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Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

Repeated calls have been made in recent decades to increase investments in health research, especially in low- and middle-income countries (LMIC). However, the perceived low relevance and quality of health research, poor visibility of outputs, and difficulties in tracking current levels of and returns on investments have undermined efforts to advocate for additional investments in these countries. Some of these issues emanate from inadequate governance and management systems for health research at the national level, which are ineffective in tracking and steering the research portfolio and investments, ensuring quality, and facilitating access to research outputs. In spite of this, the value, necessity, and cost of performing health research management and governance functions are not well appreciated, especially in LMIC.

To address this, the World Health Organization (WHO) Regional Office for the Western Pacific organized an expert consultation in August 2011, involving experts from 14 of its developed and developing member states and from leading research organizations such as the Wellcome Trust.

The consultation identified essential health research governance and management functions that must be performed by appropriate organizational entities to maximize returns on health research investments. In addition, three specific areas for intervention were considered: (1) prospective research registration in publicly accessible national health research registries; (2) systematic health research data archiving and wider access; and (3) national research ethics systems.

A consensus was reached on the need to invest more in essential health research and management functions, including establishing publicly accessible web-based national health research registries for prospective registration of health research, setting up systems to archive and share health research data, and improving the governance of research ethics committees. The consultation also concluded that the costs of performing these functions are legitimate and necessary research costs that must be shouldered by research funding organizations.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

In recent decades, evidence-based health care or practice has become a buzzword in public health policy circles and repeated calls have been made to increase investment in health research (1–3). Health research has grown into a multi-billion dollar industry, yet it is perhaps the least coordinated and regulated sector in health care, with a complex and diverse range of players and research outputs. The pursuit of institutional and individual research success, the championing of particular ideologies, and the substantial financial stakes associated with some research products have intensified vested interests. Furthermore, reports of scientific misconduct, manipulation, and incomplete and non-reporting of research are increasing (4–6).

Many have assumed that self-regulation, peer review in scientific publishing, and product licensing systems will take care of issues relating to scientific rigor, honesty, and vested interests in research. Limited formal monitoring and coordination mechanisms exist, especially for non-clinical trial research. Mechanisms that do exist include ethical reviews by research ethics committees (RECs) to protect human subjects and oversee other ethical aspects of research, and prospective clinical trial registration to address problems related to selective publication of clinical trial results. Even these measures, however, are yet to be fully implemented in 1ow- and middle-income countries (LMIC). Nonetheless, continued reports of selective publication and unfinished and poorly accessible research outputs suggest these systems are not adequate. Ensuring that researchers consider questions relevant to national health priorities is a separate challenge, as identifying and promoting national and international research priorities is complicated by the complex landscape of research stakeholders and by the need to preserve intellectual freedom while steering the direction of research.

As the volume and stakes in health research activity grow, the imperative to ensure accountability, transparency, and efficiency in health research becomes stronger. In LMIC, domestic investments in health research are limited and compete with resources needed to deliver health services. Ensuring efficiency in research investments and maximizing returns becomes all the more important in these resource-constrained settings.

How can this complex situation be remedied? How should research efficiency, accountability, and transparency be monitored? Who should ensure that publicly funded research is relevant and that research outputs meet appropriate standards and are adequately shared with relevant stakeholders? Should the responsibility be left to the myriad of funding or research organizations or even to individual researchers? If there is a need for oversight, coordination, and/or standard-setting structures or bodies, what form should they take and what functions can they perform without creating unduly expensive bureaucracy? What key interventions could substantially improve efficiency, transparency, and accountability in health research without overburdening or stifling the intellectual freedom of researchers?

To discuss these issues, the WHO Regional Office for the Western Pacific convened an Expert Consultation on Improving Health Research Management and Governance in the Western Pacific.

