questionable research practice; RI: research integrity; RCR: responsible conduct of research.

Deliberaciones éticas ante investigaciones en el área de educación: a propósito de un caso / Ethical deliberations about research in the area of education: about a case

Un equipo investigador liderado por el primer autor de este artículo propuso traducir al español, adaptar transculturalmente y validar un cuestionario para evaluar la competencia de quienes ejercen mentoría en investigación. Dado que no se trataba de una investigación clínica, en un principio, el equipo investigador le restó importancia a la deliberación ética, asumiendo que este tipo de investigación podría estar exceptuada de ser evaluada por un Comité Independiente de Ética. Sin embargo, luego de revisar la bibliografía especializada y de varias sesiones de discusión con expertos en ética de la investigación, la opinión del equipo fue cambiando. Este artículo pretende compartir esta experiencia deliberativa con todo equipo involucrado en investigaciones en educación. (AU)

A research team led by the first author of this article proposed to translate into Spanish, adapt cross-culturally and validate a questionnaire to assess the competence of those who do research mentoring. Since it was not a clinical investigation, initially, the research team downplayed ethical deliberation, assuming that this type of research could be exempted from being evaluated by an Independent Ethics Committee. However, after reviewing the specialized literature and several discussion sessions with experts in research ethics, the opinion of the team changed. This article aims to share this deliberative experience with any team involved in education research. (AU)

Evolution of research ethics in a low resource setting: A case for Uganda.

BACKGROUND: The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. METHODS: This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. RESULTS: Modern medicine evolved from 1896 and by the time of Uganda's independence in 1962, a 1500 bed national referral hospital was in place and a fully-fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. CONCLUSION: Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes.

Research ethics in inter- and multi-disciplinary teams: Differences in disciplinary interpretations.

As research teams are increasingly comprised of members from multiple disciplines, ranging from the physical sciences, life sciences, social and behavioral sciences to the arts and humanities, it is important to revisit how research is conducted at several levels. Coupled with the national concern over rigor and reproducibility in research, it is therefore crucial to ensure that all members of such multidisciplinary teams view the need for ethics in the conduct of research in similar ways. Towards this end, Wayne State University developed a course in the Responsible Conduct of Research (RCR) which was mandatory for all its 1500 doctoral students across all disciplines in its 75 PhD programs. We found that student perceptions of the validity, applicability and usefulness of the course varied by discipline. This was in spite of iterative changes made to the course by faculty in those disciplines to make the content palatable to all. The findings show that more work needs to be done to fully incorporate the needs of social sciences and humanities disciplines in a comprehensive university course. This is especially important as these students become members of large multidisciplinary research teams in order to uphold the highest levels of rigor, reproducibility and ethics.

Ethics for Laboratory Medicine.

BACKGROUND: Laboratory medicine, like other areas of medicine, is obliged to adhere to high ethical standards. There are particular ethical issues that are unique to laboratory medicine and other areas in which ethical issues uniquely impact laboratory practice. Despite this, there is variability in ethics education within the profession. This review provides a foundation for the study of ethics within laboratory medicine. CONTENT: The Belmont Report identifies 3 core principles in biomedical ethics: respect for persons (including autonomy), beneficence (and its corollary nonmalfeasance), and justice. These core principles must be adhered to in laboratory medicine. Informed consent is vital to maintain patient autonomy. However, balancing patient autonomy with the desire for beneficence can sometimes be difficult when patients refuse testing or treatment. The use of leftover or banked samples is fundamental to the ability to do research, create reference intervals, and develop new tests, but it creates problems with consent. Advances in genetic testing have created unique ethical issues regarding privacy, incidental findings, and informed consent. As in other professions, the emergence of highly contagious and deadly infectious diseases poses a difficult ethical dilemma of helping patients while protecting healthcare workers. CONCLUSIONS: Although many clinical laboratorians do not see or treat patients, they must be held accountable to the highest ethical and professional behavior. Recognition and understanding of ethical issues are essential to ethical practice of laboratory medicine.

[Training PhD students in ethics and research integrity in France in 2018]. / Formation à l'éthique et à l'intégrité scientifique au sein des écoles doctorales françaises - Un premier état des lieux en 2018.

Since 2016, the national framework for doctoral studies in France states that doctoral schools from the French universities should ensure that every doctoral student receives a training in research ethics and integrity. The doctoral schools can organize the training at their convenience. We have conducted a study among all French doctoral schools about the modalities of this training in 2018. Our inquiry shows that the doctoral schools are well engaged in this effort of training on the whole territory, and are on the verge of reinforcing it. Overall, our inquiry shows a general awareness by the doctoral schools of the importance of these topics for tomorrow research.

Empowering Graduate Students to Address Ethics in Research Environments.

In this article, we present an educational intervention that embeds ethics education within research laboratories. This structure is designed to assist students in addressing ethical challenges in a more informed way, and to improve the overall ethical culture of research environments. The project seeks (a) to identify factors that students and researchers consider relevant to ethical conduct in science, technology, engineering, and math (STEM) and (b) to promote the cultivation of an ethical culture in experimental laboratories by integrating research stakeholders in a bottom-up approach to developing context-specific, ethics-based guidelines. An important assumption behind this approach is that direct involvement in the process of developing laboratory specific ethical guidelines will positively influence researchers' understanding of ethical research and practice issues, their handling of these issues, and the promotion of an ethical culture in the respective laboratory. The active involvement may increase the sense of ownership and integration of further discussion on these important topics. Based on the project experiences, the project team seeks to develop a module involving the bottom-up building of codes-of-ethics-based guidelines that can be used by a broad range of institutions and that will be distributed widely.

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.

Recommendations for Effective Integration of Ethics and Responsible Conduct of Research (E/RCR) Education into Course-Based Undergraduate Research Experiences: A Meeting Report.

Advancement of the scientific enterprise relies on individuals conducting research in an ethical and responsible manner. Educating emergent scholars in the principles of ethics/responsible conduct of research (E/RCR) is therefore critical to ensuring such advancement. The recent impetus to include authentic research opportunities as part of the undergraduate curriculum, via course-based undergraduate research experiences (CUREs), has been shown to increase cognitive and noncognitive student outcomes. Because of these important benefits, CUREs are becoming more common and often constitute the first research experience for many students. However, despite the importance of E/RCR in the research process, we know of few efforts to incorporate E/RCR education into CUREs. The Ethics Network for Course-based Opportunities in Undergraduate Research (ENCOUR) was created to address this concern and promote the integration of E/RCR within CUREs in the biological sciences and related disciplines. During the inaugural ENCOUR meeting, a four-pronged approach was used to develop guidelines for the effective integration of E/RCR in CUREs. This approach included: 1) defining appropriate student learning objectives; 2) identifying relevant curriculum; 3) identifying relevant assessments; and 4) defining key aspects of professional development for CURE facilitators. Meeting outcomes, including the aforementioned E/RCR guidelines, are described herein.