Changes in national ethics policy for managing and sharing human research data

Kate LeMay 1

1Australian Research Data Commons, Canberra, Australia, kate.lemay@ands.org.au

 

There is a strong national and international movement from both funders and publishers of research, and in particular medical research, towards requiring digital data outputs of research to be well managed and available for appropriate reuse by other researchers. Institutional ethics policies also play a key role in determining how long and where data should be retained, and if/how it can be shared. These ethics policies are based upon the National Statement of Ethical Conduct in Human Research, which is owned by the NHMRC.

This session will examine the new version of the National Statement on Ethical Conduct in Human Research, and ways in which institutions, ethics committees and researchers can comply with the new requirements for data management and sharing.

Managing access to shared data

The Five Safes[1] framework for managing access to data is an excellent basis for planning to manage access to sensitive data. By considering the five aspects of projects, people, data, settings and outputs it addresses the risks in each of these areas and provides choices for a variety of ways to manage access.

Research data can be openly described in data repositories, without making the data openly available., which is called mediated access. This concept is consistent with the approach of making data Findable, Accessible, Interoperable and Reusable (FAIR)[2], and can be part of the Five Safes framework. There are many ways of mediating access to sensitive data, and some examples will be given in this session.

Consent

Sufficient and voluntary consent for data sharing is vital. Controls around governance, access, use, release, confidentiality and privacy of the data should be made clear during the ethical approval process, and also to participants in the research when obtaining consent. Appropriate consent must be obtained from participants for the reuse of research data. Strategies to incorporate data sharing into the ethical approval and consent processes will be discussed.

When research data is reused it must comply with the consent agreement originally formed with the participants. It may be appropriate to provide levels of consent to the participants, e.g. levels of identifiability or aggregation of their data being made available for reuse.

Often researchers are concerned that participants will not consent to their research if they ask for permission to share the data after the conclusion of the project. However, there is a growing body of research around positive participant attitudes towards data about them, even medical data, being reused for research purposes.

Conclusion

The management, retention, and appropriate sharing of research data is increasingly recognised as an important part of the research lifecycle. This is being recognised in national policies, such as the new version of the National Statement on Ethical Conduct in Human Research. Ways in which institutions and researchers can appropriately manage and share human research data will be outlined.

REFERENCES

  • Desai, T. Ritchie, F., and Welpton, R. Five Safes: designing data access for research. 2016. DOI: 10.13140/RG.2.1.3661.1604
  1. FAIR data. Available from: http://www.ands.org.au/working-with-data/fairdata, accessed 30 May 2018.

Biography:

Kate LeMay began her career as a Pharmacist, working in both community and hospital settings. She moved on to the University of Sydney and Woolcock Institute of Medical Research, where she worked on community pharmacy based programs to assist patients with chronic disease management. Kate is now in Canberra, Australia, at the Australian Research Data Commons (ARDC) as a Senior Research Data Specialist, focusing on health and medical data.

About the conference

eResearch Australasia provides opportunities for delegates to engage, connect, and share their ideas and exemplars concerning new information centric research capabilities, and how information and communication technologies help researchers to collaborate, collect, manage, share, process, analyse, store, find, understand and re-use information.

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