Relevance: Mains: G.S paper III: Science and tech
Why in news?
The Department of Biotechnology has brought a draft document, called the Biological Data Storage, Access and Sharing Policy of India on use and sharing of biological data. Background
- The draft document is primarily meant to address a long-standing concern among many scientists, that several scientists use government funds to conduct research and collect biological specimens and data such as DNA samples, cell and tissue samples, store these details in databases and often lock them up.
It blocks access to other researchers and scientists who may be interested in them.
This leads to duplication of data collection exercises, lost opportunities to access data collected over the years and a wastage of public money.
Sharing of data maximizes the collective utility of data.
- However, there are many issues that must be taken into account in the context of data sharing, the most importantly it must be done in a responsible manner.
Data may induce vulnerability to individuals and to populations. The rights to privacy and confidentiality of individuals and populations must be protected as emphasized in the U.N. Declaration of Human Rights, and no harm must be done to them as a result of data sharing.
- The document provides a framework and principles for sharing of data while protecting the rights of individuals and populations and without causing any harm to them. Broad Guidelines for Biological Data
- Framework for Data Sharing and Accesso Access to Data- Data generated from publicly-funded projects should be shared openly for public good, with few restrictions and in a timely manner, safeguarding the ethical issues that may arise out of shared data.
✓ Only under specific circumstances, data generated using public funds may not be provided open access, and may be provided under a managed/controlled access protocol.
✓ Access to data that are of “sensitive” nature may be barred, even if generated using public funds.
High standards and best practices should be used in generation, management and access to data.
Data that are valuable in the long-term should be stored in a manner that these remain accessible for a long time.
Conduct of research- must not be jeopardized by release of data.
Privileges of Data Generator- there may be a period of moratorium before the data generator releases the data in the public domain.
✓ However, the shared data will always be de-identified.
- Data Release and Timing
Raw Data- It is produced by the various equipment that are used, e.g. DNA sequencer, Flow cytometer, etc.
It must be shared within one year of its generation, by placement in a suitable database identified by the funding agency of the Government of India. Processed Data- It is the data processed from the raw data. It may be shared with others within two years of data-generation
Meta Data- It is the supplementary data as to complement the understanding of other data. It may include the gender, background etc. It should be released concurrently with other types of data.
Deposition of Data- in an appropriate database in a National Biological Data Centre, as identified by the Department of Biotechnology. It shall be the responsibility of the data generator
Withdrawal of Data- requests may be considered and granted provided that the data are identifiable in the database.
- Data User Agreement
Open Access Data- Most data stripped of all personal identifiers and data that are not subjected to any intellectual property or patent restrictions should be made accessible openly, especially if the data are generated using public funds.
✓ Here the agreement must contain the information regarding the data provider, intellectual property, sharing of data, re-identification of individuals and other legal issues.
Managed Data- Sometimes, data generated in even in publicly funded projects may not be allowed open access for a variety of reasons. Such data should still be made available to others under managed access.
✓ Here the agreement must contain the purpose of access, competence of researchers requesting data access, users authorized to access the data, duration of data etc.
- Audito For open-access data, there may be a national committee established by a consortium of national funding agencies to monitor access and use.