by David B. Resnik, J.D., Ph.D.
When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": ethics are norms for conduct that distinguish between or acceptable and unacceptable behavior.
Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?
One plausible explanation of these disagreements is that all people recognize some common ethical norms but different individuals interpret, apply, and balance these norms in different ways in light of their own values and life experiences.
Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, it is important to remember that ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers urged citizens to disobey laws in order to protest what they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of expressing political viewpoints.
Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. Finally, one may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in a complex issue like global warming, one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake in the issue.
Many different disciplines, institutions, and professions have norms for behavior that suit their particular aims and goals. These norms also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical norms govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities, and there is a specialized discipline, research ethics, which studies these norms.
There are several reasons why it is important to adhere to ethical norms in research. First, some of these norms promote the aims of research, such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the truth and avoid error. Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, many of these ethical standards promote the values that are essential to collaborative work, such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship, copyright and patenting policies, data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely. Third, many of the ethical norms help to ensure that researchers can be held accountable to the public. For instance, federal policies on research misconduct, on conflicts of interest, on the human subjects protections, and on animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public. Fourth, ethical norms in research also help to build public support for research. People more likely to fund research project if they can trust the quality and integrity of research. Finally, many of the norms of research promote a variety of other important moral and social values, such as social responsibility, human rights, animal welfare, compliance with the law, and health and safety. Ethical lapses in research can significantly harm to human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety and staff and students.
Codes and Policies for Research Ethics
Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. East Carolina University (ECU) has a variety of policies pertaining to research, which you will review in this short course. Many government agencies, such as the National Institutes of Health (NIH), the National Science Foundation (NSF), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the US Department of Agriculture (USDA) also have ethics rules for funded researchers, which we will also mention in this course. Other influential research ethics policies include the Uniform Requirements (International Committee of Medical Journal Editors), the Chemist's Code of Conduct (American Chemical Society), Code of Ethics (American Society for Clinical Laboratory Science) Ethical Principles of Psychologists (American Psychological Association), Statements on Ethics and Professional Responsibility (American Anthropological Association), Statement on Professional Ethics (American Association of University Professors), The Nuremberg Code and The Declaration of Helsinki (World Medical Association). The following is a rough and general summary of some ethical principals that various codes address*:
Ethical Decision Making in Research
Although codes, policies, and principals are very important and useful, like any set of rules, they do not cover every situation that arises in research, they often conflict, and they require considerable interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions about how to act in various situations. The vast majority of decisions that people must make in the conduct of research involve the straightforward application of ethical rules. For example, consider the following case,
The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects of the drug. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to do. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.
Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct, which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive: honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:
Dr. T has just discovered a mathematical error in a paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.
Clearly, Dr. T's error is not a form of misconduct nor is his decision to take no action to correct the error. Most researchers as well as many different policies and codes, including ECU's policies, would say that Dr. T should tell the journal about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.
There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes called "other deviations" from acceptable research practices. Some of these might include:
Many of these actions would be regarded as highly unethical and some might even be illegal. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.
Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical dilemmas. Consider the following case:
Dr. S is a post-doctoral student in computer science working on some programs that eliminate computer viruses. Two other graduate students are working with her on the project, which is directed by a senior researcher. Dr. S has just received an email from a research team that is working on a similar project at another university. The other team would like Dr. S to share some preliminary data and designs related to the project. Dr. S has not applied for a patent on this research, although she has discussed possible patents with her supervisor.
Dr. S faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data and designs with the other team. If both teams work together, they may both benefit and help each other as well as the profession and society. On the other hand, if she shares data and designs with the other team, then they may not give her (or her team) proper credit and they may win they may win the race to be the first team to be credited with the discovery. By sharing information, Dr. S could jeopardize potential patents and other intellectual property interests. It seems that there are good arguments on both sides of this issue and Dr. S needs to take some time to think about what she should do. What are some steps that researchers, such as Dr. S, can take to "solve" ethical dilemmas in research? The following is a series of questions that can help people resolve ethical dilemmas:
What is the problem or issue?
It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.
What is the relevant information?
Many bad decisions are made as a result of poor information. To know what to do, Dr. S needs to have more information concerning such matters as university policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, etc.
What are the different options?
It is important to spell out the various options as well. People may fail to see different options due a limited imagination, bias, ignorance, or fear. In this case, there may be another choice besides 'share' or 'don't share,' such as 'negotiation.'
How do ethical codes or policies as well as legal rules apply to these different options?
The university may have its own policies on intellectual property or data management that applies to this case. Broader ethical rules, such as openness and respect for intellectual property, may also apply to this case. Relevant laws that would apply to this case might include laws relating to patents, such as laws on prior disclosure and preliminary patents.
Are there any people who can offer ethical advice?
It may be useful to seek advice from a colleague, a senior researcher, your department chair, or anyone else you can trust. In the case, Dr. S might want to talk to her supervisor before making a decision.
After answering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, consider other ethical rules, and so on. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should be able to explain how he or she arrived at his or her decision. He or she should therefore examine carefully the different options in light of the information and problems raised. The following are some questions one might consider at arriving at a final decision.
After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with one's gut feeling, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational or that these other methods should be used only as a last resort. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.
Promoting Ethical Conduct in Science
Many of you may be wondering why you are being required to have training in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research.
If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the best evidence we have shows that misconduct is a very rare occurrence in research. There have been 200 confirmed cases of misconduct in federally funded research in the last 200 years, which works out to a rate of 1in 10,000 (or 0.01%). Of course, this estimate may be extremely low due to various biases related to under-reporting. Several studies have surveyed researchers to ask them whether they have observed misconduct or know about a case of suspected misconduct. There is a great deal of variation in these results, ranging from 3% to 12% who say they have observed misconduct or know about a case of suspected misconduct. These results, though much higher than 0.01%, still do not support the hypothesis that is common in science, especially when you consider these results in relation to the larger body of research. If 5-10% of drivers have witnessed a fatal traffic accident, this does not prove that fatal traffic accidents are common, if you consider this in light of total numbers of hours that people drive.
Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt. However, even if misconduct is rare, it can have a tremendous impact on research. Consider an analogy with crime: it does not take many murders or rapes in a town to erode the community's sense of trust and increase the community's fear and paranoia. The same thing is true with the most serious crimes in science, i.e. fabrication, falsification, and plagiarism. However, most of the crimes committed in science probably are not tantamount to murder or rape. Most of the crimes in science, like most of the crimes in society, are probably the less serious but ethically significant misdeeds that are classified by the government as 'deviations.' Moreover, there are many situations in research that are genuine ethical dilemmas.
Will training and education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue. According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct. Often cited here pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers. Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. To the extent that research environment is an important factor in misconduct, a course in research ethics is likely to help people to get a better understanding of these stresses, sensitize people to the various ethical concerns, and improve ethical judgment and decision making.
Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics could still be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Many of the deviations that occur in research may occur because researchers simple do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect years of tradition in the research community that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. If a drug company uses ghostwriters to write papers "authored" by its physician-employees, what's wrong about this practice? Ghost writers help write all sorts of books these days, so what's wrong with using ghostwriters in research?
Another example where there may be some ignorance or at least some mistaken traditions is the problem of conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finders fee for referring patients into a clinical trial.
If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.
Finally, training in research ethics should be able to help researchers grapple with ethical dilemmas in that it introduces researchers to some important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. In fact, the issues have become so important that the NIH has decided that all intramural researchers should receive training in research ethics. We will try to make the process as painless and interesting as possible.