COVID-19 Research Database Statement of Ethics and Intent

The COVID-19 Research Database consortium is committed to making data freely available for understanding and combating the current pandemic in the interest of patients and the public health. 

 

Currently, researchers are investigating fundamental questions on COVID-19 disease rates, disease burden, and effective therapies through large randomized controlled trials or with standalone databases with small sample sizes. This has limited the available evidence for disease treatment and public health interventions. 

 

The COVID-19 Research Database consortium partners collectively possess vast amounts of data that can inform these questions. Our intent in forming this database is to get relevant data to researchers as quickly as possible, and at a scale that can inform decision-making for healthcare providers and policy leaders. Our hope is that this effort will help limit the suffering caused by COVID-19 for patients and their families. 

 

The following defines the principles by which the consortium will act in assessing research proposals and providing access to data. 

 

  1. Benefit Patient Health

 

The database should be used first and foremost in service of patients. Data access will be granted to researchers whose study proposals are specifically focused on surfacing insights that will improve the health and well-being of patients, both in treating and preventing the spread of COVID-19.

Such proposals may include, but are not limited to: testing drug and non-drug treatments for COVID-19, assessing the impact of public health interventions on containing the spread of disease, understanding factors associated with poor health outcomes (whether demographic factors or comorbidities), and testing methods for efficient resource use and allocation. 

 

Study proposals that are deemed not to be beneficial for patient health will not be granted access to the database, and studies that specify patient benefit and involve patients in the study design process will be given preference. 

 

  1. Generate Readily Available Evidence for Decision-Making

    The rapid spread of COVID-19 has necessitated the emergency use of treatments, despite a limited understanding of treatment effectiveness. While not ideal, healthcare providers have little choice when there are no other options for patients. 

 

To expand our understanding of effective interventions, the consortium aims to provide the data needed to generate credible, peer-reviewed scientific evidence as early as possible. Our aim is to give researchers the tools to quickly test hypotheses on interventions and disprove anecdotal observations that cannot be validated with larger studies. 

 

Evidence-based medicine and public health interventions are crucial in informing healthcare provider and policy decision-making. The database is politically agnostic, and is focused on filling the need for credible evidence as country, state and local governments determine next steps and guidance to the public. To ensure the validity of study findings, we are committed to making data available for the replication of published studies.  

 

To that end, database access will be granted based on the researcher’s qualifications, and on the study’s feasibility in generating evidence that can inform clinical research, treatment or policy decisions. Study submissions that include a specific plan to make those finds public upon study completion will be given preference.  

 

  1. Protect Patient Privacy

 

It is critical that we protect the privacy of individual patients while maintaining the ability to conduct research that will benefit the general population. 

 

Beyond simply complying with regulatory standards, the consortium has designed the database to offer additional safeguards for patient privacy. In particular, only researchers with approved study proposals will be granted access, and those researchers will only be granted access to the specific data sets that are necessary to answer their research question. Only de-identified and limited data sets will be made available through the database, and all new combinations of data will be certified as adequately de-identified before being made available.  

 

  1. Support Non-Commercial Research

    Today, hundreds of clinical trials are being run to test new treatments and interventions for COVID-19. Many of these trials are being conducted by well-resourced pharmaceutical and biotechnology companies. As is often the case, public health solutions are relatively under-resourced. Given the gap, the consortium is focused on providing data to academic, medical and scientific researchers that are prepared to answer challenging questions about the disease.

    Consortium partners are contributing data on a pro bono basis, and we will continue to operate as a non-commercial effort that supports academic, medical and scientific nonprofit research only. Study proposals that are deemed commercial in nature will not be granted access to the database.