Clinical research resource support for off-site research coordinators in intensive and specialty care units.

Clinical Research Coordinators (CRCs) are vital collaborators in a clinical research project. They often are the primary liaisons between investigators and human participants in studies and are involved in every aspect of many protocols, including participant recruitment, care (both usual medical care and specific study-related monitoring and procedures), data collection, specimen processing, and follow-up. The Clinical Translational Science Award program, which was created by the National Institutes of Health in 2006, has significantly expanded the venues in which Clinical Research Resource (CRR) - based CRCs are embedded. CRCs functioning in these areas, outside of the research-focused in-patient environment of the CRR, are designated as "off-site" CRCs. Many of these locations, such as intensive care units and emergency departments, require that CRCs interact regularly with healthcare providers whose primary functions are focused on providing optimal patient care rather than research and often involving very complex patients. These off-site CRCs require additional training and support outside of the usual research-oriented environment of the CRR. They are required to function within the context of the patient-care team while fostering implementation of collaborative research. This is a description of such a program specifically geared to off-site CRCs with the goal of enhancing the quality of research and experiences of CRCs.

The NIH-led research response to COVID-19.

Investment, collaboration, and coordination have been key.

Engaging diverse populations in aging research during the COVID-19 pandemic: Lessons learned from four National Institutes of Health funded-Centers.

Background: The COVID-19 pandemic's impact on our personal and professional lives required a rapid adaptation to the evolving health crisis and accumulating social stresses. Established measures to reduce the spread of infection and potential death had a direct effect on ongoing research that involved older adults and underrepresented racial/ethnic groups. Although important to preserve public health, these measures risk further isolation of vulnerable research participant populations and threatened established community partnerships. To address the social and research challenges evolving from the COVID-19 pandemic, four National Institutes of Health funded-Centers that engage with community members to enhance research and advance the science of aging came together to learn from each other's efforts, approaches, and communication with community partners. Methods: Monthly meetings served as a venue to discuss the challenges of engagement with research participants and support community partners during the pandemic. The developed learning community also contributed to recognize and address research staff stress and isolation. We describe how these conversations led our Centers to address unprecedented challenges and sustain community engagement within diverse populations, especially Black/African Americans, Latinos, Middle Eastern/Arab Americans and the oldest-old. Results: The exchange of information resulted in maintaining long standing community relationships and partnerships in the face of the uncertainties generated by the pandemic. The strategies included adapting education programs to reduce risk of infection, recognizing symptoms, promoting vaccination and understanding of the effect of COVID-19 to the brain. Different strategies were used to address the effects of isolation and maintain community engagement. Although new research participant enrollment was a challenge, telephone and virtual visits allowed research participants to remain active in research. Community members participation in virtual learning events was variable, ranging from a dozen to hundreds of participants. Invitations to organize panels about newly developed topics indicated the need for information from trusted sources. Conclusion: In sum, the COVID-19 pandemic re - directed all four Centers' commitment to community service led to developing strategies for social support, which will potentially contribute to transforming public perceptions about research and researchers.

US National Institutes of Health Prioritization of SARS-CoV-2 Variants.

Since late 2020, SARS-CoV-2 variants have regularly emerged with competitive and phenotypic differences from previously circulating strains, sometimes with the potential to escape from immunity produced by prior exposure and infection. The Early Detection group is one of the constituent groups of the US National Institutes of Health National Institute of Allergy and Infectious Diseases SARS-CoV-2 Assessment of Viral Evolution program. The group uses bioinformatic methods to monitor the emergence, spread, and potential phenotypic properties of emerging and circulating strains to identify the most relevant variants for experimental groups within the program to phenotypically characterize. Since April 2021, the group has prioritized variants monthly. Prioritization successes include rapidly identifying most major variants of SARS-CoV-2 and providing experimental groups within the National Institutes of Health program easy access to regularly updated information on the recent evolution and epidemiology of SARS-CoV-2 that can be used to guide phenotypic investigations.

Realizing the Goals of the Advancing American Kidney Health Initiative: Toward a Better Future for Kidney Disease Research Funding.

The Executive Order on Advancing American Kidney Health aimed to slow the progression of kidney disease, increase access to kidney transplantation, and expand home dialysis. In order to support the kidney health strategy laid out by the Advancing American Kidney Health, the National Institutes of Health, the National Institute of Diabetes, and Digestive, and Kidney Diseases, as well as other funding agencies must dedicate robust research funding to kidney disease. Currently, federal research investment for kidney health is less than 1% of Medicare fee-for-service expenditures for Americans with kidney disease. To address disparities in federal research funding, nephrology organizations are working together to advocate for increased federal commitment to kidney disease research. Underfunding of kidney disease research impedes scientific opportunities and innovation and prevents the collaboration of young investigators with research faculty that can accelerate the exodus of talent within the nephrology research workforce. This review provides an overview of the current state of federal research funding for kidney disease within the United States. In addition, we discuss ongoing advocacy efforts and programs that aim to increase federal funding for kidney-related research and accelerate the development of new and better therapies.

The Women's Leadership Gap in Diabetes: A Call for Equity and Excellence.

