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Institutes of Health and Education Development Center, Exploring. Bioethics (NIH Publication No. 09-7386), NIH Curriculum Supple- ment Series (Washington ...
from reviews by Elise Cooksley, Mary Glodowski, Lori Harper, Wendy Law, Laurie Matthews, Bryan Roberts, and Lola Szobota. 1. Throughout the text, we write the name “Exploring Bioethics” without italicization or quotation marks to refer to the program or curriculum. The curriculum is, however, available in book form: National Institutes of Health and Education Development Center, Exploring Bioethics (NIH Publication No. 09-7386), NIH Curriculum Supplement Series (Washington, D.C.: Government Printing Office, 2009), at http://science.education.nih.gov. 2. National Research Council, National Science Education Standards (Washington, D.C.: National Academies Press, 1996). 3. D. Kahneman, Thinking Fast and Slow (New York: Farrar, Strauss and Giroux, 2011). 4. D. Kuhn, R. Cheney, and M. Weinstock, “The Development of Epistemological Understanding,” Cognitive Development 15 (2000): 309-28. 5. J. T. Chowning et al., “Fostering Critical Thinking, Reasoning, and Argumentation Skills through Bioethics Education,” PLoS ONE 7, no. 5 (2012): e36791, doi:10.1371/journal.pone.0036791. 6. For a description of The Hastings Center–Kent Place Bioethics Project, see http://www.kentplace.org/podium/default.

aspx?t=204&id=746356. Students’ essays are available at http://www. thebioethicsproject.org and http://blogs.kentplace.org/bioethicsproject. 7. National Governors Association Center for Best Practices & Council of Chief State School Officers, Common Core State Standards (Washington, D.C.: National Governors Association Center for Best Practices & Council of Chief State School Officers, 2010). 8. National Research Council, A Framework for K-12 Science Education: Practices, Crosscutting Concepts, and Core Ideas (Washington, D.C.: The National Academies Press, 2012); NGSS Lead States, Next Generation Science Standards: For States, By States (Washington, D.C.: National Academies Press, 2013). 9. National Governors Association Center for Best Practices & Council of Chief State School Officers, Common Core State Standards. 10. There is a large literature on social and emotional intelligence; see, for example, A. Dymnicki, M. Sambolt, and Y. Kidron, Improving College and Career Readiness by Incorporating Social and Emotional Learning (Washington, D.C.: American Institutes for Research College & Career Readiness and Success Center, 2013). 11. Collaborative for Academic Social and Emotional Learning, www.casel.org.

Pedagogical Support for Responsible Conduct of Research Training by misti au lt anderson

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he number of training programs for the responsible conduct of research (RCR) has increased substantially over the past few decades as the importance of research ethics has received greater attention. In science, the integrity of researchers is of course a vital concern because the public must be able to rely on and trust scientific findings that affect public health, the environment, industry, the economy, and society in general. It is unclear, however, whether the proliferation of RCR training programs has improved researcher integrity or the public’s trust in science. The need for better and more effective education about the ethical conduct of scientific research remains. Rather than training researchers sim-

Misti Ault Anderson, “Pedagogical Support for Responsible Conduct of Research Training,” Hastings Center Report 46, no. 1 (2016): 18-25. DOI: 10.1002/hast.533

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ply to comply with regulations, we could use the opportunity to develop researchers’ ability to understand and appreciate the ethical ideals that inform the regulations in order to help them integrate ethical decision-making into their work on a regular basis. The National Institutes of Health (NIH) specifies that RCR “involves the awareness and application of . . . ethical principles in the performance of all activities related to scientific research.”1 Incorporating ethical principles into research training requires a new way of teaching RCR and the development of support materials to facilitate its adoption. The Presidential Commission for the Study of Bioethical Issues, a panel established to advise the President on bioethical issues arising from advances in biomedicine and related areas of science and technology,2 developed and provides pedagogical materials based on its published reports to facilitate the January-February 2016

Future researchers need a deeper understanding of the ethical considerations that undergird federal regulations rather than just the basic knowledge of which regulatory checklist to follow. integration of ethics education across the curriculum and in support of RCR and general bioethics education. History of the RCR Mandates

