Genomic Data

This is a guest blog post writen by Mahsa Shabani (@Mahsashabani).

Genomic data sharing has become an ethical and scientific imperative in the recent years. Funding organizations, research institutes and journals among others, endorsed the significance of data sharing practices to the progress of research and an optimal use of community resources. Consequently, researchers all around the world are extensively involved in the data sharing process, ranging from data production to data use. As sharing practices do involve individuals’ data, the associated ethical and legal concerns should receive thorough attention in order to respect individuals’ rights and maintain public trust.

Sharing data via controlled-access public databases has been seen as an answer to the identified concerns at the moment. Data Access Committees (DACs) constructed locally or in a central fashion control access to these datasets according to defined criteria. Evaluating the qualification/eligibility of data users, ethical and scientific grounds of proposed uses and oversight on downstream data uses are considered as the main responsibilities of DACs.

Data Sharing

While the structure, membership and procedure of access review vary across DACs, some similarities in approaches and mechanisms are observed. A requirement of preparing a summary of data use and signing a data access agreement by data users and their institutions are examples of these common practices. Thereby, proposed data uses may become subject of a rather brief ethical and scientific review. In the absence of notable ethical concernsthe proposed uses may be granted data access, if the scientific relevance of the proposed research to the datasets confirmed. Data access agreements as legally binding documents include various aspects of data use, ranging from security of data storage to the publication of results, in order to respect the rights of research participants and data producers. In case of any breach of agreement, the users’ institution who signs the agreement can be held responsible. That being said, the scope and rigor of such access review and enforceability of access agreements are not crystal clear. As the volume of shared data is increasing, undertaking a thorough review of all future uses and oversight on compliance with access agreements seem challenging. Also, in the face of a global movement towards genomic data sharing, adopting a harmonized view on such access review seems necessary. Initiatives like Global Alliance for Genomics and Health are currently engaged in drafting policies and guidelines to be used globally by parties involved in data sharing.

The functioning of such access review mechanisms has been rarely received attention, also the effectiveness and adequacy of the sanctions in case of breach of access agreements.  A few cases of disrespecting publications policies such as publication embargoes have been reported so far. However, it would be helpful to analyze whether data sharing practices have generated any other material or moral harms to the involved parties. This will help to re-evaluate the current mechanisms and sanctions and tailor them to the realities of data access practices. By establishing adequate oversight mechanisms on data sharing, the progressive and responsible data use will be on the horizon.

You may read more on this topic in this recent paper by Shabani et al here