Ethics in Scientific Research PDF

Ethics in Scientiﬁc Research An Examination of Ethical Principles and Emerging Topics Cortney Weinbaum, Eric Landree, Marjory S. Blumenthal, Tepring Piquado, Carlos Ignacio Gutierrez C O R P O R AT I O N For more information on this publication, visit www.rand.org/t/RR2912 Library of Congress Cataloging-in-Publication Data is available for this publication. ISBN: 978-1-9774-0269-1 Published by the RAND Corporation, Santa Monica, Calif. © Copyright 2019 RAND Corporation R® is a registered trademark. Limited Print and Electronic Distribution Rights This document and trademark(s) contained herein are protected by law. This representation of RAND intellectual property is provided for noncommercial use only. Unauthorized posting of this publication online is prohibited. Permission is given to duplicate this document for personal use only, as long as it is unaltered and complete. 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Support RAND Make a tax-deductible charitable contribution at www.rand.org/giving/contribute www.rand.org Preface The goal of this project was to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders. The research had two motivations: (1) to inform researchers and sponsors who engage in research in emerging scientific disci- plines and who may face new ethical challenges, and (2) to inform research sponsors— including government officials—who wish to encourage ethical research without unin- tentionally encouraging researchers to pursue their research in other jurisdictions. While this report is intended for audiences with scientific expertise, it is also intended to be useful to scientists from various disciplines who have differing exper- tise from other disciplines and for citizen scientists and amateur researchers who lack formal scientific training. Therefore, it should be accessible to informed readers from a variety of backgrounds and experiences. This research was sponsored by the Intelligence Advanced Research Projects Activity (IARPA) and conducted within the Cyber and Intelligence Policy Center of the RAND National Defense Research Institute, a federally funded research and development center (FFRDC) sponsored by the Office of the Secretary of Defense, the Joint Staff, the Unified Combatant Commands, the Navy, the Marine Corps, the defense agencies, and the defense Intelligence Community. All of the data collection and analysis described in this report took place in 2018. For more information on the RAND Cyber and Intelligence Policy Center, see www.rand.org/nsrd/ndri/centers/intel or contact the center director (contact informa- tion is provided on the webpage). iii Contents Preface.................................................................................................. iii Figure, Table, and Boxes............................................................................ vii Summary.............................................................................................. ix Acknowledgments................................................................................... xiii Abbreviations......................................................................................... xv CHAPTER ONE Introduction............................................................................................ 1 Why We Did This Research........................................................................... 1 Research Methodology................................................................................. 1 How This Report Could Be Used.................................................................... 2 The Difference Between Ethics and Law............................................................ 3 CHAPTER TWO Ethical Principles for Scientific Research......................................................... 5 Duty to Society.......................................................................................... 5 Beneficence............................................................................................. 10 Conflict of Interest.................................................................................... 15 Informed Consent..................................................................................... 19 Integrity................................................................................................ 22 Nondiscrimination................................................................................... 23 Nonexploitation...................................................................................... 26 Privacy and Confidentiality........................................................................... 29 Professional Competence.............................................................................. 32 Professional Discipline................................................................................ 37 CHAPTER THREE International Landscape of Ethics................................................................ 41 The Seminal Influence of the Declaration of Helsinki........................................... 42 The Convention on Biological Diversity and Its Derivatives.................................... 43 v vi Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics The Precautionary Principle......................................................................... 44 Regional Differences................................................................................... 45 Ethics “Dumping”..................................................................................... 49 International Standards Development............................................................... 51 Concluding Observations............................................................................. 51 CHAPTER FOUR Monitoring and Enforcing Ethics................................................................. 55 CHAPTER FIVE Emerging Ethics Topics............................................................................. 61 Bystander Risk.......................................................................................... 61 Big Data................................................................................................. 63 Open Science........................................................................................... 65 Citizen Science......................................................................................... 67 CHAPTER SIX Conclusions............................................................................................ 69 APPENDIX A. Methodology...................................................................................... 71 B. Codebook.......................................................................................... 77 C. Interview Informed Consent and Protocol.................................................. 81 D. List of Interview Participants................................................................... 83 E. Bibliography of Literature...................................................................... 85 F. Bibliography of Codes of Conduct............................................................. 93 References............................................................................................. 95 Figure, Tables, and Boxes Figure A.1. Documents Reviewed by Publication Year............................................ 72 Tables S.1. Ethical Principles for Scientific Research............................................... x S.2. Categories of Ethical Principles......................................................... xi 2.1. Ethical Principles for Scientific Research............................................... 6 2.2. Categories of Ethical Principles.......................................................... 7 2.3. Informed Consent Versus Beneficence and Duty to Society........................ 21 2.4. Considerations for Research Methods.................................................. 35 4.1. Codified Ethics in Hard Law and Soft Law.......................................... 56 A.2. Documents Reviewed, by Discipline................................................... 73 A.3. Literature Review Results................................................................ 74 Boxes 2.1. The Uppsala Code and the Pugwash Tradition....................................... 11 2.2. Broad Privacy Policy Affecting Research and Beyond............................... 32 3.1. Convention on Biological Diversity and Its Supplements........................... 44 3.2. Informed Consent Around the World................................................. 46 3.3. The European Charter of Fundamental Rights....................................... 47 A.1. List of Scientific Disciplines Examined................................................ 72 vii Summary Scientific research ethics vary by discipline and by country, and this study sought to understand those variations. Our team reviewed literature from across scientific disciplines and conducted interviews with experts in the United States, Europe, and China. Our analysis led to an understanding of which ethics are common across disci- plines, how these ethics might vary geographically, and how emerging topics are shap- ing future ethics. We focused on the ethics of scientific research and how the research is conducted, rather than on how the research is applied. This distinction excluded from our research an analysis of so-called “dual use” applications for military purposes. Our literature review of more than 200 documents led us to identify ten ethical principles that are generally common from one scientific discipline to another, shown in Table S.1. We found that these principles often can be traced to such foundational docu- ments as the Nuremberg Code (in 1947), the Universal Declaration of Human Rights (1948), the Declaration of Helsinki (1968), the European Charter of Fundamental Rights (2000), and others. Our research found that ethics are created, change, and evolve due to significant historic events that create a reckoning (e.g., the Nuremberg trials), due to ethical lapses that lead researchers to create new safeguards (e.g., the Tuskegee Study), due to scientific advancements that lead to new fields of research (e.g., the emergence of experimental psychology), or in response to changes in cultural values and behavioral norms that evolve over time (e.g., perceptions of privacy and confidentiality). We found that instances of an ethical principle from Table S.1 not being dis- cussed in a particular discipline’s code of conduct can often be attributed to that disci- pline not engaging in research on human or animal subjects. Ethics such as informed consent and beneficence—which relate to the informed consent of the human subject or the beneficence toward the human or animal subject—are missing from disciplines without research participants, including most physical sciences and mathematics. This led to our next finding, that certain ethical principles are common across all fields, while other principles are specific to certain types of research, as shown in Table S.2. This finding could help researchers in a new emerging discipline determine which ethical principles best apply to their work. ix x Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics Table