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n the 1980s, federal policy-makers began to focus their attention on misconduct in scientific research following multiple high-profile incidences of wrongdoing.3 Seeking to define misconduct in research and develop procedures for reporting, investigating, and adjudicating cases of misconduct, lawmakers passed the 1985 Health Research Extension Act, which enabled the government and research institutions to identify and react to misconduct. The general assumption at the time was that misconduct was rare, and as a result, no policies addressed the notion of preemptive education on ethical conduct.4 By the close of the decade, however, an Institute of Medicine report recommended that universities provide formal instruction in good research practices and stated that such instruction should be integrated throughout undergraduate and graduate curricula. The report indicated that the lack of formal programs addressing the responsible conduct of research was a “serious flaw in the professional training of young scientists and clinicians.”5 In 1989, the NIH established an RCR training requirement for all institutions or programs applying for National Research Service Award grants (NRSA T32 and T34 grants); this mandate was expanded in 1992 to include both pre- and postdoctoral NRSA-supported trainees. A period of slow growth in RCR training programs followed, and by 1996, RCR programs varied widely with regard to content, method, and specification of the individuals required to complete the training. Approximately two-thirds of institutions reported requiring only T32-funded trainees to participate, leaving all other graduate students untrained.6 A 1995 report from the U.S. Department of Health and Human Services’ Commission on Research Integrity requested that the secretary of HHS encourage “integration of the explicit teaching of the ethics of science into the classroom, laboratory, and other research sites in precollegiate education as well as in undergraduate and graduate schools” and “funding for scholarship, teaching, and research in science ethics,” establishing one of the earliest calls for universal RCR education.7 By 1997, the National Science Foundation followed suit and established an RCR requirement for its Integrative Graduate Education and Research Traineeship programs, followed by new educational requirements from NIH for

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the protection of human research participants. The Public Health Service instituted a policy in 2000 on RCR training parameters, specifying objectives and setting minimum requirements, including an outline of nine core instructional areas, which faced pushback that soon led to its suspension.8 The end result of these collective efforts was that by the early 2000s, most institutions had some sort of RCR instruction in place to comply with the NIH training grant, NIH human research participant, or NSF IGERT requirements. Since 2002, the HHS’s Office of Research Integrity has supported fifty RCR resource development projects and a textbook.9 The Occurrence of RCR Training

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n the twenty-five years since the first federal RCR training mandates went into effect, training programs have increased in number and in how much they vary from one another. A survey of NIH-funded scientists indicates that about threequarters of early-career scientists and half of midcareer scientists surveyed reported having participated in coursework focused on specific ethical issues, and fewer reported having RCR training integrated into other coursework. About onequarter of all scientists surveyed indicated having received no additional mentoring through workshops, conferences, or roundtable discussions.10 These data imply that RCR training is being done, but without consistency across institutions or disciplines. It is clear that institutional philosophies differ not only about how to conduct the required training but also about who should participate (for example, graduate students, postdoctoral trainees, or faculty members). Recent data indicate that just over half of the institutions surveyed provide RCR training for both researchers who are mandated to be trained (those whose work is supported directly by the relevant training grants) and researchers who are not.11 The proportion of institutions with RCR training requirements that go beyond the minimum requirements of the NIH and NSF mandates is higher among those with medical schools than other academic institutions, perhaps indicating an increased emphasis on applied ethics in these programs.12 Of NIH training grant recipients surveyed, a quarter indicated that only graduate students receive RCR training, and 16 percent maintain voluntary attendance policies for RCR training despite the mandate.13 Twelve percent of the training grant recipients reported that all trainees in their institutions are required to participate in RCR instruction regardless of H AS TI N GS C EN TE R RE P O RT

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funding source, and only one institution reported requiring RCR training not only for trainees (graduate students and postdoctoral fellows) but also for faculty.14 Some of these data reflect the fact that the RCR training mandates were initially limited to the beneficiaries of NIH training grants and NSF IGERT awards. One might ask, if research ethics is relevant to all scientific researchers, why limit the mandate to NIH or NSF trainees?15 Should we not expect all researchers in science to participate in education, training, and discussions on research ethics? By 2010, NSF expanded its RCR training requirements, supported by section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act, to include all NSFsupported research and not to limit it to training grants.16 How Is RCR Training Being Conducted?

