- Email: [email protected]
An Ecological View of Research Misconduct
Ann Thorac Surg 2015;100:1534–40
ETHICS IN CARDIOTHORACIC SURGERY BANDO ET AL SCIENTIFIC INTEGRITY IN CLINICAL RESEARCH
1537
HOW EXPENSIVE IS SUSTAINED MORAL COMMITMENT? Moral progress requires change in vision and habit. Behaving ethically requires seeing the right outcome and overcoming institutional and structural barriers. Although Bando and colleagues’ [1] vision is laudable, the changes it suggests to our education habits may entail unbearable costs. Bando’s third proposal is to cultivate “the moral commitment of investigators to maintain scientific integrity. throughout their educational and professional careers.” What type of training should be required? How many should undergo it? And, what are its costs? Presumably, cultivating moral commitments requires training in ethics. Taking the University of California for example, currently, earning degrees in molecular biology (BS), medicine (MD), and biomedical sciences (PhD) requires 17 science, technology, engineering, or mathematics (STEM) courses and 13 liberal arts courses as an undergraduate, 2 years of basic science courses in medical school, and 9 STEM courses and 1 course in Ethical Conduct of Science in graduate school. Treating the basic science core as 16 STEM courses, the BS/MD/PhD thus requires 71% (34 of 48) STEM coursework, 27% (13 of 48) non-STEM coursework, and 2% (1 of 48) research ethics coursework. Cultivating the moral commitment Bando and colleagues envisions seems to call for a substantial increase from this status quo, such as between a doubling and an order of magnitude, or approximately 5 courses. How many people would take these courses, and who would teach them? National Center for Education statistics show approximately 425,000 degrees were awarded in STEM fields in 2012 to 2013. Assuming each degree represents a student, the number of students stays constant, and each student completes 1.5 ethics courses; then, to meet a 5-course ethics requirement for doctoral researchers, approximately 637,500 students would need to take an ethics course annually. To meet this demand, approximately 25,000 ethics classes would be needed (class size of 25 students). There are approximately 1,600 United States universities that could meet this demand; equally distributed, this means 15 additional ethics courses per institution annually, translating to 5 courses per year, or 3 new ethics faculty per institution.
This is a structural and institutional barrier entailed by Bando and colleagues’ proposal that we lack personnel to overcome. According to the American Philosophical Association, approximately 2,500 graduate degrees in philosophy are conferred annually. Given the field’s breadth, perhaps 20% of graduates have the competency to meet Bando and colleagues’ educational vision. If only 500 qualified individuals graduate annually, it could take a decade to fill the 4,800-person labor shortage. If educators earned a $60,000 base salary on average, meeting the demand could cost $360 million annually. Funding and ingenuity are necessary to overcome these barriers. For example, existing policy mechanisms, such as the Presidential Commission for the Study of Bioethical Issues, could develop national curricula. National institutions, such as the National Institutes of Health, National Science Foundation, and National Institute of Mental Health, could fund growth in qualified educators, and novel in-person and online curriculum designs could result in higher efficiency, reducing the number of educators required. I agree with Bando and colleagues’ proposal: improving researchers’ moral commitment to scientific integrity warrants longitudinal educational improvements. But we will not make the moral progress it envisions unless we pay the costs of changing our institutional and structural habits. Thomas V. Cunningham, PhD Division of Medical Humanities and Department of Internal Medicine University of Arkansas for Medical Sciences 4301 W Markham St, No. 646 Little Rock, AR 72205 e-mail: [email protected] http://dx.doi.org/10.1016/j.athoracsur.2015.08.042
Reference 1. Bando K, Schaff HV, Sato T, Hashimoto K, Cameron DE. A multidisciplinary approach to ensure scientific integrity in clinical research. Ann Thorac Surg 2015;100:1534–40.
