Elements of successful NIH grant applications.

Is there a formula for a competitive NIH grant application? The Serenity Prayer may provide one: "Grant me the serenity to accept the things I cannot change, the ability to change the things I can, and the wisdom to know the difference." But how to tell the difference? In this Perspective, we provide an inclusive roadmap-elements of NIH funding. Collectively, we have over 30 y of peer review experience as NIH Scientific Review Officers in addition to over 30 y of program experience as NIH Program Officers. This article distills our NIH experience. We use Euclid's 13-book landmark, The Elements, as our template to humbly share what we learned. We have three specific aims: inform, guide, and motivate prospective applicants. We also address ways that support diversity and inclusion among applicants and young investigators in biomedical research. The elements we describe come from a wide range of sources. Some themes will be general. Some will be specific. All will be candid. The ultimate goal is a competitive application, serenity, and hopefully both.

Current status of National Institutes of Health funding for thoracic surgeons in the United States: Beacon of hope or candle in the wind?

OBJECTIVE: Increasing forces threaten the viability of thoracic surgeon-initiated research, a core component of our academic mission. National Institutes of Health funding is a benchmark of research productivity and innovation. This study examined the current status of National Institutes of Health funding for thoracic surgeons. METHODS: Thoracic surgeon principal investigators on National Institutes of Health-funded grants during June 2010, June 2015, and June 2020 were identified using National Institutes of Health iSearchGrants (version 2.4). American Association of Medical Colleges data were used to identify all surgeons in the United States. Types and total costs of National Institutes of Health-funded grants were compared relative to other surgical specialties. RESULTS: A total of 61 of 4681 (1.3%), 63 of 4484 (1.4%), and 60 of 4497 (1.3%) thoracic surgeons were principal investigators on 79, 76, and 87 National Institutes of Health-funded grants in 2010, 2015, and 2020, respectively; these rates were higher than those for most other surgical specialties (P ≤ .0001). Total National Institutes of Health costs for Thoracic Surgeon-initiated grants increased 57% from 2010 to 2020, outpacing the 33% increase in total National Institutes of Health budget. Numbers and types of grants varied among cardiovascular, transplant, and oncology subgroups. Although the majority of grants and costs were cardiovascular related, increased National Institutes of Health expenditures primarily were due to funding for transplant and oncology grants. Per-capita costs were highest for transplant-related grants during both years. Percentages of R01-to-total costs were constant at 55%. Rates and levels of funding for female versus male thoracic surgeons were comparable. Awards to 5 surgeons accounted for 33% of National Institutes of Health costs for thoracic surgeon principal investigators in 2020; a similar phenomenon was observed for 2010 and 2015. CONCLUSIONS: Long-term structural changes must be implemented to more effectively nurture the next generation of thoracic surgeon scientists.

Principal Investigators' Priorities and Perceived Barriers and Facilitators When Making Decisions About Conducting Essential Research in the COVID-19 Pandemic.

At the onset of the COVID-19 pandemic in the United States, stay-at-home orders disrupted normal research operations. Principal investigators (PIs) had to make decisions about conducting and staffing essential research under unprecedented, rapidly changing conditions. These decisions also had to be made amid other substantial work and life stressors, like pressures to be productive and staying healthy. Using survey methods, we asked PIs funded by the National Institutes of Health and the National Science Foundation (N = 930) to rate how they prioritized different considerations, such as personal risks, risks to research personnel, and career consequences, when making decisions. They also reported how difficult they found these choices and associated symptoms of stress. Using a checklist, PIs indicated those factors in their research environments that made their decisions easier (i.e., facilitators) or more difficult (i.e., barriers) to make. Finally, PIs also indicated how satisfied they were with their decisions and management of research during the disruption. Descriptive statistics summarize PIs' responses and inferential tests explore whether responses varied by academic rank or gender. PIs overall reported prioritizing the well-being and perspectives of research personnel, and they perceived more facilitators than barriers. Early-career faculty, however, rated concerns about their careers and productivity as higher priorities compared to their senior counterparts. Early-career faculty also perceived greater difficulty and stress, more barriers, fewer facilitators, and had less satisfaction with their decisions. Women rated several interpersonal concerns about their research personnel more highly than men and reported greater stress. The experience and perceptions of researchers during the COVID-19 pandemic can inform policies and practices when planning for future crises and recovering from the pandemic.

China's drug clinical trial institution record-keeping system: Qualification requirements for PI are the key.