S.1 Ethical Principles for Scientific Research Ethical Principle Definition Duty to society Researchers and research must contribute to the well-being of society. Beneficence Researchers should have the welfare of the research participant in mind as a goal and strive for the benefits of the research to outweigh the risks. Conflict of interest Researchers should minimize financial and other influences on their research and on research participants that could bias research results. Conflict of interest is more frequently directed at the researcher, but it may also involve the research participants if they are provided with a financial or nonfinancial incentive to participate. Informed consent All research participants must voluntarily agree to participate in research, without pressure from financial gain or other coercion, and their agreement must include an understanding of the research and its risks. When participants are unable to consent or when vulnerable groups are involved in research, specific actions must be taken by researchers and their institutions to protect the participants. Integrity Researchers should demonstrate honesty and truthfulness. They should not fabricate data, falsify results, or omit relevant data. They should report findings fully, minimize or eliminate bias in their methods, and disclose underlying assumptions. Nondiscrimination Researchers should minimize attempts to reduce the benefits of research on specific groups and to deny benefits from other groups. Nonexploitation Researchers should not exploit or take unfair advantage of research participants. Privacy and Privacy: Research participants have the right to control access to their personal confidentiality information and to their bodies in the collection of biological specimens. Participants may control how others see, touch, or obtain their information. Confidentiality: Researchers will protect the private information provided by participants from release. Confidentiality is an extension of the concept of privacy; it refers to the participant’s understanding of, and agreement to, the ways identifiable information will be stored and shared. Professional Researchers should engage only in work that they are qualified to perform, competence while also participating in training and betterment programs with the intent of improving their skill sets. This concept includes how researchers choose research methods, statistical methods, and sample sizes that are appropriate and would not cause misleading results. Professional Researchers should engage in ethical research and help other researchers engage in discipline ethical research by promulgating ethical behaviors through practice, publishing and communicating, mentoring and teaching, and other activities. NOTE: Research participant refers to someone with an active role participating in research, whereas research subject could include someone whose data are used but who does not consent to participate. When we examined ethics by geographic region, we found a distinction between the ethical principles of researchers conducting research in their own host country compared with the ethical principles of researchers conducting research in a coun- try other than their native country. This distinction is important in understanding whether ethical differences are a result of local customs, culture, laws, and practices or instead result from one culture being subjected to the ethics of foreigners. In either Summary xi Table S.2 Categories of Ethical Principles Category Description of Category Ethical Principle Ethical scientific inquiry The research inquiry itself must Duty to society benefit society. Ethical conduct and Researchers should conduct Conflict of interest behaviors of researchers themselves in certain manners, Integrity and they are responsible for their Nondiscrimination knowledge and awareness of ethics Professional competence and appropriate research methods. Professional discipline Ethical treatment of Research participants should Informed consent research participants be treated according to certain Beneficence guidelines and treated humanely, Nondiscrimination and the environmental or secondary Nonexploitation effects of the research should be Privacy and confidentiality considered. situation, we found that the Declaration of Helsinki, which was written specifically for physicians, provides a common ethical foundation for any researcher anywhere in the world, regardless of whether his or her country has well-developed ethical standards, monitoring, or enforcement mechanisms. In situations in which researchers conduct research outside their home country, we found concerns of ethics dumping, a term coined to describe when a researcher conducts research in a region with less stringent ethical requirements than his or her own homeland. Obviously, this creates its own ethical dilemma (e.g., how can avoid- ing ethics be ethical?), yet several scientific disciplines require foreign travel to collect genetic data from or conduct anthropological research on indigenous peoples. Sev- eral governments, including the European Commission, have created guidelines for research conducted with their funds in foreign lands to mitigate the negative effects of such research on local populations. One indigenous group, the San people in Africa, has even created its own code of conduct, which the tribe published in English and requires all researchers to agree to before beginning research on its members. As we examined laws, regulations, and standards around the world, we sought an understanding of the relationship between enforceable laws and unenforceable norms. We undertook this project with an understanding that laws can be unethical and ethics can be unregulated, and we hoped to understand how the administration of both laws and ethics may better align. We found that professional societies and journals aim to fill the gap between laws and ethics by documenting ethics that they expect of their members or authors, respectively; requiring members and authors to self-certify that they complied with such rules; and providing a reporting or grievance mechanism for cases in which members or authors self-report or are reported on. When these societ- ies or journals have international membership or readership, they additionally seek to smooth out ethical differences from region to region by creating a discipline-wide xii Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics standard. These mechanisms are imperfect, however, as they are not enforceable and often not even monitored. Here, we found that emerging topics in ethics may both help and strain this cur- rent arrangement. As open science continues to give more researchers access to each other’s data and results, researchers may find their work more often peer reviewed by a wider audience (thanks to open data) or less frequently peer reviewed (thanks to open access publication). Transparency is an ally of ethics, yet the open science movement creates its own challenges. Meanwhile, citizen science, the movement of more amateur scientists participating in research, opens the doors to wider societal participation in scientific advancements along with the risk of a greater number of researchers who lack formal training in ethics or in choosing appropriate research methods. We found that society as a whole, and professional scientific societies specifically, could take proac- tive steps to engage citizen scientists in dialogues about research ethics. Today, this is particularly needed in topics that include big data and biology, two areas where citizen scientists may test the limits of research ethics. In these disciplines and others, we found a new emerging discussion in litera- ture on bystander risk, the risk levied on people who did not consent to participate in research because they are unintended bystanders. In medical research, this may include a person who comes in contact with a research participant who has been exposed to a contagious disease; in this case the research participant consented, but the persons exposed did not consent. In information science research, bystander risk may include the persons whose privacy is compromised due to big data analytics, including analyt- ics on data they themselves did not create nor authorize for use. Finally, across our research, we found several pillars that researchers and sponsors can lean on to promote and strengthen ethics—specifically, education and training of ethics and research methods; professional societies and communities that promulgate and advocate codes of ethics; and governance mechanisms that range from institu- tional oversight to law and regulation. Acknowledgments This project would not have been possible without sponsorship from the Intelligence Advanced Research Projects Activity (IARPA). We thank Jason Matheny, former director of IARPA, for having a vision of how IARPA could contribute to a societal dialogue about ethics in emerging scientific disciplines, and we are grateful that Stacey Dixon, current director of IARPA, and Jeff Alstott, our project monitor, share Jason’s vision, helped us see it through, and provided us course corrections whenever our proj- ect veered astray. This study was a team effort, and the team was significantly larger than just the authors. We thank our RAND colleagues (in alphabetical order) Nathan Beauchamp- Mustafaga, Amanda Edelman, Betsy Hammes, Scott Harold, Raza Khan, Gordon Lee, Alexis Levedahl, Alice Shih, Jirka Taylor, and Keren Zhu for helping us gather and code the literature we analyzed, translating foreign-language documents into Eng- lish and translating our interview protocol into Mandarin Chinese, helping us identify and connect with potential interview participants, editing and reviewing this report, and various other activities that improved the quality of our final work. We thank our RAND Europe colleagues, and specifically Salil Gunashekar, for helping to shape the direction of our international research by introducing us to organizations and experts whom we might not otherwise have found. Our research would not have been complete without the participation of experts around the world who took part in our interviews. They shared their time and insights with us, and we thank them. Each person’s official title and organizational affiliation is included in Appendix D. In alphabetical order, we thank Jeremy Berg, Stephanie J. Bird, Diana Bowman, Raja Chatila, 丛亚丽Yali Cong, C. K. Gunsalus, Andrew M. Hebbeler, Rachelle Hollander, Elsa Kania, Isidoros Karatzas, Annie Kersting, Gary Marchant, Anne Petersen, Edward You, and others who requested that we not include their names. You know who you are, and we appreciate your participation in this research. Thank you to Rebecca Kukla at the Georgetown University Kennedy Institute of Ethics and Ritika Chaturvedi at RAND for identifying gaps in our analysis and areas where our work could be improved. We appreciate the detailed review that you provided. xiii xiv Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics Nearly a year before this project was funded, we challenged a group of students at the Maxwell School of Citizenship and Public Affairs at Syracuse University to research and review existing codes of conduct for lessons learned that could be applied to new emerging disciplines. They accepted our challenge enthusiastically, and their work informed our research methodology. Thank you to Kashaf Ud Duja Ali, Eni Maho, Earl W. Shank, Derrick J. Taylor, and their advisor, Renée de Nevers. Throughout this research, we learned that ethics will evolve continuously over time, and we hope this report provides a positive contribution to the international dia- logue. We could not have done so without the help of each of you. Abbreviations AI artificial intelligence ACM Association for Computing Machinery AMA American Medical Association APA American Psychological Association API application program interface ASM American Society for Microbiology CBD Convention on Biological Diversity EC European Commission EU European Union FDA U.S. Food and Drug Administration GDPR General Data Protection Regulation GINA Genetic Information Nondiscrimination Act HHS U.S. Department of Health and Human Services IARPA Intelligence Advanced Research Projects Activity IEEE Institute of Electrical and Electronics Engineers IRB Institutional Review Board ISA International Sociological Association IVSA International Visual Sociology Association xv xvi Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics OECD Organisation for Economic Co-operation and Development OHRP Office for Human Research Protections (U.S. Department of Health and Human Services) R&D research and development UN United Nations WMA World Medical Association CHAPTER ONE Introduction Why We Did This Research The goal of this project was to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders. The research had two motivations: (1) to inform researchers and sponsors who engage in research in emerging scientific disci- plines and who may face new ethical challenges, and (2) to inform research sponsors— including government officials—who wish to encourage ethical research without unin- tentionally encouraging researchers to pursue their research in other jurisdictions. This project focused on the ethics of scientific research. We sought lessons for how researchers could conduct research in an ethical manner in fields such as artifi- cial intelligence (AI) and neurotechnology regardless of whether the findings from the research might be applied to beneficent goals (e.g., to assist persons with disabilities in leading fulfilling lives) or harmful goals (e.g., increasing the severity of warfare). Because so many outputs of science and engineering research can be used in civilian or military contexts (so-called dual use), our goal was to understand the ethics that shape how research is designed, conducted, and disseminated independent of how it might be used—which might not be known until long after the research is completed. We sought to describe common ethical principles and differences that exist across scientific and technical disciplines and emphases. Research Methodology The majority of our analysis was based on reviewing secondary sources (mostly jour- nal articles) and consulting experts. We started by examining literature, and where we found gaps—questions the literature did not answer—we sought additional com- mentary and documents and conducted interviews with experts. Our team collected the 200 most-cited peer-reviewed articles on ethics in scientific research from literature over time plus codes of ethics from across scientific disciplines. We began by search- 1 2 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics ing Scopus and Web of Science for the most-cited articles about ethics and research or codes of conduct and research. All of the articles we reviewed had been cited more than 300 times by other authors; the most-cited article had been cited over 5,700 times at the time of our data collection. We chose to focus on the most-cited articles to exam- ine topics that researchers and scientists themselves have indicated are worthwhile. We then searched for codes of conduct from every scientific discipline in which we had literature, and we tagged or coded all of these documents by topic. We analyzed the results for commonalities and differences across scientific disciplines. Where we found gaps in the literature, we conducted interviews with experts in relevant fields, and we searched for additional relevant documents outside of our initial scope of 200 peer- reviewed journal articles. Our methodology includes several limitations, including that citations are a lag- ging indicator of how useful researchers found the article, highly cited articles may have been controversial rather than widely accepted, and the articles we collected may reflect the topics that were in vogue at their time of publication rather than more- recent topics. Appendix A includes a detailed description of our methodology, includ- ing how we chose which articles to review and which experts to interview, and how we conducted our interviews and our analysis. We discuss this and other limitations of our methodology in Appendix A. Appendix B includes the codebook we used to code the documents; an explana- tion of how we created this codebook is provided within Appendix A. Appendix C provides the informed consent and interview protocol we used for our interviews, and Appendix D provides a list of our interview participants, with their titles and organiza- tional affiliations. All interviews were conducted under the agreement that we would not quote interview participants; therefore, we provide this list of names without citing them directly within the report. Appendixes E and F contain the list of all the docu- ments we coded during our literature review; Appendix E includes journal articles we reviewed, and Appendix F includes codes of conduct. Lastly, the References section includes all documents we cite in this report that were not part of our literature review and do not appear in Appendixes E or F. How This Report Could Be Used This report could be valuable to researchers, ethicists, scientific societies, sponsors of research, and government regulators seeking to create new codes of ethics for emerg- ing disciplines or struggling to decipher how ethics should apply to a new situation or discipline. For the experienced researchers, this report provides perspective outside of their own fields across the breadth of disciplines and ethical challenges they have yet to encounter. As more researchers collaborate across fields, sometimes helping to shape new ones, this report could aid those who find themselves working on research not Introduction 3 contemplated by their formal training and past experiences. For instance, it is common today for geneticists to work with big data and information science; for computer scien- tists to conduct sociological studies on social media; and for those who may lack formal training to engage in research that historically required considerable training. For this last group, the citizen scientist or amateur researcher, this report provides guideposts to understanding ethical norms, behaviors, and practices. The Difference Between Ethics and Law Laws are geographically based and biased by local cultural norms. Each country, state, and locality can pass its own laws legalizing or banning any behavior. Ethics, on the other hand, reflect the values of a collective—a population, at their most general, or a professional society or other group in specific instances. Ethics may or may not agree with local laws. This sometimes-difficult relationship is described succinctly in the preamble to the American Medical Association’s Code of Ethics: The relationship between ethics and law is complex. Ethical values and legal prin- ciples are usually closely related, but ethical responsibilities usually exceed legal duties. Conduct that is legally permissible may be ethically unacceptable. Con- versely, the fact that a physician who has been charged with allegedly illegal con- duct has been acquitted or exonerated in criminal or civil proceedings does not necessarily mean that the physician acted ethically. In some cases, the law mandates conduct that is ethically unacceptable. When physicians believe a law violates ethical values or is unjust they should work to change in law. In exceptional circumstances of unjust laws, ethical responsibilities should supersede legal duties.1 Another perspective comes from consideration of why codes are produced by pro- fessional societies: The organization of a profession is typically accompanied by a code, which establishes a convention among people in a field that helps to define who they are as professionals: A code of ethics... prescribe[s] how professionals are to pursue their common ideal so that each may do the best she can at minimal cost to herself and those she cares about (including the public, if looking after the public is part of what she cares about). The code is to protect each professional from certain pressures (for example, the pressure to cut corners to save money) by making it reasonably likely (and more likely than otherwise) that most other members of the profession will not take advantage of her good conduct. A code protects members of a profession 1 American Medical Association, “Code of Medical Ethics: Preface and Preamble,” 2016. 4 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics from certain consequences of competition. A code is a solution to a coordination problem.2 Thus, a code provides guidance beyond what might come from personal con- science alone. This project focused on ethics—not laws or regulations. We examined ethics across international borders to understand which ethical principles or elements are shared—across disciplines, countries, and societies—and to identify nuances within ethical elements. Throughout our research, we found examples of professional societies that hold their members to ethical standards (sometimes called “soft law”) indepen- dent of legal standards. Additionally, we found examples of professional societies that required researchers to behave ethically by abiding by national law. 2 M. Davis, “Thinking Like an Engineer: The Place of a Code of Ethics in the Practice of a Profession, Philoso- phy and Public Affairs, Vol. 20, No. 2, 1991, pp. 150–167. CHAPTER TWO Ethical Principles for Scientific Research Our team collected the 200 most-cited peer-reviewed articles on ethics in scientific research from literature over time plus codes of ethics from across scientific disciplines. We then analyzed these documents for commonalities and differences, and we present our results in this chapter. Where we found gaps in the literature, we conducted addi- tional research and interviews with experts in relevant fields.1 As a result of our analy- sis, we identified ten ethical principles that cross scientific and technical disciplines. We present this list in Table 2.1 with our definitions for each term, and throughout the remainder of the chapter, we explain what the literature said on each topic in greater detail. Each ethical principle applies to one or more of the following categories: ethical scientific inquiry ethical conduct and behaviors of researchers ethical treatment of research participants. Table 2.2 describes the categories and maps the ethical principles to them. One principle, nondiscrimination, applies in two categories: behaviors of researchers and treatment of participants. Although the principles are discussed as discrete sets of con- cerns, they interconnect, if not overlap. Duty to Society Definition: Researchers and research must contribute to the well-being of society. Duty to society is a well-documented element of ethics across our literature review, and yet it differs slightly between disciplines and countries. International dif- ferences will be discussed in Chapter Three. The primary premise of duty to society is 1 Appendix A includes a detailed description of our methodology, including how we chose which articles to review and which experts to interview and how we conducted our interviews and our analysis. 