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

IntroductionConducting 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.MethodsUsing 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.ResultsThe 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.ConclusionsResearchers 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

Aligning objectives and assessment in responsible conduct of research instruction

Efforts to advance research integrity in light of concerns about misbehavior in research rely heavily on education in the responsible conduct of research (RCR). However, there is limited evidence for the effectiveness of RCR instruction as a remedy. Assessment is essential in RCR education if the research community wishes to expend the effort of instructors, students, and trainees wisely. This article presents key considerations that instructors and course directors must consider in aligning learning objectives with instructional methods and assessment measures, and it provides illustrative examples. Above all, in order for RCR educators to assess outcomes more effectively, they must align assessment to their learning objectives and attend to the validity of the measures used

What Works in Transformative Mediator Coaching: Field Test Findings

A process for the formative assessment (coaching) of mediators practicing from the transformative orientation was field tested at six different sites. Specifically varied were whether or not the mediator\u27s original training was in the transformative orientation, the mediator\u27s amount of experience practicing from the transformative orientation, and whether the role-play mediation sessions were live or videotaped. In addition to drawing conclusions about the qualifications necessary for a coach and the pros and cons of videotaped sessions versus live stop-action sessions, we developed guidelines for structuring the coaching process. We also identified a range of possible uses of the process

Identifying Practice Competence in Transformative Mediators: An Interactive Rating Scale Assessment Model

Published in cooperation with the American Bar Association Section of Dispute Resolutio

Professional decision-making in medicine: Development of a new measure and preliminary evidence of validity

INTRODUCTION: This study developed a new Professional Decision-Making in Medicine Measure that assesses the use of effective decision-making strategies: seek help, manage emotions, recognize consequences and rules, and test assumptions and motives. The aim was to develop a content valid measure and obtain initial evidence for construct validity so that the measure could be used in future research or educational assessment. METHODS: Clinical scenario-based items were developed based on a review of the literature and interviews with physicians. For each item, respondents are tasked with selecting two responses (out of six plausible options) that they would choose in that situation. Three of the six options reflect a decision-making strategy; these responses are scored as correct. Data were collected from a sample of 318 fourth-year medical students in the United States. They completed a 16-item version of the measure (Form A) and measures of social desirability, moral disengagement, and professionalism attitudes. Professionalism ratings from clerkships were also obtained. A sub-group (n = 63) completed a second 16-item measure (Form B) to pilot test the instrument, as two test forms are useful for pre-posttest designs. RESULTS: Scores on the new measure indicated that, on average, participants answered 75% of items correctly. Evidence for construct validity included the lack of correlation between scores on the measure and socially desirable responding, negative correlation with moral disengagement, and modest to low correlations with professionalism attitudes. A positive correlation was observed with a clerkship rating focused on professionalism in peer interactions. CONCLUSIONS: These findings demonstrate modest proficiency in the use of decision-making strategies among fourth-year medical students. Additional research using the Professional Decision-Making Measure should explore scores among physicians in various career stages, and the causes and correlates of scores. Educators could utilize the measure to assess courses that teach decision-making strategies

Assimilative, Autonomous, or Synergistic Visions: How Mediation Programs in Florida Address the Dilemma of Court Connection

Over the past twenty-five years, the state of Florida has been recognized across the United States as a leader in the development of court-connected alternative dispute resolution programs. Mediation, in particular, has flourished across the state, with one hundred eleven programs in place in family, civil, community, and dependency sectors. Administrative support and oversight for court-connected mediation programs are provided by The Florida Dispute Resolution Center (DRC) - the administrative arm of the Florida Supreme Court - housed within the Office of the State Courts Administrator. In collaboration with the DRC, we designed and conducted a benchmarking study of seven selected mediation programs in the family, civil and community sectors. Our focus in this article is on certain insights that emerged at the macro level regarding the very nature of court-connected mediation, as we analyzed and tried to develop explanations for our empirical findings. Specifically, we will address the fundamental value-based dilemma of court-connected mediation programs, three different approaches to addressing this dilemma through which mediation programs and the courts have forged their relationship in Florida, and some implications of these insights for practice and policy

Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability