David E. Wright

MentOring and research misconduct: An analysis of research mentOring in closed Ori cases

We are reporting on how involved the mentor was in promoting responsible research in cases of research misconduct. We reviewed the USPHS misconduct files of the Office of Research Integrity. These files are created by Institutions who prosecute a case of possible research misconduct; ORI has oversight review of these investigations. We explored the role of the mentor in the cases of trainee research misconduct on three specific behaviors that we believe mentors should perform with their trainee: (1) review source data, (2) teach specific research standards and (3) minimize stressful work situations. We found that almost three quarters of the mentors had not reviewed the source data and two thirds had not set standards. These two behaviors are positively correlated. We did not see convincing evidence in the records that mentors were causing stress, but it was apparent in the convicted trainees’ confessions that over 50% experienced some kind of stress. Secondary data, while not created for this research purpose, allows us to look at concrete research behaviors that are otherwise not very researchable. We believe it is important for mentors and institutions to devote more attention to teaching mentors about the process of education and their responsibilities in educating the next generation of scientists. This becomes a critical issue for large research groups who need to determine who is in charge educating, supervising and assuring data integrity.

When do medical students become human subjects of research? The case of program evaluation.

Intense national dialogue exists around federal requirements protecting the rights of human subjects in clinical research. There is much less discussion surrounding protections for human subjects in such areas as evaluation research when the subjects are also students. Differential interpretation of 45 CFR 46 (the standing regulation on research involving human subjects) by institutional review boards (IRBs) leaves many confused about whether research using student data requires IRB review. At the heart of the uncertainty are “dual purpose activities,” for example, when student data from program evaluation or routine assessments subsequently become the basis for faculty scholarship that is disseminated as “generalizable knowledge” to the community of medical educators. The authors identify two factors that should be considered as institutions develop applications and interpretations of 45 CFR 46. First, medical educators should enter into dialogues with their IRBs to become more familiar with these regulations and their application in evaluation or assessment studies. Second, for reasons of professionalism, faculty should seek opportunities to model in their role as researchers those ethical behaviors that are central to an honest relationship between physician and patient. In the educational context this means faculty disclosure of how student data may be used by faculty in their own scholarship and determination of when student consent is needed. The authors also describe how one medical school addressed this thorny challenge with assistance from the university IRB and offer suggestions to improve institutional procedures.

Assessing the Preparedness of Research Integrity Officers (RIOs) to Appropriately Handle Possible Research Misconduct Cases

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. The responses to the allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs.

Methods for Practising Ethics in Research and Innovation: A Literature Review, Critical Analysis and Recommendations

This paper provides a systematic literature review, analysis and discussion of methods that are proposed to practise ethics in research and innovation (R&I). Ethical considerations concerning the impacts of R&I are increasingly important, due to the quickening pace of technological innovation and the ubiquitous use of the outcomes of R&I processes in society. For this reason, several methods for practising ethics have been developed in different fields of R&I. The paper first of all presents a systematic search of academic sources that present and discuss such methods. Secondly, it provides a categorisation of these methods according to three main kinds: (1) ex ante methods, dealing with emerging technologies, (2) intra methods, dealing with technology design, and (3) ex post methods, dealing with ethical analysis of existing technologies. Thirdly, it discusses the methods by considering problems in the way they deal with the uncertainty of technological change, ethical technology design, the identification, analysis and resolving of ethical impacts of technologies and stakeholder participation. The results and discussion of our literature review are valuable for gaining an overview of the state of the art and serve as an outline of a future research agenda of methods for practising ethics in R&I.