Political and economic solutions identified | Challenges encountered |
Strengthen global collaborations and coalitions   -Ensure global political awareness of infectious disease threats.   -Strengthen collaborations between international organisations, national leaders, public, private and local stakeholders.   -WHO to set out overarching research governance framework for research in outbreaks.   -Integrate research in international outbreak response.   -Ensure interventions are supported by all stakeholders, including national and local stakeholders.   -Close collaboration between local and international researchers from research inception, tied to capacity building and be genuinely collaborative.   -Research led by national teams.   -Invest in national public health research institutes globally, targeting epidemic-prone regions. | Geopolitical   -Ineffective global coordination and collaboration.   -Research not integrated into national outbreak response.   -Establishing outbreak as international concern may depend on the ability of LMICs to raise international interest.   -Lack of compliance with WHO core capacities to detect, assess, report and respond.   -Need for political approval.   -Political unrest.   -Research priorities dictated by funding bodies.   -Lack of communication and engagement between stakeholders. |
Funding   -Establish dedicated funding sources in inter-epidemic times.   -Establish international agreements on financial mechanisms for rapid release of funding and for addressing clinical trial liability coverage.   -National governments to strengthen investments in preparedness and response.   -Coordinate funding to ensure it is rapid and sufficient by using international coalitions and economies of scale.   -Ensure sufficient, specific and flexible funding for research staff to avoid healthcare opportunity costs.   -Explore industry funding to complement public funding.   -Provide appropriate compensation for participation in research. | Funding   -Insufficient funding resources.   -Delays in identifying funding.   -Weak funding mechanism and implementation for research in emergencies and neglected and tropical disease.   -Funding not mobilisable at sufficient pace.   -Limited national health budgets dedicated to research response efforts.   -Opportunity costs and competing interests.   -Over-reliance on unpaid staff doing research in addition to normal duties, with risk to care, staff and research. |
Health systems and infrastructure   -Strengthen health systems and research capacity.   -Strengthen supporting infrastructure, targeting regions vulnerable to epidemics.   -Expand critical care resources.   -Develop clinical research facilities in predicted ‘hot spot’ regions. | Health systems and infrastructure   -Limited healthcare systems.   -Limited supporting infrastructure, electricity and water supply and technical resources.   -Lack of national health research institutes.   -Competing interests of resources. |
Administrative, regulatory and logistic solutions identified | Challenges encountered |
Human resources and research capacity   -Ensure capacity to respond to outbreaks across departments, particularly in predictable epidemic-prone regions.   -Ensure sufficient support for ethics review boards.   -Identify and utilise existing skills and talents, re-deploy existing research staff.   -Fund dedicated study teams to avoid additional burden on other staff.   -Ensure adequate, sustained research training for staff, particularly during stable periods.   -Establish clinical research networks that are incentivised and prepared to respond to outbreaks and politically supported.   -Form research response teams, with dedicated research coordinators.   -Recruit additional staff from outside of the epidemic area to reduce strain.   -Set up mobile research teams to reach large areas.   -Improve staff perception of research as a core role of healthcare professionals. | Human resources and research capacity   -Limited number of staff.   -Risk of already scarce staff becoming overwhelmed and additional burden of research activities across services.   -Training of staff in research not seen as a priority.   -Lack of research coordinators.   -Increased workload from study protocol risk negatively affecting patient care.   -Difficulties in deploying staff internationally sufficiently rapidly in the context of an outbreak. |
Communication   -Establish direct stakeholder communication channels.   -Develop harmonised, coordinated communication activities with shared oversight structures and joint management.   -Establish detailed communication and dissemination plans and templates.   -Provide continuous updates on research activity to stakeholders as appropriate through a variety of channels.   -Set up ‘pandemic champions’ to establish links with sites, to facilitate coordination and to raise awareness. | Communication   -Data stored in countries other than that affected, disempowers the national team.   -LMICs unable to access trial results after the study is completed.   -Challenges for LMICs to gain international interest from study results.   -Challenging to control the interpretation of research output by the media and political leaders. |
Frameworks   -Establish a normative framework for research and development.   -Create frameworks and governance charts for clear decision-making procedures, standard operational procedures and administrative infrastructures.   -Prioritise research questions, pre-design study protocols and training materials in advance, ready to be deployed. | Frameworks   -Lengthy process of planning, formalising and gaining approval of study protocol.   -Lack of integrated standards for data collection and infrastructure for data sharing.   -Delays in obtaining inter-institutional data sharing agreements.   -Time lag for distant reference lab results.   -No apparent benefit to those affected to share data.   -Delayed data sharing due to academic competition culture. |