5 6 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics Table 2.1 Ethical Principles for Scientific Research Ethical Principle Definition Duty to society Researchers and research must contribute to the well-being of society. Beneficence Researchers should have the welfare of the research participant in mind as a goal and strive for the benefits of the research to outweigh the risks. Conflict of interest Researchers should minimize financial and other influences on their research and on research participants that could bias research results. Conflict of interest is more frequently directed at the researcher, but it may also involve the research participants if they are provided with a financial or nonfinancial incentive to participate. Informed consent All research participants must voluntarily agree to participate in research, without pressure from financial gain or other coercion, and their agreement must include an understanding of the research and its risks. When participants are unable to consent or when vulnerable groups are involved in research, specific actions must be taken by researchers and their institutions to protect the participants. Integrity Researchers should demonstrate honesty and truthfulness. They should not fabricate data, falsify results, or omit relevant data. They should report findings fully, minimize or eliminate bias in their methods, and disclose underlying assumptions. Nondiscrimination Researchers should minimize attempts to reduce the benefits of research on specific groups and to deny benefits from other groups. Nonexploitation Researchers should not exploit or take unfair advantage of research participants. Privacy and Privacy: Research participants have the right to control access to their personal confidentiality information and to their bodies in the collection of biological specimens. Participants may control how others see, touch, or obtain their information. Confidentiality: Researchers will protect the private information provided by participants from release. Confidentiality is an extension of the concept of privacy; it refers to the participant’s understanding of, and agreement to, the ways identifiable information will be stored and shared. Professional Researchers should engage only in work that they are qualified to perform, competence while also participating in training and betterment programs with the intent of improving their skill sets. This concept includes how researchers choose research methods, statistical methods, and sample sizes that are appropriate and would not cause misleading results. Professional Researchers should engage in ethical research and help other researchers engage discipline in ethical research by promulgating ethical behaviors through practice, publishing and communicating, mentoring and teaching, and other activities. NOTE: Research participant refers to someone with an active role participating in research, whereas research subject could include someone whose data are used but who does not consent to participate. that research must not be undertaken if it produces no benefit to society.2 Such benefit is judged by the researchers, their institution, and their sponsors, rather than by society as a whole or by historians in future decades, leading to lapses between what research- 2 Interview 11. The National Society of Professional Engineers, although focused on professional practice rather than research, has a similar concept in the Paramountcy Principle—holding paramount the safety, health, and welfare of the public. See National Society of Professional Engineers, Code of Ethics, Alexandria, Va., 2018. Ethical Principles for Scientific Research 7 Table 2.2 Categories of Ethical Principles Category Description of Category Ethical Principle Ethical scientific inquiry The research inquiry itself must Duty to society benefit society. Ethical conduct and behaviors Researchers should conduct Conflict of interest of researchers themselves in certain manners, Integrity and they are responsible for their Nondiscrimination knowledge and awareness of Professional competence ethics and appropriate research Professional discipline methods. Ethical treatment of research Research participants should Informed consent participants be treated according to certain Beneficence guidelines and treated humanely, Nondiscrimination and the environmental or Nonexploitation secondary effects of the research Privacy and confidentiality should be considered. ers and the research community believe is a benefit to society and what other members of society might believe. Some unethical activities conducted in the name of medical research involved the inhumane treatment of research participants without a broader benefit to society or with benefits that could not have been foreseen at the time. In some cases, duty to society comes in conflict with beneficence, as when society may benefit from research that may knowingly and intentionally harm research participants. Historical examples provide cases where society has benefited from research that was inhumane to its par- ticipants, and scientists still grapple today with whether it is ethical to use the results of such research. One researcher calculated that by 2010, “the data from Nazi experi- ments have been used and/or cited on over fifty occasions,” particularly “data from hypothermia experiments.”3 In modern ethics, both beneficence and duty to society are simultaneously required: Research must benefit or aim to do no harm to both the research subjects and society.4 There is no universal equilibrium, since some cultures place more emphasis on the well-being of a community over that of the individual.5 Involving members of any community can help in designing research that achieves an appropriate balance. 3 R. Halpin, “Can Unethically Produced Data Be Used Ethically?” Medicine and Law, Vol. 29, 2010, pp. 373–387. 4 E. J. Emanuel, D. Wendler, and C. Grady, “What Makes Clinical Research Ethical?” Journal of the American Medical Association, Vol. 283, No. 20, 2000, pp. 2701–2711. 5 Interviews 1 and 11. 8 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics In medical disciplines, the literature states that the primary obligation of research- ers should be to their participants, not to the objectives of their studies.6 This principle was documented in the first version of the Declaration of Helsinki in 1964 (see Chap- ter Three), which said, “[c]linical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.”7 Violations of this ethical principle can occur when research is conducted in coun- tries where regulations are less stringently observed (see discussion of “ethics dump- ing” in Chapter Three). Emanuel et al. equates ethical multinational research with avoidance of exploitation, the risk of which is greater in developing countries. Key to avoiding exploitation is a collaborative partnership in such contexts to reinforce other ethical principles.8 Nonmedical Guidelines Each discipline we examined had slightly different interpretations or applications of duty to society. None of these interpretations conflicted with the others, but each related to the specific needs of researchers in that specific field. In genomics, members of society are responsible for determining the appropriate and inappropriate use of genetic research.9 Researchers must consider the perspectives of diverse communities across society to understand their ethical boundaries, values, and concerns on how this discipline affects society.10 Overall, “respect for the dignity and well-being of persons takes precedence over expected benefits to knowledge.”11 According to the International Society of Ethnobiology, persons and organizations undertaking research activities shall do so throughout in good faith, acting in accordance with, and with due respect for, the cultural norms and dignity of all potentially affected communities, and with a commitment that collecting specimens and information, whether of a zoological, botanical, mineral or cultural nature, and compiling data or publishing information thereon, means 6 M. Angell, “The Ethics of Clinical Research in the Third World,” New England Journal of Medicine, Vol. 337, No. 12, 1997, pp. 847–849; B. Freedman, “Equipoise and the Ethics of Clinical Research,” New England Journal of Medicine, Vol. 317, No. 3, 1987, pp. 141–145; Emanuel, Wendler, and Grady, 2000. 7 World Medical Association, “DECLARATION OF HELSINKI: Recommendations Guiding Doctors in Clinical Research,” adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. 8 E. J. Emanuel, D. Wendler, J. Killen, and C. Grady, “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,” Journal of Infectious Diseases, Vol. 189, No. 5, 2004, pp. 930–937. 9 F. S. Collins, E. D. Green, A. E. Guttmacher, and M. S. Guyer, “A Vision for the Future of Genomics Research,” Nature, Vol. 422, No. 6934, 2003, pp. 835–847. 10 Collins et al., 2003; M. Minkler, “Community-Based Research Partnerships: Challenges and Opportunities,” Journal of Urban Health, Vol. 82 (SUPPL. 2), 2005, pp. ii3–ii12. 11 M. Guillemin and L. Gillam, “Ethics, Reflexivity, and ‘Ethically Important Moments’ in Research,” Qualita- tive Inquiry, Vol. 10, No. 2, 2004, pp. 261–280. Ethical Principles for Scientific Research 9 doing so only in the holistic context, respectful of norms and belief systems of the relevant communities.12 In engineering, where apart from bioengineering and some aspects of computer systems, research rarely includes research participants, duty to society assigns engineers responsibility for the safety of the public.13 In the ethical code of the Association for Computing Machinery (ACM), a professional society for computer scientists, the first principle states, “[c]ontribute to society and to human well-being, acknowledging that all people are stakeholders in computing.”14 And in ecology, researchers should strive to understand the complex relationship between biodiversity ecosystem functioning and management to minimize current losses of species and responsibly manage Earth’s ecosystems.15 Here, society is not even limited to humans, but rather includes all of Earth’s ecosystems. We found that the literature involving human participants prioritizes partici- pants’ well-being over the potential knowledge gained or the benefits expected from research; second, research design should consider diverse perspectives for how a project may affect a population. One issue that researchers may grapple with is defining the process of protecting public welfare or safety. Because this standard is subjective, view- points may differ on how to comply with such a mandate. In disciplines that are not human-centric, we found that researchers are urged to highlight the need to minimize the harm to our environment. Some codes of conduct go even further to define specific activities they deem unethical to society, and in these instances these codes ban researchers from participat- ing in such activities. Notable examples our team found include the following: The American Society for Microbiology (ASM) instructs members “to discour- age any use of microbiology contrary to the welfare of humankind, including the use of microbes as biological weapons. Bioterrorism violates the fundamental principles upon which the Society was founded and is abhorrent to the ASM and its members.”16 The International Sociological Association (ISA) warns members to be vigilant of sponsors who wish to use research for “political aims.” The association says soci- 12 International Society of Ethnobiology, “ISE Code of Ethics,” 2008. 