Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working (...) in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

Research integrity (RI) is defined as adherence to ethical principles, deontological duties, and professional standards necessary for responsible conduct of scientific research. Early training on RI, especially for early-career researchers, could be useful to help develop good standards of conduct and prevent research misconduct (RM).The aim of this study is to assess the effectiveness of a training course on RI, by mapping the attitudes of early-career researchers on this topic through a questionnaire built upon the revised version of the Scientific (...) Misconduct Questionnaire and administered to all participants at the beginning and at the end of the course.Results show that after the course, participants reporting a high understanding of the rules and procedures related to RM significantly increased (pre-course: 38.5%, post-course: 61.5%), together with the percentage of those reporting a lack of awareness on the extent of misconduct (pre-course: 46.2%, post-course: 69.2%), and of those who believe that the lack of research ethics consultation services strongly affects RM (pre-course: 15.4%, post-course: 61.5%). Early-career researchers agree on the importance to share with peers and superiors any ethical concern that may arise in research, and to create a work environment that fosters RI awareness.As a whole, results suggest the effectiveness of the course. Institutions should introduce RI training for early-career researchers, together with research methodology, integrity and ethics consultation services to support them. Senior scientists should promote RI into their research practices, and should stimulate engagement in peer-to-peer dialogue to develop good practices based on RI principles. (shrink)

Recent disputes over the NIH Neuroethics Roadmap have revealed underlying tensions between neuroethics and the broader neuroscience community. These controversies should spur neuroethicists to more clearly articulate an oft-cited ideal of “integrating” neuroethics in neuroscience. In this, it is useful to consider the integration of bioethics in medical practice as both historical precedent and context for integration in neuroethics. Bioethics began as interdisciplinary scholars joined biomedical institutions to serve on newly-created IRBs and hospital ethics committees. These early bioethicists identified as (...) outsiders and their presence was initially resisted by some in the medical establishment, but over time they became integrated into the very institutions that many had originally come to critique. This work has transformed medical practice, but also required compromises and intellectual costs. Also, the successful integration of bioethics relied in part on structural features of postwar medicine with no clear analogue in contemporary neuroscience; for neuroethics, imaginative new approaches will also be needed. While neuroethics to date has focused somewhat narrowly on questions in neurotechnology, I argue that successful integration in neuroethics will likely require a broader vision, encompassing the clinical neurosciences as well as questions at the interface of neuroscience and society. (shrink)

Research-oriented universities are known for prolific research activity that is often supported by students in faculty-guided research. To maintain ethical standards, universities require on-going training of both faculty and students to ensure Responsible Conduct of Research (RCR). However, previous research has indicated RCR-based training is insufficient to address the ethical dilemmas that are prevalent within academic settings: navigating issues of authorship, modeling relationships between faculty and students, minimization of risk, and adequate informed consent. U.S. universities must explore ways to identify (...) and improve RCR concerns for current (faculty) and future researchers (students). This article reports the findings of a self-study (_N_ = 50) of research stakeholders (students and faculty) at a top tier research institution. First, we report on their perceived importance of applying RCR principles. Second, we explore relationships between stakeholder backgrounds (e.g., prior training, field, and position) and how they ranked the degree of ethical concerns in fictitious vignettes that presented different unethical issues university students could encounter when conducting research. Vignette rankings suggested concerns of inappropriate relationships, predatory authorship and IRB violations which were judged as most unethical, which was dissimilar to what sampled researchers reported in practice as the most important RCR elements to understand and adhere to for successful research. Regression models indicated there was no significant relationship between individuals’ vignette ethics scores and backgrounds, affirming previous literature suggesting that training can be ineffectual in shifting researcher judgments of ethical dilemmas. Recommendations for training are discussed. (shrink)

The role of research ethics consultants in biomedical research has increased to the point that they have an advisory capacity at all research institutes. For such professionals, we have established an educational system, which includes teaching materials, training methods, and nationwide educational workshops. These workshops have served to examine the developed system’s usefulness and to provide realistic training for consultant candidates. In addition, we have used the current workshop to encourage clinical research investigators to participate. Subsequently, we examined its usefulness (...) as an opportunity to provide exposure to research ethics. In October 2019, we held a 1-day pilot workshop in Tokushima, Japan, which included a basic lecture in research ethics. During the lecture, two sets of materials were used for case discussion: case 1, covering issues related to a clinical trial, and case 2, covering issues related to human biological specimens. At the end of the workshop, a 30-item self-reporting anonymous questionnaire was provided. Of the 13 total participants, 9 were clinical research investigators and related personnel, while 6 had no direct intention to act as consultants. Respondents indicated that case 2 was more difficult than case 1. However, both cases were generally accepted as educational materials; thus, satisfaction was expressed in relation to both. As the evaluations of the cases were generally positive, we will further examine the usefulness of participation in the workshop in the cultivation of research ethics in the investigator community. (shrink)

For over three decades, clinical ethicists in the United States have recorded their consulting activities to supplement documentation in the medical record, often using locally developed instrument...

Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.

Protection of study participants is an integral function of the Institutional Review Board. Recently, great efforts were dedicated to enhance investigators’ awareness of ethical principles in conducting human research and to implement reviewing committees’ standards in Jordan to ensure the transparency, versatility, and responsibility in handling human subjects research in the country. The aim of the current study is to evaluate the awareness and attitudes of healthcare investigators in Jordan towards the structure and importance of IRBs. A questionnaire was distributed (...) to 200 investigators and graduate students from the Jordan University of Science and Technology. The majority of the responses indicated positive knowledge towards core ethics guidelines and the importance of IRBs. This includes beneficence, confidentiality, informed consent, and treating participants with respect. In addition, the majority of participants agreed on the importance of the IRB for ensuring the rights, safety, and well-being of the research subjects. Moreover, the majority of participants agreed that the IRB members should be trained on ethics regulations in conducting research and declare any conflict of interest with the investigators. On the other hand, about 30% of participants believed that being reviewed by the IRB would delay research and make it more difficult for the researcher. Jordanian investigators have good awareness of and knowledge about research ethics and the importance of IRBs, though more education is needed. (shrink)