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The environment researchers work in influences their ethical decisions and behavior. A "climate" for research ethics in a research lab exists when members of the lab perceive that the group values and is committed to principles of research ethics. In this study, we aimed to develop a short, reliable and valid measure assessing perceptions of climate for research ethics at the lab level. The resulting measure, Lab Climate for Research Ethics, was developed using standard scale development guidelines. In a large sample of postdoctoral researchers ( N = 570), we found preliminary evidence that the new measure has adequate internal consistency reliability. It was also correlated with an existing measure of climate for research ethics and was not correlated with social desirability, demonstrating evidence of construct validity. The new measure can be used in a variety of contexts, including research administrators seeking information about climate within labs across an institution and researchers who study lab environments.

We conducted semi-structured, telephone interviews with 52 federally funded researchers nominated as exemplars for their integrity and professional conduct, and their scientific achievements. The aim was to identify the practices they report utilizing to build respectful relationships in their teams. We found four practices, holding meetings, providing supervision and guidance, encouraging shared ownership, and expressing values, which were also important to performing high-quality, compliant research, were essential to fostering relationships. The most common practice described for building relationships was actively and deliberately cultivating a positive team environment. Additionally, exemplars described the need to lead by example, tailor their approach to the needs of individuals, address interpersonal conflict, and hire team members cautiously. We also identified practices the exemplars reported as important to managing the demands of their work and found that encouraging shared ownership and tailoring to individuals supported this goal. Additional strategies related to prioritization and planning, seeking advice, engaging in self-care, and managing emotional reactions. Finally, we identified priorities guiding the exemplars' practices. Key priorities included providing outstanding mentoring, building collaborations and relationships, and engaging in discovery and innovation. Investigators require exceptional leadership skills but receive limited systematic leadership training. Addressing this gap would advance research excellence and integrity.

The authors explore five dimensions of research ethics: (1) normative ethics, which includes meta-ethical questions; (2) compliance with regulations, statutes, and institutional policies; (3) the rigor and reproducibility of science; (4) social value; and (5) workplace relationships. Each of the five dimensions is important not only because it addresses an aspect of good research done in a good manner but also because it addresses the concerns of key stakeholders in the research enterprise. The five-dimension framework can guide institutions as they answer three questions central to any research ethics program: (1) Who should champion research ethics? (2) What should interventions look like? and (3) Who should participate in the interventions? The framework is valuable because the answers to these three questions are radically different depending on the dimension under consideration. An expanded vision of research ethics does not entail that institutions should require additional online training or approvals from institutional review boards. However, without acknowledging all five dimensions, programs risk missing an important aspect of research ethics or ignoring the interests of important stakeholders.

In this paper we describe the development and initial psychometric evaluation of a new measure, the values in scientific work (VSW). This scale assesses the level of importance that investigators attach to different VSW. It taps a broad range of intrinsic, extrinsic, and social values that motivate the work of scientists, including values specific to scientific work (e.g., truth and integrity) and more classic work values (e.g., security and prestige) in the context of science. Notably, the values represented in this scale are relevant to scientists regardless of their career stage and research focus. We administered the VSW and a measure of global values to 203 NIH-funded investigators. Exploratory factor analyses suggest the delineation of eight VSW, including autonomy, research ethics, social impact, income, collaboration, innovation and growth, conserving relationships, and job security. These VSW showed predictable and distinct associations with global values. Implications of these findings for work on research integrity and scientific misconduct are discussed.

Violations of rules and regulations in research can cause significant problems for human participants, animal subjects, data integrity, institutions, and investigators. The Professionalism and Integrity in Research Program (PI Program) provides remediation training that addresses the root causes of violations of rules and regulations in research. Through assessments, a three-day workshop, and follow-up coaching calls, the PI Program teaches evidence-based decision-making strategies designed to help researchers to compensate for bias, uncertainty, and work-related stress, and foster the skills needed to oversee research projects in today's complex regulatory environments. Across its first three years (2013-2015), the program trained 39 researchers from 24 different institutions in the United States. Participant evaluations of the program's faculty and workshop content were highly positive (4.7-4.8 and 4.5-4.6, respectively, on a 5-point scale). Preliminary program outcome assessment using validated measures of professional decision making and cognitive distortions in a pre- and postworkshop design indicated significant improvements. A follow-up survey of participants found statistically significant increases in a variety of target behaviors, including training research staff members to foster compliance and research quality, using standard operating procedures to support compliance and research integrity, performing self-audits of research operations, reducing job stressors, actively overseeing the work of the research team, and seeking help when experiencing uncertainty. Assessment of the PI Program was conducted with modest sample sizes, yet evaluation, outcome assessment, and self-reported survey data provided statistically significant evidence of effectiveness in achieving program goals.

Qualitative data provide rich information on research questions in diverse fields. Recent calls for increased transparency and openness in research emphasize data sharing. However, qualitative data sharing has yet to become the norm internationally and is particularly uncommon in the United States. Guidance for archiving and secondary use of qualitative data is required for progress in this regard. In this study, we review the benefits and concerns associated with qualitative data sharing and then describe the results of a content analysis of guidelines from international repositories that archive qualitative data. A minority of repositories provide qualitative data sharing guidelines. Of the guidelines available, there is substantial variation in whether specific topics are addressed. Some topics, such as removing direct identifiers, are consistently addressed, while others, such as providing an anonymization log, are not. We discuss the implications of our study for education, best practices, and future research.

In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research (HIT-Res) questionnaire, which is an adaptation of the How I Think (HIT) questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability (Cronbach's alpha = .92). Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement (r = .75), cynicism (r = .51), and professional decision-making in research (r = -.36). The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity., Competing Interests: Compliance with Ethical Standards Ethical Approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

In this paper, we report on the development and validity of the Professional Decision-Making in Research (PDR) measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability (alpha = .84) and parallel form correlation (r = .70). As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research.

Can scientists self-regulate effectively? The controversial select agent regulations, the recent implementation of U.S. dual-use research of concern policies, the funding moratorium on gain of function experiments, and the 2014 incidents at the Centers for Disease Control and Prevention all seem to suggest that the answer is a resounding "no." Yet history tells us that it is feasible. In this comprehensive history of the first iteration of the National Institutes of Health (NIH) Recombinant DNA Guidelines, we examine the principles, thoughts, and behaviors that resulted in successful self-regulation of scientific research for the past four decades and how engagement of scientists made it possible. Starting with a willingness on the part of researchers all over the world to pause exciting experiments, and with a genuine concern for public health, the individuals involved demonstrated unprecedented (and thus far never replicated) openness to dialogue with others from different disciplines, the media, and the public.

With supplement funding to the Washington University CTSA, the Restoring Professionalism and Integrity in Research (RePAIR) program was developed at Saint Louis University to meet the remediation needs of institutions nationwide regarding investigators who violate research regulations. With the aim of determining the frequency and kinds of wrongdoing at leading research institutions in the United States, as well as institutional responses and levels of interest in a formal remediation program, an online questionnaire was distributed by email to a research integrity officer (RIO) and institutional review board (IRB) chair at all medical schools and comprehensive doctoral institutions in the United States (N = 194). One hundred sixty-one individuals responded (44%) representing 66% of institutions. For those institutions that had both RIOs and IRB chairs responding, 96% had investigated at least one case over the past 2 years; the modal individual response was 3-5 cases, with a range from 0 to more than 16 cases. The most common forms of wrongdoing were violations of procedure, informed consent, research integrity (fabrication, falsification, plagiarism), privacy, and conflict of interest policies. Most RIOs and IRB chairs expressed interest in the RePAIR program, despite concerns about costs and faculty resistance., (© 2013 Wiley Periodicals, Inc.)

