Seeking help as a strategy for ethical and professional decision-making in research: Perspectives of researchers from East Asia and the United States.

Background: A person's cultural background shapes how they interpret and navigate problems. Given that large numbers of international researchers work and train in the U.S. we sought to better understand how researchers use the decision-making strategy of seeking help to navigate ethical and professional challenges.Methods: Participants (N = 300) were researchers working or training in the U.S. who were born in East Asia (EA) or born in the U.S. They completed a screening survey; then a subset completed think-aloud interviews (n = 66) focused on how they would respond to three hypothetical research scenarios.Results: Thematic analysis of the transcripts showed that seeking help was a commonly endorsed strategy, with some nuances between groups. Themes included seeking help in the form of getting advice, seeking someone to help solve the problem, and gathering information. Endorsement of the seeking help strategy frequently depended on participants' relationships; desiring to seek help from people they trusted. Notably, EA participants tended to prefer seeking help in ways that avoided reputational harm to others.Conclusion: A better understanding of how researchers from different cultural backgrounds use decision-making strategies can inform how to make educational programs more inclusive and comprehensive to more effectively develop researchers' ethical and professional decision-making skills.

Evaluating ApoL1 Genetic Testing Policy Options for Transplant Centers: A Delphi Consensus Panel Project with Stakeholders.

BACKGROUND: Apolipoprotein L1 (ApoL1) variants G1 and G2 are associated with a higher risk of kidney disease. ApoL1 risk variants are predominantly seen in individuals with sub-Saharan African ancestry. In most transplant centers, potential organ donors are being selectively genetically tested for ApoL1 risk variants. Transplant programs have highly variable ApoL1 testing practices and need guidance on essential ApoL1 clinical policy questions. METHODS: We conducted a Delphi consensus panel focused on ApoL1 clinical policy questions, including who gets tested, who decides whether testing occurs, how test results are shared, who receives test results, and how test results are used. A total of 27 panelists across seven stakeholder groups participated: living kidney donors ( n =4), deceased donor family members ( n =3), recipients of a deceased donor kidney ( n =4), recipients of a living donor kidney ( n =4), nephrologists ( n =4), transplant surgeons ( n =4), and genetic counselors ( n =4). Nineteen panelists (70%) identified as Black. The Delphi panel process involved two rounds of educational webinars and three rounds of surveys administered to panelists, who were asked to indicate whether they support, could live with, or oppose each policy option. RESULTS: The panel reached consensus on one or more acceptable policy options for each clinical policy question; panelists supported 18 policy options and opposed 15. Key elements of consensus include the following: ask potential donors about African ancestry rather than race; make testing decisions only after discussion with donors; encourage disclosure of test results to blood relatives and organ recipients but do not require it; use test results to inform decision making, but never for unilateral decisions by transplant programs. CONCLUSIONS: The panel generally supported policy options involving discussion and shared decision making among patients, donors, and family stakeholders. There was general opposition to unilateral decision making and prohibiting donation altogether.

Fairness and COVID: Conducting research during the crisis.

The COVID-19 pandemic forced Principal Investigators (PIs) to make rapid and unprecedented decisions about ongoing research projects and research teams. Confronted with vague or shifting guidance from institutional administrators and public health officials, PIs nonetheless had to decide whether their projects were "essential," who could conduct on-site "essential" research, how to continue research activities by remote means if possible, and how to safely and effectively manage personnel during the crisis. Based on both narrative comments from a federally sponsored survey of over a thousand NIH- and NSF-funded PIs and their personnel, as well as follow-up interviews with over 60 survey participants, this study examines various ways PI and institutional decisions raised issues of procedural and distributive fairness. These fairness issues include the challenge of treating research personnel fairly in light of their disparate personal circumstances and inconsistent enforcement of COVID-19-related directives. Our findings highlight aspects of fairness and equitability that all PIs and research administrators should keep in mind for when future research disruptions occur.

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.

Addressing serious and continuing research noncompliance and integrity violations through action plans: Interviews with institutional officials.