AN ECOLOGICAL VIEW OF RESEARCH MISCONDUCT In their thoughtful commentary, Bando and colleagues [1] consider several ways to prevent/decrease scientific misconduct, defined as “fabrication, falsification, and plagiarism” (FFP). In assessing “factors that lead researchers to engage in scientific misconduct,” Bando and colleagues have lost sight of the forest for the trees. They focus their gaze strictly on the production of the research itself and thus incorrectly conclude that what is needed is a ramping up of existing institutional compliance mechanisms: more research ethics training, Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
more research oversight, more external peer review, etc. As such two of their major recommendations include establishing “a system like that of the Office of Research Integrity (ORI). in each research institution.” and “successful completion of RCR training. for clinical investigators before the submission of any manuscript.” In contrast, an ecological understanding of research misconduct looks beyond particular institutions and compliance regimens and recognizes the codependent relations between researchers and publishers of
0003-4975/$36.00
1538
ETHICS IN CARDIOTHORACIC SURGERY BANDO ET AL SCIENTIFIC INTEGRITY IN CLINICAL RESEARCH
research, and between research publication and financial rewards: publication bonuses, future research funding, paid advisory boards, and so forth. In other words, so long as publication leads to funding and so long as unethical research practices advance publication without a significant downside, the observed increases in retracted papers and problems of reproducibility, as well as more blatant misconduct, are likely to continue. At a minimum, in order to sever the link between FFP and publication, retracted papers that are the result of willful intent to deceive or negligent supervision should not be republished after retraction; the underlying study (or relevant portion) should have to be redone by different researchers to be republishable. I am speaking here not of retracted papers that are timely corrections of unwilling errors; these could, in principle, be republished with appropriate notes by a willing journal [2, 3]. A second aspect of an ecological understanding is the degrading effect of failures of integrity on institutional and professional values. Research is a mentored profession, one in which the close relationships between mentors and mentees can also be corrupting and, for less powerful members, inescapable. This is one reason organizations, such as the military and many large corporations, regularly dismantle teams and reassign them to prevent undesirable behaviors from going undetected and from becoming endemic. Career paths that do not depend on a single relationship or laboratory should be encouraged and rewarded in science as well. Finally, failures of research integrity are costly, both to the research enterprise and to the patients and families who participate in research or are consumers of the products of research [4, 5]. It is time to hold individual researchers accountable for their failures of research integrity, including being accountable in the literal sense for the negative externalities such as additional peer reviews, investigations, promising lines of research aborted, dubious research resourced, research subjects
Ann Thorac Surg 2015;100:1534–40
and patients harmed, and so forth. Investigators who are found to have fabricated or falsified data must refund any personal compensation over and above basic salary associated with the study in question—bonus, award, indirect payments, etc. (Because plagiarism has different ethical consequences I exclude it here). An institution should use such refunded amounts first, to publicize the retraction and second, to repeat or correct the study with another research team. The recommendations above are steps toward making scientific misconduct less likely by considering the larger ecological context and reward system in which FFP thrives. Robin N. Fiore, PhD University of Miami Miller School of Medicine Bioethics Program 1400 NW 10th Ave, Ste 912 PO Box 016960 (M825) Miami, FL 33136 e-mail: rfi[email protected] http://dx.doi.org/10.1016/j.athoracsur.2015.08.040
References 1. Bando K, Schaff HV, Sato T, Hashimoto K, Cameron DE. A multidisciplinary approach to ensure scientific integrity in clinical research. Ann Thorac Surg 2015;100:1534–40. 2. Van Noorden R. The trouble with retractions. Nature 2011;478: 26–8. 3. Fang FC, Casadevall A. Retracted science and the retraction index. Infect Immun 2011;79:3855–9. 4. Haberman C. A discredited vaccine study’s continuing impact on public health. N Y Times, Feb 1, 2015. Available at http:// www.nytimes.com/2015/02/02/us/a-discredited-vaccine-studyscontinuing-impact-on-public-health.html?_r¼0. Accessed August 12, 2015. 5. Zarychanski R, Abou-Setta AM, Turgeon AF, et al. Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation systematic review and meta-analysis. JAMA 2013;309:678–88.
