Now is the time to fix the clinical research workforce crisis.

The clinical and translational research enterprise is recognized by many as the "evidence generation system." While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the "engine" of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even "business as usual" is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that's in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie.

How can community engagement in health research be strengthened for infectious disease outbreaks in Sub-Saharan Africa? A scoping review of the literature.

BACKGROUND: Community engagement (CE) is a well-established practical and scholarly field, recognised as core to the science and ethics of health research, for which researchers and practitioners have increasingly asked questions about desired standards and evaluation. In infectious disease outbreak contexts, questions may be more complex. However, it is unclear what body of knowledge has been developed for CE specifically as it applies to emerging infectious diseases. This scoping review seeks to describe (1) How CE has been conceptualised and understood; and (2) What conclusions have research teams reached on the effectiveness of CE in these settings, including challenges and facilitators. METHODS: We used a scoping review framework by Arksey and O'Malley (Int J Soc Res Methodol 8:19-32, 2005) to structure our review. We conducted a brainstorming session and initial trial search to inform the protocol, search terms, and strategy. Three researchers discussed, developed and applied agreed screening tools and selection criteria to the final search results. Five researchers used the screening tools to screen abstracts and full text for inclusion by consensus. Additional publications were sought from references of retrieved publications and an expert call for literature. We analysed and reported emerging themes qualitatively. RESULTS: We included 59 papers from a total of 722 articles derived from our trial and final literature searches, as well as a process of "citation chasing" and an expert call for grey literature. The core material related exclusively to health research trials during the 2014-2016 West Africa Ebola outbreak. We synthesized reports on components of effectiveness of CE to identify and propose three themes as essential elements of effective CE. CONCLUSIONS: While there is a large volume of literature documenting CE activities in infectious disease research settings generally, there are few accounts of effectiveness dimensions of CE. Our review proposes three themes to facilitate the effectiveness of CE initiatives as essential elements of CE activities in infectious diseases studies: (1) Communication towards building collaborative relationships; (2) Producing contextual knowledge; and (3) Learning lessons over time. As there were relatively few in-depth accounts of CE from our literature review, documentation and accounts of CE used in health research should be prioritised.

The transformative effects of a participatory social empowerment intervention in the MAISHA intimate partner violence trial in Tanzania.

Intimate partner violence is an important public health problem, with far-reaching consequences for women's physical and emotional health and social well-being. There is evidence that intimate partner violence is preventable. The MAISHA study, a randomised controlled trial of the impact of a gender training intervention on intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence. As part of the study, a sample of women participated in longitudinal qualitative enquiry. To better understand the processes of change associated with intimate partner violence prevention, we explored narratives from in-depth interviews and focus group discussions with women who had participated in the training. The study drew on feminist political theory on agency and change, which we sought to understand in a setting with high rates of intimate partner violence that a standalone intervention was unlikely to change. The study found that gender training, which seeks to develop political consciousness and transformation, can promote a sense of efficacy amongst participants who feel validated through the collective learning process. Important yet under examined cognitive elements of change processes deserve more attention in the design, delivery and evaluation of violence prevention gender training.

Perceptions around COVID-19 among patients and community members in urban areas in Cameroon: A qualitative perspective.

At the onset of the COVID-19 pandemic, the Cameroonian government, to abide by international regulations, prescribed preventive measures, which affected many aspects of social, political, economic, and cultural life. However, there needs to be more in-depth exploration of how communities in Cameroon perceived and were impacted by COVID-19. We explored perceptions and misconceptions concerning COVID-19's impact on urban communities' daily lives in Cameroon. We conducted semi-structured interviews and focus group discussions with a heterogeneous sample of 25 participants from five different social categories (health personnel, patients with a confirmed COVID-19 infection, close contacts of patients, community members, and community leaders) to assess their perceptions of the disease. Interviews and FGDs were recorded, fully transcribed, coded manually, and analyzed using a thematic analysis iterative coding process. Three main themes were identified: 1) Knowledge of COVID-19: antagonism between disease and invention, 2) Barrier measures imposed by the "dominant culture," and 3) Impact of COVID-19 on daily lives. Our study revealed perceptions around general knowledge of the COVID-19 pandemic, noting acceptance and observation of government-imposed protective measures while highlighting the significant changes endured in participants' daily lives. These findings draw attention to the need to develop flexible and appropriate response strategies for different communities. Although Cameroonian populations were not as intensely affected by the burden of the disease of COVID-19 as other regions, they were still compelled to follow static "cookie-cutter" measures that were internationally imposed, affecting their daily lives in ways that seemed disproportionate to their own experiences of the crisis. These findings have potential implications for the legitimacy of public health institutions and responses.

Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

Changing gear: Experiences of how existing qualitative research can adapt to an unfolding health emergency.

Long-term research projects are not always able to adapt to a new crisis and incorporate characteristics and approaches of rapid research to produce useful data quickly. Project AViD was a programme of research that ran between 2018 and 2022 to examine factors that shape vaccine confidence. The project initially focused on five country case studies looking at vaccines for Ebola, Measles, Rift Valley Fever and Zika. The COVID-19 pandemic emerged during this time and provided an opportunity to contribute to the pandemic's 'million-dollar question'-how to deploy COVID-19 vaccines. Drawing on our experience as researchers, and specifically from AViD, we propose seven factors that can influence when and how longer-term qualitative research projects can adapt and contribute to the response to an unfolding health emergency. These include: (1) the phase of research in which the emergency hits; (2) the relative significance of the emergency in the research setting; (3) the specific methods and research team capacities; (4) existing operational links; (5) supportive ecosystems; (6) flexibility in research contracting and funding; and (7) the research team attitude and approach. We close with two considerations for longer-term research projects that find themselves having to "change gear" amid a public health emergency-the need to re-assess risks and benefits and the need to protect equitable partnerships.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

Addressing Intimate Partner Violence Using Gender-Transformative Approaches at a Community Level in Rural Tanzania: The UZIKWASA program.

Intimate partner violence (IPV) is recognized as an important public health and social problem, with far-reaching consequences for women's physical and emotional health and social well-being, yet little is known about how behavior change campaigns (BCCs) affect this type of behavior and other related abuses in Tanzania and in other sub-Saharan African countries. UZIKWASA is a civil society organization based in Pangani District in coastal Tanzania and since 2009 has conducted BCCs focused on promoting gender justice and effective leadership. As with other complex programs there is a question about how such approaches affect norms and practice in relation to violence against women and girls. Drawing on longitudinal research utilizing more than 1000 community diary entries (hearsay ethnographies) and qualitative methods using 20 in-depth interviews and 16 focus group discussions with women and men, and adolescent girls and boys, this article explores the ways in which UZIKWASA's program effects change. The findings reveal personal and community narratives about gender-based and IPV as forms of retributive justice and assertion of authority by men. Drawing on gender performance as an explanation for violence, the research revealed changes in norms and practice in relation to violence against women and girls. Thus, we argue that UZIKWASA is gender-transformative by addressing gender norms and the critical awareness among leaders and the community of the social construction and reconstruction of gender that creates the context for real impact on changes in behavior.

Bringing the social into vaccination research: Community-led ethnography and trust-building in immunization programs in Sierra Leone.

BACKGROUND: Vaccine hesitancy is a complex, contested social phenomenon and existing research highlights the multifaceted role of trust in strengthening vaccine confidence. However, understanding public engagement with vaccination through the lens of (mis)trust requires more contextual evidence on trust's qualitative determinants. This includes expanding the geographic focus beyond current studies' focus on High Income Countries. Furthermore, obstacles remain in effectively integrating social science findings in the design of vaccine deployment strategies, and in ensuring that those who implement interventions and are affected by them are directly involved in producing knowledge about vaccination challenges. METHODS: We piloted a community-led ethnographic approach, training Community Health Workers (CHWs) in Kambia District, Sierra Leone, in qualitative social science methods. Methods included participant observation, participatory power mapping and rumour tracking, focus group discussions and key stakeholder interviews. CHWs, with the support of public health officials and professional social scientists, conducted research on vaccination challenges, analysed data, tested new community engagement strategies based on their findings and elicited local perspectives on these approaches. RESULTS: Our findings on vaccine confidence in five border communities highlighted three key themes: the impact of prior experiences with the health system on (mis)trust; relevance of livelihood strategies and power dynamics for vaccine uptake and access; and the contextual nature of knowledge around vaccines. Across these themes, we show how expressions of trust centered on social proximity, reliability and respect and the role of structural issues affecting both vaccine access and confidence. The pilot also highlighted the value and practical challenges to meaningfully co-designed research. CONCLUSION: There is scope for broader application of a community-led ethnographic approach will help redesign programming that is responsive to local knowledge and experience. Involving communities and low-cadre service providers in generating knowledge and solutions can strengthen relationships and sustain dialogue to bolster vaccine confidence.