13L. J. Shuman, S. M. Besterfield-Sacre, and J. McGourty, “The ABET ‘Professional Skills’: Can They Be Taught? Can They Be Assessed?” Journal of Engineering Education, Vol. 94, No. 1, 2005, pp. 41–55. 14 ACM, “ACM Code of Ethics and Professional Conduct,” 2018. 15 D. U. Hooper, F. S. Chapin III, J. J. Ewel, A. Hector, P. Inchausti, S. Lavorel, J. H. Lawton, D. M. Lodge, M. Loreau, S. Naeem, B. Schmid, H. Setälä, A. J. Symstad, J. Vandermeer, and D. A. Wardle, “Effects of Biodiversity on Ecosystem Functioning: A Consensus of Current Knowledge,” Ecological Monographs, Vol. 75, No. 1, 2005, pp. 3–35. 16 ASM, “Code of Ethics,” 2005. 10 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics ologists “should also refrain from cooperating in the fulfillment of undemocratic aims or discriminatory goals.”17 The International Society for Environmental Epidemiology advocates for research that “place[s] the health of exposed or at-risk populations ahead of concern for the reputation and financial well-being of any institution or organization.”18 All professional societies that we studied instruct their members to fundamentally serve the public with the fruits of their research and practice. Some societies provide guidance on unique issues when attempting to comply with that mission. The vast majority of statements about duty to society focus on protecting public welfare. The ASM, ISA, and the International Society for Environmental Epidemiology are unique examples from our research in how they specify the threats that their discipline could pose to the public by making explicit what constitutes unethical research and behavior. In modern research, duty to society continues to exert ethical dilemmas in emerg- ing research disciplines, such as information science research conducted on society- wide data sets. In some cases, it is possible to ask whether the benefits to society for such research will ever be realized. See Box 2.1 for a discussion of the Uppsala Code, which calls on researchers to ponder the prospective societal impacts as individuals and eschew research that could support war or oppression. Beneficence Definition: Researchers should have the welfare of the research participant in mind as a goal and strive for the benefits of the research to outweigh the risks. Beneficence is a core tenet of any research that involves human participants, and, as such, it could be called a pillar of medical research. Simply put, beneficence requires that research be designed to maximize the benefits to research participants while mini- mizing the harm to them. According to the literature, the benefits of the research may not be artificially inflated by researchers to disguise the harms nor to offset the severity of the harms.19 In other words, any financial or nonfinancial benefits offered to research participants—including payment for participation, free medical tests, free medical exams, free vaccinations, and so on—cannot be considered in an assessment of beneficence. Accordingly, monitoring boards, including institutional review boards 17 International Sociological Association, “Code of Ethics,” 2001. 18 International Society for Environmental Epidemiology, “Ethics Guidelines for Environmental Epidemiolo- gists,” 2012. 19 G. B. Drummond, “Reporting Ethical Matters in the Journal of Physiology: Standards and Advice,” Journal of Physiology, Vol. 587, No. 4, 2009, pp. 713–719; Emanuel, Wendler, and Grady, 2000; T. S. Behrend, D. J. Sharek, A. W. Meade, and E. N. Wiebe, “The Viability of Crowdsourcing for Survey Research,” Behavior Research Meth- ods, Vol. 43, No. 3, 2011, pp. 800–813. Ethical Principles for Scientific Research 11 Box 2.1 The Uppsala Code and the Pugwash Tradition The Uppsala (Sweden) Code of Ethics for Scientists was developed in the early 1980s to address the potential for scientists to influence the balance between war and peace (and to protect the environment), since research can either ameliorate or aggravate problems in society. Notwithstanding these broad concerns, the Uppsala Code focuses on the responsibilities of individual scientists: “We consider the ethical dilemmas that the code addresses to be personal ones; they are matters of conscience.” This code invokes a “duty to inform”: “When a scientist finds his/her own work unethical he/she should interrupt it.” The Uppsala Code drew from Pugwash discussions, which involve scientists exploring how they can contribute to evidence-based policymaking intended to combat the threat of weapons of mass destruction. Whereas much of the discussion so far has addressed protections for individuals and definable groups, the Uppsala Code has a broader societal focus. According to the people spearheading its development, “A code should give some details about the responsibility of the scientist and some advice on how to act when an ethical dilemma arises.” They observed that codes of ethics associated with research typically are written in a general way. That circumstance opens the door to both interpretation and ambiguity, both of which can undercut [implementation]. The developers of the Uppsala Code also put a spotlight on the responsibility of scientists to consider how their work might be used. SOURCES: Bengt Gustafsson, Lars Rydén, Gunnar Tybell, and Peter Wallensteen, “Focus on: The Uppsala Code of Ethics for Scientists,” Journal of Peace Research, Vol. 21, No. 4, 1984, pp. 311–316; Pugwash, “Pugwash Conferences on Science and World Affairs,” homepage, 2018. (IRBs) that evaluate the continuation of research on human participants, have become an important element of ensuring beneficence. 20 In medicine, adherence to the principle of beneficence reconciles the tensions between the responsibility to provide a quality of care and the need for research to test new treatments by requiring researchers to hold the welfare of the research participant to the highest standards. Thus, for example, researchers must consider whether using a placebo or untreated control group is ethical when effective treatments exist. The ethics of using placebos during medical research are still under debate;21 placebos are generally accepted when they present low risk and are essential to a methodology. One notorious example in which researchers did not take the standard of care into account was the “Tuskegee Study of Untreated Syphilis in the Negro Male,” whose research participants were allowed to suffer the effects of untreated syphilis despite an effec- 20 An IRB is a group that has formal, designated authority to review and monitor research involving human sub- jects. An IRB has the authority to approve, require modifications in, or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investiga- tor brochures) to ensure protection of the rights and welfare of human subjects of research (U.S. Food and Drug Administration, “Institutional Review Boards Frequently Asked Questions: Information Sheet,” fact sheet, July 12, 2018). 21 A. Skierka and K. Michels, “Ethical Principles and Placebo-Controlled Trials: Interpretation and Implemen- tation of the Declaration of Helsinki’s Placebo Paragraph in Medical Research,” BMC Medical Ethics, 2018; J. Millum and C. Grady, “The Ethics of Placebo-Controlled Trials: Methodological Justifications,” Contemporary Clinical Trials, Vol. 36, No. 2, 2013, pp. 510–514. 12 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics tive treatment existing during the study.22 The Tuskegee study has become the case example of research that lacked beneficence. Research literature discusses the need to provide high-quality care to research participants who might not otherwise receive it due to geographic location, illiteracy, poverty, or other factors. In clinical contexts, as opposed to research contexts, a physician is expected to be guided by both beneficence and the complementary concept of avoiding harm (non- maleficence). Because research involves more uncertainty than clinical care—reducing uncertainty is a goal of research—it is understood that there is a risk of harm (see the discussion of informed consent later in this chapter), which should be outweighed by the potential for benefit. The Declaration of Helsinki, the history of which is discussed in Chapter Three, states that “[i]t is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidential- ity of personal information of research subjects.”23 This usage of integrity as a compo- nent of beneficence “includes respect for the autonomy of individuals, achieved mainly by the mechanism of informed consent; respect for privacy, achieved at least partly by rules relating to confidentiality and secure storage of data; and respect for the dignity of persons.”24 (Integrity as an attribute of researcher behavior is discussed later in this chapter.) Beneficence is also closely linked to informed consent (another topic discussed later in this chapter). “The subjects should be volunteers,” says the Declaration of Hel- sinki, which goes on to state, “[w]hile the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and inter- ests of individual research subjects.”25 A research participant should not be asked to consent to a study that lacks sufficient benefits, and informed consent does not replace the need for beneficence.26 Incentives to research participants, such as financial pay- ments, free vaccines, or medications, should not be used to tip the scale of beneficence, making the benefits of the study appear to outweigh the harms to the research partici- pants. Nor should these benefits be used to coerce informed consent. Research studies have been conducted in which research participants have expe- rienced psychological stress and other negative effects that can be unexpected by 22 Centers for Disease Control and Prevention, “U.S. Public Health Service Syphilis Study at Tuskegee,” 2015. 23 WMA, “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects,” Jour- nal of the American Medical Association, Vol. 310, No. 20, 2013. 24 Guillemin, 2004. 25 WMA, 2013. 