Women are broadly underrepresented in scientific leadership positions and their accomplishments are not provided equal recognition compared with those of men, but the imbalance in the field of diabetes is unknown. Hence, we analyzed multiple aspects of historical and present-day female representation in the diabetes field.We quantified gender representation at annual American Diabetes Association (ADA) meetings; editorial board service positions for ADA and the European Association for the Study of Diabetes (EASD) journals; principal investigators for ADA, JDRF, and National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases P30 grant funding; and ADA, JDRF, and EASD award recipients. There are many women in the field of diabetes: registration for the ADA Scientific Sessions has been 43% female since 2016, and for over five decades, women comprised 83% of ADA Presidents of Health Care and Education. Yet, only 9% of ADA Presidents of Medicine and Science have been women. Women were well represented on editorial boards for journals focused on diabetes education (Diabetes Spectrum, 89% female) and primary care (Clinical Diabetes, 49% female) but not for the more academically targeted Diabetes Care (34% female), Diabetes (21% female), and Diabetologia (30% female). Only one-third of ADA Pathway to Stop Diabetes and JDRF grants have been awarded to women, and females only lead 2 of 18 (11%) of the P30-supported Diabetes Research Centers. Finally, only 2-12% of major ADA, JDRF, and EASD awards were given to women, without significant change over time. Despite increasing recognition of gender imbalance in research and medicine, many disparities in the field of diabetes persist. We call for decreasing barriers for advancement of female investigators and creating environments that promote their retention and equitable recognition for their contributions to the field.

Gender Differences in National Institutes of Health Grant Submissions Before and During the COVID-19 Pandemic.

Introduction: Emerging data suggest that the COVID-19 pandemic has disproportionately impacted women in academic medicine, potentially eliminating recent gains that have been made toward gender equity. This study examined possible pandemic-related gender disparities in research grant submissions, one of the most important criteria for academic promotion and tenure evaluations. Methods: Data were collected from two major academic institutions (one private and one public) on the gender and academic rank of faculty principal investigators who submitted new grants to the National Institutes of Health (NIH) during COVID-19 (March 1st, 2020, through August 31, 2020) compared with a matched period in 2019 (March 1st, 2019, through August 31, 2019). t-Tests and chi-square analyses compared the gender distribution of individuals who submitted grants during the two periods of examination. Results: In 2019 (prepandemic), there was no significant difference in the average number of grants submitted by women compared with men faculty. In contrast, women faculty submitted significantly fewer grants in 2020 (during the pandemic) than men. Men were also significantly more likely than women to submit grants in both 2019 and 2020 compared with submitting in 2019 only, suggesting men faculty may have been more likely than their women colleagues to sustain their productivity in grant submissions during the pandemic. Discussion: Women's loss of extramural funding may compound over time, as it impedes new data collection, research progress, and academic advancement. Efforts to support women's research productivity and career trajectories are urgently needed in the following years of pandemic recovery.

The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.

BACKGROUND: The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research. METHODS: We collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. A COVID-19 impact questionnaire was administered electronically to principal investigators in June 2020. Text responses were analyzed thematically, and qualitative summaries were subsequently reviewed by five independent reviewers, who made iterative revisions. Additional COVID-19-related impacts were identified during virtual meetings with trial teams during April-July 2020 and combined with questionnaire responses for analysis. RESULTS: Impacts of the pandemic were broadly classified into two main types: healthcare operations and social distancing. In some instances, trial delays created statistical challenges, particularly with trials using stepped-wedge designs, and necessitated changing data collection strategies or modifying interventions. The majority of projects used existing stakeholder-driven approaches to adapt interventions. Several benefits of these adaptions were identified, including expanded outreach capabilities and ability to study virtual intervention delivery. All trial teams were able to adapt to pandemic-related modifications. CONCLUSION: In a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives.

Efforts to advance NIH-funded behavioral and social sciences research on structural racism and health.

This commentary provides background and context for the increasing attention to research designed to better understand and address the impact of structural racism on health, with particular attention to the role of the behavioral and social sciences. The manuscript describes the impetus provided to this work by recent public health crises of COVID-19 and the racial justice movement that emerged following the murder of George Floyd in the summer of 2020. A range of initiatives from the National Institutes of Health (NIH) focused on structural racism and health equity are discussed in this context and opportunities and gaps for future research are identified.

Opportunities and challenges in translational science.

The mission of translational science is to bring predictivity and efficiency to the development and dissemination of interventions that improve human health. Ten years ago this year, the National Center for Advancing Translational Sciences was founded to embody, conduct, and support this new discipline. The Center's first decade has brought substantial progress across a broad range of translational areas, from diagnostic and drug development to clinical trials to implementation science to education. The origins of the translational science and advances to this point are reviewed here and allow the establishment of an ambitious future research agenda for the field.

A Concept Development for the Symptom Science Model 2.0.

BACKGROUND: The National Institute of Nursing Research developed the National Institutes of Health symptom science model (SSM) in 2015 as a parsimonious conceptual model to guide symptom science research. OBJECTIVES: This concept development paper synthesizes justifications to strengthen the original model. METHODS: A literature review was performed, discussions with symptom science content expert stakeholders were held, and opportunities for expanding the current model were identified. Concept elements for a revised conceptual model-the SSM 2.0-were developed. RESULTS: In addition to the four original concept elements (complex symptom presentation, phenotypic characterization, biobehavioral factors [previously biomarker discovery], and clinical applications), three new concept elements are proposed, including social determinants of health, patient-centered experience, and policy/population health. DISCUSSION: There have been several calls to revise the original SSM from the nursing scientific community to expand its utility to other healthcare settings. Incorporating three additional concept elements can facilitate a broader variety of translational nursing research symptom science collaborations and applications, support additional scientific domains for symptom science activities, and produce more translatable symptom science to a wider audience of nursing research scholars and stakeholders during recovery from the COVID-19 pandemic. The revised SSM 2.0 with newly incorporated social determinants of health, patient-centered experience, and policy/population health components now empowers nursing scientists and scholars to address specific symptom science public health challenges particularly faced by vulnerable and underserved populations.