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Research Ethics for the Biomedical Sciences
Introduction
Science is practiced within society. After sharing his experience of viewing Nagasaki in November 1945, the late mathematician and author Jacob Bronowski stated:
We looked up and saw the power of which we had been proud loom over us like the ruins of Nagasaki. The power of science for good and for evil has troubled other minds than ours…. Nothing happened in 1945 except that we changed the scale of our indifference to man; and conscience, in revenge, for an instant became immediate for us. Before this immediacy fades in a sequence of televised atomic tests, let us acknowledge our subject for what it is; civilisation face to face with its own implications.1
Bronowski’s concerns reflect both the impact of society on science and science’s impact on society. Despite its emphasis on objectivity and method, science is practiced by humans within human society. Thus, ethical issues are enmeshed within scientific research. Ethics is the science of right and wrong, good and evil. Morals are accepted norms of ethical behaviour. People argue over the definition, foundation, application and existence of ethical theories and views. But almost everyone agrees that without some sense of ethics we couldn’t live successfully in society. That is why Aristotle, Confucius and Plato, to list just a few, considered their ethical theories as part of their political theories. Ethics helps people work together. Without an ethical foundation, scientific progress would suffer.
Thomas Hobbes described life without ethics as a war of all against all.2 When everyone is looking out solely for one’s own interest, then the cooperation that is necessary for the developing and flourishing of science is impossible. Some degree of trust, respect, honesty, concern for others, cooperation and fairness is necessary to practice research and advance knowledge. Consider, for example, what it would be like to try to learn your discipline if you could not trust anyone. Could you accomplish your research without depending on and trusting in the reliability of others’ work? Think about how many people helped you get where you are right now.
In this chapter, I will present a set of precepts for the ethical practice of scientific research that are derived from the social foundations of the practice of research, as opposed to any one worldview of ethics.
Social Foundations of Science
Throughout the history of science, philosophers and scientists have sought to describe a single systematic procedure that can be used to generate scientific knowledge, but they have never been completely successful. The practice of science is too multifaceted and its practitioners are too diverse to be captured in a single overarching description. Researchers develop hypotheses, replicate and extend earlier work, collect and analyse data, communicate their results with others, review and critique the results of their peers, train and supervise associates and students and otherwise engage in the life of the scientific community.
Science is far from a self-contained or self-sufficient enterprise. Technological developments critically influence science, as when a new device, such as a telescope, imaging device, rocket, or computer, opens up whole new areas of inquiry. Societal forces also affect the directions of research, greatly complicating descriptions of scientific progress. The continuation of a line of inquiry may depend on ongoing funding and institutional support, for example. The direction and speed of scientific progress is affected by political regimes, media campaigns, advocacy groups, business interests, etc.
Another factor that confounds analysis of the scientific process is the tangled relationship between individual knowledge and social knowledge in science. At the heart of the scientific experience is an individual’s insight into the workings of nature. Many of the outstanding achievements in the history of science grew out of the struggles and successes of individual scientists who were seeking to make sense of the world.
So in sharp contrast to a popular stereotype of science as a lonely, isolated search for truth, science is inherently a social enterprise. With few exceptions, scientific research cannot be done without drawing on the work of others or collaborating with others. It inevitably takes place within a broad social and historical context, which gives substance, direction and ultimately meaning to the work of individual scientists.
The object of research is to extend human knowledge. But the generation of research results is only the beginning of this quest. The results must be presented to others in such a fashion that they can be independently judged for validity. This process occurs in many different ways. Researchers talk to their colleagues and supervisors in laboratories, in hallways and over the telephone. They discuss data and speculations over computer networks. They give presentations at seminars and conferences. They write up their results and send them to scientific journals, which in turn send the papers to be scrutinised by reviewers. After a paper is published or a finding is presented, it is judged by other scientists in the context of what they already know from other sources. Throughout this continuum of discussion and deliberation, the ideas of individuals are collectively judged, sorted and selectively incorporated into the consensual but ever-evolving scientific worldview. In the process, individual knowledge is gradually converted into generally accepted knowledge.
This ongoing process of review and revision is critically important. It reduces the influence of individual subjectivity by requiring that research results be accepted by other scientists. It also is a powerful inducement for researchers to be critical of their own conclusions because they know that their objective must be to try to convince their skeptical colleagues.
The social mechanisms of science do more than validate what comes to be known as scientific knowledge. They also help generate and sustain the body of experimental techniques, social conventions and other ‘methods’ that scientists use in conducting and reporting research. Some of these methods are permanent features of science; others evolve over time or vary from discipline to discipline. Because they reflect socially accepted standards in science, their application is a key element of responsible scientific practice. Furthermore, they create a set of moral expectations for the practice of research.
Concerns about research ethics can occur because of problems at any point in the journey from hypothesis to new knowledge. A researcher might fake data. A scientist may unfairly review a competitor’s paper. Poor treatment of animal or human subjects may cause a project to be stopped or pulled from publication. Progress could be stalled by a disagreement over ownership or authorship. Poor education of the public can spark unjustified media campaigns that block the transfer of knowledge into public goods. Attention to research ethics is an inherent part of the practice of science.
Basic Moral Precepts for Ethical Research Practice
There is no doubt that research ethics is a complex subject. Research is increasingly global. Researchers on the same project may have different moral viewpoints, regulatory requirements and cultural expectations. However, the basics of research ethics come from the scientific method and some simple ethical principles, taught to children across the globe:
- Tell the truth
- Be proud of your accomplishments
- Don’t be a tattle-tale, unless it is important
- Share
- Be nice to animals
- It is wrong to hurt people
- Avoid doing two things at once
- Look both ways before crossing the street
This chapter uses these basic moral precepts as guides for the sometimes complicated issues that arise in research practice. Ethics differs from law, policy and regulation. Ethical inquiry asks what one ought to do or what character traits one should develop in an ideal situation. Research ethics is a form of practical ethics. As such, it must take into account the realities of current research practice. This includes, among other things, considering how existing law, policy and regulation may restrict or encourage certain options.
In research ethics there are some areas of strong consensus, for example fabrication of data is wrong. There are also many areas of disagreement over what is best, such as when and how to share data. As will be discussed in the sections on whistleblowing and conflict of commitment, there may be factors in a situation that lead an individual to decide that the best choice fails to uphold a well-recognised principle of research ethics. In each situation, an individual will need to use judgement to determine how to act. This chapter is a guide for practice. But the final decision in a specific case is the individual’s responsibility. Good decisions require consideration of all of the relevant factors in a case. Ultimately, there is no way to avoid the responsibility of making a decision. Even the people who close their eyes to avoid a situation are responsible for choosing to be blind. Hopefully, these rules will help the reader navigate safe passage even through difficult situations.
Tell the Truth
One of the first lessons children are taught is to tell the truth. It is a tricky skill to master because of truth’s nebulous nature. Children are encouraged to practice honesty. Aristotle saw this virtue as a mean between extremes.3 Too much truth can cause embarrassment or even harm, for example consider when a child tells a pregnant woman, ‘You look fat’. This child voices an excess of truth. Too little truth includes lying as well as culpable ignorance. These are both deficits of truth.
Misconduct
Similarly, misconduct in science can be due to either intentional lying or irresponsible ignorance or reporting, such as not checking one’s protocol or accepting gift authorship without even reading the paper. We will return to these latter issues later in the chapter. In this section, I will deal with intentional dishonesty.
In a 2005 paper in the Lancet, Jon Sudbø and his co-authors claimed that the use of non-COX2-NSAIDs reduced the risk of oral cancer in smokers but heightened the risk of cardiovascular problems. Three months later it was revealed that the patient data used in the study was fraudulent. Dr Sudbø admitted to fabricating the data used in this study and two previously published papers. 4 Dr Sudbø committed research misconduct, and in the process violated what is the most integral virtue in science, honesty.
The purpose of science is to find answers to questions. But not just any answers will do. Science strives to find the truth. The scientific method was developed and refined in order to discover truth. Making up data undermines science. Besides creating false information, there are secondary consequences. In the Sudbø case, one can easily imagine that patient care was affected. It may have affected the work of other scientists. Sudbø’s co-authors were all investigated. Finally, cases like this erode public trust and support for science.
The US National Institutes of Health (NIH) defines scientific misconduct as’ fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results … Research misconduct does not include honest error or differences in opinion’.5 The NIH definition demonstrates a general consensus on research ethics. While there may be international disagreement about some of the finer points of ethical research conduct, all agree that intentionally falsifying or fabricating data is wrong. Charles Babbage discussed them in his treatise, ‘Reflections on the Decline of Science in England’.6 He discussed a number of forms of misconduct in this text, including conflicts of interest. But he made a particular point of defining four types of scientific fraud: hoaxing, forging, trimming and cooking. Babbage singles out these forms of deceit as particularly connected with science in that they offend science’s commitment to truth and are often difficult for the nonscientist to discover, thus being a particular offense to the profession of science.6
Hoaxing and forging are forms of outright fabrication of data or other evidence. Babbage distinguishes the two by intention. He assumes that the hoaxer expects his fabrication to be discovered and thereby ridicule those who believed it. In forging, the intention is merely personal gain and the expectation is that these data will be incorporated into the scientific cannon. Trimming involves smoothing irregular data in order to improve the appearance of one’s statistical results. Cooking is where the researcher picks and chooses which data to include based on what supports the preferred conclusion. Cooking can also include applying a statistical method after the collection of data in order to generate significance or a preferred end.6
Hoaxing and forging are always wrong. They are directly dishonest. Cooking is also wrong in that it violates the scientific method which requires adherence to the protocol as a means towards objectivity of the data collected. The exception may be if a change in statistical method is merited by the science. However, this change and the rationale must be made plain in any presentation or presentation of the research. Similarly, trimming is only acceptable if the researchers openly and honestly report the removal of aberrant data and provide a justification for the removal that fits with the scientific method. For example, researchers may discover after the final collection of data that a study participant did not adhere to the protocol requirements to abstain from taking other drugs, which caused a side effect with the study drug. This would be a good reason to remove that participant’s data. The researchers would then report in any study presentation or writing that one participant’s data was removed due to failure to complete the study requirements. In this way, the researchers are transparent about the removal of data and the reasons for it. This honesty is consistent with good science.
Telling the truth is important in all aspects of research, from the writing of the proposal to the dissemination of study results. This includes any grant proposals, committee reports or anything else related to the study, including one’s resume. For example, imagine a scientist lying about experience in order to get a job with a prestigious research group. This seemingly minor lie can hurt many people. People who were better suited for the position are unfairly passed over. The group becomes less efficient because they now have a member who cannot do the job. Others will have to devote time to teach this scientist the necessary skills. Worse yet, in an effort to hide the lie, the scientist may try to hide a lack of knowledge or skill. This would lead to mistakes which could undermine the data quality, break lab equipment or even harm research subjects. The quality of data from the lab could suffer, impacting other researchers and the public. If the group includes this falsified resume in their grant applications and the lie is discovered, it could cost them the grant. On a personal level, consider how the willingness to lie in order to get a position reflects on the researcher’s commitment to scientific integrity and personal integrity in general. Science functions in an atmosphere of trust. Should a colleague who lies for personal gain be trusted? A failure to be honest often has reverberations beyond the initial lie. Short-term gains can lead to long-term losses.
Up until now this chapter has focused on the importance of intending to be honest and the problems with intentional dishonesty. However, honesty is often complex. Similarly, honesty can sometimes conflict with other virtues, such as fidelity (promise-keeping). Responsible reporting of unexpected or potentially harmful results is an example. For example, let’s say a small study indicates an unexpected causal link between a vaccine and a childhood illness. This presents a difficult ethical situation. The researcher could wait until more data is collected. But this assumes that there is money for continuation of the research. The scientist may also have to weigh the risk of delayed publication for him and the public. If the report is published and picked up by the newspapers or Internet, then some parents may choose to forgo the vaccination. If the connection is ultimately disproven, then those children who did not receive the vaccine will have been put at risk for no benefit. There is a potential for harm either way. A researcher in such a position must first go over the research and confirm that there has been no error, sloppiness or misconduct. Assuming that all is in order, the researcher should consult a more experienced colleague for advice. Ultimately, each individual must make a judgement about what is the best decision in the circumstances and be willing to defend it.
Another issue may arise regarding prior agreements about publication rights and permissions. Sometimes the funding organisation may require a final say as to what gets published. This is a conflict of interest in that science is harmed when information is restricted because of interests other than the advancement of knowledge. However, if a researcher has signed a contract that contains such a clause, a promise has been made. The organisation acted in good faith by funding the research. Submitting a paper for publication without the organisation’s permission is a violation of the promise made when the contract was signed. The best rule of thumb is to avoid situations where one must compromise the honest reporting of scientific results. Still, this may be unavoidable if one works in areas where research is classified or if one is directly paid by a company to do research on the company’s products. This issue will be revisited in the section on conflicts of interests.
The major forms of scientific misconduct are failures of the intent to be honest. An honest mistake is not misconduct. Failure is to try to correct the mistake. For example, consider a hypothetical situation where a researcher mislabels a graph and does not pick up the error prior to publication. As soon as the error is brought to the researcher’s attention, the researcher should contact the journal in order to correct the error. But if the researcher does not correct the error in a timely manner, then the researcher is responsible for allowing the false information to continue to be communicated to others. That affects all who depend on that information, potentially causing serious harm. It also undermines the trustworthiness of science in general.