26 K. J. Rothman and K. B. Michels, “The Continuing Unethical Use of Placebo Controls,” New England Jour- nal of Medicine, Vol. 331, No. 6, 1994, pp. 394–398. Ethical Principles for Scientific Research 13 researchers.27 It is the responsibility of researchers to consider possible harm that may come to a participant and to respond when new unexpected harms occur.28 Research that uses human subjects’ data—without experimenting on research participants themselves—is similarly required to adhere to beneficence. Even if data are “de-identified,” the literature says they “must be justified to the IRB as having some expected benefits.... One cannot perform data analysis for frivolous or nefari- ous purposes.” This applies to vast web-based data sets that may be publicly available (including social media data).29 Challenges associated with big data are addressed in Chapter Five. Conflicts of interest, a major area of concern in their own right discussed later in this chapter, can affect beneficence. As described by the American Psychological Association (APA): Psychologists strive to benefit those with whom they work and take care to do no harm. In their professional actions, psychologists seek to safeguard the welfare and rights of those with whom they interact professionally and other affected per- sons, and the welfare of animal subjects of research. When conflicts occur among psychologists’ obligations or concerns, they attempt to resolve these conflicts in a responsible fashion that avoids or minimizes harm. Because psychologists’ scien- tific and professional judgments and actions may affect the lives of others, they are alert to and guard against personal, financial, social, organizational, or political factors that might lead to misuse of their influence. Psychologists strive to be aware of the possible effect of their own physical and mental health on their ability to help those with whom they work. 30 APA continues, “[p]sychologists take reasonable steps to avoid harming their clients/patients, students, supervisees, research participants, organizational clients, 27 B. DiCicco-Bloom and B. F. Crabtree, “The Qualitative Research Interview,” Medical Education, Vol. 40, No. 4, 2006, pp. 314–321. 28 For research on animals, literature on beneficence requires minimizing pain and using anesthesia and “pain blocking agents.” Animals should be housed and fed in humane conditions, and different levels of protections are applied to cats, dogs, primates, and horses versus invertebrates and “lower levels” of species. In some countries (such as the United Kingdom), these rules are written in law, and violations are punishable with prison sentences (Drummond, 2009). Guidelines for use of wild mammal species are updated from an American Society of Mam- malogists 2007 publication (R. S. Sikes and W. L. Gannon, “Guidelines of the American Society of Mammalo- gists for the Use of Wild Mammals in Research,” Journal of Mammalogy, Vol. 92, No. 1, 2011, pp. 235–253). Of course, reasonable members of society can debate whether research conducted on animals is ever humane, yet we found no literature that required the researcher to adjudicate this ethical debate. Instead, the literature requires researchers to treat animals humanely and with beneficence and often stipulates that animals should be used only when necessary, though such necessity is rarely, if ever, defined. 29 K. J. Cios and G. W. Moore, “Uniqueness of Medical Data Mining,” Artificial Intelligence in Medicine, Vol. 26, No. 1–2, 2002, pp. 1–24. 30 APA, “American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct,” 2017. 14 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics and others with whom they work, and to minimize harm where it is foreseeable and unavoidable.” In the ACM code of ethics for computer scientists, the first principle states, “[c] ontribute to society and to human well-being.” Its second principle states simply, “[a] void harm,” which is defined thus: In this document, “harm” means negative consequences, especially when those consequences are significant and unjust. Examples of harm include unjustified physical or mental injury, unjustified destruction or disclosure of information, and unjustified damage to property, reputation, and the environment. This list is not exhaustive. Well-intended actions, including those that accomplish assigned duties, may lead to harm. When that harm is unintended, those responsible are obliged to undo or mitigate the harm as much as possible. Avoiding harm begins with careful consid- eration of potential impacts on all those affected by decisions. When harm is an intentional part of the system, those responsible are obligated to ensure that the harm is ethically justified. In either case, ensure that all harm is minimized.31 The American Statistical Association says researchers should “[Strive] to avoid the use of excessive or inadequate numbers of research subjects—and excessive risk to research subjects (in terms of health, welfare, privacy, and ownership of their own data)—by making informed recommendations for study size.”32 Our analysis suggested that beneficence may be in the eye of the beholder for both research participants and researchers. Without clear guidelines on how to achieve it, beneficence is described in cost-benefit terms comparing human participants’ gains against the risk of harm that they might incur, and the research participant makes this assessment when asked to give his or her informed consent. The various codes use phrases like “safeguard his or her integrity” (medicine), “recognizes the autonomy of individuals” (general sciences), “minimize harm where it is foreseeable and unavoid- able” (psychology), and “consider the potential impact” (social science). These are not clear distinctions between research that is good (beneficent) and bad (maleficent). Rather, these statements call on researchers to use their best judgment and honor for the sake of their participants. Similarly, in the engineering field, the challenge to work under cost and schedule pressures can increase risks. Engineers have a responsibility to ask when the risk has increased such that it is no longer acceptable.33 An interesting exception, where beneficence is defined in black-and-white terms rather than being left to the interpretation of the researcher, can be found in the APA’s 31 ACM, 2018. 32 American Statistical Association, “Ethical Guidelines for Statistical Practice,” 2018. 33 Shuman, Besterfield-Sacre, and McGourty, 2005. Ethical Principles for Scientific Research 15 code of conduct, which specifically calls on psychologists not to “participate in, facili- tate, assist, or otherwise engage in torture.” To prevent any misunderstanding, the code defines torture as “any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person, or in any other cruel, inhuman, or degrading behavior that violates 3.04(a).3.” This level of specificity is rare among codes of conduct and is an issue the APA has publicized extensively.34 We found widespread agreement across the literature on what beneficence means, though certain disciplines add additional insights and nuance as to how it applies in their respective fields. Disciplines that do not engage routinely with research partic- ipants—such as computer science/information science and mathematics/statistics— lack comprehensive literature on this topic, despite the potential for their research to affect persons whose data are used, analyzed, and reported on. This is one reason why we make a distinction in this report between research participants (who have an active participatory role in the research) and research subjects (who do not consent to participate but may be affected by research or whose data may be used). Technology fields, including computer science, are more recently coming to terms with their role in affecting human subjects and their ethical responsibility to beneficence. Given that we focused our research on highly cited articles, we would anticipate that newer literature has or could address this perceived gap. The recent emergence of codes of ethics and related scholarship for researchers working on AI illustrates a corresponding evolution in thinking. Conflict of Interest Definition: Researchers should minimize financial and other influences on their research and on research participants that could bias research results. Conflict of interest is more fre- quently directed at the researcher, but it may also involve the research participants if they are provided with a financial or nonfinancial incentive to participate. The National Academies of Sciences, Engineering, and Medicine describe con- flicting interests thus: “in some cases the prospect of financial gain could affect the design of an investigation, the interpretation of data, or the presentation of results. Indeed, even the appearance of a financial conflict of interest can seriously harm a researcher’s reputation as well as public perceptions of science.”35 Across our research, we found literature that sets guidelines for how to identify conflicts while acknowledg- ing that they may arise in many forms. 34 See APA, Timeline of APA Policies and Actions Related to Detainee Welfare and Professional Ethics in the Con- text of Interrogation and National Security, Washington, D.C., 2019b; APA, Position on Ethics and Interrogation, Washington, D.C., 2019a. 35 National Academy of Sciences, National Academy of Engineering, and Institute of Medicine of the National Academies, On Being a Scientist: A Guide to Responsible Conduct in Research, 3rd Edition, 2009. 16 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics The literature documents how conflicts of interest can be financial or nonfinan- cial (including the provision of equipment, services, speaking and publishing opportu- nities, professional opportunities, or any other personal gain to the researcher). Codes of conduct that discuss conflicts of interest place responsibility on researchers to pre- vent and/or disclose any such relationships. Many journals require such disclosure of support for their research from authors prior to accepting articles for publication. For research participants who are paid for their participation, the payment itself, as well as any nonmonetary benefits of participating, can create a conflict in prevent- ing the participant from accurately weighing the risks and benefits of the research. In this sense, a financial or nonfinancial benefit for participating (including free medi- cal exams, free medical tests, free vaccinations, and so on), can influence whether a research participant provides an uncoerced consent to participate. In this sense, any financial or nonfinancial benefits to research participants should be evaluated by IRBs or other oversight boards, as both the research participant and researcher may be unable to assess the potential coercive effect of the benefit without bias. Undisclosed conflicts of interest could cast doubt on the validity of the data, the analysis, the selection of research participants, the public’s trust in research, and other factors. The literature addresses conflicts relating to either the funder or the research participant. Conflicts associated with the nature of funders are widely dis- cussed, especially throughout medical research literature, since a significant amount of that research is funded by pharmaceutical companies, medical device companies, and other for-profit entities that may benefit from findings. Conflicts of interest can also affect what, when, and how the results of research are published and therefore benefit the larger research community. Our review found reports “that studies sponsored by a pharmaceutical company were less likely to be published, whatever the results” and “selectivity in the submission for publication of drug company sponsored studies, according to the direction of the result.”36 In neuro- surgery specifically, researchers found, “Industry funding was associated with a much greater chance of positive findings in [randomized controlled trials] published in neu- rosurgical journals. Further efforts are needed to define the relationship between the authors and financial sponsors of neurosurgical research and explore the reasons for this finding.”37 In an article titled, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research,” researchers said, 36 P. J. Easterbrook, R. Gopalan., J. A. Berlin, and D. R. Matthews, “Publication Bias in Clinical Research,” The Lancet, Vol. 337, No. 8746, 1991, pp. 867–872. 