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The lab management practices of "Research Exemplars" that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators.

ABSTRACT: INTRODUCTION:Conducting rigorous scientific inquiry within the bounds of research regulation and acceptable practice requires a principal investigator to lead and manage research processes and personnel. This study explores the practices used by investigators nominated as exemplars of research excellence and integrity to produce rigorous, reproducible research and comply with research regulations. METHODS:Using a qualitative research design, we interviewed 52 principal investigators working in the United States at top research universities and the National Institutes of Health Intramural Research Program. We solicited nominations of researchers meeting two criteria: (1) they are federally-funded researchers doing high-quality, high-impact research, and (2) have reputations for professionalism and integrity. Each investigator received an initial nomination addressing both criteria and at least one additional endorsement corroborating criteria 2. A panel of researchers and our research team reviewed the nominations to select finalists who were invited to participate. The cohort of "Research Exemplars" includes highly accomplished researchers in diverse scientific disciplines. The semi-structured interview questions asked them to describe the routine practices they employ to foster rigor and regulatory compliance. We used inductive thematic analysis to identify common practices. RESULTS:The exemplars identified a core set of 8 practices and provided strategies for employing them. The practices included holding regular team meetings, encouraging shared ownership, providing supervision, ensuring adequate training, fostering positive attitudes about compliance, scrutinizing data and findings, and following standard operating procedures. Above all, the use of these practices aim to create a psychologically safe work environment in which lab members openly collaborate to scrutinize their work and share in accountability for rigorous, compliant research. CONCLUSIONS:Researchers typically receive limited systematic training in how to lead and manage their research teams. Training and education for principal investigators should include essential leadership and management practices and strategies that support doing high-quality research with integrity.

SUBMITTER: Antes AL

PROVIDER: S-EPMC6481787 | biostudies-other | 2019

REPOSITORIES: biostudies-other

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The lab management practices of "Research Exemplars" that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators.

Antes Alison L AL Kuykendall Ashley A DuBois James M JM

PloS one 20190424 4

<h4>Introduction</h4>Conducting rigorous scientific inquiry within the bounds of research regulation and acceptable practice requires a principal investigator to lead and manage research processes and personnel. This study explores the practices used by investigators nominated as exemplars of research excellence and integrity to produce rigorous, reproducible research and comply with research regulations.<h4>Methods</h4>Using a qualitative research design, we interviewed 52 principal investigato ...[more]

PMID: 31017929

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Project description:BackgroundEven though research integrity (RI) training programs have been developed in the last decades, it is argued that current training practices are not always able to increase RI-related awareness within the scientific community. Defining and understanding the capacities and lacunas of existing RI training are becoming extremely important for developing up-to-date educational practices to tackle present-day challenges. Recommendations on how to implement RI education have been primarily made by selected people with specific RI-related expertise. Those recommendations were developed mainly without consulting a broader audience with no specific RI expertise. Moreover, the academic literature lacks qualitative studies on RI training practices. For these reasons, performing in-depth focus groups with non-RI expert stakeholders are of a primary necessity to understand and outline how RI education should be implemented.MethodsIn this qualitative analysis, different focus groups were conducted to examine stakeholders' perspectives on RI training practices. Five stakeholders' groups, namely publishers and peer reviewers, researchers on RI, RI trainers, PhDs and postdoctoral researchers, and research administrators working within academia, have been identified to have a broader overview of state of the art.ResultsA total of 39 participants participated in five focus group sessions. Eight training-related themes were highlighted during the focus group discussions. The training goals, timing and frequency, customisation, format and teaching approach, mentoring, compulsoriness, certification and evaluation, and RI-related responsibilities were discussed. Although confirming what was already proposed by research integrity experts in terms of timing, frequency, duration, and target audience in organising RI education, participants proposed other possible implementations strategies concerning the teaching approach, researchers' obligations, and development an evaluation-certification system.ConclusionsThis research aims to be a starting point for a better understanding of necessary, definitive, and consistent ways of structuring RI education. The research gives an overview of what has to be considered needed in planning RI training sessions regarding objectives, organisation, and teaching approach.

Project description:BackgroundLack of reproducibility of preclinical studies has been identified as an impediment for translation of basic mechanistic research into effective clinical therapies. Indeed, the National Institutes of Health has revised its grant application process to require more rigorous study design, including sample size calculations, blinding procedures, and randomization steps. We hypothesized that the reporting of such metrics of study design rigor has increased over time for animal-experimental research published in anesthesia journals.MethodsPubMed was searched for animal-experimental studies published in 2005, 2010, and 2015 in primarily English-language anesthesia journals. A total of 1466 publications were graded on the performance of sample size estimation, randomization, and blinding. Cochran-Armitage test was used to assess linear trends over time for the primary outcome of whether or not a metric was reported. Interrater agreement for each of the 3 metrics (power, randomization, and blinding) was assessed using the weighted κ coefficient in a 10% random sample of articles rerated by a second investigator blinded to the ratings of the first investigator.ResultsA total of 1466 manuscripts were analyzed. Reporting for all 3 metrics of experimental design rigor increased over time (2005 to 2010 to 2015): for power analysis, from 5% (27/516), to 12% (59/485), to 17% (77/465); for randomization, from 41% (213/516), to 50% (243/485), to 54% (253/465); and for blinding, from 26% (135/516), to 38% (186/485), to 47% (217/465). The weighted κ coefficients and 98.3% confidence interval indicate almost perfect agreement between the 2 raters beyond that which occurs by chance alone (power, 0.93 [0.85, 1.0], randomization, 0.91 [0.85, 0.98], and blinding, 0.90 [0.84, 0.96]).ConclusionsOur hypothesis that reported metrics of rigor in animal-experimental studies in anesthesia journals have increased during the past decade was confirmed. More consistent reporting, or explicit justification for absence, of sample size calculations, blinding techniques, and randomization procedures could better enable readers to evaluate potential sources of bias in animal-experimental research manuscripts. Future studies should assess whether such steps lead to improved translation of animal-experimental anesthesia research into successful clinical trials.

Project description:Objective The role of the community in the research process in Ethiopia has not been documented. This study aims to explore the existing practices and challenges of community engagement in health research in Ethiopia. Design A qualitative study with a narrative approach was conducted. Data were audio-recorded, transcribed, inductively coded and analysed thematically. Setting Participants were recruited from members of institutional review boards, academic and research staff of Addis Ababa and Jimma universities, research institutions and key development partners. Participants Thirty-six participants were involved in the study. They were purposively selected on the basis of their diverse research experiences and disciplinary profiles with clinical, biomedical and public health representation. Data collection Twenty-two key informant interviews were conducted with members of the institutional review board, community representatives in the institutional review board, community engagement officers, and research focal persons of the universities, research intuitions and key development partners. Fourteen participants who were senior PhD students or senior researchers in academic and research institutions were involved in the in-depth interviews. Results Despite differences of justification, all participants believed in the importance of the participating research community not only to own the research outcome but also contribute to the research planning, sharing of evidence, managing the research process and dissemination of findings. However, it was argued that lack of guidance, skills and experience on how to engage the community at different levels of the research process and limitation of resources affect community engagement in research. Conclusion As an important component of the research process, community engagement facilitates the research process and ensures community ownership of the outcome. Nevertheless, lack of experience and limitation of resources affect operationalisation of community engagement in health research. This calls for building capacity and advocacy to consider community engagement as an integral component of the research process.

Dataset Information

The lab management practices of "Research Exemplars" that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators.

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The lab management practices of "Research Exemplars" that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators.

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