Interview with bioethicist Chris Simon, Associate Professor in the Duke Trent Center of Bioethics, Medical Humanities & History of Medicine, and the Department of Population Health Sciences.
Dr. Chris Simon is a bioethicist and medical anthropologist at Duke. He teaches and conducts research on ethics topics such research integrity, the responsible conduct of research (RCR), and the protection of human participants in research. Professor Simon has written on the ethics of research recruitment and informed consent in cancer trials, researcher identity, community health services, and genomics. He has been a PI or co-investigator on many federally-funded and local projects on research ethics.
Dr. Chris Simon: "There may be a feeling that we are in such a crisis state that we have to sacrifice some of our usual ethical benchmarks and standards in the effort to speed up research on COVID 19"
Emilia Chiscop-Head, PhD: What difficulties do researchers face during the present pandemic?
Chris Simon, PhD: Researchers face all sorts of difficulties that really started with the closing down of many campuses and research facilities – which meant that researchers had to physically remove themselves from the places where they do research - shutting down labs, taking all sorts of steps to ensure that research materials were safely stored and animals were taken care of. It was a stressful time for many researchers. Some researchers had to stop their clinical trials or their lab work and find other things to do. Others needed to adapt to doing research virtually, including recruiting human subjects remotely. Challenges affected the whole span of the research cycle and especially impacted the actual Implementation and logistics of doing research. And if you are doing any research related to COVID 19, then your life has changed dramatically. You have to consider the enormous pressure to get the results of your research published as quickly as possible. You might consider the temptation to pre-publish your article online. There are all sorts of platforms where you can put your articles without having them peer reviewed or selected by an editorial board for peer review. Your intentions may be very good, which is to get the information out as quickly as possible so that other researchers can act on it. But there are issues with pre-prints and with circumventing the peer review system.
Dr. Chris Simon: “Whenever you have a situation in which enormous time pressures act out on a research community, the institutions as well as investigators, directors of labs and research centers need to be worried about the effects of that pressure on researchers”
Watch the video: Dr. Chris Simon about the pressures of doing research during COVID 19 pandemic and their impact on research quality and ethics
Whenever you have a situation in which enormous time pressures act out on a research community, the institutions as well as investigators, directors of labs and research centers need to be worried about the effects of that pressure on researchers and the possibility that people will make more mistakes. Mistakes may creep in to the design of research studies, the implementation of those studies, the collection of data, data quality steps, analysis of the data and the writing up of data. These are not necessarily driven by any kind of malice or desire to deceive people, but simply unintentional mistakes or errors that creep into any kind of activity when we do things too fast without adequate thought regarding the steps that we need to take to ensure that we do our work properly and that the end product is really high quality.
But we may also be tempted to lower the bar a bit. IRBs in different parts of the world are seeing more and more questionable COVID research protocols, designs that have been thrown together too quickly or that may undermine the safety of research subjects, and the integrity of the informed consent process. We are also beginning to see examples of detrimental research practices appearing in the literature on COVID-19. Just in the last few months we have seen studies of questionable quality, studies that have had glaring errors, both in the design and implementation, and studies that have been retracted, including two prominent –and peer-reviewed – publications on chloroquine and hydroxychloroquine.
These are a group of malaria drugs that were initially earmarked with possible effectiveness in the treatment of coronavirus. But their efficacy was – and currently remains - unclear. A number of studies were rolled out and two from a particular research group made it into the Lancet and the New England Journal of Medicine. Within a very short amount of time - a few days - they were retracted because letters were written from research communities raising questions about these studies, about the data, and data transparency. Two co-authors on these papers said they could no longer vouch for the veracity of the published data. This led to editorial decisions by The Lancet and The New England Journal of Medicine to formally retract the papers.
These kinds of situations raise deep questions about the adequacy of the editorial and peer review systems, particularly during a crisis such as the current one. Scientists need to be very clear with respect to their responsibilities when they put their name on a paper. They must do so only with the best possible confidence that the data, the analysis, and the study as a whole has the kind of integrity and robustness that all science should have.
There are professional and institutional mechanisms and sources of support to help ensure that research gets done properly and a quality product emerges. But ultimately it's the researchers themselves who have to reset their moral compass in a time like the current one and say, ‘I'm not going to give in to pressures acting out on me right now and I'm going to approach my science in the same steady, effective, and robust way in which I've always done my research.’
There may be a feeling that we are in such a crisis state that we have to sacrifice some of our usual ethical benchmarks and standards in the effort to speed up research on COVID 19. And yes, there may be justifications to the easing of some standards in the interests of time and public health. We have so-called preclinical and “human challenge” trials that probably would not be allowed in normal times. These trials raise ethical questions about whether the “larger good” that these trials may lead to justifies the risk of harm to study volunteers.
Dr. Chris Simon: "I would recommend that researchers and their communities, as well as sponsors and other stakeholders, engage in structured dialogue on the complex ethical challenges raised by research on COVID-19"
ECH: What would you advise researchers to do in order to overcome some of these issues we've been talking about?
Chris Simon: Researchers need to be as vigilant and mindful as possible with respect to the ethical side of their work. To help them, we need to encourage awareness and discussion of the ethical challenges faced in the current pandemic. Alongside discourse on the important clinical dilemmas such as the allocation of ventilators to patients, we need active reflection on dilemmas such as the pressure to publish, funding challenges, public mistrust and denialism of COVID science, publication ethics, and commercialization issues, among others. Research teams should encourage discussion and debate of these issues. Conferences need to address them. Published papers are needed to work through the issues.
It’s also important that institutions help researchers think about these issues, through responsible conduct of research activities, town halls and outreach to the scientific community – activities supported by the Duke Office of Scientific Integrity, for example.
In other words, I would recommend that researchers and their communities, as well as sponsors and other stakeholders, engage in structured dialogue on the complex ethical challenges raised by research on COVID-19. Though highly challenging, this is also an exciting time to learn. The pandemic is an opportunity to reflect on core principles and practices for supporting robust science and the integrity of all its stakeholders.