Research as Profession and Practice: Frameworks for Guiding the Responsible Conduct of Research

Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims. By elucidating these features, these perspectives can serve to guide the development of RCR education programs.     

Student Projects in Medicine: A Lesson in Science and Ethics

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good researchers in the future. Furthermore, it is curious to want to change the system of ethics review specifically for students when it is the science that is at stake, and when the science now falls largely outside the ethics remit. I further show that ethics review is nevertheless important since students carry a new potential conflict of interests that warrants independent oversight which supervisory support does not offer. This potential conflict may become more morally troublesome the greater the risks to the subjects of the research, and students may impose greater risks on their subjects (relative to professional researchers) by virtue of being inexperienced, whatever the nature of the project. Pragmatic concerns may finally be allayed by organizing the current system more efficiently at critical times of the university calendar.     

Balancing Scientific and Community Interests in Community-Based Participatory Research

Community-based participatory research is an approach to studying human populations that emphasizes extensive partnerships between researchers and community members. While there are many advantages of this approach, it also faces a number of conceptual and practical challenges, one of which is managing the conflict that sometimes arises between promoting scientific and community interests. This essay explores the potential conflict between scientific and community interests in several different stages of community-based participatory research, including research design, data interpretation, and publication, and makes some suggestions for practice and policy. To manage potential conflicts between scientific and community interests, investigators and community partners should enter into written agreements at the beginning of the study. In some cases, it may be necessary for a third party, such as a review committee from a supporting institution, the community, or a funding agency, to help investigators and community partners resolve disagreements. It may also be useful, in some situations, to publish a dissenting opinion when investigators and community partners cannot agree on how to interpret findings resulting from a study. These strategies may help address some of the challenges of implementing community-based participatory research.     

Malaysian researchers talk about the influence of culture on research misconduct in higher learning institutions

Based on a previous survey by the Office of Research Integrity (ORI) in the USA, a considerable number of foreign research scientists have been found guilty of research misconduct. However, it remains unclear as to whether or not cultural factors really contribute to research misconduct. This study is based on a series of interviews with Malaysian researchers from the local universities regarding their own professional experiences involving working with researchers or research students from different countries or of different nationalities. Most of the researchers interviewed agreed that cultures do shape individual character, which influences the way that such individuals conduct research, their decision-making, and their style of academic writing. Our findings also showed that working culture within the institution also influences research practices, as well as faculty mentorship of the younger generation of researchers. Given the fact such misconduct might be due to a lack of understanding of research or working cultures or practices within the institution, the impact on the scientific community and on society could be destructive. Therefore, it is suggested that the institution has an important role to play in orienting foreign researchers through training, mentoring, and discussion with regard to the “does” and “don’ts” related to research, and to provide them with an awareness of the importance of ethics when it comes to conducting research.     

What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of “informational manipulation”; that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers’ and their sponsors’ financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

Dealing with Misconduct in Biomedical Research: A Review of the Problems and the Proposed Methods for Improvement

The increasing complexity of scientific research has been followed by increasing varieties of research misconduct. Dealing with misconduct involves the processes of detection, reporting, and investigation of misconduct. Each of these steps is associated with numerous problems which need to be addressed. Misconduct investigation should not stop with inquiries and disciplinary actions in specific episodes of misconduct. It is necessary to decrease the personal price paid by those who expose misconduct and to protect the personal and professional interests of honest researchers accused of misconduct unfairly or mistakenly. There is no dearth of suggestions to improve the objectivity and fairness of investigations. What is needed is the willingness to test the various options and implement the most suitable ones.     

Accessing a hard to reach population: reflections on research with young carers in Ireland

In keeping with developments in children's rights, research is increasingly including the views of children. Accessing a hard to reach population of children can, however, raise significant ethical and methodological challenges for researchers. Negotiating access through gatekeepers, securing parental consent and limits on confidentiality are central issues in the recruitment process of children. This paper is based on a qualitative study of young carers in the Irish population. It outlines the methodological approaches employed to access a representative sample of young carers and the measures taken to fulfil ethical obligations. In the recruitment phase of the study, researchers attempted to strike a balance between two sometimes competing requirements, the need to protect children from harm and to respect children's competence. This paper reflects on the success and limitations of the approaches adopted towards achieving this balance, exploring the use of gatekeepers as a method to identify and recruit a hidden population, and revisiting the measures taken to comply with the ethical requirements of parental consent and limits on confidentiality.     

