Research ethics cases

Working with the cases

When working with the cases, the following steps can be useful:

1. Read the case and think it through
2. Formulate the main ethical issue (if you think there are several issues you can discuss more than one, but it is a good idea to first identify the main issue and focus on that)
3. Formulate your view on how to act
4. Formulate your arguments for and against your view on how to act (what are arguments for, what are arguments against)

Already point no 2 is often subject to discussion. That is ok, but do not dwell on that for too long. If there are diversities about what is the main issue, choose one suggestion and work on that.

One might think that the proper way to go about this is to let the arguments lead to a conclusion, and that you should therefore start with the arguments, but it is often easier to start at the opposite end, i.e. with presenting a solution, and then take a closer look at the arguments. When you contemplate what speaks for and against your own solution more closely, you might perhaps change your mind.

Research ethics cases

1.The doctoral student Patricia suspects that Eve, one of the other doctoral students at the department, has fabricated her new data (made up instead of produced by researching). Patricia and Eve work together most of the time and have become good colleagues. Patricia believes she knows quite well what Eve is working on. However, at the latest research seminar Patricia was surprised when Eve presented new data that Patricia could not understand when she would have had the time to collect and work with. Eve has often complained lately that it is difficult for her to find the time to do all her tasks at work. That she would have had the time to do all the work presented at the seminar seems to be too good to be true.

Questions: (i) What courses of action does Patricia have to consider in this situation?
(ii) What speaks in favor of and against each alternative? (iii) What should she do?

2. Börje, a researching PhD without a permanent position, is in trouble. His research funding is about to run out, and he has no indication that his professor will be able to provide a solution for him. When considering his options, he realizes that a research fund he could send in an application to has a deadline only a few days away. Börje starts working on the application immediately, works hard for the next few days, and gets most of the parts of the application in place – it looks pretty good too. However, he still lacks the background section, and now the deadline for the electronic submission is only an hour and a half away. (Below two alternative chains of events are described.)

1. Among his files he finds a copy of an application that his professor audited a year ago. The background section is highly relevant for Börje’s application. With only minor adjustments and an update of the references (he knows exactly which ones to add), the background would be suitable for the application. Börje inserts the background section from the old application into his own application, deletes a few passages, makes a few changes in the text, adds his new references, and he is done.
2. Fortunately the research group that Börje belongs to has a common application resource in the form of application text that is used, reused, changed, and added to as seen fit for different applications. Updates and new references are added over time. It would be useful for the background section in Börje’s application.

Questions: (i) Do you find Börje’s behavior in (a) ethically problematic? Why/Why not? (ii) Do you find Börje’s behavior in (b) ethically problematic? Why/Why not? (iii) Would you be willing to argue that the behavior in (a) and (b) nevertheless is overall justified? Why/why not?

3. Paulo is a preclinical researcher. In his present study, it looks very good in six experiments out of a series of eight. In two of them, however, the outcome is not in line with what he expected and hoped for. Besides, these two experiments affect the overall results negatively if included. Paulo is convinced about the soundness of his conclusions and decides not to report on the two deviating experiments in his article, since he means that something technical must have happened that explains the outcome in those two. He has simply not found the time yet to explore that. By doing it this way the results in his paper will appear more interesting.

Questions: Is Paulo making the right or wrong decision? Why?

4. Kathinka has just defended her doctoral thesis. In the beginning of her employment as doctoral student she was working with two different projects. The thesis was later based on only one of them. Now she has got an employment as postdoc at another university. There she would like to continue with the other project, which is far from completed. Before she leaves her present employment for good, she downloads all the files relating to the project to her server space at the new university. She sends an email to her professor informing about what she is doing. The professor, who is away at a conference, responds in an upset tone that these unused data do not belong to her – they are a collective good tied to the department, where they should stay. Kathinka protests and claims that it is her ideas, thoughts, and results, but they do not come to an agreement. Kathinka hurrys to finish what she has started, which ends with her deleting the (now transferred) data from the old university’s server, in order for her to have exclusive access.

