Building Diverse Mentoring Networks that Transcend Boundaries in Cancer Research.

Scientists at all career stages can benefit from building diverse mentoring networks that transcend boundaries and promote inclusion. In this piece, we define mentoring networks, describe examples of how mentoring networks can reinforce scientific identity, and help minority scientists overcome unique challenges to achieve their goals in cancer research.

Fostering Radiation Oncology Physician Scientist Trainees Within a Diverse Workforce: The Radiation Oncology Research Scholar Track.

There is a need to foster future generations of radiation oncology physician scientists, but the number of radiation oncologists with sufficient education, training, and funding to make transformative discoveries is relatively small. A large number of MD/PhD graduates have entered he field of radiation oncology over the past 2 decades, but this has not led to a significant cohort of externally funded physician scientists. Because radiation oncologists leading independent research labs have the potential to make transformative discoveries that advance our field and positively affect patients with cancer, we created the Duke Radiation Oncology Research Scholar (RORS) Program. In crafting this program, we sought to eliminate barriers preventing radiation oncology trainees from becoming independent physician scientists. The RORS program integrates the existing American Board of Radiology Holman Pathway with a 2-year post-graduate medical education instructor position with 80% research effort at the same institution. We use a separate match for RORS and traditional residency pathways, which we hope will increase the diversity of our residency program. Since the inception of the RORS program, we have matched 2 trainees into our program. We encourage other radiation oncology residency programs at peer institutions to consider this training pathway as a means to foster the development of independent physician scientists and a diverse workforce in radiation oncology.

Good Financial Practice and Clinical Research Coordinator Responsibilities.

OBJECTIVES: To describe clinical research billing pitfalls and good financial practices the research nurse coordinator can implement to decrease billing errors in clinical practice. DATA SOURCES: Government websites, published articles, and the author's expertise in national/international research studies. CONCLUSION: Clinical research billing is a risky business. It involves many steps in the process and requires good communication among all key stakeholders. The clinical research coordinator is the key team player to facilitate good financial practices for research billing. Creating and applying standards, cross-functional transparent communication, and effective processes across the organization can help to increase billing compliance and decreases billing risk to the organization. IMPLICATIONS FOR NURSING PRACTICE: The research billing process is a critical component of clinical research. However, billing in the process of generating evidence to inform clinical practice is not included in the core competencies in nursing curriculum. As such, in the real world many nurses grapple with taking on the new role of being a clinical research coordinator. Developing knowledge and understanding about the potential billing pitfalls and good financial practices can support clinical research nurses to decrease billing errors and exposure to risk.

US Food and Drug Administration Clinical Investigator Inspections.

OBJECTIVE: To review the US Food and Drug Administration (FDA) Bioresearch Monitoring clinical investigator inspection process from start to final classification to support clinical research nurses in practice. DATA SOURCES: Published articles, websites, and author's expertise with FDA inspections. CONCLUSION: Clinical research nurses should conduct and manage every clinical trial as if it were to be inspected by the FDA. This recommendation is considered best practice for clinical research nurses to prevent last-minute preparations to organize and clean up research data and records retrospectively. IMPLICATIONS FOR NURSING PRACTICE: This article will assist the oncology research nurse and interdisciplinary research members at the research site in the preparedness for an FDA inspection.

Perspectives of Oncology Nursing and Investigational Pharmacy in Oncology Research.

OBJECTIVES: This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process. DATA SOURCES: Government regulations, professional guidelines, and best practices. CONCLUSION: ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse's role in the process of clinical trial ID management is dependent on each institution's expectations of clinical research nurses and the scope of their role. IMPLICATIONS FOR NURSING PRACTICE: Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse's involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research.

Risks at the Intersection of Research and Oncology Nursing.

OBJECTIVES: To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe patient care and study data integrity. DATA SOURCES: Textbooks, journal publications, federal regulations, US Food and Drug Administration documents, clinical practice guidelines. CONCLUSION: The immune system, genetics, and molecular pathology are not new in the context of oncology treatments. The reliability and clinical validation of in vitro diagnostic medical devices is, however, becoming increasingly more important in the development of marker driven targeted therapies, immunotherapy, and adoptive T-cell transfer. Protecting patients and preserving the integrity of clinical trials is of utmost importance. IMPLICATIONS FOR NURSING PRACTICE: The role and scope of oncology and research nurses will intersect and shift as clinical care continues to involve high-acuity patients who participate in complex in vitro diagnostic and therapeutics clinical trials. The expertise of oncology nurses may vary in skills and knowledge domain; however, all scopes of practice are underpinned by the nursing code of ethics to ensure accountability for all aspects of patient care.