Meeting format and methods

The Expert Consultation was convened at the WHO Western Pacific Regional Office in Manila, Philippines from 15 to 17 August 2011. Participants came from Australia, Cambodia, China, Fiji, Japan, Laos, Malaysia, Mongolia, New Zealand, the Philippines, South Korea, Singapore, and Vietnam. In addition to WHO staff, representatives were also in attendance from several other organizations: Demographic and Health Surveys (ICF Macro, USA); Department of Health, Philippines; International Organization for Migration; Korea Health Industry Development Institute; Philippine Council for Health Research and Development; and Wellcome Trust (UK). The experts were heads of national health research councils or equivalent organizations (Fiji, Malaysia, New Zealand, Philippines), managers of clinical trial registries (China, Malaysia, South Korea), focal persons for RECs (Cambodia, Laos), and experts involved with other aspects of health research management and governance.

Starting with unanimous agreement on broad goals of health research management and governance—namely, accountability, transparency, and efficiency in health research—the consultation discussed the following: functions that may be essential to achieve the broad goals; the current status of those functions in countries and areas in the Western Pacific; and interventions and approaches that may facilitate performance of these functions. Three specific interventions that have substantial potential to improve research governance and management were considered: (1) prospective registration of health research; (2) systematic archiving and wider access to research data; and (3) national research ethics systems. For each of these topics, a series of presentations were given by participating experts, followed by group work sessions and sharing of group feedback at the plenary session. For each, preliminary recommendations based upon the discussions were agreed upon by consensus. In the final session, these preliminary recommendations were combined into a set of final recommendations. The following sections briefly describe the proceedings and conclusions. A full report of the consultation, approved by all participants, will be published by the Western Pacific Regional Office of WHO.

Health research: essential governance and management functions

Each essential health research governance and management function was examined according to three criteria: (1) the relevance of the function to improving accountability, efficiency, and transparency; (2) the current status and barriers preventing the performance of the function; and (3) how the function might be performed by national organizations. The potential relevance of the functions and the barriers that affect their fulfillment in LMICs are presented in Table 1.

Table 1.  Health research: essential governance and management functions
FunctionFunction's relevanceCurrent status and barriers
1. Monitoring overall research activity at the national levelPublicly accessible prospective monitoring of health research activity will improve transparency and accountability, increase efficiency by avoiding duplication and aligning research with national priorities, and facilitate assessment of returns on national research investments.Some individual institutional mechanisms monitor research for their own use, but there is no national publicly accessible system that includes studies irrespective of source of funding, and no formal system to track overall health research investments. Other common barriers include disconnected research funding organizations, incomplete reporting of final research, and limited awareness of the value of monitoring research.
2. Identifying and pursuing national priorities in health researchWill improve efficiency by increasing returns on research investments.Countries have either no articulation of national research priorities or no mechanism to track adherence to set priorities; little control and influence over external funding agencies.
3. Oversight of health research to ensure ethical conductWill ensure accountability of health researchers to research participants.Many developing countries lack national systems, standards, and guidance as well as infrastructural, human, and financial resources and capacities. The importance of oversight is often under-appreciated.
4. Monitoring, building, strengthening, and sustaining national health research capacityWill improve efficiency by improving quality of health research, reducing research costs, and minimizing unnecessary duplication of specific resources or skills.None of the participating countries coordinate, systematically assess, and build national research capacity. LMICs have limited career structures and report “brain drain.” Clinician researchers prioritize private practice over research.
5. Creating systems to facilitate wider access to and dissemination of all research outputsEssential for accountability and transparency, and to maximize returns on investment (efficiency).Mechanisms and organized systems to improve access to published or unpublished research outputs are limited. Researchers tend to focus on publishing in scientific journals, which are not easily accessible.
6. Developing and pursuing national research strategiesMay provide clarity on the direction of health research and assign roles and responsibilities to specific stakeholders.Where national health strategies exist, they often relate only to government-funded research. There were conflicting views as to whether development of detailed strategies is justified or whether statements and pursuit of concise research missions or visions may be more effective.
Recommendations

The consultation concluded that governance and management of health research at the national level is relatively neglected, especially in LMIC. The priority functions as identified by consensus included: effective monitoring of national health research activity and financial investments to guide priority setting and resource allocation; effective oversight of ethical and technical quality of research; and development of systems to ensure wider access to and wider use of research results and other outputs. It was recommended that appropriate bodies be identified or created to perform these essential governance and management functions. In addition, human and financial resources needed to execute these functions should be acknowledged as legitimate research costs by national and international funding agencies. Options should be explored to mobilize or channel these funds from the research funding agencies to appropriate agencies responsible for governance and management functions.