Community engagement is increasingly becoming an integral part of research. "Community-engaged research" (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We--a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR--have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.

"Ethical disasters" or egregious violations of professional ethics in medicine often receive substantial amounts of publicity, leading to mistrust of the medical system. Efforts to understand wrongdoing in medical practice and research are hampered by the absence of a clear taxonomy. This article describes the authors' process of developing a taxonomy based on (1) reviews of academic literature, ethics codes, government regulations, and cases of wrongdoing; (2) consultation with experts in health law and healthcare ethics; and (3) application of the taxonomy to published cases of wrongdoing in medical research and practice. The resulting taxonomy includes 14 categories of wrongdoing in medical practice and 15 categories of wrongdoing in medical research. This taxonomy may be useful to oversight bodies, researchers who seek to understand and reduce the prevalence of wrongdoing in medicine, and librarians who index literature on wrongdoing., (Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: To describe community-engaged research (CEnR) and how it may improve the quality of a research study while addressing ethical concerns that communities may have with mental health and substance abuse research. This article includes a review of the literature as well as recommendations from an expert panel convened with funding from the US National Institute of Mental Health., Recent Findings: CEnR represents a broad spectrum of practices, including representation on institutional ethics committees, attitude research with individuals from the study population, engaging community advisory boards, forming research partnerships with community organizations, and including community members as co-investigators., Summary: CEnR poses some challenges; for example, it requires funding and training for researchers and community members. However, it offers many benefits to researchers and communities, and some form of CEnR is appropriate and feasible in nearly every study involving human participants.

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.

In an effort to increase the number of researchers with skills "in identifying and addressing the ethical, legal, and social implications of their research," the National Institutes of Health (NIH) solicited training grant proposals from 1999 to 2004 and subsequently funded approved programs. The authors describe the content, format, and outcomes of one such training program that ran from 2002 to 2006 and share key lessons learned about program formats and assessment methods. Jointly developed by the Saint Louis University Center for Health Care Ethics and the Missouri Institute of Mental Health Continuing Education department, the training program focused on mental health research and adopted a train-the-trainer model. It was offered in on-site and distance-learning formats. Key outcomes of the program included educational products (such as 70 case studies posted on the course Web site, a textbook, and an instructional DVD) and program completion by 40 trainees. Assessment involved pre- and posttesting focused on knowledge of research ethics, ethical problem-solving skills, and levels of confidence in addressing ethical issues in mental health research. The program succeeded in increasing participants' knowledge of ethical issues and their beliefs that they could identify issues, identify problem-solving resources, and solve ethical problems. However, scores on the case-based problem-solving assessment dropped in posttesting, apparently because of diminished confidence about the right course of action in the specific dilemma presented; the implications of this finding for ethics assessment are discussed. Overall satisfaction was high, and dropout rates were low but three times higher for distance-learners than for on-site participants.

Participants in substance abuse research may be vulnerable for multiple reasons. International research ethics guidelines and policy statements require that researchers provide extra protections when conducting research with vulnerable subjects, but it is uncertain which measures best protect vulnerable individuals. Concerns about vulnerability have been translated into only the vaguest regulatory requirements, and very little empirical data exist to guide researchers and ethics review committee members who want to protect participants. This article reviews two bodies of substance abuse research ethics literature. First, "normative" articles, that is, articles that discuss ethical issues that may arise in substance abuse research, are discussed. The resulting taxonomy of ethical issues then guides a review of empirical studies on issues like the informed consent process and the use of financial incentives in substance abuse research. While the ethical issues in substance abuse research are numerous and well-documented, the evidentiary base for addressing these issues is inadequate. If any one major theme emerged from the existing studies, it is that many well-intentioned, protectionist concerns--about recruitment incentives, consent comprehension, and drug administration studies--are not supported by empirical data. While these findings are at best tentative, they suggest how research on research ethics might ultimately benefit participants.

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs--now mandated by IRBs--offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality.