It was great to see this statement about data sharing coming out of the recent WHO consultation that I know Andrew was involved with:
I wonder if those present could provide any more insights into the discussion. Wish I could have been there!
Developing Global Norms for Sharing Data and Results during Public Health Emergencies
WHO Consultation 1-2 September 2015: Summary and Key Conclusions
In line with open access policies, the timely sharing of information on clinical, epidemiologic and genetic features of emerging infectious diseases as well as information on experimental diagnostics, therapeutics and vaccines, is critical for actions during a rapid public health response.
WHO held a consultation in Geneva, Switzerland, on 1-2 September 2015 to advance the development of global norms on data and results sharing in public health emergencies. Government representatives, public health agencies, scientists, research funders, ethicists and industry representatives attended the consultation. Acknowledging the years of work that many groups have engaged in to support data sharing in health research, the following consensus emerged from the meeting specific to the emergency perspective.
It was recognized that epidemiologic data belong to the countries where they are generated, but there was consensus that the default option is that data should be shared (i.e. opt-out policy) to ensure that the knowledge generated becomes a global public good.
It was also recognized that pathogen genetic sequence and associated clinical and epidemiologic data are of greatest value if made openly available, in as close to real-time as possible, during a public health emergency.
It was unequivocally agreed by representatives from leading biomedical journals that public disclosure of important information of potential relevance to public health emergencies should not be delayed by publication timelines, and that pre-publication disclosure must not and will not prejudice journal publication. It was agreed that pre-publication information sharing should become the global norm in the context of public health emergencies. Researchers should take the responsibility to ensure that results – even when preliminary – are adequately robust and have undergone quality control, prior to public disclosure to enable an evidence-based dialogue with the media and communities.
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.
There was consensus that the risks and potential harms to individuals of non-disclosure of important information provide a strong ethical rationale for rapid sharing of data.
The meeting reaffirmed that funders and sponsors have a crucial role to play in requiring that expedited timelines for sharing of data and interim results in public health emergencies are a precondition for approval of study initiation, disbursement of funds and in monitoring compliance.
Participants called upon all researchers from public and private sectors to make data publically available, including results from studies that are inconclusive or have not led to the expected results.
The meeting agreed on a series of short-, medium- and long-term actions that can be implemented to build on achievements and lessons learned during the Ebola crisis to improve data and results sharing during the next emergency. These will be developed and submitted to the WHO emergency R&D preparedness blueprint Advisory Group for endorsement and action by WHO and partners.
The meeting recognized the imperative for capacity strengthening and creation of an enabling environment in low- and middle-income countries that is conducive to locally led research and structures for data sharing.
A longer version of the meeting report will be made available in the next weeks.