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.     

Linking the university and the social agency in collaborative evaluation research: principles and examples

This paper presents an analysis of components of successful social work evaluation research practice. Among the key obstacles to successful evaluations of social work intervention are the impoverished knowledge base on which many social work interventions are based, the isolation of researchers and practitioners in the conduct of evaluations, and during research implementation failure to cope with the changing field context. To remedy this situation social work needs to invest in university and social agency partnerships focussed on knowledge building for the profession. In such partnerships the traditional roles of the researcher and the practitioner are altered so that shared responsibility for knowledge development is possible. In addition, to deal with changing field contexts the research team needs to be continuously engaged in problem solving and redesign. An initial example of such a partnership is described together with a case study illustrating implementation of a multi-site field experiment evaluation.     

The nature and quality of engineering research

Engineering is the application oí science to design and development of products intended for useful social purposes. Engineering research consists of a wide variety of activities ranging from study of material properties for possible future application to the testing necessary to establish design parameters or to verify the adequacy of new design concepts. Professors of engineering are generally expected to conduct research, preferably in the “engineering sciences”; (e.g. thermodynamics, metallurgy), to publish their results, and find their own sources of funding. Many private corporations maintain departments of research and development, the findings of which are often proprietary and not subject to peer review. Managers of engineering research projects attempt to assure the quality of their results by “instrumental”; or “organizational”; methods. Instrumental methods assure accuracy in data collection and processing, while organization methods maintain a work environment conducive to creativity and integrity among researchers. Organizational conditions can affect research quality adversely, by giving rise to ethical problems associated with conflicts between corporate interests and those of individuals.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Taking Financial Relationships into Account When Assessing Research

Many scientific journals, government agencies, and universities require disclosure of sources of funding and financial interests related to research, such as stock ownership, consulting arrangements with companies, and patents. Although disclosure has become one of the central approaches for responding to financial conflicts of interest (COIs) in research, critics contend that information about financial COIs does not serve as a reliable indicator of research credibility, and therefore, studies should be evaluated solely based on their scientific merits. We argue that, while it is indeed important to evaluate studies on their scientific merits, it is often difficult to detect significant influences of financial relationships that affect research credibility. Moreover, at least five factors can be examined to determine whether financial relationships are likely to enhance, undermine, or have no impact on the credibility of research. These include as follows: whether sponsors, institutions, or researchers have a significant financial stake in the outcome of a study; whether the financial interests of the sponsors, institutions, or researchers coincide with the goal of conducting research that is objective and reliable; whether the sponsor, institution, or researchers have a history of biasing research in order to promote their financial goals; how easy it is to manipulate the research in order to achieve financial goals; and whether oversight mechanisms are in place which are designed to minimize bias. Since these factors vary from case to case, evaluating the impact of financial relationships depends on the circumstances. In some situations, one may decide that the financial relationships significantly undermine the study's credibility; in others, one may decide that they have no impact on credibility or even enhance it.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

Institutional Pathology and the Death of Dan Markingson

In the spring of 2015, 11 years after a mentally ill young man named Dan Markingson stabbed himself to death in an industry-sponsored drug study, officials at the University of Minnesota suspended recruitment of subjects into drug trials in its Department of Psychiatry. University officials agreed to act only after a scathing investigation by Minnesota Office of the Legislative Auditor found damning evidence of coerced recruitment, inadequate clinical care, superficial research oversight, a web of serious, disturbing conflicts of interest, and a pattern of misleading public statements by university officials aimed at deflecting scrutiny. In this article, I examine the larger institutional factors leading up to Markingson’s suicide and prevented corrective action for so long.     

Emphasizing the experiences of researchers after RCR instructions: Introduction to Responsible Conduct of Research (RCR) in Malaysia

The purpose of this study is to highlight the experiences of individuals who participate in the Responsible Conduct of Research (RCR) training program held at various universities in Malaysia. In response to a mailing request sent to 40 individuals who had undertaken a RCR training program, 15 participants agreed to be interviewed. The results of the study showed that the three main reasons for participating in the training were as follows: anticipation for knowledge gained; personal experience with research misconduct; and establishing a new network of researchers. In terms of the positive effects gained from undertaking the training, the participants highlighted an increased awareness of the issues and problems related to research misconduct; the need to promote integrity in research conduct; a change in the way they conduct their research; and a change in the way they confront and address misconduct. The findings of this study should be valuable for policy makers and those involved in the management of research programs and ethics, as it demonstrated the importance of RCR training in equipping researchers with the necessary knowledge to conduct research responsibly, and to avoid research misconduct.     

Critical Commentary: Who Decides Now? Protecting and Empowering Vulnerable Adults Who Lose the Capacity to Make Decisions for Themselves

The implementation of the 2005 Mental Capacity Act in Englandand Wales heralds a new era for social work practitioners andresearchers. Protecting and empowering vulnerable adults—animportant element of adult-care social work—relies ona legal framework that attempts to balance adults’ rightswith the desire to protect them. The new Act is part of thatframework, addressing the fundamental issue of when and howdecisions can be made on behalf of people who lose decision-makingabilities (‘capacity’). The Act encompasses themeaning of incapacity and best interests, advance directivesconcerning treatment, managing people’s affairs and makingdecisions for them, overseeing the delegation process, and research.In explaining how the Act addresses some of these challenges,the article alerts practitioners and researchers to the keyareas in which the Act will make a major impact.     

Effective Practices in the Delivery of Research Ethics Education: A Qualitative Review of Instructional Methods

In order to delineate best practices for courses on research ethics, the goal of the present effort was to identify themes related to instructional methods reflected in effective research ethics and responsible conduct of research (RCR) courses. By utilizing a qualitative review, four themes relevant to instructional methods were identified in effective research ethics courses: active participation, case-based activities, a combination of individual and group approaches, and a small number of instructional methods. Three instructional method themes associated with less effective courses were also identified: passive learning, a group-based approach, and a large number of instructional methods. Key characteristics of each theme, along with example courses relative to each theme, are described. Additionally, implications regarding these instructional method themes and recommendations for best practices in research ethics courses are discussed.     

The Inappropriate Use of Risk-Benefit Analysis in the Risk Assessment of Experimental Trauma-Focused Research

A large body of research has explored the impact of questioning participants about traumatic experiences. To determine the level of risk, these studies have relied, to various degrees, upon a risk-benefit calculus, whereby risks are weighed against the benefits that an individual can receive from participating. In the case of trauma-focused studies this approach is erroneous. The procedures involved in trauma-focused studies do not meet the criteria to be considered therapeutic, and the benefits associated with these procedures do not carry the moral weight to offset risk. Applying the risk-benefit calculus to non-therapeutic procedures inevitably leads to inaccurate risk assessments and ethically problematic claims, examples of which can be found throughout traumatic stress literature. This article outlines how the standard approach to risk assessment in trauma-focused studies is fallacious, and presents an established alternative model that researchers can use to accurately assess the risks of asking participants about their traumatic experiences.     

The Challenges for Scientists in Avoiding Plagiarism

Although it might seem to be a simple task for scientists to avoid plagiarism and thereby an allegation of research misconduct, assessment of trainees in the Responsible Conduct of Research and recent findings from the National Science Foundation Office of Inspector General regarding plagiarism suggests otherwise. Our experiences at a land–grant academic institution in assisting researchers in avoiding plagiarism are described. We provide evidence from a university–wide multi–disciplinary course that understanding how to avoid plagiarism in scientific writing is more difficult than it might appear, and that a failure to learn the rules of appropriate citation may cause dire consequences. We suggest that new strategies to provide training in avoiding plagiarism are required.