Serious and continuing research noncompliance and integrity violations undermine the quality of research and trust in science. When researchers engage in these behaviors, institutional officials (IOs) often develop corrective action plans. Ideally, such plans address the root causes so noncompliance or research integrity violations discontinue. The aim of this study was to identify what IOs perceive as causes and action plan activities typically prescribed. We conducted semi-structured in-depth interviews with 47 IOs at research institutions across the U.S. including: institutional review board and institutional animal care and use committee chairs and directors, chief research officers, research compliance and integrity officers, and institutional conflicts of interest chairs and directors. The most common root causes identified were: 1) lack of knowledge or training, 2) failure to provide research team supervision, and 3) researcher attitudes toward compliance. The most common action plan activities include: 1) retraining in compliance or research integrity, 2) follow-up and hands-on involvement with the researcher, and 3) mandated oversight or mentoring. Because the most commonly identified action plan activities fail to adequately address the majority of root causes, our findings suggest a need for IOs to rethink existing approaches to action plan development to more effectively target root causes.

A survey of solid organ transplant recipient attitudes and concerns regarding contraception and pregnancy.

INTRODUCTION: Many women who are solid organ transplant (SOT) recipients wish to have children after transplantation. Contraception is an important component of post-transplant planning and care, given the increased risk associated with post-transplant pregnancies. We sought to understand patient attitudes and concerns about post-transplant contraception and pregnancy. METHODS: Following a comprehensive literature review, our team developed a survey that was administered to female SOT recipients of childbearing age. We used descriptive and inferential statistics to characterize participant views RESULTS: A total of 243 transplant recipients completed the survey (80.7% response rate). The mean age of respondents was 37.5 years (±8.1 years), 66.7% were kidney recipients, and 40.7% were within the first year after transplant. The most common concerns among respondents included fetal and maternal health complications. Participants generally did not agree that transplant recipients should be advised to avoid pregnancy. There was strong support for shared decision-making about pregnancy after transplantation CONCLUSION: Understanding patient perspectives can help transplant providers make better care recommendations and support patient autonomy in reproductive decisions post-transplant. Given that there are some differences in views by transplant type, individualized conversations between patients and providers are needed.

What Can State Medical Boards Do to Effectively Address Serious Ethical Violations?

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team's larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

Receiving the Gift of Life: Stories from Organ Transplant Recipients.

This symposium includes thirteen personal narratives from people who have received at least one organ transplant from a living or deceased donor. These narratives foster better understanding of the experiences of life-saving organ recipients and their families, including post-transplant difficulties experienced-sometimes requiring multiple transplants. This issue also includes three commentaries by Macey L. Levan, Heather Lannon, and Vidya Fleetwood, Roslyn B. Mannon & Krista L. Lentine. Dr. Levan is a living kidney donor and associate professor of surgery and population health. She writes and teaches on organ transplant and has expertise and experience in governance at the federal level as a member of the board of directors for the U.S. Organ Procurement and Transplantation Network. Dr. Lannon is a social worker and transplant advocate. Her work and interest in the topic were inspired by her husband who needed a heart transplant. Dr. Fleetwood is a surgeon specializing in liver transplantation, pancreas transplantation, kidney transplantation, as well as living donor nephrectomy. Dr. Mannon is a nephrologist and professor of medicine, pathology and microbiology. Her work focuses on understanding and improving long-term kidney transplant outcomes for patients, donors, and caregivers. Dr. Lentine is a nephrologist specializing in treatment of adult patients with kidney disease. She is a researcher and co-chaired the international work group that developed guidelines for living donor kidney transplantation.

Responding to Sexual Abuse in Health Care: Development of a Guide for Patients.

This report details the development of a stakeholder- and evidence-informed online resource guide for patients that provides information to raise awareness about sexual abuse in health care, the value of chaperones, and options for responding to sexual abuse. The guide was developed to reflect lessons learned from 10 years of researching physician wrongdoing (ie, sexual violations, improper prescribing, and unnecessary invasive procedures), a 5-year National Institutes of Health-funded mixed-methods study of 280 cases of egregious wrongdoing in medicine, and an expert working group. Focus groups were conducted with 22 patients from diverse backgrounds to obtain feedback on the acceptability of the guide. Thematic analysis of the focus groups yielded 6 key themes: 1) empowering patients, 2) recognizing and responding to sexual abuse, 3) educating patients about reporting options, 4) educating patients on availability of chaperones, 5) balancing trust and mistrust, and 6) using simple language. Qualitative data from the focus groups (ie, audio files and detailed notes taken by the research team) suggested that the guide effectively informed and empowered patients to recognize and effectively respond to sexual misconduct in health care. The guide is publicly available and has been disseminated nationally to patient health advocates and public health agencies.