Questions: (i) Legally speaking, is Kathinka allowed to do what she did? (ii) Ethically speaking, did Kathinka do the right or wrong thing with the contested data? Why?

5. Alex and Max have had a hard time recruiting research participants to a study that they have got a large research grant for. Eventually they see no other solution but to offer a fairly large economic compensation for those choosing to participate in the study. “That should be enough to make some people change their minds”, they reason.

Questions: (i) What speaks in favor of – and against – this recruitment approach? What ethical considerations become relevant to the case?
(ii) Now assume that the money does not tempt anyone to participate in the study who would otherwise not have participated – but the money makes those who have consented to participate to actually show up for sample-taking, etc. Does this make an ethical difference compared to a case where the money has a decisive effect on willingness to participate, so that people who would otherwise not participate decide to participate?

6.The population in an isolated region builds its identity on a strong conviction about its own historical origin – they have “always” been the guardians over the majectic mountains and rivers of the region. This shared understanding of their history has created a strong sense of belonging and unity in this population. Historical and genetic research, carried out without having contacted any of these individuals, now shows that the group identity builds on mistaken assumptions – in fact, the population immigrated to the area from another region no more than 10–12 generations ago. The results still remain unpublished.

Questions: (i) Should the results be published? Provide arguments for and aginst publishing.
(ii) Generally speaking, should research that threatens to harm the cultural self image and social bonds in a population be avoided? Provide arguments for and against.

7. Ashkar is writing a thesis about a Swedish novelist, who still lives in his cottage on the countryside in spite of high age. They meet and have open-hearted conversations, which surprises Ashkar – the author has been known throughout his career to keep the private out of any discussion with journalists or others curious about his life. They meet several times. The author eventually tells about his alcoholism and periodic acquaintances with criminals. None of this is previously known outside the family. ”Great, that surely has the potential to become a colorful portrait”, a colleague at the department comments. ”What an intricate ethical problem for your thesis”, another colleague remarks.

Questions: (i) What is the cost of including this new knowledge (about alcoholism and criminal acquaintances) about the author in the thesis? (ii) What is the cost of abstaining? (iii) What is a reasonable way to deal with sensitive personal data about single individuals, like artists, musicians, authors, TV celebrities, influencers, and wellknown business leaders?

8. Rebecca is doing research about how to treat people with hypothermia. For safety reasons,  research participants cannot have their body temperature reduced to less than 36 degrees C. Great caution needs to be shown also when people are regaining body heat. There is limited other research to consult. Rebecca finds a report that thoroughly describes results from research in Nazi Germany during World War II. The german researchers had used prisoners from a concentration camp. This research included lowering and raising body temperature of research subjects by use of different methods. Causalties during the experiments were common. From a knowledge perspective, the results are interesting. However, Rebecca hasn’t decided whether she should use this research or not.

Question: Is it acceptable to use research results that have been produced in unethical ways? Provide arguments!

 9. John would like to do a field study, but he hasn’t narrowed down the purpose yet. He is trying to think through what research ethical aspects would be particularly relevant in that kind of study. He is thinking about how to handle informed consent, if to be handled at all. Research that he considers: a field study in a clothing store, with focus on power structures and interaction; a field study at a hospital clinic, with focus on patient centredness; a field study with a criminal gang, with focus on the importance of trust for fruitful interaction.

Questions: (i) What research ethical issues do you identify in the studies John is considering?
(ii) How should informed consent be handled when studies are located to “open environments” (where “participants” happen to be at the time)? Should one insist on informed consent or should such requirement be abandoned? (iii) Similarly when it comes to study information – what requirements, if any, should be fulfilled? (iv) How should one think about voluntary participation when it comes to field studies?

10. Nadia and Shaofan are doing research on tissue samples that have been collected over a time period of several years. They have also done registry research and matched lifestyle data with test analysis data. They have obtained informed concent from all sample providers for the ongoing study, which is about to end. They now want to do a follow-up on existing tissue samples. Since the material is large and comes from many patients, it would likely be timeconsuming to obtain new consents. There is also a considerable risk for dropouts since some sample providers will probably not be reachable (either because they are dead or have moved) and since others, due to various circumstances, simply will not respond. The dropout risks to decrease the quality of the study – selection bias can not be excluded. In their application to the ethical review board, they therefore argue that informed consent should not be obtained.

Question: (i) What legal space do the ethical review boards in Sweden have when they make a decision (what regulations are they restricted by)? How should the ethical review board act from a purely ethical perspective (not excluding the best option for legal reasons), and why?

11. Mattias and Maria have isolated a hormon in rats that causes aggressive behavior. Unfortunately some rats who get the hormon injected become very aggressive. Several rats have died or got seriously injured due to attacks from aggressive rats. It is, however, difficult to predict appropriate dosage – the sensitivity to the hormone seems to vary considerably between rats.

Questions: A study of this kind would probably not get ethical approval. Why not? Is it possible to change the study in a way that would make it acceptable?

12. An ongoing study requires blood samples from a large number of donors. In connection with the sample collection, blood donors are informed about the study and are given the opportunity to ask questions. They are thereafter asked to approve – or disapprove – of the use of the blood for the specific study. The consent includes that no one will get any individual feedback on the results of the analyses. Later, when the blood samples are analyzed, it turns out that a number of donors have an increased risk of developing a serious condition. There are preventive measures that can reduce the otherwise high probability of developing the disease.

Questions: (i) Should blood donors with increased risk to develop the serious condition participating in the study be informed about the identified health risks and the means to reduce those risks or should the researchers keep to the agreement in the consent not to provide any inividual feedback from the analyses? Argue for your view. (ii) What difference, if any, does the seriousness of the identified risks make to what steps should be taken, if we think about this more broadly? Argue for your view. (iii) How important is it that there is a treatment or preventive measures to be taken for the question of whether or not to inform high risk donors of the discovery? (iv) Does the number of identified high risk individuals make a difference to what should be done?

13. Dentist/nurse/physioterapeut Hansson wants to do a study using patients medical records.  She is first surprised, then somewhat irritated when a colleague asks about how she plans to obtain informed consent from the patients. The colleague also asks about the information she plans to provide the patients with. “No no, we don’t have to involve ourselves with that,” Hansson responds avertingly. (Consider the following alternative continuations of the story one at the time.)

1. “We are dentists/nurses/physiotherapeuts. The requirements you mention don’t apply to us. The Ethical Review Act is there for researching physicians who make physical interventions on patients or feed them with new drugs with yet unestablished side effects.”
2.  ”This is quality assurance. You have always been able to do that within the healthcare system (including dental care) without any ethical approval or informed consent from patients, as long as the head of the clinic approves. We simply explain to the journal we submit our paper to that no ethical approvl is required for the kind of research we plan to do.”
3. ”Informed consent is only meaningful if you expose a person to danger. Then they should, of course, be given the opportunity to say no if they don’t want to be exposed to the risk. But there are no such risks with this study using patient medical records.”

Question: How should the colleague respond to Hansson?

14. In the 1970s Beatrice made research on baboons. The aim of the research was to develop an animal model that could increase our understanding of the physiological effects of head injuries on human beings. The apes first got a seditive to make it easier to strap them up. Thereafter they got nitrous oxide (laughing-gas). However, the treatment ended about thirty minutes before the intervention, since they needed to be conscious before they were inflicted injuries. Some necessary tests would not be possible to make if the animals were then given anaesthetics. The injury was caused by a hydraulic devide, with the immediate effect that the baboons become unconscious or paralyzed – a few died on the spot. The baboons were then kept alive for two months, in order to study their brains, before they were euthanized.