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n addition to variation in who is compelled to participate in RCR training, there is significant variation in methods of implementation. A 2007 study by Michael W. Kalichman and Dena K. Plemmons found wide disparity in instructors’ goals for their RCR instruction and varied understanding of the overall goals for RCR instruction, leading to a disparate set of outcomes.17 “Assuming that effective educational experiences depend first on being clear about educational objectives, it is worrisome if RCR instructors are unclear about their aims,” Kalichman and Plemmons write (p. 848). RCR standards or accreditation requirements might remedy these disparities, but none are in place at this time. In general, institutional RCR programs are underfunded and have low priority compared with regulatory compliance programs and mandated human and animal subject reviews.18 The RCR mandates themselves present an interesting paradox: without them, there would be few to no programs promoting RCR training, but training also should not be overly prescriptive and compliance based. Clearly, providing just enough funding support to meet the minimum amount of training for compliance is inadequate to ensure effective ethical training.19 Most universities host semester-long RCR training courses and require online modules as part of the first-year graduate school curriculum, while some have brief weekly discussions in lieu of formal classroom sessions.20 A survey of NIH Clinical and Translational Science Award recipient institutions found no unified approach to RCR training, and in many cases the program directors did not have a clear understanding of the RCR training going on at their institutions.21 Additionally, most of these institutions have not developed their own tailored instructional materials, with approximately half using existing online training programs and just under 90 percent offering any form of in-person training.22 The instructional component of the NIH requirement specifies that “online instruction is not considered adequate as the sole means of instruction” but that it can be used to supplement instruction.23 Typically, RCR training focuses on knowing and complying with current regulations, defining the punishable line 20 HASTI N G S C E N T E R R E P ORT

between what should and should not be done, and encouraging compliance, rather than addressing the ethical foundation of the regulations.24 In addition to an emphasis on federal regulation compliance, much RCR instruction employs the basic use of case studies. While case studies can help students and researchers work through example scenarios, when used alone—in the absence of supporting ethical training—they do not support the development of problem-solving skills needed when new, real-life problems arise, forcing students to make decisions based not on ethical analysis but on personal previous experience.25 If future researchers are going to be able to handle these types of issues, which are certain to arise in their careers, they must be taught basic tools for ethical analysis and have a deeper understanding of the ethical considerations that undergird the federal regulations rather than just the basic knowledge of which regulatory checklist to follow. Is Current RCR Training Effective?

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iven that much of the current RCR training available to graduate students and postdoctoral trainees is focused on regulatory compliance, the question becomes whether the training is effective. With training requirements focused on recipients of specified funding categories, faculty and research trainees view the RCR training as an obstacle to be overcome rather than an opportunity with real value.26 Research indicates that around one-third of scientists are not always able to recognize and adhere to accepted standards of conduct, indicating that they lack the foundational tools, resources, and standards that help maintain integrity.27 In a survey of NIH-funded scientists, research ethics training showed little relationship with the incidence of problematic behavior, and approximately one-quarter of survey respondents felt less than well prepared to handle ethical issues in their work.28 The literature provides little evidence of positive impacts of RCR training. A 2010 study on the effect of RCR training on ethical decision-making found that the training led to increases in the students’ abilities to recognize ethically problematic circumstances, question their own judgment, manage emotions, and analyze self-motivation; the same study also revealed, however, that it had little to no effect on issues of data management, study conduct, and professional practice and a negative effect on business practices.29 While a study of first-year biomedical science graduate students shows that recipients of RCR training score higher on assessments than nonrecipients, among the students who had received the training, “most students’ scores fell below what might be considered an adequate minimum level of knowledge of the basics of RCR”; this suggests that a singular training experience is likely insufficient to impart understanding of research ethics and standards in a lasting way, and it highlights the need for ongoing and embedded exposure to research ethics throughout a researcher’s training.30 The study further demonstrated that aside from theoretical bioethics classes, “neither undergraduate courses in research methods or undergraduate January-February 2016