37 N. R. Khan, H. Saad, C. S. Oravec, N. Rossi, V. Nguyen, G. T. Venable, J. C. Lillard, P. Patel, D. R. Taylor, B. N. Vaughn, D. Kondziolka, F. G. Barker, L. M. Michael, and P. Klimo, “A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature: The Elephant in the Room, Neurosur- gery, Vol. 83, No. 5, 2018, pp. 890–897. Ethical Principles for Scientific Research 17 Consistent evidence also demonstrated that industry ties are associated with both publication delays and data withholding. These restrictions, often contractual in nature, serve to compound bias in biomedical research. Anecdotal reports sug- gest that industry may alter, obstruct, or even stop publication of negative studies. Such restrictions seem counterproductive to the arguments in favor of academic industry collaboration, namely encouraging knowledge and technology transfer. Evidence shows, however, that industry sponsorship alone is not associated with data withholding. Rather, such behavior appears to arise when investigators are involved in the process of bringing their research results to market.38 Minor gift-giving is even less monitored and governed than industry sponsor- ship of research. Even minor gifts—well below any reporting threshold—can create loyalty and bias for the recipient to the giver or lead to an expectation of reciprocity, and some argue that gifts of any size should be banned.39 In lieu of tangible gifts, some medical companies and industry groups offer speaking or publication opportunities to researchers, which present nonfinancial conflicts that can aggravate the pressure to be recognized and the bias to publish only research with positive results. This is especially risky when the gift is nonfinancial and not easily recognized as a gift, such as a profes- sional opportunity, speaking opportunity, or other nonfinancial benefit.40 Conflicts of interest between researcher and research participants are less widely discussed within the ethical principle of conflict of interest yet present their own chal- lenges. In the social sciences, two articles in our data set addressed conflicts that arise when the researcher has or develops a personal relationship with the subject. The poten- tial results of personal relationships could affect whether researchers make the best judgments for the research rather than for their friend the research participant.41 In the medical field, the American Medical Association warns its physicians to be careful of conflict when a patient becomes a research participant in the physician’s own clinical trial: the physician will have conflicting loyalty to the patient and the research.42 When 38 J. E. Bekelman, Y. Li, and C. P. Gross, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” Journal of the American Medical Association, Vol. 289, No. 4, 2003, pp. 454–465. 39 T. A. Brennan, D. J. Rothman, L. Blank, D. Blumenthal, S. C. Chimonas, J. J. Cohen, J. Goldman, J. P. Kas- sirer, H. Kimball, J. Naughton, and N. Smelser, “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” Journal of the American Medical Association, Vol. 295, No. 4, 2006, pp. 429–433. 40 A. W. Chan, J. M. Tetzlaff, P. C. Gøtzsche, D. G. Altman, H. Mann, J. A. Berlin, K. Dickersin, A. Hróbjarts- son, K. F. Schulz, W. R. Parulekar, K. Krleza-Jeric, A. Laupacis, and D. Moher, “SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials,” British Medical Journal (Clinical Research Edition), Vol. 346, No. 2, 2013. 41 See C. Ellis, “Telling Secrets, Revealing Lives: Relational Ethics in Research with Intimate Others,” Qualita- tive Inquiry, Vol. 13, No. 1, 2007, pp. 3–29; Behrend, 2011. 42 American Medical Association, 2016, chapter 7; American Medical Association, “Principles of Medical Ethics,” 2018. 18 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics the researcher has a vested interest in the research participant, such as via the doctor- patient relationship, the researcher may be divided in loyalties between wanting the patient to live a good quality of life and wanting to conduct unbiased research. Across the literature, we found widespread agreement that conflicts of interest should be addressed in a timely manner, managed by the researcher(s) and institution(s), and disclosed to the public and the research participants.43 And yet disclosure to research participants and the public may be insufficient: Can the researcher know the extent to which the conflict affected his or her results? How would a research par- ticipant appreciate the significance of the conflict? And how would other experts in the field be able to judge the validity of the research without reproducing the results? Research participants may have a strong desire for continuing in the research treatment and be unable to judge objectively the importance of the conflict. Meanwhile, outside readers of published research results may be unable to adequately judge the effect the conflict had on the research. Some professional societies mitigate these risks by providing specific guidance, recommendations, or disclosure requirements to their researchers. The Society of Toxicology provides disclosure forms, documents, and definitions for researchers.44 The Ethical Standards in Sport and Exercise Science Research requires authors to “include details of any incentives for participants and provisions for treating and/ or compensating participants who are harmed as a consequence of participation in the research study.”45 The American Association of Physicists in Medicine informs its members that NIH has established a reporting requirement of financial gains of $10,000 or more and addresses nonfinancial gains, such as prestige.46 In the business sector, we found that the Academy of Management tells its mem- bers to avoid both actual conflicts of interest and the appearances of conflicts.47 43 National Academy of Sciences, National Academy of Engineering, and Institute of Medicine of the National Academies, 2009. 44 Links to these resources are at the bottom of Society of Toxicology, “Code of Ethics and Conflict of Interest,” webpage, last revised 2012. 45 D. J. Harriss and G. Atkinson, “Ethical Standards in Sport and Exercise Science Research: 2014 Update,” International Journal of Sports Medicine, Vol. 34, No. 12, 2013, pp. 1025–1028. 46 American Association of Physicists in Medicine, Code of Ethics for the American Association of Physicists in Medicine: Report of Task Group 109, 2009. 47 Academy of Management, “AOM Code of Ethics,” December 6, 2017. Ethical Principles for Scientific Research 19 An international code for sociologists warns its members of sponsors “interested in funding sociological research for the sake of their own political aims. Whether they share such aims, sociologists should not become subordinate to them.”48 In anthropology, “Anthropologists have an obligation to distinguish the differ- ent kinds of interdependencies and collaborations their work involves, and to consider the real and potential ethical dimensions of these diverse and sometimes contradictory relationships, which may be different in character and may change over time.” The code specifically calls out “obligations to vulnerable populations” and declares that “Anthropologists remain individually responsible for making ethical decisions.”49 The International Society for Environmental Epidemiology holds that members should “not accept funding from sponsors, accept contractual obligations, or engage in research that is contingent upon reaching particular conclusions from a proposed environmental epidemiology inquiry.”50 Across disciplines, we found varied discussions about what types of activities, relationships, or behaviors constitute or indicate a possible conflict of interest. At the same time, we found less discussion about the difference between disclosing conflicts and managing conflicts. Most articles focus on identifying the conflict—how to know it when it occurs—and places the responsibility on researchers to disclose or miti- gate them. But these same literature sources lack sufficient and useful strategies for researchers trying to manage conflicts in a world awash with industry funding and interconnected relationships. Informed Consent Definition: All research participants must voluntarily agree to participate in research, without pressure from financial gain or other coercion, and their agreement must include an understanding of the research and its risks. When participants are unable to consent or when vulnerable groups are involved in research, specific actions must be taken by research- ers and their institutions to protect the participants. Informed consent may be one of the best-defined ethical elements across our research. Every discipline we examined that uses human research participants agrees on the need for informed consent, and we found few variations in how it should be applied. We found widespread agreement in the literature that informed consent 48 International Sociological Association, 2001. 49 American Anthropological Association, “Principles of Professional Responsibility,” November 1, 2012. 50 International Society for Environmental Epidemiology, 2012. 20 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics must use language the research participant understands and comprehends to explain the research, its risks to the participant, and its benefits to the participant must be given freely by the research participant may be revoked by the research participant at any time may only be asked of and given by adults who are capable of making an informed consent, and when research participant are neither adults nor capable of making an informed consent, review boards should provide oversight to protect the rights of research participants, which could involve engaging surrogates or proxies (who raise their own issues).51 Debate on this topic begins to arise in two areas, the first of which regards whether pregnant women should be considered a vulnerable group. U.S. federal regulations define three groups of vulnerable populations in research: pregnant women, human fetuses, and neonates; children; and prisoners.52 New research and analysis indicates that including pregnant women with other groups of vulnerable persons implies that pregnant women are unable to make an informed consent,53 and the result of this grouping is that pregnant women lose the benefits that medical research and other research provide.54 In a second area for debate, ethical deficiencies exist in the gap between informed consent and beneficence, and between informed consent and duty to society. In both cases (beneficence and duty to society), the literature widely agrees that informed con- sent may not replace the need for either of these additional elements. In other words, a research participant may not consent to participate in research that would harm him- self or that would not benefit society, and it is the duty of researchers to never request such consent. This dilemma is shown in Table 2.3. An example where informed consent and beneficence are in direct conflict can be found in the U.S. Right to Try Act of 2017, which allows terminally ill and informed patients the opportunity to knowingly request access to experimental drugs, although these drugs may cause them unknown harms. Before that law was enacted, patients could apply to the U.S. Food and Drug Administration (FDA) for access to 51 Such protected groups include, but are not exclusive to, children, prisoners (or other persons under duress), and adults without the mental capacity to make informed consent. 