Questions: (i) Does the expected gain in knowledge justify the described use of the baboons? Why/why not? (ii) Is research using animals that can obviously experience pain and distress justifiable if, at the same time, it is not permitted to do such research on (a) adult human beings? (b) infants? If so, what is (are) the morally justifying difference(s)?

15. Professor Agne is the main supervisor of the doctoral student Michael. The last few months Michael has analyzed data that were previously collected in an extensive questionnaire survey. Michael has written a preliminary version of the manuscript and leaves it to Agne for a critical review. When Michael gets the manuscript in return, he notices that three researchers have been added as co-authors of the paper. None of these have contributed to data collection, analysis, manuscript writint or critical revision, but Agne argues that they have contributed substantially to the theoretical underpinnings of Michael’s work. Agne provides a rather vague explanation regarding the content of this contribution.

Questions: (i) Can it be reasonable that the three added researchers are included as co-authors on the paper? (ii) Do the authorship criteria in the ICMJE Recommendations (the Vancouver rules) permit this? Argue your case!

16. A global plant breeding company researches genetic modification of wheat. The new kind of wheat has gained a number of desirable characteristics from a cultivation perspective. For instance, it is more resistant to cold and infestations, grows better under less advantageous cultivation conditions, and generally produces a larger harvest. The modified wheat also turns out to have a strong tendency to spread and then tend to displace more sensitive crop.

Questions: (i) What different types of interests/considerations are at stake? (ii) Is it fair to say that some aspect is more important than others? If so, which one and why? If not, why not? (iii) How should one act regarding this specific crop?

17. Dembe and Clare are newly employed researchers in a group that is developing advanced technical appliances. It looks very promising – the appliances that are developed may make life easier for many people in the near future. Nevertheless Dembe and Clare hesitate about whether their research is justifiable. This is because they both believe that a continuing development of the appliances will most likely increase global differences in wellbeing, since the technique will probably remain expensive and therefore be accessible only to the richer parts of the world. On the other hand, it may become very profitable.

Questions: Expected distribution of the benefits of research is rarely discussed in research ethics. (i) Should it be discussed more often? (ii) Is distribution effects of benefits from research a matter to be handled by researchers or at some other level? (iii) Are there ways to benefit from research progress without getting the consequence of increasing global injustice? (iv) Is distribution of benefits from research more important than academic freedom – at least to the extent that funding agencies should take this into consideration before deciding what research to support?

18. Hakim is four years old and is unwilling to led a researcher in white coat prick his arm in order to draw some blood that is needed for a study on child diabetes. Hakim’s mother has already agreed to let Hakim participate. Hakim protests and does not cooperate when it is time to insert the needle. Unless he sits still, there is a risk that the blood vessle is damaged if the needle is inserted.

Questions: (i) Should Hakim’s mother, or a research assistant, hold Hakim to prevent him from moving to make it possible to draw the blood for the study. Provide arguments. (ii) Young children are normally not understood as sufficiently decision competent to decide on their own whether or not to participate in research – this responsibility instead  lies with the parents (or other legal guardians9. What impact should this have on children’s participation in research when the legal guardians agree to participation while the child disagrees (to do what is required)?

19. Researcher A notes that researcher B has published a new book. In the new book, researcher B uses certain concepts central to the research area, concepts that researcher A has also written about. In one paper, A critized B’s handling of the concepts in an earlier book. According to A’s understanding, the criticism A then presented was right on target and should not be possible to disregard by an intellectually honest person. But researcher B describes these concepts in the new book in exactly the same way as in the old one, as if B were unaware of the criticism – which B is not – or because B simply has decided to disregard the criticism.

Questions: (i) Would you say that researcher B is involved in scientific misconduct? Why/why not? (ii) Would you say that what B is doing is not scientific misconduct, but that B nevertheless is dishonest in the concerned research? Why/why not?

Contact

Feel free to contact us if you have your own research ethical cases to share with us – or to develop together with the medical ethicists at LIME. You may contact: gert.helgesson@ki.se