Fabrication and falsification of data are two major forms of scientific misconduct. They are failures of the virtue of honesty. Honesty underlies all of research ethics. It is reflected in each of the remaining topics, including the next two, plagiarism and authorship.
Be Proud of Your Accomplishments
‘Mommy, come see what I did!’ Young children can hardly suppress their excitement over their accomplishments. While adults are generally more reserved and humble, good work justifies pride and warrants recognition. In publication and research ethics, the emphasis is on giving credit where credit is due. Plagiarism is wrong in part because it steals the work of others. Similarly, authorship is something that is earned, not given.
Plagiarism
As a professor, during every academic term I encounter at least one case of plagiarism by a student. This is the representation of someone else’s work as one’s own. Usually, the student will claim that he or she did not know it was wrong. However, plagiarism does not depend on intent. Plagiarism is akin to taking something that is not yours. In this case, it is someone else’s words, work or ideas.
It can be confusing since science is built on the work of those who have gone before you. Sharing and cooperation are virtues of scientific enterprise. But the point in plagiarism is not that you should not use the work of others. Rather it is that you should give credit to those who did that work when you use it. Why is this important? First, it is a matter of respect. By representing someone else’s work as one’s own, the original author(s) are not recognised. More relevant to science, referencing the original work enables readers to more thoroughly assess the reliability and applicability of the information presented. When a student presents statistics in a paper without a citation, the professor has no way to assess the quality of those statistics. Did the student make them up? Were they based on a representative population? Were the statistics collected by a group with a foreordained agenda? Or, were they the result of a well-designed and performed study? Without the proper citation, the reader cannot make a judgement regarding the reliability of the information.
Furthermore, rules against plagiarism work to limit duplicate publication and the theft of work or ideas, while encouraging students and researchers to earn their recognition. Plagiarism also undermines relationships. For example, a professor who plagiarises from a student commits more than the theft of words. The professor violates a relationship of trust, undermines the very basis of the mentor–mentee relationship. Mentors should model good behaviour and professional integrity. Instead of fostering a student or mentee’s career, the theft may undermine it by reducing present and future publications. In worst case scenarios, promising students may be turned off by the whole affair, abandoning their research in disgust.
In practice, what constitutes plagiarism can be confusing. A good rule of thumb is ‘when in doubt, cite’. Sometimes a spontaneous idea will occur, only to be discovered in the published work of another. While definitely annoying, it is safest to reference that work with maybe a note explaining its discovery after the fact. With regards to commonly known information, consider your audience. Do they know the source of say, E = MC2? If not, it would be helpful to mention it. In rare instances, a referral to the original source may uncover an error or useful clarification. Citations improve the value and clarity of your paper and increase the recognition of the sources used.
Many people do not realise that they can plagiarise their own work.7 Just as it is wrong for students to submit work for one class as completion of an assignment in another class without the instructor’s approval, it is wrong to publish a paper in whole or in part more than once, without approval from both the original and intended secondary publisher and a clear citation of the original publication.
The first reason for this is ethical. For the most part, a researcher should be adding to the literature, not repeating what has already been said. Of course, sometimes repetition is useful, as in a book which collects one’s work together in one place or a textbook which collects valuable papers on a topic. These texts make it easier for the work to be understood within a broader research aim, analysed against other comparative papers on the subject or grasped by individuals new to the subject. Dual publication may be necessary in order to reach a different audience, say one speaking a different language. But citing and referencing the original publication is important for fairness sake. The number of publications is often part of a researcher’s review for tenure, promotion and even for consideration in grants and awards. It would be unfair to count two virtually identical publications as equal to two unique publications.
Another reason against self-plagiarism is that authors usually give up ownership of their work to the publisher. Most authors must sign a waiver that says that the work is not plagiarised and has not been published elsewhere. Technically, the work is not the author’s to use without permission from those who own the copyright. Reuse of small bits may only require the typical use of quotation marks (or other means indicative of quotation) and a citation. Paraphrasing of small portions of the work would only require a citation.
Finally, it is in authors’ interests to cite their previous work. It increases the visibility of the previous work and demonstrates the authors’ expertise in their area of research. Through the appropriate use of references and citations, the author can encourage readers to look up their previous work as well as help to explain the progress of their research over time.
In summary, plagiarism undermines scientific integrity. It steals others’ ideas, words and work, undermines trust, destroys relationships meant to foster scientific enterprise and may break the law. Proper citation and referencing promotes the communication, analysis and understanding of research within its historical context.
