Abstract
Time and resource constraints, combined with competing priorities, mean that research prioritization is a critical ethical consideration in pandemics and emergencies, given the increased need for relevant research findings to address health needs, and the multiple adverse ways that emergencies can impact capacities to conduct research. At international, national and local levels, careful consideration is needed of which research topics should be prioritized and on what grounds. This needs to take into account the ethically significant considerations that should inform prioritization; existing frameworks to guide prioritization decisions; and the consequences associated with prioritizing or de-prioritizing research. The need to prioritize research that is directly responsive to the pandemic may generate debate about which types of research should be prioritised, and within fields of research, which studies should be continued, paused, or re-oriented. In determining which research proposals may have the greatest likelihood of reducing urgent epidemic health burdens, both the nature and distribution of such burdens are key considerations. Epidemics and pandemics typically disproportionately affect the most disadvantaged and vulnerable people in society, highlighting the necessity of inclusive and responsive approaches, which evaluate not just which research approaches have the greatest potential public health benefit, but also the likelihood that they will help address inequities. Key questions also arise when determining if current studies should be de-escalated or stopped, particularly when this may result in highly compromised results. It is also important to consider what obligations arise for research communities (including funders) to pledge to taking the outcomes of research prioritisation processes into account. The case studies in this chapter prompt consideration of how qualitative research into the impacts of isolation should be prioritised, and whether and how research prioritization measures should be responsive to widespread use of traditional medicine and off-label use of medications. The cases also highlight issues that research teams may face as research priorities are re-evaluated in pandemics, including whether and how to redesign proposed research in response to the logistical challenges posed by the pandemic and evolving pandemic research priorities.
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Keywords
- COVID-19 pandemic
- Research ethics
- Public health emergencies
- Research priority setting
- Resource allocation
- Risk/benefit analysis
- Vulnerability and inclusion
- Social and scientific value
- Researcher roles and responsibilities
- Ethical review
- Traditional medicine
- Research design and adaption
- Access to experimental treatments
- Non COVID-19 research
- Pausing and halting research
2.1 Introduction
Generally speaking, research prioritization is the process of determining which research topics or approaches should be considered a priority for approval, funding and staffing, and it allows for the reasoned allocation of scarce resources (Etti et al. 2021). Priority-setting is an important and common challenge for institutions, governments and funders, as there are always limitations on capacities and resources for research. It is, however, a heightened consideration in epidemics and pandemics, given the increased need for relevant research findings to address pandemic health needs, and the multiple adverse ways that epidemics and emergencies can impact the capacity to conduct research. Whether at the international level or the local level, the idea of research prioritization calls for attention to factors such as which research topics should be prioritized and on what grounds, the ethically significant considerations that should inform prioritization, existing frameworks to guide prioritization decisions, and the risks and burdens that may be associated with prioritizing or de-prioritizing research. A prioritization exercise may also give clarity on whether and when it may be appropriate to prioritize research over the provision of health care during pandemics.
2.2 The Role of Research Prioritization in Epidemics
Epidemics are disruptive of normal life, at the level of both the individual and the community, and research also gets interrupted. Particular challenges that arise in epidemics and which influence priority-setting for research, include resource shortages, especially in acute crises; uncertainty over what type of knowledge will be most useful in addressing the epidemic (clinical, epidemiological, virological, social science or economic data for instance); and the implications of neglecting non-emergency research. In addition, epidemics often give rise to new priorities in medical, scientific or social research, especially if they involve new pathogens or variants. This may cause competition between long-standing and emerging research priorities. For example, as resources get re-allocated to addressing a pandemic, there is a risk that important on-going research and disease-control interventions for illnesses that kill more people than the pandemic does – such as malaria in tropical regions – will be suspended (Weiss et al. 2021). During times where some research institutions suspended all non-COVID-19 research activities, concerns may arise that important research areas that were deprioritized may continue to be perceived as no longer as important as the pandemic abates. The potential neglect of non-pandemic research may cause professional rivalry among researchers and have inequitable impacts on capacities to conduct research and on career progression. Furthermore, in the context of epidemics, an important question arises about whether and when it is justifiable for resources to be spent on research rather than on the delivery of health care. Addressing these challenges is difficult and can be frustrating. It makes priority-setting more complex and demanding of time, energy, critical thinking and resources than it otherwise would be. Research prioritization activities need to balance conflicting priorities and create clarity on these issues.