52 National Institutes of Health, “Vulnerable and Other Populations Requiring Additional Protections,” web- page, updated January 7, 2019. 53 Indira S. E. van der Zande, Rieke van der Graaf, Martijn A. Oudijk, and Johannes J. M. van Delden, “Vulner- ability of Pregnant Women in Clinical Research,” Journal of Medical Ethics, Vol. 43, No. 10, October 2017, pp. 657–663. 54 C. B. Krubiner and R. R. Faden, “Pregnant Women Should Not Be Categorised as a ‘Vulnerable Population’ in Biomedical Research Studies: Ending a Vicious Cycle of ‘Vulnerability,’” Journal of Medical Ethics, Vol. 43, 2017, pp. 664–665. Ethical Principles for Scientific Research 21 unapproved drugs. The FDA reviewed existing nonpublic data and clinical trials and approved “more than 99% of requests between 2010–2015.”55 Under the new law, patients will have access to the same drugs while circumvent- ing the FDA’s process. Opponents of the bill argued that this puts patients at unknown risks. An article in the New England Journal of Medicine argued that “granting very sick patients early access to unapproved products may be more likely to harm patients than to help them. Many drugs that look promising in early development are ultimately not proven safe or efficacious.”56 Other literature considers what happens when informed consent cannot be obtained—either because the identities of affected participants are unknown at the onset of the research or because information about people is collected without their being formally enrolled as participants. Increasingly, as discussed in Chapter Five, “big data” or social media research involves the procurement and manipulation of infor- mation without explicit informed consent for each investigation. Emerging research fields that require large data sets—such as those used to train artificial intelligence algorithms—may require new ways of thinking about how to protect the interests of research subjects: people who have not consented to participate in research but who are affected nonetheless. While informed consent may be clearly defined and documented, its implemen- tation continues to create gray areas, such as “bystander risk,” discussed in Chapter Five, where ethics can be debated by the best-informed experts. Table 2.3 Informed Consent Versus Beneficence and Duty to Society... Beneficence... Duty to Society When informed A research participant cannot consent to A research participant cannot consent to consent conflicts research that may cause harm to himself research that may cause harm to society. with… or herself. Example A new drug is not yet approved for A couple wants to edit a gene in their human trials, but patients with terminal embryo to protect their child from a illnesses want access to try the drug. disease, but the effect of this mutation on future descendants is unknown. 55 Peter Lurie, M.D., MPH, Associate Commissioner for Public Health Strategy and Analysis, U.S. Food and Drug Administration, statement before the U.S. Senate Committee on Homeland Security and Government Affairs, September 22, 2016. 56S. Joffe and H. F. Lynch, “Federal Right-to-Try Legislation: Threatening the FDA’s Public Health Mission,” New England Journal of Medicine, Vol. 378, No. 8, 2018, pp. 695–697. 22 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics Integrity Definition: Researchers should demonstrate honesty and truthfulness. They should not fabricate data, falsify results, or omit relevant data. They should report findings fully, mini- mize or eliminate bias in their methods, and disclose underlying assumptions. The most frequently discussed aspect of integrity is the importance of honest and truthful reporting of results. These principles entail avoiding plagiarism and fal- sification of data and results and striving to remove bias from research methods and analysis. A great number of articles discussed risk of overrepresentation of positive results and underrepresentation of negative results in publications. The Declaration of Helsinki emphasizes that “Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.” In publication of the results of research, both positive and negative results should be published or be publicly available. Sources of funding, institutional affiliations, and any possible conflicts of interest should be declared in the publication. Underreporting should be viewed as scientific misconduct.57 Additionally, the rush or desire to publish leads researchers to prefer research methods that are likely to lead to surprising, or publishable, results, even if those results are not rigorous.58 Studies have shown that scientific studies that produced results that were sta- tistically significant (i.e., rejected a hypothesis or otherwise did not result in the null hypothesis) or that produced positive results were more like to be published than stud- ies that reported the null hypothesis.59 The persistence of this publication bias, along with the pressure on researchers to publish to advance their own professional careers, can lead to dishonest actions, such as manipulating research results, on the part of the researcher.60 This pressure and the potential for researchers to engage in dishon- est actions is not unique to any one country. However, it is possible that such behav- iors may be more prevalent in countries where there are fixations on numerical mea- sures of productivity such as the quantity of publications (over quality of publication) 57 World Medical Association, 2013. 58 K. S. Button, J. P. A. Ioannidis, C. Mokrysz, B. A. Nosek, J. Flint, E. S. J. Robinson, and M. R. Munafò, “Power Failure: Why Small Sample Size Undermines the Reliability of Neuroscience,” Nature Reviews Neurosci- ence, Vol. 14, No. 5, 2013, pp. 365–376. 59 M. Malički and A. Marušić, “Is There a Solution to Publication Bias? Researchers Call for Changes in Dis- semination of Clinical Research Results,” Journal of Clinical Epidemiology, Vol. 67, No. 10, 2014, pp. 1103–1110. 60 N. Matosin, E. Frank, M. Engel, J. S. Lum, and K. A. Newell, “Negativity Towards Negative Results: A Dis- cussion of the Disconnect Between Scientific Worth and Scientific Culture,” Disease Models and Mechanisms, Vol. 7, No. 2, 2014, pp. 171–173; A. Mlinarić, M. Horvat, and V. Šupak Smolčić, “Dealing with the Positive Pub- lication Bias: Why You Should Really Publish Your Negative Results,” Biochemia Medica, Vol. 27, No. 3, 2017. Ethical Principles for Scientific Research 23 and where researchers who are discovered engaging in fraudulent research practices encounter minimal consequences.61 Another important component of integrity lies in conforming to ethical rules in applying placebo and deception in research. Using a placebo as an alternative to the experimental treatment is accepted only when no current proven intervention exists or participants will not be subject to irreversible harm.62 However, the use of deception in research is sometimes justified, such as during psychological, behavioral, and socio- logical studies, and must be merited such that there are no reasonable alternatives for obtaining data, and participants should not incur pain or emotional distress. In stud- ies when deception is used, IRBs have a responsibility to consider the ramifications of its use to research participants. Participants must be accurately informed of risks and debriefed at the conclusion of the study, with the option to withdraw their data.63 Integrity is also important in the treatment of data. For example, data recording and data analysis should be blinded to the operator and analysts. The British Journal of Pharmacology states that normalization—changes to raw data—should not be under- taken unless a scientific rationale is presented.64 Nondiscrimination Definition: Researchers should minimize attempts to reduce the benefits of research on specific groups and to deny benefits from other groups. The principle of nondiscrimination seeks “to guarantee that human rights are exercised without discrimination of any kind based on race, colour [sic], sex, language, religion, political or other opinion, national or social origin, property, birth or other status such as disability, age, marital and family status, sexual orientation and gender identity, health status, place of residence, economic and social situation.”65 Nondis- 61 A. Quin, “Fraud Scandals Sap China’s Dream of Becoming a Science Superpower,” New York Times, October 13, 2017. 62 D. J. Harriss and G. Atkinson, “Update Ethical Standards in Sport and Exercise Science Research,” Interna- tional Journal of Sports Medicine, Vol. 32, No. 11, 2011, pp. 819–821. 63 Harriss and Atkinson, 2011; M. A. Hall, E. Dugan, B. Zheng, and A. K. Mishra, “Trust in Physicians and Medical Institutions: What Is It, Can It Be Measured, and Does It Matter?” Milbank Quarterly, Vol. 79, No. 4, 2001, pp. 613–639; D. Papademas, “IVSA Code of Research Ethics and Guidelines,” Visual Studies, Vol. 24, No. 3, 2009, pp. 250–257; APA, 2017. 64 M. J. Curtis, R. A. Bond, D. Spina, A. Ahluwalia, S. P. A. Alexander, M. A. Giembycz, A. Gilchrist, D. Hoyer, P. A. Insel, A. A. Izzo, A. J. Lawrence, D. J. Macewan, L. D. F. Moon, S. Wonnacott, A. H. Weston, and J. C. McGrath, “Experimental Design and Analysis and Their Reporting: New Guidance for Publication in BJP,” Brit- ish Journal of Pharmacology, Vol. 172, No. 14, 2015, pp. 3461–3471. 65Committee on Economic, Social, and Cultural Rights, “General Comment No. 20, Non-Discrimination in Economic, Social and Cultural Rights,” 2009. 24 Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics crimination may apply to the population of research participants, the population affected by the research results, or the researchers themselves. We found that when nondiscrimination is applied to research participants or the affected population, literature says that discrimination is unacceptable and that certain groups may not be excluded from research populations unless such decision is war- ranted by the research objectives. Even when certain groups are not excluded intention- ally, there are unintentional effects of research when research participants are skewed toward one gender, race, or group. When research benefits are not equally enjoyed by all groups, discrimination may have occurred.

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