Authorship and Writing
Normally, all authors are held responsible for the work presented in the published paper. However, there have been situations where the primary author was found guilty of serious research misconduct and the co-authors denied knowledge of the misconduct and responsibility for the fraudulent paper. In response to a few prominent such cases, the International Committee of Medical Journal Editors (ICMJE) created instructions on who should qualify as an author for a paper submitted to one of their journals.8 Many other journals have accepted the ICMJE guidelines.9 According to the ICMJE, ‘An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study …’10 Substantive contribution requires all three of the following:
- Substantial contributions to conception and design, acquisition of data or analysis and interpretation of data.
- Drafting the article or revising it critically for important intellectual content.
- Final approval of the version to be published.10
The report goes on to clarify that not only should all authors listed meet these criteria, but all who meet these criteria should be listed as authors. To be an author means that one has’ participated sufficiently in the work to take public responsibility for appropriate portions of the content’.10
The case of Dr Gerald Schatten, a stem cell researcher and tenured professor at the University of Pittsburgh, illustrates the risks of gift authorship. In a June 2005 paper published in the journal Science, Schatten was listed as the senior author. The primary author was Woo-Suk Hwang. The article claimed to have created embryonic stem cell lines from cloning technology using the DNA from adult skin cells and donor eggs.11 In 2005, Schatten contacted Science to ask that his name be retracted from the list of authors for the article due to concerns he had about the article. The journal refused to do so, noting that, ‘All authors of a paper would need to agree to make a retraction possible’.12
The article in question was retracted in January 2006, after an investigative committee at Seoul National University discovered that this and another paper from Hwang’s group was based on fabricated data.13 Schatten was investigated by his University, which determined that while he did not engage in data fabrication, he did engage in scientific misbehaviour by not fulfilling the responsibilities of a co-author.14 Schatten’s name and reputation have been permanently connected with an infamous case of scientific misconduct because he was willing to accept what amounted to gift authorship on a paper. In the end, he did not want to accept public responsibility for the paper. But by signing the Journal’s author release, he already had.
Not all journals follow the ICMJE recommendations. So it is important to read the requirements for each journal for which one submits a manuscript. The ICMJE requirements represent the general consensus. However, a recent study of 234 biomedical journals found that only 29% based their authorship criteria on the ICMJE guidelines and 41% did not include any guidance about authorship.9
Standards for authorship are useful for those who find themselves in situations where someone asks for unwarranted authorship. The journal guidelines provide power to resist such requests. Whether or not the journal has guidelines, it is usually best to work out responsibilities with the research team prior to the beginning of work on a project, including discussing requirements for authorship, authorship order and acknowledgement. This way, if someone wants to be an author, the rest of the group can negotiate for that person to do sufficient work on the project and paper to warrant it. This will not prevent all abuses of authorship but at least it gets the issues on the table from the beginning.
In summary, people should be proud of their own accomplishments and not try to take credit for others’ work. Plagiarism is the theft of someone’s work. When in doubt, cite the source or words, paraphrasing, ideas, data, etc. While the rules for determining who deserves authorship are not set in stone, their moral basis is on who has done sufficient work to deserve credit and who accepts responsibility for the work done. With regards to gift authorship, just because everyone else is doing it, does not make it right. Furthermore, it does not mean you will not be held accountable if you get caught.
Don’t Be a Tattle-Tale, Unless It Is Important
Gandhi said that noncooperation with evil is as much a duty as cooperation with good; Burke said that the only thing necessary for the triumph of evil is for good men to do nothing. Both concepts are still viable… although expensive.
Joseph Rose (whistleblower)15
This is another area where childhood and Aristotle teach us about a principle of research ethics. As mentioned earlier, Aristotle thought most virtues were means between two extremes. In the case of knowing when to report wrongdoing, the ideal of whistleblowing is somewhere between tattling and the code of silence. For example, Jimmy’s little sister should not call her mom every time he throws a rock. But she better call her if he hits someone in the head with it. Similarly, while someone who reports every instance of drinking coffee or tea in the lab may quickly become a social pariah, the person who fails to report witnessed scientific misconduct does not act as a professional. Knowing when to report wrongdoing is a difficult, yet important skill.
Whistleblowing
Whistleblowing involves speaking out against wrongdoing (ethical or legal). This can be handled by going through the standard organisational channels. If that is not effective or you have good reason to believe that it will make the matter worse, then one has to consider going outside the standard channels. This could be within the organisation or, if necessary, outside it, such as reporting directly to a professional organisation or governmental group. Try to choose the group that is most relevant in the given situation.
Before blowing the whistle, the individual who perceives an instance of moral or legal wrongdoing in the organisation should consider the following:
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