Impact of education on APOL1 testing attitudes among prospective living kidney donors.

It is unknown how providing prospective living donors with information about APOL1, including the benefits and drawbacks of testing, influences their desire for testing. In this study, we surveyed 102 participants with self-reported African ancestry and positive family history of kidney disease, recruited from our nephrology waiting room. We assessed views on APOL1 testing before and after presentation of a set of potential benefits and drawbacks of testing and quantified the self-reported level of influence individual benefits and drawbacks had on participants' desire for testing in the proposed context of living donation. The majority of participants (92%) were aware of organ donation and more than half (56%) had considered living donation. And though we found no significant change in response following presentation of the potential benefits and the drawbacks of APOL1 testing by study end significance, across all participants, "becoming aware of the potential risk of kidney disease among your immediate family" was the benefit with the highest mean influence (3.3±1.4), while the drawback with the highest mean influence (2.9±1.5) was "some transplant centers may not allow you to donate to a loved one". This study provides insights into the priorities of prospective living donors and suggests concern for how the information affects family members may strongly influence desires for testing. It also highlights the need for greater community engagement to gain a deeper understanding of the priorities that influence decision making on APOL1 testing.

Barriers and facilitators to qualitative data sharing in the United States: A survey of qualitative researchers.

Qualitative health data are rarely shared in the United States (U.S.). This is unfortunate because gathering qualitative data is labor and time-intensive, and data sharing enables secondary research, training, and transparency. A new U.S. federal policy mandates data sharing by 2023, and is agnostic to data type. We surveyed U.S. qualitative researchers (N = 425) on the barriers and facilitators of sharing qualitative health or sensitive research data. Most researchers (96%) have never shared qualitative data in a repository. Primary concerns were lack of participant permission to share data, data sensitivity, and breaching trust. Researcher willingness to share would increase if participants agreed and if sharing increased the societal impact of their research. Key resources to increase willingness to share were funding, guidance, and de-identification assistance. Public health and biomedical researchers were most willing to share. Qualitative researchers need to prepare for this new reality as sharing qualitative data requires unique considerations.

Development of a Resource Guide to Help Patients Receive Appropriate Care.

After 10 years researching physician wrongdoing (i.e., sexual violations, improper prescribing, and unnecessary procedures), we developed a resource guide to help patients receive appropriate care and respond to inappropriate care. We gathered evaluative patient feedback, engaged physicians, and disseminated the guide. It is available at beforeyourvisit.org.

Navigating Complex, Ethical Problems in Professional Life: a Guide to Teaching SMART Strategies for Decision-Making.

This article demonstrates how instructors of professionalism and ethics training programs can integrate a professional decision-making tool in training curricula. This tool can help trainees understand how to apply professional decision-making strategies to address the threats posed by a variety of psychological and environmental factors when they are faced with complex professional and ethical situations. We begin by highlighting key decision-making frameworks and discussing factors that may undermine the use of professional decision-making strategies. Then, drawing upon findings from past research, we present the "SMART" professional decision-making framework: seeking help, managing emotions, anticipating consequences, recognizing rules and context, and testing assumptions and motives. Next, we present a vignette that poses a complex ethical and professional challenge and illustrate how each professional decision-making strategy could or should be used by characters in the case. To conclude, we review a series of educational practices and pedagogical tools intended to help trainers facilitate trainee learning, retention, and application of "SMART" decision-making strategies.

Research Participant Views regarding Qualitative Data Sharing.

