Medical and health data, including clinical data and clinical trials are a type of sensitive data.
There are privacy issues to consider when a researcher wants to access or share medical and health data. The consideration of ownership, ethical issues, and legislation can be daunting. The good news is that sensitive data that has been de-identified can be shared.
- Openly shared de-identified data such as the Pregnancy and Lifestyle Study
- Mediated access, where someone wanting to use the data has to apply to the owner of the data, giving their reasons for use, such as the Australian Longitudinal Study on Women’s Health (ALSWH) and the Epidemiology of chronic ankle problems in the community dataset.
Advice on sharing sensitive medical data
ANDS has comprehensive Guides giving practical advice and exploring ethical considerations around publishing and sharing sensitive data. These Guides will assist clinical researchers, and those who support them, to de-identify and publish sensitive data with confidence.
- ANDS Guide - Data sharing considerations for Human Research Ethics Committees (HRECs)
- Ethics and data overview
- Sensitive data overview
- ANDS Guide to publishing and sharing sensitive data
- Sensitive data playlist on ANDS' YouTube channel
- ANDS Guide to de-identifying your data
- Ethics and data poster
Publishing sensitive medical data
An increasing number of medical journals now require or request access to underlying research data when submitting or publishing articles. Planning to publish your data from the beginning of your project or clinical trial will help your workflow and reduce the burden at the end of your project.
- PLOS journals make all data available "with rare exception"
- The BMJ requires data sharing on request for all trials.
- The International Committee of Medical Journal Editors require a data sharing statement for all manuscripts that describe a clinical trial from 1 July 2018, and a data sharing plan to be submitted with trial registration from 1 January 2019.
- Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers (BMJ 2010;340:c181, Iain Hrynaszkiewicz et al)
Where to publish? First check to see if you have an institutional or discipline repository for your data. Scientific Data (published by Nature Publishing Group) has a list of recommended health data repositories.
Describing medical and health data
If you are describing data for deposit in a database or repository, you may find existing standards and protocols helpful, to ensure consistency with national and international best practice. Richly described data is more likely to be found, reused and cited.
- Standards for medical health data (ANDS' slides)
- Controlled vocabularies in medical and health research (ANDS' slides)
ORCID provides a persistent digital identifier that supports automated linkages between researchers and their professional activities ensuring that their work is recognised. It integrates key research workflows such as manuscript and grant submissions enabling the construction of a full record of research outputs.
ORCID has created partnerships with their members to allow users to import publications and other works into their ORCID record from outside databases.
Want to learn more about medical and health data?
ANDS has adapted its 23 (research data) Things to create 10 medical and health research data Things. This is a self paced learning program that explores important aspects of managing medical and health data.