The flexibility of the Bioethics Commission’s module format supports the idea that ethics instruction should be woven throughout a scientist’s education, training, and career. classes in RCR, research integrity, or research ethics . . . affected students’ knowledge of core concepts and standards” (p. 842). Clearly the methodology of RCR training courses needs to be revisited if it is to affect—and strengthen—how future researchers view the ethical aspects and implications of their work. Outside of the traditional training methods of online modules and classroom instruction, professional mentorship has been identified as another mechanism by which to train scientists in the ethical conduct of research. For example, select NIH K series grants include research mentorship requirements. Four of the K grant awards require the applicant to specify both a mentor and an RCR training plan; in addition to other aspects of mentoring, the mentors are expected to provide guidance and advice to help tailor the applicant’s RCR instruction.31 In a survey of K grant awardees and their mentors, both mentees and mentors agreed that the actual importance of the mentor’s role was less than what it ideally should be; only half of the K grant recipients planned on including their mentor, and 40 percent of them reported that their mentor played no role in their RCR training.32 Proposed Improvements for RCR Training

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CR training initiatives require additional support—both financially and organizationally—to begin improving the means and methods of training investigators in ethical research. Institutions and funding agencies are asked to promote and support RCR initiatives, and although budgets are always tight, even modest increases in RCR budgets can make a difference. For example, Kalichman proposed a modest allocation target of just 0.1 percent of an institution’s direct research funding to support RCR education; with this amount, large research institutions would be able to support reasonable training programs, and smaller institutions would be able to partner with others, pool their resources, and collaborate on training programs.33 The overall strategy of RCR training sets the tone for the implementation of training programs. While programs need some flexibility in training requirements to suit each institution’s needs and goals, it is “important to clarify both what are and what should or can be our common goals.”34 Nicholas Steneck and Ruth Ellen Bulger assert that training initiatives should be designed to reinforce the positive, and counteract the negative, effects of the current research environment.35 Laura S. Weyrich and Eric T. Harvill emphasize January-February 2016

that it is imperative for the focus of RCR training to move away from simply knowing the rules to understanding and appreciating the guiding principles that support and inform them.36 To that end, Weyrich and Harvill contend that students, trainees, and researchers should have an introduction to basic ethical theory in order to encourage a more nuanced and creative approach to their research and its ethical components.37 Learning to appreciate how ethical norms and moral standards came to be will help researchers understand why their work is bound by these standards, and a grasp of basic ethical principles will help them to engage ethics in challenging decision-making situations.38 Institutions and funding agencies could promote and support RCR initiatives that not only meet federal standards but also integrate “bona fide ethics education and responsible conduct across [the] entire research community.”39 Institutional support can come directly from university ethics centers, where they are present. Ethics centers are well positioned to take advantage of this opportunity to move RCR training beyond “compliance mentality” and support an understanding of and respect for adherence to the ethical norms inherent in research and to pursue the goal of integrating ethics across the curriculum.40 University ethics centers can work with departments to integrate ethics education into the existing training sessions and coursework, for example, by hosting a discussion on strategies to avoid fabrication, falsification, and plagiarism within a grant-writing training session sponsored by a graduate school.41 Individual departments and faculty members also share responsibility in supporting effective strategies for RCR training and can help ensure that faculty can be involved without creating excessive burdens or animosity.42 Various models have been proposed to improve the current state of RCR training. One of the main ideas is requiring some form of ongoing training or advanced RCR instruction that extends beyond the requisite introductory course.43 Some suggest combining a minimal single-credit course for all incoming graduate students on ethical theory with methods that can be taught in parallel with the existing institutional RCR training modules.44 Another suggestion is to incorporate ethical theory into existing curricula, pairing relevant real-life cases studies with the applicable ethical theories in order to model ethical analysis and decision-making.45 Others have suggested building on existing institutional RCR training by encouraging research groups to implement weekly short discussions (of fifteen minutes) in conjunction with H AS TI N GS C EN TE R RE P O RT

