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

Establishing the need and identifying goals for a curriculum in medical business ethics: A survey of students and residents at two medical centers in Missouri

BACKGROUND: In recent years, issues in medical business ethics (MBE), such as conflicts of interest (COI), Medicare fraud and abuse, and the structure and functioning of reimbursement systems, have received significant attention from the media and professional associations in the United States. As a result of highly publicized instances of financial interests altering physician decision-making, major professional organizations and government bodies have produced reports and guidelines to encourage self-regulation and impose rules to limit physician relationships with for-profit entities. Nevertheless, no published curricula exist in the area of MBE. This study aimed to establish a baseline level of knowledge and the educational goals medical students and residents prioritize in the area of MBE. METHODS: 732 medical students and 380 residents at two academic medical centers in the state of Missouri, USA, completed a brief survey indicating their awareness of major MBE guidance documents, knowledge of key MBE research, beliefs about the goals of an education in MBE, and the areas of MBE they were most interested in learning more about. RESULTS: Medical students and residents had little awareness of recent and major reports on MBE topics, and had minimal knowledge of basic MBE facts. Residents scored statistically better than medical students in both of these areas. Medical students and residents were in close agreement regarding the goals of an MBE curriculum. Both groups showed significant interest in learning more about MBE topics with an emphasis on background topics such as “the business aspects of medicine” and “health care delivery systems”. CONCLUSIONS: The content of major reports by professional associations and expert bodies has not trickled down to medical students and residents, yet both groups are interested in learning more about MBE topics. Our survey suggests potentially beneficial ways to frame and embed MBE topics into the larger framework of medical education

Potentially Identifying Variables Reported in 100 Qualitative Health Research Articles: Implications for Data Sharing and Secondary Analysis

There is a growing trend in social science research to share qualitative data in a repository for others to access. However, some researchers are reticent to share qualitative data. One major concern is how to de-identify qualitative data while maintaining adequate contextual detail to allow secondary users to meaningfully interpret de-identified data. To help inform discussions regarding qualitative data sharing, we reviewed 100 qualitative health science studies to determine what potentially identifying variables (PIVs) are reported in the published literature. There are relatively few PIVs reported in each qualitative study; the majority of studies (n=64) reported two or fewer PIVs. The most commonly reported PIVs were profession, sex or gender, and age. Our findings can help guide de-identification efforts going forward as presumably the PIVs that are most commonly reported provide essential contextual details that will also be needed by secondary users, while PIVs that are rarely reported may not provide essential contextual information for interpretation of data. This suggests it is possible to share qualitative data that are both de-identified and useful for secondary analysis. As data are shared, we recommend researchers mask study sites, as these may uniquely increase the chance of re-identification.In der sozialwissenschaftlichen Forschung gibt es einen wachsenden Trend, qualitative Daten in einem Repository für andere zugänglich zu machen. Einige Forscher*innen sind jedoch zurückhaltend, wenn es um die Weitergabe qualitativer Daten geht. Ein Hauptproblem für sie ist die Frage, wie anonymisiert und gleichzeitig ein angemessener Detailkontext beibehalten werden kann, damit Sekundärnutzer*innen Daten sinnvoll interpretieren können. Um die Diskussion über die gemeinsame Nutzung qualitativer Daten zu unterstützen, haben wir 100 qualitative gesundheitswissenschaftliche Studien darauf hin untersucht, welche potenziell identifizierenden Variablen (PIVs) berichtet wurden. In der Mehrheit der Studien (n=64) waren es relativ wenige, nämlich max. zwei PIVs. Die am häufigsten berichteten PIVs waren Beruf, Geschlecht oder Gender und Alter. Unsere Ergebnisse können als Orientierungshilfe für künftige De-Identifizierungsbemühungen dienen, da die am häufigsten berichteten PIVs vermutlich wesentliche kontextbezogene Details liefern, die auch von Sekundärnutzer*innen benötigt werden, während PIVs, die selten berichtet werden, möglicherweise keine wesentlichen kontextbezogenen Informationen für die Interpretation von Daten enthalten. Dies deutet darauf hin, dass es möglich ist, qualitative Daten weiterzugeben, die sowohl de-identifiziert als auch für Sekundäranalysen nützlich sind. Bei der Weitergabe von Daten empfehlen wir, die Studienorte zu maskieren, da diese die Wahrscheinlichkeit einer Identifizierung erhöhen können

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

Curricular priorities for business ethics in medical practice and research: Recommendations from Delphi consensus panels

BACKGROUND: No published curricula in the area of medical business ethics exist. This is surprising given that physicians wrestle daily with business decisions and that professional associations, the Institute of Medicine, Health and Human Services, Congress, and industry have issued related guidelines over the past 5 years. To fill this gap, the authors aimed (1) to identify the full range of medical business ethics topics that experts consider important to teach, and (2) to establish curricular priorities through expert consensus. METHODS: In spring 2012, the authors conducted an online Delphi survey with two heterogeneous panels of experts recruited in the United States. One panel focused on business ethics in medical practice (n = 14), and 1 focused on business ethics in medical research (n = 12). RESULTS: Panel 1 generated an initial list of 14 major topics related to business ethics in medical practice, and subsequently rated 6 topics as very important or essential to teach. Panel 2 generated an initial list of 10 major topics related to business ethics in medical research, and subsequently rated 5 as very important or essential. In both domains, the panel strongly recommended addressing problems that conflicts of interest can cause, legal guidelines, and the goals or ideals of the profession. CONCLUSIONS: The Bander Center for Medical Business Ethics at Saint Louis University will use the results of the Delphi panel to develop online curricular resources for each of the highest rated topics. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1472-6920-14-235) contains supplementary material, which is available to authorized users

Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises

Protecting Patients from Physicians Who Inflict Harm: New Legal Resources for State Medical Boards

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary actions against physicians, including political and professional independence and adequate funding and staffing. However, there has been little attention paid to elements of the state level legal framework that governs SMB licensing and disciplinary function, or what legal or policy tools would make SMBs more effective at protecting patients in serious cases.This Article offers solutions in the form of model language with commentary for five high-impact statutory provisions that address board composition and function, reporting to the board, and adjudication of disciplinary matters. It brings together consensus recommendations from an expert panel, the results of legal mapping of relevant state laws, and original legal and policy analysis. The model provisions and commentary are intended to serve as a new resource for SMBs, state legislatures, and other policymakers to encourage and support examination of existing medical practice acts to improve SMB function and better protect patients from harmful physicians. Note:Funding Information: The research was supported by a grant from the Greenwall Foundation..Declaration of Interests: None to declare