Although research prioritization during a pandemic may be informed by “the most pressing questions for clinicians and public health professionals” and may involve determining which research is likely going to be of the greatest health benefit to the relevant populations (Etti et al. 2021), other value-based approaches may play equally significant roles. A priority-setting exercise which draws on the views of a broad range of persons involved in addressing the epidemic, can help in the identification and ranking of the main questions surrounding the epidemic, and assist funding organizations and national governments to decide which research should be conducted first and why. In contrast, if research prioritization activities are not undertaken and aligned during pandemics, a number of challenges can arise. In the absence of priorities, scarce resources, including funds, research personnel, facilities, equipment and time, may be used ineffectively in research which is irrelevant or insignificant in the face of the bigger aim of addressing health burdens in pandemics or epidemics. Fragmented approaches may result in a lack of focus on important research areas and poor coverage of key research topics in epidemics.
Epidemics tend to be sudden, unexpected and uncertain – and usually funding is not readily available to address the urgent questions they raise. Furthermore, time is important – understood not only in terms of the time it takes to do good research, but also in terms of the time health workers may have to spend on research, given their clinical care responsibilities. In that context, it is very important to ensure that there is an appropriate decision-making process to help make informed decisions about how scarce resources are to be used for maximum effect. Finally, when a resource-allocation process is administered locally or nationally, it can help identify local research priorities which are likely to promote effective problem-solving in affected communities (Etti et al. 2021). Within countries undergoing pandemics, there are likely to be multiple explicit and implicit priority-setting exercises undertaken at different organizational levels, all of which have some influence. In such contexts, aligning or streamlining research priorities may be important.
2.3 What Considerations Should Inform Research Prioritization?
Setting priorities for research involves considering questions about which kinds of research ought to be supported or conducted in emergency situations. In determining which research is likely going to be of the greatest health benefit to the relevant populations, on the one hand there may be uncertainty about what type of knowledge would be most valuable to address the emergency, and on the other there are assumptions about the relative utility of some types of research over others. The need to prioritize specific research themes related to the epidemic may generate controversies on what is a more significant priority: clinical research versus epidemiology; people’s social behaviour versus pathogen mutations; public health versus the economic impact of the epidemic. For instance, there may be a focus on health science research rather than research in the humanities, even though the latter may be equally important for the design of interventions that are widely supported by the people who need to adopt those interventions. Concerns have arisen, for example, that the initial absence of social science research during the West African Ebola outbreak played a role in the design of interventions that were not broadly supported. The absence of local support for the way the interventions had been designed resulted in the continuation of traditional burial practices, and avoidance of clinical care facilities, which contributed to further spread of the epidemic. Social scientists’ engagement with the socio-cultural aspects of the epidemic played a role in building a response that contributed to the end of the epidemic, and a key lesson learned was that “understanding social dynamics is essential to designing robust interventions and should be a priority in public health and emergency planning” (Wilkinson et al. 2017). Case 2.1 in this chapter provides an example of a social science study which researchers thought might play an important role in understanding how pandemic burdens are experienced by families of patients with severe COVID-19, and inform the design of protocols for support.
In determining which research has the greatest likelihood of reducing epidemic health burdens in relevant populations, both the nature and distribution of such burdens is a key consideration. Epidemics and pandemics tend to disproportionately affect the most disadvantaged and vulnerable people in society, highlighting the importance of using theoretical approaches that take account of their struggles, not approaches that keep these struggles from view (Nussbaum 2009). Pratt and Hyder (2016) recommend the use of concepts that best reflect moral commitments to perform research focused on reducing health inequalities or systematic disadvantage more broadly, which would lead to the prioritization of research with outcomes that are likely to advance the interests of people who are more disadvantaged and would thus have the greatest potential to increase health equity (Nussbaum 2009; Barsdorf and Millum 2017). Certain types of intervention and forms of research are more likely to benefit those whose overall lives and health situations reflect the worst possible disadvantages, and not just those who will be faced with temporary difficulties at the time of research (Barsdorf and Millum 2017). These considerations demonstrate the importance of evaluating not just which research approaches have the greatest potential public health benefit, but also the likelihood that they will help reduce unjust health disparities and address the most pressing health needs of vulnerable and disadvantaged groups (Pratt et al. 2018).
2.4 Research Prioritization in Practice
When developing robust, inclusive and accountable priority-setting exercises in epidemics, the challenges and tensions outlined above emphasize the importance of carefully thinking about which ethical concepts and values should inform priority-setting, how such decisions should be made, who should be involved, and what interests should be represented. The World Health Organization has developed a three-step process for research prioritization in emergency and disaster-management situations, with each step outlining what actions need to be taken by researchers in such situations (Nasser et al. 2021). The first step involves forming a leadership team, understanding context and collecting necessary data, identifying and engaging with stakeholders, and collecting background information. The second step is to identify research options, decide on what criteria to use to prioritize them, and rank the research options. The third step involves actions after the priority-setting exercise, namely conducting the prioritized research projects, implementing their findings, evaluating the impact of those findings, reporting and publishing the priority-setting exercise, evaluating the process and outcome of the exercise, and feeding the results back to inform future exercises (Nasser et al. 2021). The evaluation and feedback are especially important for informing future prioritization.
Another source of guidance for research priority setting exercises has been developed by the Johns Hopkins COVID-19 Clinical Research Coordinating Committee (CCRCC 2021). These guidelines articulate the overarching principles that should be considered when conducting COVID-19 research. They include the following: scientific and ethical soundness, potential to be informative, minimal risks and burdens, safety and effectiveness, the needs of those affected by COVID-19, room for changes in priorities during the pandemic, and transparency to stakeholders. Case 2.2 demonstrates some of the competing considerations that can arise in such exercises, as an example of research which is prioritized not because the treatment is necessarily anticipated to be effective (given limited evidence and low credibility), but because, problematically, it is being widely prescribed or accessed despite the absence of an appropriate evidence base. In this example a proposed study has the potential to be informative in terms of an anticipated lack of evidence about amantadine’s value in treating COVID, but arguably there is no scientific foundation that would typically justify research into the drug’s safety and efficacy for such off-label use.
In order to streamline the process and to increase the consistency in priority-setting exercises, Viergever et al. (2010) developed a checklist that incorporates nine common elements of good practice in research priority setting intended to “assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit”. These common elements are context, inclusiveness, information-gathering, planning for implementation, criteria, methods for deciding on priorities, use of a comprehensive approach, transparency and evaluation” (Mador et al. 2016; Viergever et al. 2010). The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it discusses stakeholder participation and information-gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency (Viergever et al. 2010).
The importance of ensuring that priority-setting is appropriately informed and responsive to the context, rather than being a one-size-fits-all or other externally imposed approach, is clear. In the COVID-19 pandemic, the COVID-19 Clinical Research Coalition has been established to, among other things, support the “development of locally identified, context-specific research priorities” (Norton et al. 2021). Case 2.3 is an example of where local knowledge – in this case about the widespread use of traditional medicines to alleviate symptoms of COVID-19 – can inform potential national research priorities.
In low-income settings, such as those found in many parts of Africa, past research experiences in previous epidemics may inform research priority setting. At the Africa Centres for Disease Control, a task force for COVID-19 has worked with experts to identify six key priority areas. These are: epidemiology and surveillance of COVID-19; development of diagnostics; clinical characterization of cases; drug and vaccine clinical trials; investigation of the impact of COVID-19 on the health systems; and social science and policy research ACDC (2021). We can see these research priority areas are broad and may not be easy to fund. The team engaged experts from various research institutes in the six research areas and proposed “a limited number of actionable policy statements”. The recommendations from the experts provided further details on each research priority area for ease of understanding and implementation, providing a useful example of how some of the procedural considerations outlined above have been met in practice.
2.5 Challenges in Research Priority Setting
Research-prioritization exercises are not straightforward, and they may be controversial. For instance, in some settings, challenges may emerge which may complicate the research. A first and important challenge relating to research priority setting exercises is that they necessarily risk curtailing academic freedom, especially if some research is de-prioritized (Khumalo et al. 2020). Since epidemics cannot usually be accurately predicted, they take place in contexts where researchers are already engaged in other research activities. New priorities may deprioritize current research and constrain researchers’ freedom to engage in a subject they are passionate about and would like to develop to a conclusion.
