Essential medicines and health products

Developing global norms for sharing data and results during public health emergencies

Statement arising from a WHO Consultation held on 1-2 September 2015

Leading international stakeholders from multiple sectors convened at a WHO consultation in September 2015, where they affirmed that timely and transparent pre-publication sharing of data and results during public health emergencies must become the global norm.

The following summary points represent WHO’s position with regard to data and results sharing in public health emergencies, having taken into account the perspectives of those who attended the meeting.

Summary Points

  • Research is essential in the context of public health emergencies. The primary purpose of such research is to advance public health, prevent illness and save lives. Researchers should always weigh the public health consequences of their actions in withholding and sharing results.
  • Every researcher that engages in generation of information related to a public health emergency or acute public health event with the potential to progress to an emergency has the fundamental moral obligation to share preliminary results once they are adequately quality controlled for release. The onus is on the researcher, and the funder supporting the work, to disseminate information through pre-publication mechanisms, unless publication can occur immediately using post-publication peer review processes.
  • WHO seeks a paradigm shift in the approach to information sharing in emergencies, from one limited by embargoes set for publication timelines, to open sharing using modern fit-for-purpose pre-publication platforms. Researchers, journals and funders will need to engage fully for this paradigm shift to occur.
  • Representatives from major biomedical journals who attended the meeting agreed that public disclosure of information of relevance to public health emergencies should not be delayed by publication timelines and that early disclosure should not and will not prejudice later journal publication1 . WHO calls on all journals to follow this example, and help to be an important part of the solution of information sharing in public health emergencies, and to never be a hindrance when timelines for information sharing are critical.
  • Researchers should be responsible for the accuracy of shared preliminary results, ensuring that they have been subjected to sufficient quality control before public dissemination. Opting in to data and results sharing should be the default practice and the onus should be placed on data generators and stewards at the local, national and international level to explain any decision to opt out from sharing data and results during public health emergencies
  • Incentives for sharing data and results should be created and tailored for each type of data generator and steward.
  • The origin of data on an emerging pathogen is frequently obtained from biomedical samples. The ethical requirements of informed consent must be respected. The legitimate needs of the originating country must be taken into account. These include acknowledgement in future research reporting, inclusion in decision-making before any next steps are taken with information arising from samples (including with regard to intellectual property, access to knowledge and benefits), and a commitment from the international community to capacity development in settings with less experience in clinical research, pathogen genome sequencing and evaluation of diagnostics and experimental products.
  • Patents on natural genome sequences could be inhibitory for further research and product development. Research entities should exercise discretion in patenting and licensing genome-related inventions so as not to inhibit product development and to ensure appropriate benefit sharing.
  • The following critical ethical perspective must be borne in mind in the context of public health emergencies: there are very great risks in withholding data and results arising from analyses of that data, and these risks are to both the individual and community from which the data arises, and for nations, regions and the globe. The risks of withholding data and results must always be taken into account in the context of emergencies.
  • A critical point is to clearly distinguish between different issues related to individual participant level data sharing (where there are legitimate concerns about privacy) and sharing of results arising from analyses of those data which does not hold the same privacy concerns.
  • WHO considers that the principles outlined in this document should be considered during the current review of the International Health Regulations, and that sharing of epidemiological and population-based data should be strongly encouraged

1 The group of journals that attended the meeting agreed a consensus statement which is appendix 1 below.

Appendix 1

A Consensus statement made by (in alphabetical order) British Medical Journal, the Nature Journals, the New England Journal of Medicine, and the 7 PLoS Journals is published here by WHO. Italics have been added for emphasis by WHO.

Public health emergencies of global significance constitute compelling examples of the importance of sharing data. Journals should not hinder the sharing of data that could help mitigate the impact of such emergencies.

In such scenarios, journals should not penalize, and, indeed, should encourage or mandate public sharing of relevant data, which may include results of laboratory studies (for example, genomic and immunological data), demographic data, results of animal studies, and de-identified clinical data from individual study participants. Data sharing should occur no later than the time of publication of the related article, and earlier in the evaluation process if the situation warrants.

Journals should not penalize authors who, prior to manuscript submission, share data in the interest of resolving an urgent situation, for example with public health authorities or more broadly when warranted.

The editorial leaders of these journals agree to make clear by endorsing the statement that they have no interest in blocking access to information that would help save life in the short term. To help implementation and provide leverage, this group of editors recommend the following:

  • To have this statement appear in a WHO published document acting as a declaration around which signatories' journals can rally journals in case of public health emergency.
  • To determine the definition of public health emergency — it should be clear that the definition of compliance is at the discretion of the journal or is defined by a body like the WHO (as opposed to just reliance on claims by the authors alone).
  • To make clear that the statement is not intended in any way to supersede the scope or scientific standards of individual journals

The table below identified key issues, and corresponding actions required. WHO calls for these actions to be undertaken to address these issues before the next public health emergency occurs. 



Perception that pre-publication disclosure of key results may prejudice journal publication.

A consensus statement from biomedical journals present at the meeting that pre-publication information sharing should become the norm during future emergencies, with parallel development of submission procedures to journals along longer timeframes.


ICMJE is considering new language following request from WHO

Patchy public disclosure of genome sequence data related to emerging pathogens.

A code of conduct, to be developed by the genome sequencing community and WHO, for the public disclosure of genome sequence data in future public health emergencies.

Delays introduced by data use agreements for evaluation of interventions before or during public health emergencies.

Development of template data use agreements that outline governing principles for data sharing, benefits for those sharing data, responsibilities of those using data, and obligations to publicly disclose results of data analyses within specified timeframes.

Delays introduced by clinical trial agreements for evaluation of interventions before or during public health emergencies.

Development of template clinical trial and consortium agreements using United Nations jurisdiction to overcome contrasting national legal requirements.

Non-disclosure of epidemiologic data related to potential public health emergencies

Agreements that default should be for opting-in to data and results sharing.

Non-disclosure of clinical trial data related to R&D in the context of public health emergencies.

Funders to change wording in agreements so that there is a requirement for expedited information sharing of quality-controlled interim results, as well as disclosure of final results when available.


Call for public disclosure of existing Ebola results from animal models and clinical trials that are related to diagnostics, therapeutics, prophylactics. In order to audit success in this area a publicly available log of all conducted studies should be developed.


Outside emergencies, 12 months is often considered an appropriate timeframe from study completion to public disclosure. In the emergency context, there was unanimity that 12 months should be greatly shortened from the time that interim results are available for public disclosure and that a specific expedited timeline commitment for results sharing should be made in protocols and analysis plans before trial commencement.


Capacity development in resource-poor settings to support research and product development for emerging pathogens


This is required in the following areas with regard to R&D for emergencies: data management and analysis, clinical trial GCP capacity, GMP manufacturing capacity to meet local needs, laboratory capacity to support diagnostics and other product evaluation

Ethical considerations focusing on research and product development prior to and during public health emergencies

Development of international ethical considerations from the perspective of data and results sharing in public health emergencies

Lack of awareness about pre-publication data and results sharing mechanisms

Internet sites that direct users to web resources where information is shared pre-publication related to genome sequences, clinical trial activity through registry sites and preliminary results from clinical research and clinical trials.


WHO calls attention to existing relevant WHO positions, and publications:

WHO Position that all interventional clinical trials are prospectively registered in clinical trial registry

WHO Position that public disclosure of all interventional clinical trials must occur by 12 months from the primary completion date of the trial at the latest – this timeframe is far too long in the context of emergencies, and preliminary results must be disclosed before trial completion as discussed above.

WHO Open Access Policy

Initial summary of outcome of 1-2 Sep 2015 WHO consultation “Developing Global Norms for Sharing Data and Results during Public Health Emergencies” with List of Participants