Nov 26, Health-y sharing of human data

2 Plan ahead.. It can be done in many cases, to great success and benefit!

Borders and boundaries 3

4 Lets talk about data ‘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)

5 Human data is data collected from or about individuals Health data includes information about their health (or others’) Today, we focus on health data that may also be sensitive – individual-level health data (ie, not aggregated)

Publishing vs. Sharing 6 Publishing = making data, or a record about the data (metadata) publically available Sharing = giving others data

Data sharing landscape NHMRC..encourages data sharing and providing access to data and other research outputs … arising from NHMRC supported research NHMRC Statement on Data Sharing (April 2015): data-sharing data-sharing JOURNALS (e.g. BMJ, PLOS) PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception ARC Discovery Program Funding International Funders

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

10 What do we want to know about health and sensitive data?

What are sensitive data? How do my guidelines support/conflict with sharing health data? Where does health data sit within open access agenda? What if the data come from multiple (health) sources? What do I need to discuss with participants? Will the Ethics Committee go for it? Where does the Privacy Act come in? How do I licence sensitive health data? How/do these data have to be modified before they can be shared?

What makes health data sensitive? 12 Personal (identifiable) information + potential for harm or discrimination

13 Privacy Act (1988, s6) Personal information + one or more of: health info, genetic, biometric, political opinion, certain group membership = Sensitive information Legally: Privacy Law What’s required to share these data? Cannot be used beyond original purpose of collection without consent * NSW Act: exceptions if use is ‘necessary for research or the compilation of statistics in the public interest’ or ‘..not be published.. where individual’s identities can be ascertained’

Ethically 14 ‘any data that contain information that can be used to identify an individual and introduce a risk of discrimination, harm, or unwanted attention.’

Ethically 15 What’s required? 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

Confidentialising data  ‘de-sensitising’  ‘confidentialisation', ‘de-identification', and ‘anonymisation’ 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. * See ‘how to’ resources 16 Can my data be confidentialised? Some data cannot be modified enough to adequately minimise the risk of identification without rendering the data invaluable.

17 Your institutional policies, eg Policy statement on open access to University research Health Records and Information Privacy Act 2002 National Statement on Ethical Conduct in Human Research Future use – s2 ‘Consent to future use of data and tissue in research’. NHMRC/ARC Australian Code for the Responsible Conduct of Research - s2 guidelines retain data (not destroy!) Other frameworks

18 Sharing and re-using human data is ethical?

19 link

20 Depends on Sensitivity (identifiability/confidentiality) Participant consent Ethics approval How do I share health data?

Pre & during research planning 21 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: integrity-ethics/human-research- ethics/forms/

Putting it all together ANDS Guide to Publishing and Sharing Sensitive Data Get this decision tree here: ment/sensitivedata.html If you can’t share the data itself, publish metadata so its discoverable

23 What does this look like in the real world?

27 Screenshot: Yale University Open Data Access (YODA) Project Screenshot:

Take away 28 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?

Resources 29 ANDS Guide to Publishing & Sharing Sensitive Data - includes info on confidentialisation. See also Hrynaszkiewicz et al paper.Hrynaszkiewicz et al paper  ANDS webinar recordings on ethics and sensitive data preparation Website on Ethics and Best Practices in Sharing Individual-level Research Data Digital data: Centre for Advancing Journalism and the Carlton Connect Initiative, Guidelines for the Ethical Use of Digital Data in Human Research