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a regular lab function, such as journal club, to engage lab members spanning all levels of training in group discussion.46 Frequent integration of ethical discussions, as in this proposed model, demonstrates a tangible commitment to ethical training. When this method was tested over a three-year period, investigators found that the participants demonstrated increased confidence in discussion. They progressed from talking about theoretical cases to considering the ethical implications of their own research and lab policies. Over time, the discussions sparked follow-up conversation outside of the appointed time and marked a change in the everyday lab culture, shifting collective consideration of research ethics from a retrospective viewpoint that assigned blame to a feeling of responsibility to develop and evaluate actions in the future.47 Integrative training models, whether focused on integration into coursework or lab policies, are particularly strong because they demonstrate commitment to ethical research and include all members of the research team, as opposed to only trainees or incoming students. In the absence of institutional guidelines regarding RCR instruction, the principal investigator—the person in charge of a lab or a project and its research—is responsible for providing ethics training (mandated and otherwise) to students and fellows. This might involve taking advantage of teachable moments, orientation training, intermittent discussions or lectures, weekly discussions in conjunction with lab meetings or journal clubs, design of formal graduate-level courses, integrating ethics into the existing curriculum, or scheduling short training courses for postdoctoral fellows.48 Elizabeth Ripley et al. assert that faculty members ought to participate in a mentor training seminar to support this role and that training should include mentoring skills, ethical theory and principles, and the development of ethical deliberation and interpersonal skills.49 Clearly, research faculty members play a significant part in supporting the ethical training of their students and trainees, and involving faculty in the design and implementation of RCR training is imperative to its success. Taking on this role formally, as in the case of mentoring a recipient of an NIH K grant, is a commitment and requires time and resources for which the mentor might seek institutional support. Faculty members that have not been formally trained in ethical discourse and research ethics need support in preparing for this role. Given necessary support, they could be encouraged to develop seminars, conferences, or lectures that complement formal RCR instruction.50 In a 2012 article, Stephanie Bird highlights key points for an effective program, many of which are vastly strengthened with the support of dedicated faculty. Her recommendations include the following: training must be required and viewed as essential for students, trainees, and faculty members; training should emphasize interactive discussion; there should be many different faculty members or senior professionals involved, emphasizing RCR as a core community value; training must incorporate discipline-relevant topics; ethical education should start at orientation and continue throughout a student’s degree program and career; 22 HASTI N G S C E N T E R R E P ORT

and RCR training should incorporate a variety of activities (for example, courses, seminars, and lab meetings).51 Assessment of RCR Training Programs Is Needed

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trengthening RCR training requires appropriate assessment of the impact of these programs and documentation of how new training methods improve their impact. Various aspects of a program need to be assessed. For example, the immediate influence of courses and training sessions can be assessed using online comprehension assessments, audience polling and response systems feedback, participant surveys, and peer-review instructor feedback.52 One way to assess the effect of RCR training programs overall is by measuring effect on students’ ethical decision-making processes.53 Weyrich and Harvill assert that graduate students should be held accountable for their RCR training and should be required to demonstrate applicable knowledge of ethical theory as a component of major qualifying exams.54 Longer-term affects also can be measured with less traditional indicators such as improved consent processes and decreased instances of suspected plagiarism.55 How the Bioethics Commission Supports RCR Training

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he Bioethics Commission’s publicly available reports not only advise the President but also inform the American public about important ethical issues in biomedicine and related areas of science and technology. The Commission has incorporated the importance of ethics education as an overarching theme in its reports. The Commission encourages ethics education for researchers and the expansion of RCR training programs to include ethics throughout the education, training, and careers of scientists. Its reports offer numerous recommendations about ethics education. For example, the Commission recommended that ethics education be developed and required for researchers and student-investigators outside the medical setting, including fields such as engineering and materials science.56 It also recommended the adoption of strategies to integrate understanding of personal responsibility into professional research practice, the development and expansion of rigorous courses in bioethics at the undergraduate and graduate levels, and ongoing engagement for investigators at all levels of experience.57 In addition, the Commission recommended research to develop new models for integrating ethics and science through education at all levels and to evaluate both new and existing models.58 The Commission articulated a number of goals for ethics education, including promoting ethical conduct in professional practice,59 establishing ethical responsibility as a part of professionalism,60 and emphasizing the relationship between scientific and ethical literacy.61 These goals are aligned with those of RCR training programs. Research and innovation are becoming increasingly interdisciplinary, and not all January-February 2016

disciplines have established the same standards or levels of standards for ethical and responsible professional conduct.62 Robust RCR training infused with ethics education could provide a common foundation for ethical research among disciplines. The Commission developed educational materials based on its published reports to support ethics education and facilitate the integration of ethical analysis into existing curricula across traditional and nontraditional educational and professional settings, including RCR training programs.63 The Bioethics Commission’s pedagogical materials provide instructional support for the integration of ethical principles into RCR training, as is indicated by the NIH mandate, to help move RCR programs away from a singular focus on compliance.64 The NIH mandate specifically includes “contemporary ethical issues in biomedical research, and . . . societal impacts of scientific research” in the list of topics for acceptable RCR instruction programs.65 The Commission’s materials include topic-based modules and other report-specific resources; topics include, for example, informed consent, community engagement, vulnerable populations, and compensation for research-related injury, which exemplify contemporary issues in biomedical research. Some topic-based modules, such as those on research design, apply broadly to research in many fields and include research that does not involve human participants. One proposed improvement put forth for RCR training is the idea that it should include an introduction to ethical theory to promote a more nuanced approach to ethical research design and conduct. In support of this effort, within each topic addressed, the Bioethics Commission materials include a background module that provides an explanation of the ethical underpinning of both ethical research practices and current policies and regulations, when applicable, in addition to discussion questions and points and additional resources. Other proposed improvements include the integration of ethics education into existing coursework, the integration of ethics education throughout the education and training of researchers (at the undergraduate, graduate, and postdoctoral levels), and the notion that training should extend beyond what is covered by the federal mandate and include all researchers, regardless of funding source. Early exposure to ethics and ethical considerations related to specific subject matter facilitates deeper understanding of potential implications of the work and better prepares students to consider ethics when they conduct their future work.66 The Bioethics Commission’s topic-based modules are designed to facilitate integration of ethics discussion into traditional and nontraditional educational settings—including all levels of RCR instruction—through existing course material, seminars, or professional settings that lend themselves to a particular topic. The flexibility of the module format makes possible integration of the material over time and through differing instructional models, which supports the idea of ongoing ethics instruction that is woven throughout a scientist’s education, training, and career. January-February 2016

Building on the background module, report-specific modules highlight ethical analysis on each topic across Bioethics Commission reports, providing examples for consideration, case-based scenarios that can be used in group discussion, and exercises to facilitate applied ethical discussions. Combining relevant scholarship with contemporary case studies is an example of a proven effective method to teach ethics and engage students in ethical deliberation.67 Rather than simply using isolated cases as examples, these modules are intended to work with the background module to provide a context of ethical reasoning that can support student understanding of the case, its ethical implications, and how it might be resolved in an ethical way. Additionally, other report-specific materials, for example, A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, provide more in-depth guidance to the overall ethical analysis of applied bioethical issues provided in a given report.68 Finally, other proposed improvements include the incorporation of ethics and RCR training into nontraditional settings, for example, encouraging the integration of ethical discussion into laboratory meetings or the development of faculty mentoring programs to encourage explicit consideration of the ethical conduct of research outside of the classroom and within the context of ongoing research. While the Commission’s educational materials do not address these approaches specifically, the flexibility of the short topic-based module format allows them to function as reference materials for even brief informative discussions on topics applicable to a laboratory’s or project’s ongoing work. Where the head of the laboratory or research project might lack formal training in ethical analysis, these modules are designed to provide support for efforts to integrate ethics, ethical analysis, and ethical decision-making into instruction and mentoring. Particularly of use in institutions that lack an ethics center or in nontraditional settings without curricular support, the Bioethics Commission modules provide information and resources for building ethical principles and analysis into education, including RCR training programs. The responsible conduct of research is an important part of researcher education and training and encompasses a set of generally accepted core areas that include data acquisition and management, mentor or trainee responsibilities, responsible publication and authorship practices, peer review, collaboration, research involving human subjects, research involving animals, research misconduct, and conflicts of interest and commitment.69 It is important to note that the Commission’s pedagogical materials do not address all core areas and are not intended to serve as curriculum for RCR training. Rather, these materials seek to provide educational support to instructors for the integration of ethics and ethical analysis into RCR training sessions and classes as well as ethics education more broadly. The Commission’s educational resources are also appropriate for ethics education across the curriculum, in professional development, and for other forms of outreach beyond the university setting. Pedagogical materials are updated periodically to reflect the Bioethics H AS TI N GS C EN TE R RE P O RT

