Brisbane Health-y Data: What are health and sensitive data and why are they trickier to publish and share?
1 like510 views
The document discusses strategies for ethically sharing and managing sensitive human health data in research, emphasizing informed consent, data confidentiality, and compliance with ethical guidelines. It highlights the importance of planning ahead and implementing practices that enhance the value and reuse of research data, while also detailing legal considerations and institutional policies governing data sharing. Resources and frameworks are provided to assist researchers in responsibly navigating the complexities of sharing sensitive data.
Brisbane Health-y Data: What are health and sensitive data and why are they trickier to publish and share?
- 1. Sarah Olesen 16 March, 2016 sarah.Olesen@biotext.com.au 1 Health-y sharing of human data
- 2. 2 Plan ahead where possible It can be done safely, ethically to great success
- 3. Who are ANDS? ‘..make Australian research data collections more valuable by managing, connecting, enabling discovery and supporting the reuse of this data..’ 3
- 5. Resources Research Data Australia (https://researchdata.ands.org.au/) Guides (http://ands.org.au/guides) Workshops, seminars, webinars 5
- 6. What today’s all about 6
- 7. Confessions of a sensitive soul Image: CC-BY-SA Aaron Filler, MD, PhD
- 9. Getting on the same page 9
- 10. 10 Lets talk about data
- 11. 11 ‘records, files or other evidence, irrespective of their content or form (e.g. in print, digital, physical or other forms), that comprise research observations, findings or outcomes, including primary materials and analysed data’ (Monash University 2010)
- 12. 12 • Human data is data collected from or about individuals • Health data includes information about their health (or others people’s health) • Health data that is also sensitive – individual-level health data (ie, not aggregated)
- 13. Publishing vs. Sharing 13 Publishing = making data, or a record about the data (metadata) publically available Sharing = giving others data
- 14. ARC NHMRC NHMRC Statement on Data Sharing ..encourages data sharing New Human Research Ethics Application (HREA – replaces NEAF) National Statement on Ethical Conduct in Human Research (s2 consent to future use) Australian Code for the Responsible Conduct of Research (s2 retain data) Data sharing landscape International funders e.g. NIH, Wellcome
- 15. JOURNALS e.g. BMJ & PLOS - all data underlying findings described must be fully available without restriction, with rare exception The International Committee of Medical Journal Editors ‘..believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.’ ‘As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results’
- 16. Institutional data policies Federal and State policies Australian Government Public Data Policy Statement ‘..release non sensitive data as open by default; and to collaborate with the private and research sectors to extend the value of public data for the benefit of the Australian public..’
- 18. 1. Increase citations 2. Expand network 3. Boost profile 4. Improve grant success 5. Efficiency 6. Ethics – participant fatigue, getting needed information out there quickly Image from: Eresearch SA
- 19. What makes health data sensitive? 19 Personal (identifiable) information + potential for harm or discrimination
- 20. 20 Privacy Act (1988, s6) Personal information + one or more of: health info, genetic, biometric,..politics = Sensitive information Legally: Privacy Law Cannot be used beyond original purpose of collection without consent
- 21. Ethically 21 ‘any data that contain information that can be used to identify an individual and introduce a risk of discrimination, harm, or unwanted attention.’ http://www.ands.org.au/datamanagement/sensitivedata.html
- 22. Ethically 22 • Informed consent • Avoid harm (= remove/minimise sensitivity) ‐ Where possible, modify data to protect privacy ‐ i.e. Confidentialising data ‐ Conditions around access to data • Ethics Committee approval
- 23. Confidentialising data ‘confidentialisation', ‘de-identification', ‘anonymisation’ ‘de-sensitising’ 1. De-identifying - removing info that can identify person/s; and 2. Continuing to manage the risk of identification even after the dataset has been de-identified. 23
- 24. Confidentialising data 1. Removing direct identifiers 2. Removing or altering other information that may allow an individual to be identified E.g. unusual characteristics Indirect identifiers (commonly, combinations of information) http://ands.org.au/guides/sensitivedata Hrynaszkiewicz et al. 2010 24
- 25. 25 Can my data be confidentialised? Some data cannot be modified enough to adequately minimise the risk of identification without rendering the data invaluable. Other options for publications? conditional/restricted access
- 26. 26 Depends on • Whether its sensitive; how sensitive (identifiability/confidentiality) • Participant consent • Ethics approval How do I share health data?
- 27. Pre & during research planning 27 1. Informed consent 2. Confidentialise/modify data if possible 3. Conditions to accessing data 4. Negotiate ownership & licencing of data 5. HREC Application Curtin University now requires data management plan in their HREC application: http://research.curtin.edu.au/research-integrity- ethics/human-research-ethics/forms/
- 29. Publishing & Sharing How? If you have permission from participants & HREC And (perhaps) confidentised data Publish ‘openly’ 29 Or with conditions / restrictions ‘conditional access’
- 30. 30 What does this look like in the real world?
- 35. Take away 35 • It can be done in many cases! • Be a scout: plan ahead • Before publishing, ask about: participant consent? ethics approval (from all parties)? modify data first? • (For later) Conditional access? Or a public and restricted version of data?
- 36. Resources 36 • ANDS Guide to Publishing & Sharing Sensitive Data http://www.ands.org.au/datamanagement/sensitivedata.html - includes info on confidentialisation. See also Hrynaszkiewicz et al paper. ANDS webinar recordings on ethics and sensitive data preparation https://www.youtube.com/playlist?list=PLG25fMbdLRa5pvodHMYDi3c0LTu8N3Ks- • Website on Ethics and Best Practices in Sharing Individual-level Research Data https://bioethicsresearchreview.tghn.org/research-data-sharing/ • Digital data: Centre for Advancing Journalism and the Carlton Connect Initiative, Guidelines for the Ethical Use of Digital Data in Human Research http://carltonconnect.com.au/wp-content/uploads/2015/06/Ethical-Use-of-Digital-Data.pdf