Navegando em águas raras: notas de uma pesquisa com famílias de crianças e adolescentes vivendo com doenças raras / Navigating in rare oceans: notes from a family survey of children and adolescents living with rare diseases

Resumo No presente artigo, procura-se evidenciar a construção da navegação social em um hospital. O enfoque dado privilegiou os bastidores da aplicação de um questionário quantitativo sobre os custos da família com os cuidados/tratamento de seu(sua) filho(a) com doença rara. Permeando a descrição desses processos estão os marcadores de gênero, raça e geração de um dos autores deste artigo. A interação entre pesquisador e sujeitos da pesquisa em campo é socialmente construída, conforme as circunstâncias específicas que demarcam o convite para participar da pesquisa, bem como a coleta de dados, por isso o lugar que ocupa e a postura ética precisam estar bem definidos e claros para o pesquisador. O exercício metodológico e ético de construção desta navegação social com a instituição hospitalar e os sujeitos pesquisados foi permeada por dificuldade e incertezas, mas também por surpresas e aprendizados. Foi possível observar características marcantes da instituição, de seus funcionários e das famílias entrevistadas e, avaliar as estratégias metodológicas utilizadas.

Abstract This article seeks to highlight the construction of social navigation in a hospital. Our focus is to reflect on scenes of application of a questionnaire on family costs of care/treatment of children with rare diseases. These processes are linked to the markers of gender, race, and generation of one of the authors. The interaction between researcher and subjects of field research is socially constructed according to the specific circumstances that demarcate the invitation to participate in the research, as well as data collection. It implies that his position as a researcher and the ethical perspective need to be well defined. The approach and ethics build this social navigation with the hospital and the subjects are permeated by difficulty and uncertainty, but also by surprises and learning. It was possible to observe remarkable characteristics of the institution, of their employees and the families, to evaluate the used methodological strategies.

Os desafios éticos da Razão Empreendedora / The ethical challenges of Entrepreneurial Logic

Resumo O texto apresenta e discute os novos personagens que têm crescente presença no ambiente de pesquisa, quais sejam o pesquisador empreendedor e a universidade empreendedora. Discute ainda o cenário atual da difusão de conhecimento científico que apresenta crescentes problemas, com dificuldade de publicação de resultados e dificuldades de acesso a resultados de pesquisa publicados. Discute também o significado da estratégia da pesquisa translacional e apresenta e discute alguns desafios éticos relevantes que resultam da reorganização das relações entre ciência e negócio. Em particular trata dos conflitos de interesse e dos resultados da supercompetição entre cientistas e instituições em um cenário de encurtamento de apoio financeiro público à ciência.

Abstract The paper introduces and discusses the new players that now have a growing presence on the research scene, namely the entrepreneurial researcher and the entrepreneurial university. It also discusses the current scenario of the diffusion of scientific knowledge that presents increasing problems, with difficulty in publishing results and difficulties in accessing the results of published research. It also discusses the implications of the strategy of translational research and presents and discusses some relevant ethical challenges that result from the reorganization of the relationship between science and business. In particular, it deals with conflicts of interest and the results of excessive competition between scientists and institutions in a scenario of diminished public financial support for science.

A Razão Empreendedora na pesquisa em saúde / Entrepreneurial Logic in health research

Resumo Discute-se a reorganização das relações entre a produção científica e as inovações produtivas a partir do quarto final do século XX cuja expressão mais geral foi uma intensa aproximação espaço-temporal entre essas duas atividades. O setor de saúde humana foi um dos setores onde essa aproximação ocorreu com grande intensidade e o texto discute algumas bases conceituais importantes nesse processo, trazendo as contribuições de Gibbons, Stokes e Lundvall-Freeman, bem como as de Merton, Kuhn e Bourdieu no que se refere à organização do trabalho científico. Aponta e discute três processos derivados dessa reorganização, quais sejam a erosão do conceito do conhecimento científico como um bem público, a difusão de um personagem denominado 'pesquisador empreendedor' e o aparecimento da estratégia da pesquisa translacional.

Abstract The scope of this paper is a discussion of the transformative relationship between scientific research and productive innovation, which occurred from the final quarter of the twentieth century onwards. The main characteristic of the phenomenon was an intense space-time approximation of the two activities. The human health sector has been one of the main fields where that approximation was most markedly observed. Some major conceptual bases of the reorganization are discussed, and the text examines works by Gibbons, Stokes and Lundvall-Freeman, as well as Merton, Kuhn and Bourdieu with respect to the organization of the scientific work. The paper highlights and discusses three aspects that arose from the new configuration, namely the erosion of the well-established concept of scientific knowledge as a public good, the appearance of the individual referred to as the 'entrepreneurial researcher' and the emergence of the strategy of translational research in health.