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Commission’s growing body of work, and materials can be accessed at http://www.bioethics.gov. Disclaimer

The findings and conclusion in this paper are those of the author and do not necessarily represent the official position of the Presidential Commission for the Study of Bioethical Issues, the Office for Human Research Protections, or HHS. 1. National Institutes of Health, “Update on the Requirement for Instruction in the Responsible Conduct of Research,” Notice Number: NOT-OD-10-019, November 24, 2009, http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-10-019.html. 2. Executive Order No. 13521, 74 F.R. 62671, 2009. 3. N. H. Steneck, “Research Universities and Scientific Misconduct: History, Policies, and the Future,” Journal of Higher Education 65 (1994): 310-30. 4. N. H. Steneck and R. E. Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research,” Academic Medicine 82, no. 9 (2007): 829-34. 5. Institute of Medicine Committee on the Responsible Conduct of Research, The Responsible Conduct of Research in the Health Sciences (Washington, D.C.: Institute of Medicine, National Academy Press, 1989), 30. 6. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research.” 7. Commission on Research Integrity, Integrity and Misconduct in Research (Washington, D.C.: Department of Health and Human Services, 1995), 26. 8. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research.” 9. Office of Research Integrity, “RCR Resource Development Program,” 2012, http://ori.hhs.gov/rcr-resource-development-program. 10. M. S. Anderson et al., “What Do Mentoring and Training in the Responsible Conduct of Research Have to Do with Scientists’ Misbehavior? Findings from a National Survey of NIH-Funded Scientists,” Academic Medicine 82, no. 9 (2007): 853-60, at 859. 11. D. B. Resnik and G. E. Dinse, “Do U.S. Research Institutions Meet or Exceed Federal Mandates for Instruction in Responsible Conduct of Research? A National Survey,” Academic Medicine 87, no. 9 (2012): 1237-42. 12. Ibid. 13. M. W. Kalichman and D. K. Plemmons, “Reported Goals for Responsible Conduct of Research Courses,” Academic Medicine 82, no. 9 (2007): 846-52. 14. Ibid. 15. M. W. Kalichman, “Overview: Underserved Areas of Education in the Responsible Conduct of Research: Authorship,” Science and Engineering Ethics 17, (2011): 335-39. 16. National Science Foundation, “Responsible Conduct of Research (RCR)” (section B. in chapter IV, “Grantee Standards”) 2010, accessed February 14, 2013, at http://www.nsf.gov/pubs/policydocs/pappguide/ nsf10_1/aag_4.jsp#IVB. 17. Kalichman and Plemmons, “Reported Goals for Responsible Conduct of Research Courses.” 18. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research.” 19. M. Kalichman, “Ethics and Science: A 0.1% Solution,” Issues in Science and Technology Online (2006), at www.issues.org/23.1/p_kalichman.html. 20. L. S. Weyrich and E. T. Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers,” Accountability in Research Policies and Quality Assurance 20, no.1 (2013): 5-12.