A second, related, challenge is that research priority setting during an epidemic invariably introduces questions about whether research that is on-going should be de-escalated or stopped. An example is Case 2.4, in which researchers had to postpone research on sexual assault in order to prioritize COVID-19 prevention and infection control. Research can be de-escalated or stopped not just because of priority-setting exercises, but also because the risk–benefit profile has been so altered by the pandemic that it is no longer justifiable to undertake the study. Concerns arise especially on research projects which, if stopped or de-escalated, may lead to highly compromised, or altogether unhelpful, results. A few hypothetical responses may suffice. One response is to perceive research and other academic engagements as dispensable luxuries so that we focus only on epidemic-focused research. Another response is to undertake all the research for which resources are available, but establish a dedicated team looking into nothing but the pandemic. A third response is to de-escalate on-going research to give priority to the epidemic, especially in resource-scarce contexts. This could be combined with a policy that allows for some non-pandemic research to be continued, provided that a request is made and approved by an ethics committee and the relevant institutions. Research that is long-standing – for instance, cohort studies – or where the pausing of research activities constitutes a risk for those involved – for instance, clinical trials that require regular follow-up and where the trial drug cannot simply or easily be replaced with standard clinical care – could then be continued without interruption.
A third challenge relating to research priority setting activities relates to their implementation in practice. If priority-setting activities are not accompanied by a plan for implementation or a broad commitment by the research community (including funders) to consider taking the priorities into account, then the exercise is meaningless. For instance, one study conducted in South Africa concluded that “under one-third of the themes of priority questions developed in the KZN [Kwa-Zulu Natal] research prioritization process were reflected in subsequent research projects. Thus, many areas of health and healthcare considered as priorities remain under-researched” (Khumalo et al. 2020).
The case studies in this chapter highlight how some of the challenges discussed above have manifested in practice. Case 2.1 asks what priority should be placed on conducting qualitative research into the experiences of family members of severely ill and dying COVID-19 patients while isolation measures prohibit in-person visits, and how such research should be conducted. Cases 2.2 and 2.3 demonstrate how research prioritization measures may need to be responsive to widespread use of traditional medicine and off-label use of medications to treat COVID-19, despite the lack of evidence about their efficacy in this context. Cases 2.4 and 2.5 illustrate the issues that research teams may face as research priorities are re-evaluated in pandemics. Case 2.4 prompts reflection on the questions research teams may need to consider when determining whether to completely redesign proposed research in response to the logistical challenges posed by the pandemic and evolving pandemic research priorities. In Case 2.5 questions arise about continuing recruitment into oncology trials in public hospitals, as infection-control measures and anticipated constraints on capacities to provide health care prompt a re-revaluation of research priorities.
References
ACDC. 2021. Research and development priorities for COVID-19 in Africa. Addis Ababa: Africa Centres for Disease Control. February.
Barsdorf, N., and J. Millum. 2017. The social value of health research and the worst off. Bioethics 31(2): 105–115.
CCRCC. 2021. Prioritisation process for COVID-19 research involving participant interaction. Baltimore: Johns Hopkins COVID-19 Clinical Research Coordinating Committee. https://ictr.johnshopkins.edu/covid-research-center/review-committees/ccrcc/.
Etti, M., J. Alger, S.P. Salas, R. Saggers, T. Ramdin, M. Endler, et al. 2021. Global research priorities for COVID-19 in maternal, reproductive and child health: Results of an international survey. PLoS One 16(9): e0257516.
Khumalo, G., R. Desai, X. Xaba, M. Moshabela, S. Essack, and E. Lutge. 2020. Prioritising health research in KwaZulu-Natal: Has the research conducted met the research needs? Health Research Policy and Systems 18(1).
Mador, R.L., K. Kornas, A. Simard, and V. Haroun. 2016. Using the nine common themes of good practice checklist as a tool for evaluating the research priority setting process of a provincial research and program evaluation program. Health Research Policy and Systems 14(1).
Nasser, M., R.F. Viergever, and J. Martin. 2021. Prioritization of research. WHO guidance on research methods for health emergency and disaster risk management. Geneva: World Health Organization. https://apps.who.int/iris/bitstream/handle/10665/345591/9789240032286-eng.pdf.
Norton, A., and The other members of the GloPID-R, UKCDR, and COVID-19 Clinical Research Coalition Cross-Working Group on COVID-19 Research in LMICs. 2021. Priorities for COVID-19 research response and preparedness in low-resource settings. The Lancet 397(10288): 1866–1868.
Nussbaum, M.C. 2009. Creating capabilities: The human development approach and its implementation. Hypatia 24(3): 211–115.
Pratt, B., and A.A. Hyder. 2016. How can health systems research reach the worst-off? A conceptual exploration. BMC Health Services Research 16.
Pratt, B., M. Sheehan, N. Barsdorf, and A.A. Hyder. 2018. Exploring the ethics of global health research priority-setting. BMC Medical Ethics 19. https://doi.org/10.1186/s12910-018-0333-y.
Viergever, R.F., S. Olifson, A. Ghaffar, and R.F. Terry. 2010. A checklist for health research priority setting: Nine common themes of good practice. Health Research Policy and Systems 8. https://doi.org/10.1186/1478-4505-8-36.
Weiss, D.J., A. Bertozzi-Villa, S.F. Rumisha, P. Amratia, R. Arambepola, K.E. Battle, et al. 2021. Indirect effects of the COVID-19 pandemic on malaria intervention coverage, morbidity, and mortality in Africa: A geospatial modelling analysis. The Lancet Infectious Diseases 21(1): 59–69.
Wilkinson, A., M. Parker, F. Martineau, and M. Leach. 2017. Engaging ‘communities’: Anthropological insights from the west African Ebola epidemic. Philosophical Transactions of the Royal Society B 372(1721). https://doi.org/10.1098/rstb.2016.0305.
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Appendices
Case 2.1: Should Death and Grieving During the Pandemic Be Studied?
This case study was written by members of the case study author group.
Keywords
Research priority setting; Risk/benefit analysis; Safety and participant protection; Vulnerability and inclusion; Qualitative research
Among the consequences of the COVID-19 pandemic is that, because of infection-control measures, patients may die without their family and friends being present. Saying goodbye is an important act for patients and their families, and helps to initiate healthy grieving. Rituals, performed either by a priest or other religious figure, or by a friend or family member, can help during this process. This kind of farewell, if performed by an appropriate figure, constitutes an act of respect towards the family and an acknowledgement of the human dignity of the person who has passed away (Consuegra-Fernández and Fernández-Trujillo 2020; Eisma and Tamminga 2020).
Social distancing measures profoundly changed the way we interacted with each other at work, and at home, and the way patients received visits in hospital. During the COVID-19 pandemic, visits were restricted, in order to protect patients and health-care personnel. It was necessary for hospitals to design protocols that allow patients to say goodbye to their loved ones through electronic devices, with the patient supported by a member of the medical team (Wakam et al. 2020). If these painful experiences are not processed in an appropriate and timely manner, they can be traumatic and have negative effects on families and communities in the medium and long term. Disease and death without the presence of family members can be a painful experience for all concerned, including the health-care team.
A group of intensive care unit (ICU) health-care professionals and a mental health team suggested conducting qualitative research to find out about the experiences of people saying goodbye to relatives dying of COVID-19 in hospital, in order to propose measures and protocols for support and care in end-of-life situations. The study would use in-depth interviews to study the experiences and perspectives of relatives of patients who died of COVID-19 in ICUs during the first 6 months of the pandemic. The relatives would be contacted by telephone to ask if they would be willing to participate. The interviews would cover aspects of health care, participants’ perceptions of their experience (including being with their loved ones), and the communication and support provided by the medical staff.
The researchers considered that the study posed a minimal risk to participants. In the protocol, when describing the consent process, they did not mention any possible adverse effects except for feelings of sadness and pain related to the memory of the participants’ loved ones who had died. The interviews would be carried out by three qualified researchers with training in both qualitative research and conducting in-depth interviews with participants in vulnerable situations. The interviews would be recorded and transcribed, and the audio files would subsequently be destroyed, in order to keep the information confidential and protect the identity of the participants. Participants would be advised that they could opt out of the research at any time.
The study protocol was presented for assessment and approval by a research ethics committee.
Questions
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1.
Should this type of research be conducted during a pandemic? Why?
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2.
What are the ethical issues raised by this proposed study?
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3.
What safeguards should be put in place when seeking to recruit participants who are grieving?
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4.
Should the research be considered to be minimal risk research? What are the risks of such research and how should they be addressed?
References
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Consuegra-Fernández, Marta, and Alejandra Fernández-Trujillo. 2020. La soledad de los pacientes con COVID-19 al final de sus vidas (The loneliness of COVID-19 patients at the end of their lives). Revista de Bioética y Derecho 50: 81–98. November 23. http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1886-58872020000300006&lng=es&tlng=es.
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Eisma M.C., and A. Tamminga. 2020. Grief before and during the COVID-19 pandemic: Multiple group comparisons. Journal of Pain and Symptom Management 60(6): e1–e4. https://doi.org/10.1016/j.jpainsymman.2020.10.004.
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Wakam G.K., J.R. Montgomery, B.E. Biesterveld, and C.S. Brown. 2020. Not dying alone – Modern compassionate care in the Covid-19 pandemic. New England Journal of Medicine 382: e88. https://doi.org/10.1056/nejmp2007781.
Case 2.2: Should Widespread Off-Label Use of Medication Influence Research Prioritisation?
This case study was written by members of the case study author group.
Keywords
Research priority setting; Social and scientific value; Resource allocation; Treatment repurposing
In late October 2020, the media in Country X reported that a medication containing amantadine was effective against COVID-19. Amantadine is commonly used to treat neurological disorders, including Parkinson’s disease and multiple sclerosis. It also exerts some virustatic activity and was previously used in the prevention and treatment of influenza. A media storm was triggered after one doctor from Country X posted his experience of using it to help treat COVID-19 on the website of a health centre. The doctor’s statement indicated that amantadine had helped him and his patients to recover from COVID-19. Moreover, interest in the drug increased further after one politician announced that he had recovered thanks to amantadine.
The initial data about amantadine’s potential efficacy with regard to COVID-19 appeared in April 2020. Scientists from Country X observed that some patients who were treated for neurological disorders with this drug and were directly exposed to COVID-19 did not develop severe clinical symptoms of COVID-19. Similar reports were published in Country Y. However, except for some anecdotal and poor-quality evidence from case reports and observational trials with a small number of participants, there were no publicly available data from clinical trials about amantadine’s efficacy and safety in treating COVID-19. This raised serious doubts and provoked discussion in the scientific community in Country X. In response, the national health authorities commissioned a review of all available data on the use of amantadine in COVID-19 treatment. The report appeared at the end of November 2020. It was concluded that, because of the limited scientific evidence and its low credibility, there was uncertainty about the efficacy and safety profile of amantadine in COVID-19 treatment. The national health authorities did not recommend that amantadine be used to treat COVID-19 but undertook to monitor emerging data about its use.
Although no strong clinical evidence was reported and amantadine did not appear in the COVID-19 treatment guidelines, many doctors continued prescribing it off-label to treat COVID-19. Consequently, sales of the drug increased significantly. Pharmacists soon began to report problems with amantadine availability for patients with long-term neurological disorders who had been taking it for some time. Compared to September 2020, sales of the drug in October were over three times higher (jumping from 5000 to 17,000 packages a month), and in November they continued to increase. Consequently, in December 2020, the national health authorities decided to introduce limits on sales to ensure on-going access to amantadine for patients with neurological disorders. However, problems with the availability persisted, with problematic consequences. People, especially those who were interested in amantadine as a treatment for COVID-19, began seeking sources of the drug beyond pharmacies. Offers to sell amantadine appeared in social media and online forums.
The national interest in amantadine as a potential treatment for COVID-19 was enormous, leading to a risk of widespread off-label use of amantadine to treat COVID-19 without an appropriate evidence base. As a result, the national health authorities decided to fund two clinical trials to evaluate the safety and efficacy of amantadine for COVID-19, including whether it prevents the development of severe COVID-19 symptoms. The trials were run by two research centres with multiple trial sites in Country X. Starting in March 2021, they sought to recruit about 700 patients in total.
Questions
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1.
What considerations should be taken into account when setting national priorities for clinical research addressing health needs during a pandemic?
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2.
Should anecdotal data and increased prescriptions for off-label use of a drug to treat COVID-19 influence which clinical trials should be conducted? Why?
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3.
Should the limited availability of amantadine for patients with neurological disorders prompt the conduct of research evaluating its efficacy at treating COVID-19? Why?
Case 2.3: Studying the Treatment of COVID-19 Patients with Traditional Medicine
This case study was written by members of the case study author group.
Keywords
Research priority setting; Social and scientific value; Researcher roles and responsibilities; Ethical review; Traditional medicine
In the early months of the COVID-19 pandemic there was a lack of evidence about effective biomedical treatments for COVID-19 to inform treatment guidelines. In some countries the absence of effective treatment elicited an unprecedented response from traditional medicine (TM) practitioners and researchers, who sought to evaluate the effect of known traditional or herbal remedies in tackling COVID-19 (Kuntia et al. 2022). In seeking to develop safe and efficacious alternatives to the prevalent biomedical standards of care, many studies focused on prophylaxis or the treatment of mild to moderate COVID-19, and in some instances TM was used as an add-on therapy to complement biomedical treatment. As the efficacy of TM for similar conditions (as described in authoritative TM texts) is not routinely assessed in biomedical preclinical studies, the use of repurposed or novel TM formulations as alternatives or to complement biomedical treatment for COVID-19 requires justification.
