brisbane health-y data: legislation, ethics and governance

Update on legislation, ethics and governance for re-use of identifiable

health and clinical data in the Qld public health sector

Melissa Hagan Manager

Health and Medical Research Unit

Update Overview• Share Queensland Health’s strategy to

streamline researcher access to health data• Increasing researcher access to health

information- with consent• Increasing researcher access to health

information- without consent• Giving Information To Research (GIFTR)

Initiative• Questions

Policy Initiative

• Health and Medical Research Unit strategy to make access to data held by Queensland Health the most streamlined in Australia.

• Our measure of success is a decrease in time from research ethics submission to research governance authorisation.

Our Goals

• Our goals are to improve application and approval processes and to increase the publication of non-identifiable datasets from and for researchers.

• We will compare research approval timeframes, research activity and dataset publication with baseline data.

• Goldilocks requirements – JUST RIGHT.

Where and how will we apply effort?

• We will focus on Queensland state legislation and Queensland Health policy.

• We will remove barriers to researcher access to information and leverage other jurisdictional efforts to avoid duplication of review.

Skill and System Requirements

1. Human resources with skills in health and medical research, policy, legislative change, database management, training and education.

2. Maintenance of the Australian Research Ethics Database to provide reports on research activity and research approval times.

Increasing Researcher Access to Health Information- With Consent

• By extending consent that is accepted in the Hospital and Health Boards Act 2011 (HHB Act). Amendment to legislation is required to recognise consent according to the Statutory Health Authority Framework.

• By increasing the pool of patients who give broad, unspecified consent for future research to use their Health Information (Giving Information to Research – GIFTR initiative).

Increasing Researcher Access to Health Information- Without Consent

1. Clearly defining how permissions other than consent to disclose confidential information operate under the HHB Act by:

A. Publishing the Research Ethics and Governance Health Service Directive

B. Implementing a statewide education program


1. Providing new Qld Privacy Guidelines as an alternative to an application under the Public Health Act 2005 for ethics committees to apply where the HHB Act is not being breached but where activity is not in accord with the Information Privacy Act 2009 (IP Act).


1. Promoting inter-jurisdictional data sharing as a working agenda item for the National Mutual Acceptance Jurisdictional Working Group (NMA JWG) – Noting work being done by the National Health Information and Standards and Statistics Committee http://www.aihw.gov.au/nhissc/

GIFTR

• GIFTR is consent process with an approved toolkit that includes statewide forms i.e. the information sheets and consent forms.

• The consent allows researchers at a health service to access health information for the purpose of future, low risk, GIFTR research projects.

Why GIFTR?

• A number of Hospital admission forms had a broad request for consent to future research that only had a couple of lines of information.

• Legal advice was that this was NOT informed consent.

• No ethics committees would allow that consent to be used for research.

Why GIFTR

• In 2014, the Ministerial Advisory Committee requested a compulsory opt out consent for future research.

• Legal advice is that opt out consent is not sufficient for the consent permission s144 of the Hospital and Health Boards Act 2011 or Information Privacy Act 2009.

GIFTR Status

• GIFTR is approved by the Department of Health.

• GIFTR is not compulsory and will be implemented locally by Hospital and Health Services.

• Gold Coast and Sunshine Coast HHSs are currently beginning implementation.

What is in the tool kit?1 FrequentlyAskedQuestionsforthePatients,EthicsCommittees,Cliniciansand

Researchers

2 SW545GIFTRPatientInformationandConsentForm- Adult

3 SW619WithdrawalofConsent-AdultandCompetentChild

4 SW544GIFTRPatientInformationandConsentForm- Child

5 Afieldtocollecttheresponse inHBCISandareport thatcanberunbyHIMS

6 GIFTR5FactsForStaff- Animation

7 GIFTRForPatients- Animation

8 GIFTRbusinessprocessdiagrams

9 RetrospectiveChartReviewProtocolTemplate

10 Webpages,QHEPS(thisweek),https://www.health.qld.gov.au/clinical-practice/innovation/health-research/default.asp,https://www.qld.gov.au/health/services/hospital-care/before-after/[email protected]

Broad Consultation• Legal Unit and Crown Law• Ethics Committee Chairs, Research Governance

Officers• Researchers• Clinical Networks, Ministerial Advisory

Committee• Heart Foundation, Cancer Council, Consumer

Health Forum• Privacy team, HIMS, Integrated Communications

Expected Benefits• Discussions about research to be embedded into

routine, everyday practice.• An increase in research activity where GIFTR is

implemented (we have base line metrics for the last 5 years).

• A new role of HHS based GIFTR Champion who may not be a clinician but who is trained to take consent and refer to a clinician if capacity to consent is an issue.

• More respectful research where GIFTR can be used rather than waiving the requirement for consent.

• Decreased PHA applications.

brisbane health-y data: legislation, ethics and governance

Health & Medicine