A Razão Empreendedora na pesquisa em saúde / Entrepreneurial Logic in health research

Resumo Discute-se a reorganização das relações entre a produção científica e as inovações produtivas a partir do quarto final do século XX cuja expressão mais geral foi uma intensa aproximação espaço-temporal entre essas duas atividades. O setor de saúde humana foi um dos setores onde essa aproximação ocorreu com grande intensidade e o texto discute algumas bases conceituais importantes nesse processo, trazendo as contribuições de Gibbons, Stokes e Lundvall-Freeman, bem como as de Merton, Kuhn e Bourdieu no que se refere à organização do trabalho científico. Aponta e discute três processos derivados dessa reorganização, quais sejam a erosão do conceito do conhecimento científico como um bem público, a difusão de um personagem denominado 'pesquisador empreendedor' e o aparecimento da estratégia da pesquisa translacional.

Abstract The scope of this paper is a discussion of the transformative relationship between scientific research and productive innovation, which occurred from the final quarter of the twentieth century onwards. The main characteristic of the phenomenon was an intense space-time approximation of the two activities. The human health sector has been one of the main fields where that approximation was most markedly observed. Some major conceptual bases of the reorganization are discussed, and the text examines works by Gibbons, Stokes and Lundvall-Freeman, as well as Merton, Kuhn and Bourdieu with respect to the organization of the scientific work. The paper highlights and discusses three aspects that arose from the new configuration, namely the erosion of the well-established concept of scientific knowledge as a public good, the appearance of the individual referred to as the 'entrepreneurial researcher' and the emergence of the strategy of translational research in health.

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

Towards post-colonial capacity-building methodologies - some remarks on the experiences of health researchers from Mozambique and Angola / Em torno de metodologias de capacitação pós-coloniais: algumas notas acerca das experiências de pesquisadores de saúde de Moçambique e Angola

Abstract This paper analyzes capacity building in practice, addressing the expectations, imaginaries and experiences of health researchers from Mozambique and Angola. The empirical data stems from the Erasmus+ funded project "University Development and Innovation - Africa (UDI-A)", a consortium established between European and African institutions to promote the mobility and empowerment of African academics, the establishment of North/South research partnerships and the strengthening of African institutions. Through qualitative research methods - semi-structured interviews and a focus group with African participants, and participant observation - this article analyzes the experiences of African academics working in the health field, their perceptions of capacity building and aspirations during their stay in Portugal in 2018. By addressing some of their concerns and achievements, this paper reflects on the performativity of capacity building methodologies, exploring a wide range of issues that emerge within the framework of North/South partnerships, inquiring whether it would be possible to decolonize capacity-building methodologies.

Resumo Este artigo analisa dispositivos de capacitação na prática, explorando as expetativas, os imaginários e as experiências de pesquisadores de saúde de Moçambique e Angola. Os dados empíricos resultam do projeto "University Development and Innovation - Africa (UDI-A)", financiado pelo programa Erasmus+, um consórcio estabelecido entre instituições europeias e africanas para promover a mobilidade e a capacitação de académicos africanos, o estabelecimento de parcerias de investigação Norte/Sul e o fortalecimento das instituições africanas. Através de metodologias qualitativas - entrevistas semiestruturadas e grupos de discussão com participantes africanos, e observação participante - este artigo analisa as experiências de académicos africanos trabalhando no setor da saúde, as suas perceções da capacitação e as suas ambições durante a estadia em Portugal em 2018. Através da análise das suas preocupações e sucessos, este artigo reflete acerca da performatividade das metodologias de capacitação, explorando um vasto leque de tópicos que emergem no contexto das parcerias Norte/Sul, questionando a possibilidade de uma descolonização das metodologias de capacitação.

[Turn-over of non-tenured public health research personnel in an Italian public research institute (IRCCS).] / Il turn-over del personale con contratti di lavoro flessibili o borse di studio dedicato alla ricerca sanitaria in un IRCCS pubblico italiano.

BACKGROUND: The objective is to show variations in the number of non-tenured personnel (NTP) in a public health research centre (IRCCS) between 30th June 2016 and 31st December 2017. In this time interval, the issue of NTP was at the centre of governmental discussions. METHODS: Data collection was performed from CVs and scientific publications of NTP working at the Fondazione IRCCS Istituto Nazionale dei Tumori (INT). We compared the characteristics of NTP entering or leaving INT and those of NTP who remained in the considered time interval. RESULTS: NTP in INT counted 465 members of staff at 30th June 2016 and 472 at 31st December 2017. 75% of these works in the research. 26% of NTP left INT and their position resulted entirely substituted by other NTP. NTP staff who left are mainly aged under 40 and show fewer publications than those who stayed. Newly acquired NTP are younger and show a fewer number of publications compared to the personnel who left. CONCLUSIONS: 1 out of 4 NTP members of staff moved to a new job during a period in which the uncertain future of NTP research staff was under the spotlight. It appears that IRCCS are progressively being identified as suitable for hands-on, post university internships from which researchers would then choose to move, in search of a new job in public or private centres, with a consequent decline of IRCCS' role in health research.