Data and sample sharing   -International agencies (e.g. WHO) to establish international data sharing frameworks.   -Refinement of international agreements, such as the Declaration of Helsinki to include instructions on how to handle benefit sharing for sponsor and host countries.   -Develop templates and platforms for data and sample sharing.   -Enhance the value of research output dissemination to all stakeholders through long-term collaboration and health system improvements.   -Funding approvals to incorporate agreement on data dissemination.   -Establish data sharing ahead of emergencies.   -Develop a mechanism to manage intellectual property and data governance.   -Establish standard to reduce uncredited secondary analysis to facilitate data sharing.   -Ensure global sharing of data with fair distribution.   -Enhance the value of the research to each beneficiary through fair dissemination of knowledge, product development, long-term research collaboration, and/or health system improvements. | Data and sample sharing   -Data collection and sharing on paper records sometimes not possible due to infection control and confidentiality issues.   -Loss of control and ownership of data following dissemination.   -Data not made available during outbreaks and long delays in publishing data after outbreaks.   -Issues around maintaining participant confidentiality when sharing data.   -Lack of control of communication.   -Confidentiality requirements imposed by commercial entities. |
Publication standards   -Agree open data sharing and publication standards.   -A shift in paradigm to a common goal of data sharing rather than publication.   -Ensure pre-prints of novel data are available prior to publication.   -Develop and use an ‘emergency research pledge’ by journals.   -Ensure researchers, including local collaborators, are credited for their work. | Traditional publication process   -Traditional journal review processes are too slow to inform emergency outbreak response strategies.   -Publication authorship imbalances. |
Pathways for regulatory and ethics approvals   -Establish accelerated regulatory pathways and expedited ethical review processes for emergencies.   -Establish institutional review boards in epidemic ‘hot spot’ regions.   -Enable single portals for applications.   -Establish joint ethics review committees.   -Enable parallel submission of ethical, financial and scientific approvals.   -Develop pre-approved study protocols with agreed acceptable study design modifications.   -Develop pre-approved site agreements, between multiple sites and organisations, in geographically strategic regions.   -Consideration of the management of bio-samples should be part of the ethical and protocol review. | Pathways for regulatory and ethics approvals -Delays caused by existing ethical frameworks.   -Complex ethic committee forms and inconsistencies between forms.   -Variation in REB responses to the same study.   -Lack of framework to fast-track vaccine trials or drug testing.   -Existing frameworks not fit for emergency research.   -Lengthy time taken to gain research approvals during epidemics and pandemics.   -Requirement of approval from multiple entities (including political) and variations between countries.   -Reluctance from national officials to approve trials. |
Drug and vaccine licencing and access   -Form Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a specific intervention or group of interventions.   -Global regulatory agencies should collaborate to ensure accelerated licensure strategy.   -Contracts with multiple manufacturing and distribution units to improve resilience in the supply of medicines to participating trial site.   -Primary role of authorising use of investigational vaccines and drugs should be given to the affected countries. | Drug and vaccine licencing and access   -Length of time for drugs and vaccines to be approved.   -Lack of framework to fast-track vaccine trials and drug testing. |
Research support systems   -Provide sufficient funds for the renovation of study facilities and provide supportive infrastructure.   -Strengthen satellite and wireless internet access in epidemic-prone regions.   -Use existing infrastructure, e.g. from other disease programmes.   -Set up logistical support platforms.   -Ensure flexible solutions that can be readily adaptable depending on the context. | Research support systems   -Rudimentary and overwhelmed healthcare facilities.   -Technical resource limitations.   -Limited access to freezer storage facilities.   -Difficulty reaching remote field sites.   -Lack of effective personal protective equipment   -Poor safety for staff and participants. |
Ethical and social solutions identified | Challenges encountered |
Standards   -Develop standards for the conduct of research in emergencies, including frameworks for the inclusion of vulnerable groups and appropriate study designs.   -Ensure equitable access to best available evidence-based care for all patients, regardless of consent to participate.   -Ensure appropriate compensation for participation in research. | Standards   -Lack of uniform standards for research ethics committees.   -Lack of international consensus about research groups’ obligations to provide trial participants health benefits.   -Non-transparent ethical approval processes.   -Exclusion of pregnant women and children from trials.   -Expedited review might pose a risk to patients.   -Research perceived as the only way to access care/treatment.   -Lack of agreement on appropriate study designs for emergencies. |
Consent methods   -Evaluate alternative consent methods proposed during emergencies.   -Ensure consent methods are culturally appropriate. | Consent methods   -Obtaining complex informed consent, from severely ill patients and from relatives.   -Verbal proxy consent contested at later date. |
Community engagement   -Invest in community engagement from inception.   -Explore outbreak and community context, and use the findings to inform the study design, set-up, delivery and dissemination.   -Ensure protocol and consent forms are consistent with community values and internationally accepted ethical principles.   -Build trust through understanding and respect of different cultures.   -Ensure study design meets cultural needs.   -Manage expectations of all stakeholders.   -Facilitate community empowerment.   -Provide outreach community information sessions.   -Establish community advisory boards.   -Use social messaging and informational materials to improve the knowledge and perception of the study and disease and to address rumours.   -Ensure effective consultation and communication with affected or at-risk communities, for example, through community liaison teams.   -Involve social scientists and medical anthropologists to help understand the concerns and needs of the community.   -Translate social science research into practice.   -Facilitate relationships between groups with cultural differences. | Community engagement   -Mistrust, suspicion and rumours around clinical trials, national and international response, sometimes due to local media and other sources.   -Poor understanding of how to address rumours.   -Fear of the disease.   -Cultural perceptions of tissue and blood sampling.   -Poor understanding of how to respect different cultures.   -Lack of community engagement and poor perception of power dynamics.   -Perception of research being unfair. |