We found no studies in the United States that explored research participants' perspectives about sharing their qualitative data. We present findings from interviews with 30 individuals who participated in sensitive qualitative studies to explore their understanding and concerns regarding qualitative data sharing. The vast majority supported sharing qualitative data so long as their data were deidentified and shared only among researchers. However, they raised concerns about confidentiality if the data were not adequately deidentified and about misuse by secondary users if data were shared beyond the research community. These concerns, though, did not deter them from participating in research. Notably, participants hoped their data would be shared and may have expected or assumed this was already happening. While many could not recollect details about data-sharing plans for studies in which they participated, they trusted researchers and institutions to appropriately handle data sharing. If individuals view data sharing as an extension or integral part of their participation in qualitative research, then researchers may have a stronger obligation to share qualitative data than previously thought. Guidelines and tools to assist researchers and institutional review board members in ethical and responsible qualitative data sharing are urgently needed.

Are we ready to share qualitative research data? Knowledge and preparedness among qualitative researchers, IRB Members, and data repository curators.

Data sharing maximizes the value of data, which is time and resource intensive to collect. Major funding bodies in the United States (US), like the National Institutes of Health (NIH), require data sharing and researchers frequently share de-identified quantitative data. In contrast, qualitative data are rarely shared in the US but the increasing trend towards data sharing and open science suggest this may be required in future. Qualitative methods are often used to explore sensitive health topics raising unique ethical challenges regarding protecting confidentiality while maintaining enough contextual detail for secondary analyses. Here, we report findings from semi-structured in-depth interviews with 30 data repository curators, 30 qualitative researchers, and 30 IRB staff members to explore their experience and knowledge of QDS. Our findings indicate that all stakeholder groups lack preparedness for QDS. Researchers are the least knowledgeable and are often unfamiliar with the concept of sharing qualitative data in a repository. Curators are highly supportive of QDS, but not all have experienced curating qualitative data sets and indicated they would like guidance and standards specific to QDS. IRB members lack familiarity with QDS although they support it as long as proper legal and regulatory procedures are followed. IRB members and data curators are not prepared to advise researchers on legal and regulatory matters, potentially leaving researchers who have the least knowledge with no guidance. Ethical and productive QDS will require overcoming barriers, creating standards, and changing long held practices among all stakeholder groups.

Leading the people and leading the work: Practical considerations for ethical research.

Scientific work is demanding and complex, requiring those leading research to be simultaneously innovative and ethical in their work. Along with this, those leading scientific teams need to be able to influence both the work being done and lab members doing the work. Thus, both leadership and management skills are necessary to navigating the organizational, social, and ethical components of the research process in order to do rigorous, ethical, and high-quality scientific work. This paper recommends a number of practices that leaders of research teams should engage in, including management behaviors for "leading the work" and leadership behaviors for "leading the people" that foster excellence and integrity in research labs. Researchers can take an intentional approach to leadership and management to create a robust environment for ethical research. Overall, a researcher's routine behaviors as leaders of their labs should establish a healthy work environment and promote effective interpersonal interactions among lab members. Further, the lab requires routine procedures and structure to provide adequate oversight of the research. This paper also addresses challenges that may arise when implementing leadership and management practices, along with strategies for overcoming these strategies. Avenues for future research and policy development related to leadership and management in scientific contexts are discussed.

Self-Focused Emotions and Ethical Decision-Making: Comparing the Effects of Regulated and Unregulated Guilt, Shame, and Embarrassment.

Research has examined various cognitive processes underlying ethical decision-making, and has recently begun to focus on the differential effects of specific emotions. The present study examines three self-focused moral emotions and their influence on ethical decision-making: guilt, shame, and embarrassment. Given the potential of these discrete emotions to exert positive or negative effects in decision-making contexts, we also examined their effects on ethical decisions after a cognitive reappraisal emotion regulation intervention. Participants in the study were presented with an ethical scenario and were induced, or not induced, to feel guilt, shame, or embarrassment, and were asked to reappraise, or not reappraise, the situation giving rise to those emotions. Responses to questions about the ethical case were evaluated for the quality of ethical sensemaking, perceptions of moral intensity, and decision ethicality. Findings indicate that guilt, shame, and embarrassment are associated with different sensemaking processes and metacognitive reasoning strategies, and resulted in different perceptions of moral intensity. Additionally, cognitive reappraisal had a negative impact on each of these factors. Implications of these findings for ethical decision-making research are discussed.