ADDRESSING SCIENTIFIC INTEGRITY THROUGH EDUCATION IN THE RESPONSIBLE CONDUCT OF RESEARCH Bando and colleges [1] highlight the fact that the incidence of academic misconduct in published clinical research has been increasing during the past decade. The reasons for this misconduct are multifactorial, and as such, there is no single solution to addressing this important issue. Bando and colleges suggest four sound proposals, for which we wish to discuss the third—the establishment of a solid research training system. Before the institution of any systemic measures to address scientific integrity, one must first begin with establishing a clear understanding of the problem itself, and we therefore agree that further work needs to be done in education and training. However, many medical schools have already introduced courses in Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
evidence-based medicine at a time when there is increasing pressure to master a growing body of medical knowledge [2, 3]. In addition, there may be significant lag time between graduate or postgraduate training and the time when a student will become the primary investigator in a study. We therefore feel that the most effective solution to providing education in scientific misconduct would be to design a research training system administered through the major medical journals or societies using a Web-based curriculum. This curriculum will have at its core the already developed and successful “responsible conduct of research training program” [4]. Successful completion of the curriculum would be a condition for publication. 0003-4975/$36.00
ETHICS IN CARDIOTHORACIC SURGERY BANDO ET AL SCIENTIFIC INTEGRITY IN CLINICAL RESEARCH
1537
HOW EXPENSIVE IS SUSTAINED MORAL COMMITMENT? Moral progress requires change in vision and habit. Behaving ethically requires seeing the right outcome and overcoming institutional and structural barriers. Although Bando and colleagues’ [1] vision is laudable, the changes it suggests to our education habits may entail unbearable costs. Bando’s third proposal is to cultivate “the moral commitment of investigators to maintain scientific integrity. throughout their educational and professional careers.” What type of training should be required? How many should undergo it? And, what are its costs? Presumably, cultivating moral commitments requires training in ethics. Taking the University of California for example, currently, earning degrees in molecular biology (BS), medicine (MD), and biomedical sciences (PhD) requires 17 science, technology, engineering, or mathematics (STEM) courses and 13 liberal arts courses as an undergraduate, 2 years of basic science courses in medical school, and 9 STEM courses and 1 course in Ethical Conduct of Science in graduate school. Treating the basic science core as 16 STEM courses, the BS/MD/PhD thus requires 71% (34 of 48) STEM coursework, 27% (13 of 48) non-STEM coursework, and 2% (1 of 48) research ethics coursework. Cultivating the moral commitment Bando and colleagues envisions seems to call for a substantial increase from this status quo, such as between a doubling and an order of magnitude, or approximately 5 courses. How many people would take these courses, and who would teach them? National Center for Education statistics show approximately 425,000 degrees were awarded in STEM fields in 2012 to 2013. Assuming each degree represents a student, the number of students stays constant, and each student completes 1.5 ethics courses; then, to meet a 5-course ethics requirement for doctoral researchers, approximately 637,500 students would need to take an ethics course annually. To meet this demand, approximately 25,000 ethics classes would be needed (class size of 25 students). There are approximately 1,600 United States universities that could meet this demand; equally distributed, this means 15 additional ethics courses per institution annually, translating to 5 courses per year, or 3 new ethics faculty per institution.
This is a structural and institutional barrier entailed by Bando and colleagues’ proposal that we lack personnel to overcome. According to the American Philosophical Association, approximately 2,500 graduate degrees in philosophy are conferred annually. Given the field’s breadth, perhaps 20% of graduates have the competency to meet Bando and colleagues’ educational vision. If only 500 qualified individuals graduate annually, it could take a decade to fill the 4,800-person labor shortage. If educators earned a $60,000 base salary on average, meeting the demand could cost $360 million annually. Funding and ingenuity are necessary to overcome these barriers. For example, existing policy mechanisms, such as the Presidential Commission for the Study of Bioethical Issues, could develop national curricula. National institutions, such as the National Institutes of Health, National Science Foundation, and National Institute of Mental Health, could fund growth in qualified educators, and novel in-person and online curriculum designs could result in higher efficiency, reducing the number of educators required. I agree with Bando and colleagues’ proposal: improving researchers’ moral commitment to scientific integrity warrants longitudinal educational improvements. But we will not make the moral progress it envisions unless we pay the costs of changing our institutional and structural habits. Thomas V. Cunningham, PhD Division of Medical Humanities and Department of Internal Medicine University of Arkansas for Medical Sciences 4301 W Markham St, No. 646 Little Rock, AR 72205 e-mail: [email protected] http://dx.doi.org/10.1016/j.athoracsur.2015.08.042
Reference 1. Bando K, Schaff HV, Sato T, Hashimoto K, Cameron DE. A multidisciplinary approach to ensure scientific integrity in clinical research. Ann Thorac Surg 2015;100:1534–40.
