In 2011, the Secretariat on Responsible Conduct of Research launched a set of educational opportunities to facilitate and enhance the dissemination of TCPS 2, the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, which guides Canadian research ethics. Three educational modalities were implemented to aid participants in developing or refining their ethical understanding and practice: Regional Workshops, which brought together diverse disciplinary perspectives; the CORE tutorial, which enabled individuals to discover the various aspects and applications (...) of the Policy; and Webinars, which provided participants with the opportunity to explore deeper dimensions of research ethics. This article reports on the findings of a national program evaluation team which measured the effectiveness of the educational program and provided recommendations for future opportunities. (shrink)

Volume 20, Issue 7, July 2020, Page 82-84.

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical (...) research to discover the most effective way to act on their moral sense. On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment. (shrink)

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

In this paper, we report on the development and validity of the Professional Decision-Making in Research 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 and parallel form (...) correlation. 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. (shrink)

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs of disciplines outside the biomedical sciences. (...) This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable. (shrink)

Research integrity is a continuously developing concept, and increasing emphasis is put on creating RI promotion practices. This study aimed to map the existing RI guidance documents at research performing organisations and research funding organisations. A search of bibliographic databases and grey literature sources was performed, and retrieved documents were screened for eligibility. The search of bibliographical databases and reference lists of selected articles identified a total of 92 documents while the search of grey literature sources identified 118 documents for (...) analysis. The retrieved documents were analysed based on their geographical origin, research field and organisational origin of RI practices, types of guidance presented in them, and target groups to which RI practices are directed. Most of the identified practices were developed for research in general, and are applicable to all research fields and medical sciences. They were mostly written in the form of guidelines and targeted researchers. A comprehensive search of the existing RI promotion practices showed that initiatives mostly come from RPOs while only a few RI practices originate from RFOs. This study showed that more RI guidance documents are needed for natural sciences, social sciences, and humanities since only a small number of documents was developed specifically for these research fields. The explored documents and the gaps in knowledge identified in this study can be used for further development of RI promotion practices in RPOs and RFOs. (shrink)

In this paper, we report on the development and validity of the Professional Decision-Making in Research 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 and parallel form (...) correlation. 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. (shrink)

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 questionnaire, which is an adaptation of the How I Think 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. Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement, cynicism, and professional decision-making in research. 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. (shrink)

Drawing on Pennock’s theory of scientific virtues, we are developing an alternative curriculum for training scientists in the responsible conduct of research that emphasizes internal values rather than externally imposed rules. This approach focuses on the virtuous characteristics of scientists that lead to responsible and exemplary behavior. We have been pilot-testing one element of such a virtue-based approach to RCR training by conducting dialogue sessions, modeled upon the approach developed by Toolbox Dialogue Initiative, that focus on a specific virtue, e.g., (...) curiosity and objectivity. During these structured discussions, small groups of scientists explore the roles they think the focus virtue plays and should play in the practice of science. Preliminary results have shown that participants strongly prefer this virtue-based model over traditional methods of RCR training. While we cannot yet definitively say that participation in these RCR sessions contributes to responsible conduct, these pilot results are encouraging and warrant continued development of this virtue-based approach to RCR training. (shrink)

Successfully navigating the norms of a society is a complex task that involves recognizing diverse kinds of rules as well as the relative weight attached to them. In the United States, different kinds of rules—federal statutes and regulations, scientific norms, and professional ideals—guide the work of researchers. Penalties for violating these different kinds of rules and norms can range from the displeasure of peers to criminal sanctions. We proposed that it would be more difficult for researchers working in the U.S. (...) who were born in other nations to distinguish the seriousness of violating rules across diverse domains. We administered a new measure, the evaluating rules in science task, to National Institutes of Health-funded investigators. The ERST assessed perceptions of the seriousness of violating research regulations, norms, and ideals, and allowed us to calculate the degree to which researchers distinguished between the seriousness of each rule category. The ERST also assessed researchers’ predictions of the seriousness that research integrity officers would assign to the rules. We compared researchers’ predictions to the seriousness ratings of 112 RIOs working at U.S. research-intensive universities. U.S.-born researchers were significantly better at distinguishing between the seriousness of violating federal research regulations and violating ideals of science, and they were more accurate in their predictions of the views of RIOs. Acculturation to the U.S. moderated the effects of nationality on accuracy. We discuss the implications of these findings in terms of future research and education. (shrink)