It has been 3 years since China implemented new management regulations for drug clinical trial institutions in December 2019, the most important of which is to change the qualification recognition of drug clinical trial institutions into record-keeping system. The original intention of the institution record-keeping system was to solve the shortage of clinical trial resources in China, effectively expand the number of clinical trial institutions, and effectively alleviate the contradiction between medical treatment and scientific research. After implementing the record-keeping system, although these goals have been achieved to a certain extent, there are still areas worthy of optimization and improvement. Therefore, we evaluated the new process, in particular the requirements, in order to see what possible barriers in the record-keeping system of institutions. We find that the requirements for principal investigator (PI) qualifications are the key to the record-keeping system. This reflects the shift of Chinese regulators' supervision of clinical trials to supervision of the ability to conduct clinical trials. However, the ambiguity of the definition of PI qualification has hindered implementation of the record-keeping system and reduced the release of clinical trial resources.

Women's leadership in clinical research: A retrospective observational study over two decades in Spain.

BACKGROUND AND OBJECTIVE: Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. MATERIALS AND METHODS: Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. MAIN OUTCOME: proportion of CI led by female doctors (FD) during the study period. SECONDARY OUTCOMES: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. DATA SOURCES: Research Ethics Committee (REC) and Human Resources Department registries. RESULTS: During the study, the REC approved 8466 protocols, 52% (4408/8466) were EC, the rest were NIR. Women led 39.7% (3360/8466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1391/4408) and 48.5% (1969/4058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. CONCLUSIONS: Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research.

Experience and thinking of principal investigator system management in laboratories of medical schools / 中华医学科研管理杂志

Objective:Principal Investigator (PI) system is the most common model of scientific research organization and management in colleges and universities. PI is the head of the laboratory or the leader of the research team who has the authority to manage the supporting team, funds, and space (laboratory). We aim to explore the advantages and problems of the PI system implementation and deeply understand how to effectively and scientifically manage the project management, personnel coordination, and fund use of the entire team to promote the scientific research output of the PI platform of medical schools in China.Methods:By concluding and analyzing the management experience and main bottlenecks of PI laboratories at home and abroad, and summarizing our center's experience in assisting the management of PI laboratories in life sciences, we explored a new model of PI system development suitable for China.Results:Under PI system, the person in charge systematically learns to operate his or her laboratory scientifically. Perfection and improvement of the methodologies of team formation, laboratory public affairs management, and laboratory fund management can effectively avoid existing problems and follow the intrinsic laws of scientific research development and truth-seeking, promote the development in discipline development, interdisciplinary cooperation, personnel training, and study style construction.Conclusions:As the leader and manager of the scientific research team, PI is critical to the development of scientific research in universities in China. The incubation of a new scientific management model for the PI team is conducive to promoting the scientific and technological innovation of the PI team and the long-term development of scientific research institutions.

Exploring enablers and barriers toward COVID-19 vaccine acceptance among Arabs: A qualitative study.

Background: With the emergence of the coronavirus disease 2019 (COVID-19) and rapid vaccine development, research interest in vaccine hesitancy (VH) has increased. Research usually focuses on quantitative estimates which largely neglected the qualitative underpinnings of this phenomenon. This study aimed to explore the beliefs and views towards COVID-19 vaccination among Arabs in different countries. Furthermore, we explored the effect of confidence in the healthcare system, misinformation, and scientific approaches adopted to mitigate COVID-19 on how individuals are following the recommended preventative actions including vaccination. Methods: This study was based on the Strategic Advisory Group of Experts (SAGE)-VH Model: A qualitative design that utilized in-depth, online interviews. The study was conducted in seven Arab countries (Egypt, Qatar, Kingdom of Saudi Arabia, Libya, Sudan, United Arab Emirates and Jordan) from June 2020 to December 2021. Transcripts were analyzed using NVivo 12 Software. Results: A total of 100 participants, 44 males and 56 females, of different age groups (37.1 ± 11.56 years) were interviewed. Findings revealed six themes as enablers and barriers to COVID-19 vaccination. Many participants indicated trusting the vaccines, the healthcare systems, and the vaccination policies were the main driver to get the vaccine. Participants showed concerns towards potential long-term vaccine effects. A consistent inclination towards collective responsibility, which is the willingness to protect others by own vaccination, was also reported. Conclusion: Enablers and barriers of COVID-19 vaccination acceptance in the Arab region, from sociocultural and political perspectives, are critical to guide policymakers in designing target-oriented interventions that can improve vaccine acceptance.

Why I shrank my lab by half.

A medical diagnosis sets a principal investigator on a new path.

Student views on the culture of STEM research laboratories: Results from an interview study.

In this article, we present the results of 30 ethnographic interviews in which we asked STEM graduate and undergraduate students at a Midwest university in the United States about topics related to the culture of their research group, how group members communicate and interact, and their experience with ethical issues that arise within the laboratory. Here we focus on the culture of research laboratories and describe the key categories that emerged through analysis, including communication, community structure, governance, and collaboration that influence and shape lab culture. We also consider the critical role of the principal investigator (PI) to influence conditions in the lab that facilitate or inhibit lab culture and the subsequent effects on student feelings and behaviors, interpersonal communication, collaboration, work output, and ethics. Our findings suggest that the quality of research and the wellbeing of the lab members depend not only on purely scientific factors and routine research practices but are also dependent on the culture of the lab as it manifests in interpersonal relationships. The interviews reveal the critical role students ascribe to the PI in shaping the lab culture. Based on this study, we suggest how ethical lab cultures might be encouraged.

Analyzing factors associated with clinical trial publication in radiation oncology.

Clinical trials are considered the gold standard of clinical research and are sought in the medical literature for the goal of providing quality care. To identify factors associated with successful or unsuccessful publication of clinical trials in radiation oncology, data on trial characteristics were collected from the National Institutes of Health database on clinicaltrials.gov. To assess studies that had adequate time to accrue, trials between 2000 and 2005 were extracted by filtering for "radiation oncology". Studies were excluded if they were incomplete, observational, Phase 4, or lacked sufficient method descriptions. Included studies underwent independent samples t-tests and Pearson Chi-Square bivariate analyses. 538 studies were candidates for analysis of clinical trial characteristics. United States (US) origin, multi-center sites, government funding, Phase III status, and randomized allocation were factors associated with increased publication rate. The number of study arms, study length, and number of participants were significantly greater in published trials. The review's results demonstrate potential barriers or facilitators to publication, and they suggest that publication status may be influenced by geographic, financial, and temporal characteristics of clinical trials. Understanding trial background factors that may impact publication improve data visibility and clinical advancements for all.

Gender profile of principal investigators in a large academic clinical trials group.

Introduction: Gender equity in medicine has become a significant topic of discussion due to consistently low female representation in academia and leadership roles. Gender imbalance directly affects patient care. This study examined the gender and craft group of the Principal Investigators (PI) of clinical trials run by the Australasian Gastro-Intestinal Trials Group (AGITG). Methods: Publicly available data was obtained from the AGITG website. Trials were divided into upper, lower gastrointestinal cancer, miscellaneous (neuroendocrine and gastrointestinal stromal tumours). Where multiple PIs were listed, all were counted. Craft group was assigned as surgical, medical, radiation oncology or other. Results: There were 69 trials with 89 PI, where 52 trials were represented exclusively by male PIs. Of all PIs, 18 were women (20.2%); all were medical oncologists. Prior to 2005, all PIs were male. The craft group distribution of PIs was: 79% medical oncologists, 12% surgical oncologists, 8% radiation oncologist, 1% nuclear medicine physicians. Regarding trials with multiple PI's, there were 19 in total. Of these, 11 had only male PIs, which included 5 surgeons. Females were more likely to be a co-PI (42%) as opposed to sole PI (18%). There was no gender policy publicly available on the AGITG website. Conclusions: There is a low percentage of female PIs in academic oncology trials in the portfolio of this large international trials group. No trial was led by a female surgical or radiation oncologist. There is a need to understand the reasons driving the disparity so that specific strategies can be put in place.

Creating and Implementing a Principal Investigator Tool Kit for Enhancing Accrual to Late Phase Clinical Trials: Development and Usability Study.

BACKGROUND: Accrual to oncology clinical trials remains a challenge, particularly during the COVID-19 pandemic. For late phase clinical trials funded by the National Cancer Institute, the development of these research protocols is a resource-intensive process; however, mechanisms to optimize patient accrual after trial activation are underdeveloped across the National Clinical Trial Network (NCTN). Low patient accrual can lead to the premature closure of clinical trials and can ultimately delay the availability of new, potentially life-saving therapies in oncology. OBJECTIVE: The purpose of this study is to formally create an easily implemented tool kit of resources for investigators of oncology clinical trials within the NCTN, specifically the NRG Oncology cooperative group, in order to optimize patient accrual. METHODS: NRG Oncology sought to formally develop a tool kit of resources to use at specific time points during the lifetime of NRG Oncology clinical trials. The tools are clearly described and involve the facilitation of engagement of the study principal investigator with the scientific and patient advocate community during the planning, activation, and accrual periods. Social media tools are also leveraged to enhance such engagement. The principal investigator (PI) tool kit was created in 2019 and thereafter piloted with the NRG Oncology/Alliance NRG-LU005 phase II or III trial in small-cell lung cancer. The PI tool kit was developed by the NRG Oncology Protocol Operations Management committee and was tested with the NRG/Alliance LU005 randomized trial within the NCTN. RESULTS: NRG Oncology/Alliance NRG-LU005 has seen robust enrollment, currently 127% of the projected accrual. Importantly, many of the tool kit elements are already being used in ongoing NRG Oncology trials, with 56% of active NRG trials using at least one element of the PI tool kit and all in-development trials offered the resource. This underscores the feasibility and potential benefits of deploying the PI tool kit across all NRG Oncology trials moving forward. CONCLUSIONS: While clinical trial accrual can be challenging, the PI tool kit has been shown to augment accrual in a low-cost and easily implementable fashion. It could be widely and consistently deployed across the NCTN to improve accrual in oncology clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT03811002; https://clinicaltrials.gov/ct2/show/NCT03811002.

Quantitative goals for research output and scholarly impact to enhance basic science R01 grant renewal for cardiothoracic surgeons.

Objectives: Cardiothoracic (CT) surgeons with National Institutes of Health (NIH) R01 funding face a highly competitive renewal process. The factors that contribute to successful grant renewal for CT surgeons remain poorly defined. We hypothesized that renewed basic science grants are associated with high research output and scholarly impact during the preceding award cycle. Methods: Using a database of academic CT surgeons (n = 992) at accredited training institutions in 2018, we identified basic science R01 grants awarded to CT surgeon principal investigators since 1985. Data for each award were obtained from publicly available online sources. Scholarly impact was evaluated using the NIH-validated relative citation ratio (RCR), defined as an article's citation rate divided by that of R01-funded publications in the same field. Continuous data are presented as medians and analyzed using the Mann-Whitney test. Results: We identified 102 basic science R01 award cycles, including 33 that were renewed (32.4%). Renewed and nonrenewed awards had a similar start year and funding period. Principal investigators of renewed versus nonrenewed awards were similar in surgical subspecialty, research training, attending experience, academic rank, and previous NIH funding. Renewed awards produced more publications per year over the funding cycle (3.4 vs 1.5; P = .0010) and exhibited a greater median RCR during the funding cycle (0.84 vs 0.66; P = .0183). Conclusions: CT surgery basic science R01 grants are associated with high research output and scholarly impact. At the 50th percentile among renewed grants, CT surgeons published 3.4 funded manuscripts per year with a median RCR of 0.84 during the previous award cycle.

Suggestions on leading an academic research laboratory group.

This commentary is about running an academic research laboratory group, including some reflections, memories, and tips on effectively managing such a group of scientists focused on one's research. The author's academic career has spanned from 1982 to 2022, including postdoctoral research associate through the rank of professor with tenure. Currently, the author is in the final year of 3 years of phased retirement. One must be willing to work hard at running a research laboratory. Also, stay focused on funding the laboratory tasks and publishing one's work. Recruit the best people possible with advice from the collective laboratory group. Laboratory group members felt more like they were a part of a collective family than simply employees; however, what works best for the researcher is what matters. Several other points to discuss will include managing university roles, recruiting laboratory personnel, getting recognition, dealing with intellectual property rights, and publishing work. In closing, there are many more positives than negatives to leading a research laboratory group. Finally, one cannot replace the unforgettable memories and the legacy of a research laboratory group.

Building Leadership Skills in Research Groups.

The academic research enterprise currently suffers from a culture of "academic bullying" and an unprecedented worldwide mental health crisis among trainees and faculty. These struggles, in part, result from a lack of leadership skills. Mental health, well-being, intrinsic motivation, and engagement at work are linked to three fundamental needs of self-determination: autonomy, competence, and relatedness. A great leader will first ensure they are meeting their own needs and, secondly, will support their team members in increasing their needs without decreasing autonomy. This article is a practical "how-to" guide for researchers at every stage of the academic career path. It distinguishes management from leadership and addresses three key leadership competencies related to the self-determination needs: 1. Increasing one's personal power as a foundation for autonomy, 2. building a culture of belonging and psychological safety to nurture relatedness, and 3. supporting and encouraging the need for competence by enabling people to self-evaluate performance and direct professional growth. © 2022 Wiley Periodicals LLC.

Effect of maternal employment on child nutritional status in Bale Robe Town, Ethiopia: a comparative cross-sectional analysis.

Adequate nutrition is essential for early childhood to ensure healthy growth, proper organ formation, and function, a strong immune system, neurological and cognitive development. The main aim of the present study was to assess the effect of maternal employment on nutritional status among children aged 6-23 months in the town of Bale Robe, Ethiopia. A community-based comparative cross-sectional study was conducted on about 597 (293 unemployed and 304 employed) having children aged 6-23-month-old children sampled were employed with a multistage sampling technique. A face-to-face interview was conducted using a structured pretested questionnaire. Descriptive statistics, binary and multivariable logistic regression analyses were used for the statistical analysis. The magnitude of stunting (39.9 %), underweight (39⋅9 %) and wasting (22⋅2 %) was greater in 6-23-month-old children born to employed mothers than their counterparts in unemployed ones [stunted (31⋅3 %), underweight (24⋅0 %) and wasted (11⋅8 %)]. Being a girl [AOR 0⋅31; 95 % CI (0⋅17, 0⋅54)] in employed mothers and [AOR 0⋅29; 95 % CI (0⋅16, 0⋅51)] in unemployed people significantly protected stunting. This study demonstrated that the nutritional status of 6-23-month-old children is better among unemployed mothers than among employed mothers. Therefore, concerted efforts may decrease child undernutrition in a study area.

Finding the right candidate: Developing hiring guidelines for screening applicants for clinical research coordinator positions.

Impact: The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project. Objective/Goals: HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration. Methods/Study Population: Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced. Results/Anticipated Results: Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.

A Course Design for Remote Teaching Advanced Topics in Neuroscience.

The COVID-19 pandemic pushed educators to engage in remote teaching out of necessity, but as our relationship with teaching technology grows, remote teaching has emerged as a suitable substitute for in-person education. In this manuscript, we detail a course design for remote teaching advanced topics in neuroscience at the undergraduate level. The course and its different features were designed to fulfill a set of learning goals that closely align with those put forth by the Faculty for Undergraduate Neuroscience (FUN) and the American Association for the Advancement of Science (AAAS). Furthermore, these learning goals can be applied to any advanced neuroscience class, regardless of the topic material. To achieve these goals, we created a curriculum with distinct design features. These features included a synchronous lecture-discussion system, asynchronous lesson content videos, guest principal investigators, and deemphasized grading. Instead of traditional examination, the students participated in assignments designed to give them extensive science communication experience. At the end of the course, we indirectly assessed student outcomes using an Instructor Course Evaluation survey distributed by the university. From this survey, we were able to conclude that students' perception of the final course outcome was highly satisfactory, with strong indications that the students believed we met our learning goals. Thus, the course design described herein represents a tool for others wishing to utilize it for remote teaching advanced topics in science.

Trainee Principal Investigator Could Improve Recruitment in Trauma Trials: Review of Literature and Experience From a Trauma Center.

INTRODUCTION: Recruitment of patients to participate in randomized control trials (RCT) is a challenging task, especially for trauma trials in which the identification and recruitment are time-limited. Multiple strategies have been tried to improve the participation of doctors and the recruitment of patients. The aim was to study the effect of a trainee principal investigator (TPI) on the efficacy of recruitment for a multicenter hip fracture RCT. METHODS: A retrospective study comparing the number of junior doctors participating in the WHiTE 8 COPAL RCT and patients recruited before and after the introduction of formal TPI role at a major trauma center in the UK. Data was collected for nine months "before" (Nov 2018-July 2019) and six months "after" (Sept 2019-Feb 2020) the role of TPI was assigned. RESULTS: From November 2018 to February 2020, a total of 292 patients were eligible for recruitment into this trial, out of which 196 (67.12 %) were successfully recruited. Excluding the research team, there were seven junior doctors actively recruiting in the "before period" in comparison with 10 in the "after period." Significantly more patients were recruited by junior doctors after a TPI was assigned. Overall, more percentage of eligible patients were recruited into the trial after a TPI was assigned, and this was statistically significant. CONCLUSION: The allocation of a formal TPI significantly improved the recruitment of patients in a national RCT. TPI can work alongside the principal investigator and research team to be a valuable link person coordinating and engaging local trainees to take part in trials.

Ending Gender Inequality in Cardiovascular Clinical Trial Leadership: JACC Review Topic of the Week.

Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed. The benefits of diverse randomized controlled trial leadership extend to patients and professionals. In this position statement, we present strategies adopted by some organizations to end gender inequality in research leadership. We offer an actionable roadmap for early-career researchers, scientists, academic institutions, professional societies, trial sponsors, and journals to follow, with the goal of harnessing the strength of women and under-represented groups as research leaders and facilitating a just culture in the cardiovascular clinical trial enterprise.