AN ECOLOGICAL VIEW OF RESEARCH MISCONDUCT In their thoughtful commentary, Bando and colleagues [1] consider several ways to prevent/decrease scientific misconduct, defined as “fabrication, falsification, and plagiarism” (FFP). In assessing “factors that lead researchers to engage in scientific misconduct,” Bando and colleagues have lost sight of the forest for the trees. They focus their gaze strictly on the production of the research itself and thus incorrectly conclude that what is needed is a ramping up of existing institutional compliance mechanisms: more research ethics training, Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
more research oversight, more external peer review, etc. As such two of their major recommendations include establishing “a system like that of the Office of Research Integrity (ORI). in each research institution.” and “successful completion of RCR training. for clinical investigators before the submission of any manuscript.” In contrast, an ecological understanding of research misconduct looks beyond particular institutions and compliance regimens and recognizes the codependent relations between researchers and publishers of
0003-4975/$36.00
1538
ETHICS IN CARDIOTHORACIC SURGERY BANDO ET AL SCIENTIFIC INTEGRITY IN CLINICAL RESEARCH
research, and between research publication and financial rewards: publication bonuses, future research funding, paid advisory boards, and so forth. In other words, so long as publication leads to funding and so long as unethical research practices advance publication without a significant downside, the observed increases in retracted papers and problems of reproducibility, as well as more blatant misconduct, are likely to continue. At a minimum, in order to sever the link between FFP and publication, retracted papers that are the result of willful intent to deceive or negligent supervision should not be republished after retraction; the underlying study (or relevant portion) should have to be redone by different researchers to be republishable. I am speaking here not of retracted papers that are timely corrections of unwilling errors; these could, in principle, be republished with appropriate notes by a willing journal [2, 3]. A second aspect of an ecological understanding is the degrading effect of failures of integrity on institutional and professional values. Research is a mentored profession, one in which the close relationships between mentors and mentees can also be corrupting and, for less powerful members, inescapable. This is one reason organizations, such as the military and many large corporations, regularly dismantle teams and reassign them to prevent undesirable behaviors from going undetected and from becoming endemic. Career paths that do not depend on a single relationship or laboratory should be encouraged and rewarded in science as well. Finally, failures of research integrity are costly, both to the research enterprise and to the patients and families who participate in research or are consumers of the products of research [4, 5]. It is time to hold individual researchers accountable for their failures of research integrity, including being accountable in the literal sense for the negative externalities such as additional peer reviews, investigations, promising lines of research aborted, dubious research resourced, research subjects
Ann Thorac Surg 2015;100:1534–40
and patients harmed, and so forth. Investigators who are found to have fabricated or falsified data must refund any personal compensation over and above basic salary associated with the study in question—bonus, award, indirect payments, etc. (Because plagiarism has different ethical consequences I exclude it here). An institution should use such refunded amounts first, to publicize the retraction and second, to repeat or correct the study with another research team. The recommendations above are steps toward making scientific misconduct less likely by considering the larger ecological context and reward system in which FFP thrives. Robin N. Fiore, PhD University of Miami Miller School of Medicine Bioethics Program 1400 NW 10th Ave, Ste 912 PO Box 016960 (M825) Miami, FL 33136 e-mail: rfi[email protected] http://dx.doi.org/10.1016/j.athoracsur.2015.08.040
References 1. Bando K, Schaff HV, Sato T, Hashimoto K, Cameron DE. A multidisciplinary approach to ensure scientific integrity in clinical research. Ann Thorac Surg 2015;100:1534–40. 2. Van Noorden R. The trouble with retractions. Nature 2011;478: 26–8. 3. Fang FC, Casadevall A. Retracted science and the retraction index. Infect Immun 2011;79:3855–9. 4. Haberman C. A discredited vaccine study’s continuing impact on public health. N Y Times, Feb 1, 2015. Available at http:// www.nytimes.com/2015/02/02/us/a-discredited-vaccine-studyscontinuing-impact-on-public-health.html?_r¼0. Accessed August 12, 2015. 5. Zarychanski R, Abou-Setta AM, Turgeon AF, et al. Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation systematic review and meta-analysis. JAMA 2013;309:678–88.
ADDRESSING SCIENTIFIC INTEGRITY THROUGH EDUCATION IN THE RESPONSIBLE CONDUCT OF RESEARCH Bando and colleges [1] highlight the fact that the incidence of academic misconduct in published clinical research has been increasing during the past decade. The reasons for this misconduct are multifactorial, and as such, there is no single solution to addressing this important issue. Bando and colleges suggest four sound proposals, for which we wish to discuss the third—the establishment of a solid research training system. Before the institution of any systemic measures to address scientific integrity, one must first begin with establishing a clear understanding of the problem itself, and we therefore agree that further work needs to be done in education and training. However, many medical schools have already introduced courses in Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
evidence-based medicine at a time when there is increasing pressure to master a growing body of medical knowledge [2, 3]. In addition, there may be significant lag time between graduate or postgraduate training and the time when a student will become the primary investigator in a study. We therefore feel that the most effective solution to providing education in scientific misconduct would be to design a research training system administered through the major medical journals or societies using a Web-based curriculum. This curriculum will have at its core the already developed and successful “responsible conduct of research training program” [4]. Successful completion of the curriculum would be a condition for publication. 0003-4975/$36.00