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21. M. H. DuBois et al., “Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs,” Clinical Translational Science 3, no. 3 (2010): 109-11. 22. Ibid. 23. National Institutes of Health, “Update on the Requirement for Instruction in the Responsible Conduct of Research.” 24. Weyrich and Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers”; A. M. Peiffer, C. E. Hugenschmidt, and P. J. Laurienti, “Ethics in 15 Min per Week,” Science and Engineering Ethics 17 (2011): 289-97. 25. Weyrich and Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers” 26. Kalichman, “Ethics and Science.” 27. Ibid. 28. Anderson et al., “What Do Mentoring and Training in the Responsible Conduct of Research Have to Do with Scientists’ Misbehavior?” 29. A. L. Antes et al., “Evaluating the Effects that Existing Instruction on Responsible Conduct of Research Has on Ethical Decision Making,” Academic Medicine 85, no. 3 (2010): 519-26. 30. E. Heitman et al., “New Graduate Students’ Baseline Knowledge of the Responsible Conduct of Research,” Academic Medicine 82, no. 9 (2007): 838-45, at 842. 31. E. Ripley et al., “Guiding the Next Generation of NIH Investigators in Responsible Conduct of Research: The Role of the Mentor,” Accountability in Research Policies and Quality Assurance 19, no. 4 (2012): 209-19. 32. Ibid. 33. Kalichman, “Ethics and Science.” 34. Kalichman and Plemmons, “Reported Goals for Responsible Conduct of Research Courses,” 848. 35. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research.” 36. Weyrich and Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers.” 37. Ibid. 38. Ibid. 39. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research”; J. McCafferty et al., “New NSF and NIH Responsible Conduct of Research (RCR) Guidelines: A Three-Phase Plan,” Teaching Ethics 12, no. 2 (2012): 23-33, at 23. 40. D. E. Wueste, “RCR: Some Splendid Opportunities,” Teaching Ethics 12, no. 2 (2012): 57-64. 41. A. G. Ratterman, “Developing Diverse and Robust Research Ethics Education: One Office’s Approach,” Teaching Ethics 12, no. 2 (2012): 43-47. 42. Ibid. 43. Heitman et al., “New Graduate Students’ Baseline Knowledge of the Responsible Conduct of Research,” 44. Weyrich and Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers.” 45. Ibid. 46. Peiffer, Hugenschmidt, and Laurienti, “Ethics in 15 Min per Week.” 47. Ibid. 48. V. L. McGuffin, “Teaching Research Ethics: It Takes More Than Good Science to Make a Good Scientist,” Annals of Bioanalytical Chemistry 390, (2008): 1209-15. 49. Ripley et al., “Guiding the Next Generation of NIH Investigators in Responsible Conduct of Research.” 50. Ibid.; McCafferty et al., “New NSF and NIH Responsible Conduct of Research (RCR) Guidelines.” 51. S. J. Bird, “Involving Faculty in Teaching the Responsible Conduct of Research,” Teaching Ethics 12, no. 2 (2012): 65-75. 52. McCafferty et al., “New NSF and NIH Responsible Conduct of Research (RCR) Guidelines.” January-February 2016

53. Antes et al., “Evaluating the Effects that Existing Instruction on Responsible Conduct of Research Has on Ethical Decision Making,” 54. Weyrich and Harvill, “Teaching Ethical Aptitude to Graduate Student Researchers.” 55. A. G. Ratterman, “Developing Diverse and Robust Research Ethics Education: One Office’s Approach,” Teaching Ethics 12, no. 2 (2012): 43-47. 56. Presidential Commission for the Study of Bioethical Issues, New Directions: The Ethics of Synthetic Biology and Emerging Technologies (Washington, D.C.: PCSBI, 2010). 57. Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (Washington, D.C.: PCSBI, 2011). 58. Presidential Commission for the Study of Bioethical Issues, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Washington, D.C.: PCSBI, 2014). 59. Presidential Commission for the Study of Bioethical Issues, New Directions. 60. Presidential Commission for the Study of Bioethical Issues, Moral Science.

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61. Presidential Commission for the Study of Bioethical Issues, New Directions. 62. Ibid. 63. Presidential Commission for the Study of Bioethical Issues, A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948; Presidential Commission for the Study of Bioethical Issues, “Education,” accessed October 27, 2014, http://bioethics.gov/ education. 64. National Institutes of Health, “Update on the Requirement for Instruction in the Responsible Conduct of Research.” 65. Ibid. 66. Presidential Commission for the Study of Bioethical Issues, Gray Matters. 67. Presidential Commission for the Study of Bioethical Issues, Moral Science. 68. Presidential Commission for the Study of Bioethical Issues, A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948. 69. Steneck and Bulger, “The History, Purpose, and Future of Instruction in the Responsible Conduct of Research.”

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