Country A has a heritage of traditional systems of medicine for the prevention and treatment of diseases, and well-established formal education systems are in place for these. As previous research had demonstrated that some TM remedies were good immunomodulators (Akram et al. 2018), it was thought that they could play a role in controlling COVID-19 infection. Within Country A initial government advice on treatment schedules for COVID-19 included several potential biomedical treatments, including hydroxychloroquine, ivermectin and Remdesivir, although there was still lack of evidence about whether they could be repurposed to effectively treat COVID-19. These were complemented by guidance about infection-control measures. Government guidance did not, however, address the role of any TM formulations or herbal treatments in treating COVID-19. As health is managed at a state level within Country A, some states permitted the use of TM as a prophylaxis or for treating mild to moderate COVID-19, in the absence of clear evidence about appropriate biomedical standards of care.
An investigator from a biomedical institution submitted a proposal to conduct a randomized, open-label clinical trial using an interdisciplinary (TM and biomedical) approach, as many patients in the region preferred TM formulations. Patients with confirmed mild and moderate COVID-19 would receive a TM formulation in one arm of the study or a government-approved potential biomedical treatment in the other arm. As the TM formulation was a well-known and proven immunomodulator used widely by TM practitioners, the researcher wanted to assess its safety and efficacy in comparison to the government advice about potential biomedical treatment s for COVID-19. In country A, specific guidelines have to be followed if biomedical researchers conduct research using TM formulations, and all such research should be conducted in collaboration with TM researchers. The researcher’s proposal was approved by the local research ethics committee.
Questions
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1.
In contexts with well-established traditional systems of medicine, should research into the safety and efficacy of TM remedies in preventing and treating pandemic disease burdens be conducted (particularly in the absence of an evidence base about effective biomedical approaches)? Why?
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2.
What ethical issues might be associated with incorporating TM into expedited pandemic research pathways?
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3.
What sort of expertise is required to inform expedited ethical review of interdisciplinary research proposals incorporating TM?
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4.
Should biomedical investigators conduct research on the safety and efficacy of a TM formulation in a pandemic without the involvement of a TM practitioner or researcher? Why?
References
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Akram, M., I.M. Tahir, S.M.A. Shah, Z. Mahmood, A. Altaf, K. Ahmad, N. Munir, M. Daniyal, S. Nasir, and H. Mehboob. 2018. Antiviral potential of medicinal plants against HIV, HSV, influenza, hepatitis, and coxsackievirus: A systematic review. Phytotherapy Research 32(5): 811–822. https://doi.org/10.1002/ptr.6024.
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Khuntia BK, Sharma V, Wadhwan M Chhabra V, Kidambi B, Rathore S, Agarwal A, Ram A, Qazi S, Ahmad S, Raza K and Sharma G. 2022. Antiviral Potential of Indian Medicinal Plants Against Influenza and SARS-CoV: A Systematic Review. Natural Product Communications 17(3). https://doi.org/10.1177/1934578X221086988.
Case 2.4: Research Reprioritization During the COVID-19 Pandemic
This case study was written by members of the case study author group.
Keywords
Research priority setting; Social and scientific value; Research design and adaption; Vaccines
Prior to the COVID-19 pandemic, a research team in a sub-Saharan African country was planning to conduct a study on reproductive health with a focus on sexual assault. Sexual assault was an important issue in the community with major consequences. The study team was made up of female physicians with complementary medical specialities. The cross-sectional interventional study aimed to investigate the prevalence, types, risk factors, psychological impact and perpetrators of sexual abuse against adolescents.
The study team prepared to submit their protocol to the national ethics review committee. However, plans to conduct the research were suspended during the first wave of the COVID-19 pandemic in the country, owing to the lockdown and preventive measures put in place to contain and limit the spread of SARS-CoV-2 infection. Not only would data collection not be possible for the study, it was also considered important to focus research efforts on COVID-19, given its status as a public emergency and the associated morbidity and mortality.