National Health Research Registries (NHRRs)

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

Link between health research governance and management and NHRRs

Despite intentions and efforts to set national research priorities and increase utilization of health research, progress has been limited. One of the main factors hindering progress has been the lack of appropriate information systems, along with uncoordinated and diverse research stakeholders operating somewhat autonomously. Prospective registration of research in a publicly accessible web-based register with collection of key information on each research activity may serve as an important tool to inform governance and management of health research.

Explanation of the concept

Prospective registration of health research in publicly accessible web-based registries has been advocated since the 1990s, but mainly for clinical trial research. The prospective registration of clinical trial research was promoted primarily from the perspective of improved transparency and accountability in reporting all clinical trials irrespective of the outcomes. Non-interventional research such as observational studies and health policy and systems research are as important as clinical trials for informing public health policies and decisions, especially in LMICs. NHRRs were proposed to expand the scope of prospective registration of health research beyond clinical trials. The potential of NHRRs was highlighted as key research management and governance tools for stewardship, oversight, priority setting, and tracking of financial investments in addition to their role in improving accountability and transparency in health research (7, 8).

Notwithstanding the stated objectives and scope of registration, several Clinical Trials Registers (CTRs) already register non-clinical trial research, and many are used to perform essential governance functions including monitoring/enforcing ethical review of research and future research priority setting (9, 10). Hence, the experience of CTRs provides important lessons and a proof of concept for countries considering NHRRs for prospective registration of health research (7).

Country experiences

A number of countries, mainly developed ones, have set up systems for prospective registration of clinical trials since the establishment of the first CTR by the National Institutes of Health in the United States in 2000. To inform discussion of NHRRs, experts from China, South Korea, and Malaysia shared their countries’ experiences in establishing and operating prospective research registries.

The National Medical Research Register (NMRR) in Malaysia is unique because it is not limited to clinical trials and because it links research registration with the funding application, ethical approval, and submission of final reports. However, registration is limited to research involving Ministry of Health personnel, resources, or funding. Operating in its present form since 2008, the NMRR is perceived to have improved the efficiency of research review and approval processes and transparency in research practice.

South Korea's Clinical Research Information Service (CRIS) began operation in early 2010 with approval from the Department of Health. CRIS allows prospective registration of all types of health research, but the stated focus is clinical trials. CRIS staff review submitted data to ensure methodological quality, confirm REC approval, and verify aims, interventions, and outcomes before making them available publicly. The data are updated every six months, with reminder e-mails sent to researchers.

The Chinese Clinical Trials Registry (ChiCTR) was established in 2004 and designated the national registry in 2007. The registry is hosted by the Chinese Evidence-based Medicine Center and Chinese Cochrane Center at West China Hospital, Sichuan University. While both CRIS and ChiCTR are primary registries in ICTRP and comply with the requirements of The International Committee of Medical Journal Editors (ICMJE), NMRR is yet to qualify as a primary registry in ICTRP.

ICMJE's 2005 policy requiring researchers to prospectively register all clinical trials as a condition for publication in its member journals is the key driver for Korean researchers to register their research. However, in both South Korea and China, it is estimated that only a small proportion of clinical trials are registered. There are various reasons for this, including a preference amongst researchers to register in international registries such as clinicaltrials.gov. Registration remains voluntary, but mandatory registration policies are being developed in both countries. The use of data collected by ChiCTR and CRIS is still limited, but emerging Ministry of Health policy on health technology assessment may lead to increased use of ChiCTR data domestically.

While CRIS in South Korea and NMRR in Malaysia are entirely funded by their respective Ministries of Health, the personnel and maintenance costs of ChiCTR are borne by West China Hospital.

Discussion issues

There was broad agreement on the potential value of NHRRs in facilitating various governance and management functions. These included the monitoring of health research activities and investments, allowing future priority setting and monitoring of adherence to established priorities, facilitating researcher networking and collaboration, and, to a limited extent, informing capacity-building and expanding the use of health research. Other key issues discussed included the type of research that should be registered in NHRRs, the research registration dataset that should be collected at the time of registration, mechanisms to ensure compliance with prospective registration, and challenges that may affect the establishment or operation of an NHRR.

Scope of registration by type of research and registration metadata

Some participants felt that countries without a research registration system should build upon the global experience of clinical trials registries and start with registration of clinical trial research only, progressively increasing the scope of the research to be registered in stages over time. The counterview was that repeated changes in policy would require not only programming changes to the registration platform but also substantial policy dissemination efforts that may lead to confusion among researchers. Also, since non-clinical trial research accounts for the majority of health research in LMIC and currently has almost no regulatory mechanisms, prospective registration is all the more urgent for this type of research. Thus, it may be best to set a policy at the outset that would require registration of all desired research, acknowledging that the registration coverage may be suboptimal in the initial years. As for what research should be registered, it was felt that the most pragmatic policy may be to include all research that needs prior ethical approval as per national standards, although this would introduce national differences and might not include some nationally and internationally valuable research activities such as meta-analyses, systematic reviews, and health technology assessments.

An optimal registration data set needs to be defined that facilitates the performance of governance and management functions while placing a minimal burden on researchers. The 20 data items specified by WHO as the minimum trial registration data set, and required for any ICMJE-approved registry, may be necessary but not sufficient as an appropriate data set for NHRRs (11). Additional work is needed to identify other important information that would be required to register study types other than clinical trials and that would be of optimal use for research governance purposes.

Challenges

Government support and leadership would be needed to establish NHRRs and to ensure adequate legal and regulatory frameworks. The challenges involved in establishing and operating NHRRs were felt to be considerable, varied, and country-specific, including the development of secure, user-friendly, and reliable information technology elements and mobilization of adequate human and financial resources to manage and operate registers. Opportunities to look to international donors to assist with funding were discussed. Whilst the challenges were acknowledged, it was felt that the potential benefits offered by NHRRs in terms of more effective and efficient research systems with less waste and duplication of effort may outweigh any associated costs.

Recommendations

In conclusion, the consultation recommended that NHRR should be acknowledged by member countries as a mechanism with considerable potential to improve the governance and management of health research, leading to more relevant, transparent, efficient, and quality research. All member states should be encouraged to identify and designate focal agencies to develop and implement time-bound plans to establish and operate an NHRR covering at least health research requiring prior ethical approval. Joint subregional or regional development of shared hosting of national data may be considered for smaller member states, along the lines of the joint Australia New Zealand Clinical Trials Registry. In partnership with the WHO Regional Office for the Western Pacific, it was recommended that countries should work together and share experiences as they develop NHRRs in order to avoid duplication of efforts and collaborate on devising appropriate formats and minimum data requirements for NHRRs.

Systematic archiving of research data and wider access to data

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

Link between governance and management of health research and data archiving and access

Systematic archiving and wider access to research databases can preserve valuable scientific resources and may enhance efficiency in health research by reducing duplicative data collection efforts, and by facilitating the triangulation of multiple data sources to help researchers answer complex heath research questions. In addition, wider sharing of health research databases may substantially enhance accountability and transparency in health research with a positive impact on research quality.

The consultation examined the rationale and feasibility of systematic data archiving and of wider data access. Are routine archiving and wider access to research data desirable and achievable and worth the investment of limited resources? Who will perform archiving and access functions: can these functions be left to individual researchers or individual research organizations? And what are the potential infrastructural, human, and financial implications? Participants reviewed ongoing global discussions and data-sharing practices in other fields such as genetics, molecular biology, and astrophysics, as well as the current status of data-sharing by member states in the Western Pacific. Representatives from the Wellcome Trust and Demographic and Health Surveys also shared their experiences.

Global initiatives for wider data sharing

Calls for systematic archiving and wider access to health research data are gaining global momentum, with high-level dialogue and statements involving prominent global research funding organizations. The Organization for Economic Cooperation and Development issued principles and guidelines for access to data from publicly-funded research in 2007 (12). Several prominent research funding organizations, such as the National Institutes for Health in the United States, the Wellcome Trust in the United Kingdom, and leading research universities such as the University of Edinburgh have adopted data-sharing policies in recent years. The World Bank and the H8 group made commitments toward data-sharing in early 2010. A global consultation held in 2008 to reach consensus on data-sharing led to the endorsement of a Joint Statement of Purpose on sharing research data by 17 major research organizations in early 2011 (13–16). The signatories have created a Public Health Research Data Forum and three cross-funder working groups focusing on capacity and skills, culture and incentives, and infrastructure and tools.

Good practice examples

Current efforts to promote systematic data archiving and access benefit from several good practice examples such as the Demographic and Health Surveys (DHS), funded by the United States Agency for International Development, which has followed the principles of data-sharing from its inception. The databases generated by 290 DHS surveys in 89 countries can be accessed for free by researchers globally and have demonstrated that cultural, ethical, and technical barriers to data-sharing can be overcome. The survey organization reported no negative experiences emanating from wider data sharing, but found many positive outcomes in terms of better data use and improved research quality.

Country experiences

Most of the countries in the Western Pacific Region do not have formal policies or dedicated mechanisms and infrastructure to support systematic archiving and data sharing. In general, data archiving and access is reportedly better for Ministry of Health-sponsored national surveys than for individual researcher-initiated projects. However, data archiving and access to Ministry of Health-sponsored health surveys is still far from optimal. Most countries reported a scattering of databases across different institutions, lack of any central register of databases, and poor access, although encouragingly, several initiatives were reported from developed countries to rectify the situation. Several government initiatives are under way in Australia under an eResearch initiative, including a network of research data storage and collaboration infrastructure, Australia Research and Education Network, and Australian Research Data Commons. Japan reported ongoing initiatives in the form of a database integration program, but also admitted to many challenges, including a need for efficient mechanisms to register and transfer research datasets, as well as incentives for researchers to collaborate.

Although the situation is suboptimal in both developed and developing countries, awareness of issues is much higher in developed countries, and there are several ongoing initiatives to improve the situation. Australia's National Health and Medical Research Council (NHMRC) and New Zealand's Health Research Council (HRC) are signatories to the Joint Statement, and while NHMRC has an open-access policy requiring researchers to deposit data from a NHMRC-funded project into a repository within 12 months of research completion, HRC is in the process of developing formal policies on data-sharing for research it funds. The importance of data archiving and data-sharing is recognized in the Australian Code for the Responsible Conduct of Research.

Malaysia, while acknowledging its lack of policies and suboptimal use of health research data, reported on current efforts to improve archiving and access to large-scale nationwide surveys sponsored by the Ministry of Health, and on future plans to set up a central data warehouse for research databases under the National Institutes for Health (under the leadership of the Ministry of Health). Both Vietnam and the Philippines reported no specific ongoing efforts to improve archiving of or access to health research data.

Discussion issues

Systematic archiving of databases and increased access to and use of data raises many challenges large and small–cultural, political, regulatory, capacity-related, technical, economic, and ethical. The challenges were grouped under three categories for discussion purposes: culture and incentives, capacity and skills, and infrastructure and tools.

It was felt that current research and institutional cultures may be reluctant to comply because of long-established–albeit unfounded–attitudes, and intellectual property issues. Increased understanding of the potential benefits of wider data access, greater recognition of the value of database creation and data management, and mechanisms to ensure that those who create databases are acknowledged academically and in publications may go some way toward reducing such reluctance.

Although there is a perception that increased data-sharing may lead to increased ethical risks, these risks must be balanced with other ethical imperatives: the need to make the best use of scientific data to improve health; the need to make best use of taxpayer and funder investments; and the need to avoid research fatigue in populations by avoiding duplication of data collection.

Although initiatives for the systematic archiving of data sets to preserve their long-term value may face less resistance than policies for wider access, they may face similar challenges in terms of inadequate technical infrastructure and financial and human resources, and will require development of appropriate technologies and protocols for secure and efficient archiving. However, returns on investments in data archiving alone–without increased data access and use–are questionable.

Recommendations

The consultation concluded that systematic archiving and sharing can substantially improve research quality and efficiency, and though there are challenges to overcome, some existing examples such as DHS surveys suggest the feasibility of this. Hence, member states and research stakeholders should actively support and take action toward systematic data archiving and wider access to health research data. Member states were encouraged to identify mechanisms to develop, oversee, and ensure compliance with data archiving and access policies. The consultation felt that development work should be supported and agreements pursued on common data formats and database architectures. It was recommended that WHO advocate data archiving and access and that organizations that fund research should acknowledge the cost of data archiving and access as legitimate research costs.

National Health Research Ethics Systems

Link between health research governance and management and RECs

Oversight of health research involving human subjects by independent RECs is the research governance mechanism that has been most widely promoted globally in recent decades. RECs spread following several well-publicized instances of abuse of human participants in health research, such as the American Tuskegee study of the natural history of syphilis. Developing efficient systems for independent ethical review and monitoring of health research is not only an essential governance and management function, but also has the potential to enforce compliance by researchers with various guidelines and regulatory requirements for health research.

Country experiences

The research ethics review systems in the region were reported to vary from well-organized and well-enforced systems in developed countries such as Australia and New Zealand, to reasonably well-developed and expanding systems in Malaysia, Mongolia, and the Philippines, to rudimentary systems comprised of just one REC in countries such as Cambodia and Laos.

A few common issues emerged irrespective of countries’ development status. RECs often operate in an isolated and fragmented manner, with little networking among them. Few member states have clear guidelines or standards for the constitution of RECs or mechanisms to monitor their activities. Few countries maintain databases on their operations. The Philippines is an exception among LMIC, with the Philippine Health Research Ethics Board (PHREB) mandated to formulate guidelines for the ethical conduct of health research and establishment and management of RECs.

RECs in most of the countries, including developed countries, operate with limited resources and inadequate capacity to perform the expected roles of continued review, oversight, and monitoring of adverse events after initial review. The infrastructure and human resource needs to manage the review process–ranging from submission, scheduling meetings, archiving proposals, and managing and communicating feedback adequately–are frequently not fully appreciated, with severely under-resourced REC secretariats in many countries. Some countries reported charging user fees for the review, the desirability of which remains contentious.

Limited organized efforts were reported to build the research ethics capacity of researchers or REC members in any of the countries, except in the Philippines, where a training center for Health Research Ethics and Good Clinical Practice has been established in the National Institutes of Health at the University of Philippines, Manila.

A major challenge reported by the majority of experts was the lack of awareness and appreciation of independent ethics reviews among researchers, with many considering it an unnecessary bureaucratic burden, and among many directors of research institutions, who do not give priority to RECs at the institutional level. Lack of clear national guidelines on ethical review processes in many countries means that many researchers find it difficult to navigate ethical review systems that are often characterized by onerous and inconsistent requirements. In the absence of centralized mechanisms dictating ethical review processes, the requirement for REC oversight of research is mainly enforced via research funding agencies and by publishers. In most of the countries, it is difficult to estimate the proportion of research that undergoes review.

Discussion issues

The discussion was organized around three major themes: strategies for establishing efficient REC systems, including capacity-building; the role of national governance bodies in oversight and/or monitoring of RECs; and the potential of RECs to enforce compliance with other research guidelines and regulatory requirements.

Capacity-building is much needed in terms of human resources and infrastructure, but funding is a perpetual problem. Training is needed for REC members and researchers alike, and development is needed in the ongoing monitoring of approved research.

More consistent and streamlined submission, review, and notification processes for RECs are needed. With work and resources, it would be possible and appropriate in the future for systems of web-based central submission and application-tracking to be established, linked to NHRRs and to other research governance functions.

Well-organized REC systems are in a unique position to play key roles in the governance of health research, and may serve as instruments to enforce other requirements such as compliance with prospective research registration and systematic archiving of databases.

Recommendations

In conclusion, the consultation recommended that appropriate bodies should be identified or created within member states to develop and support REC systems and to set up appropriate policies, standards, and guidelines targeted to different stakeholders. Member states should set ethical standards for health research in line with international standards and guidelines, and these should be monitored and enforced by systems of adequately trained and resourced research ethics committees. The human and financial resources required to perform these functions should be recognized and supported as legitimate research costs. Mechanisms that can realize the potential of research ethics committees to contribute to essential research governance functions such as research registration and data archiving should be explored.

Overall recommendations and the way forward

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

In the final session the experts discussed the overarching recommendations on all the issues considered during the consultation (Box 1) and focused on identifying follow-up actions needed to facilitate execution of the recommendations.

The proposed follow-up actions included national consultations, especially in LMIC, to raise awareness and reach consensus on the issues. These consultations should include all stakeholders, such as researchers and research institutions, national and international health research funders, and other relevant organizations in the health and science sectors.

At the international level, mechanisms need to be developed to encourage and facilitate collaboration and shared learning in the development of policies, infrastructures, methods, and materials for use in the three intervention areas discussed at the expert consultation. For example, development by WHO of an online repository for resources such as national policies and guideline documents and training materials may be very useful. It was also suggested that commitment to skill-sharing was needed from those countries with more developed and well-resourced health research systems. The participants felt that WHO could play an important role in awareness-raising and advocacy at the national and international levels, including support for national consultations. In addition, it was considered important that WHO country and subregional offices be directly involved in eliciting the support of national ministries and institutions. It was specifically suggested that WHO could coordinate a subregional follow-up meeting for the Pacific region, which is in special need of development in health research governance and management.

To conclude, this consultation was just the beginning of a long road. It is hoped that its recommendations will serve to advocate for, and provide direction and momentum to, efforts to improve overall governance and management of health research in the Western Pacific, leading to more effective and efficient health research outcomes.

Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

Recognizing and performing essential health research governance and management functions to ensure effectiveness and efficiency of health research

  • 1
    Appropriate bodies should be identified or created within member states and assigned responsibility for the following essential health research governance and management functions:
  • - 
    defining national health research policies and strategies
  • - 
    effective monitoring and direction of national health research activities and investments;
  • - 
    oversight, support, and development of systems to ensure ethical standards and technical quality in research;
  • - 
    development and oversight of systems to ensure efficient data archiving and wider access to data for health research; and
  • - 
    ensuring that the value of national research outputs is realized and communicated to policy-makers.
  • 2
    The human and financial resources required to discharge these functions should be recognized and supported as legitimate research costs.

Prospective registration of health research and national health research registries

  • 3
    Member states should acknowledge the importance of national health research registries in improving the governance and management of health research.
  • 4
    Appropriate bodies should develop and implement time-bound plans to establish and operate national or subregional health research registries covering at least health research requiring ethical approval.

Archiving of and access to health research data

  • 5
    Each member state is encouraged to develop and implement data archiving and wider access policies with time-bound goals and targets.
  • 6
    Member states should encourage the active collaboration and cooperation of diverse research stakeholders in the implementation of data archiving and access policies.

Research ethics

  • 7
    Member states should set ethical standards for health research that are in line with international standards and guidelines. These standards should be monitored and enforced by systems of adequately trained and resourced research ethics committees.
  • 8
    Mechanisms that can realize the potential of research ethics committees to contribute to wider research governance functions, such as research registration and data archiving, should be explored.

WHO Regional Office for the Western Pacific

  • 9
    WHO will advocate effective governance and management of health research and, in partnership with member states, will coordinate the sharing of knowledge and experience in the development of policies, standards, methods, and technologies.

Acknowledgements and Funding

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References

The authors gratefully acknowledge thefinancial support for the organization of the Expert Consultation that was provided to the WHO Regional Office for the Western Pacific by the Government of Japan and the Wellcome Trust, United Kingdom. We also thank all the participants in the expert consultation for their inputs and contributions and Ms. Rhonda Vandeworp for her editorial assistance. One of the co-authors, Dr. Brian Buckley, was contracted and paid by the WHO Regional Office for the Western Pacific to document the proceedings of the Consultation and to assist in the writing of this report. The views expressed in this report are those of the authors and do not necessarily reflect the views or policy of the World Health Organization.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. National Health Research Registries (NHRRs)
  5. Systematic archiving of research data and wider access to data
  6. Overall recommendations and the way forward
  7. Box 1: Recommendations from the WHO expert consultation on improving health research management, governance, and data-sharing in the Western Pacific
  8. Conflicts of interest:
  9. Acknowledgements and Funding
  10. References
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