The research team decided to conduct a study on COVID-19 infection, prevention and control, given the global scarcity of personal protective equipment (PPE) at the time. Health-care workers were facing one of the worst times of their lives as they encountered COVID-19 patients in emergency rooms and isolation and treatment centres. Studies of the impact of COVID-19 on the well-being of health-care workers, and of their perceptions about COVID-19 were consequently considered to be a priority. In particular it was thought important to investigate the impact of the infection prevention and control measures on health-care workers’ well-being, as both the measures and compliance with them could affect their mental health. Study objectives included assessment of doctors’ risk perception in relation to COVID-19, the prevention and control measures they practised, and their use of PPE. The study sought to assess health-care workers’ well-being and perceptions of local infection prevention and control procedures, using the World Health Organization protocol on the perceptions of health-care workers on infection prevention and control (WHO 2020).
This study was considered very relevant in the context of the pandemic and the researchers developed plans to present the results to policy-makers. The study protocol was approved and the study was conducted. The results of the study were written up and reported at various conferences. Two of the conference abstracts won awards.
Questions
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1.
When and how should decisions be made about prioritizing COVID-19 research and deprioritizing non-COVID-19 research? What are the ethical implications of such decisions?
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2.
Should research on health-care workers’ well-being in the context of COVID-19 have been prioritized over the planned study involving sexual assault if the sexual assault study could have been completed safely? Why?
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3.
What can research teams and institutions do to facilitate appropriate research prioritization decisions during a pandemic? What ethical issues should be taken into consideration?
Reference
WHO. 2020. Perceptions of healthcare workers regarding local infection prevention and control procedures for COVID-19: Research protocol. R&D Blueprint COVID-19. Version 1.0. Geneva: World Health Organization. https://www.who.int/docs/default-source/blue-print/perceptions-of-healthcare-workers-protocol-v1–0.pdf?sfvrsn=3f0dd47c_4.
Case 2.5: Challenges with Continuing Cancer Research in a Publicly Funded Hospital
This case study was written by members of the case study author group.
Keywords
Research priority setting; Resource allocation; Access to experimental treatments; Non COVID-19 research
A cancer research unit situated within a large, publicly funded hospital in a high-income country ran a wide range of clinical trials of treatments for cancer. Owing to restrictions on the public funding of pharmaceuticals in the country, some cancer treatments that were widely used internationally and of potential benefit to patients were sometimes only available in the context of a clinical trial at the unit. Some of the trials run by the unit involved intravenous treatments and oral agents administered in the same facility in which routine cancer treatments were also provided.
When COVID-19 emerged as a significant threat to populations globally, this country instituted a lockdown prohibiting non-essential movement outside the home. The hospital postponed elective procedures and limited its activities in preparation for an influx of COVID-19 patients, and to reduce the risk to vulnerable patients and staff. Social distancing was instituted and treatment spaces were spread out to increase the distance between patients, reducing the number of patients that wards and units were able to accommodate at any one time.
The treatment facility was able to continue to provide care exclusively to cancer patients during the COVID-19 restrictions, but with reduced capacity. The research unit was faced with a decision about whether to continue enrolling patients into clinical trials involving onsite administration of intravenous treatments and oral agents, or whether to halt recruitment until it became clearer what impact the pandemic would have upon the health system. The team were aware of the need to consider carefully how they allocated resources, including clinical staff and clinic space, as they prepared for the possible effects of the uncontrolled spread of COVID-19. Social distancing limited the number of patients able to receive cancer treatment at any one time, whether for routine care or as part of a clinical trial. Because a single facility undertook clinical and research procedures, conducting research in which participants received onsite oral or intravenous medications could have had knock-on effects for clinical patients, including delayed access to routine chemotherapy. However, halting recruitment to some trials could leave patients who might have benefited from in-trial access to a cancer treatment worse off. In addition, running trials requiring onsite procedures would increase the amount of personal contact between patients, staff and participants, thereby potentially increasing the risk of COVID-19 transmission.
Questions
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1.
When a pandemic limits available resources, what ethical considerations should influence decisions about whether priority should be given to patients receiving chemotherapy as part of standard clinical care or to participants receiving chemotherapy in a clinical trial?
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2.
Should patients be told that they might have been eligible for participation in a trial if the pandemic had not impacted clinical resources and created the need for social distancing? Why?
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3.
Who should decide whether, when or how to reinstitute recruitment to trials involving onsite components such as intravenous treatment? What ethical considerations should they take into account?
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Obengo, T., de Vries, J. (2024). Setting Research Priorities. In: Bull, S., et al. Research Ethics in Epidemics and Pandemics: A Casebook. Public Health Ethics Analysis, vol 8. Springer, Cham. https://doi.org/10.1007/978-3-031-41804-4_2
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