Clinical Records Interactive Search– CRIS –

Matthew Broadbent, Clinical Informatics LeadSLaM Biomedical Research Centre

Consent, ethics and data security of

Aims:

To provide searchable access to clinical records from the South London and Maudsley NHS Foundation Trust (SLAM) for research purposes

To ensure the legal and ethical rights of patients are protected

Summary

Dedicated CRIS Security project team set up, including representation and expertise in: -• Ethics• R&D• SLaM Caldicott Guardian• SLaM child protection• Service user (chair)

Deliverables: - • Ethics approval for CRIS as a research data repository• SLaM Caldicott and Trust Executive sign-off

To ensure the legal and ethical rights of patients are protected

Consent - 2 options

Ethics approval for CRIS as a research data repository

1. Opt-in model

Action:

Implement and initiative across SLAM asking clinicians to consent all current and past patients for their records to appear available for research

2. Opt-out model

Actions:

Anonymise all data

Implement a communications programme to inform patients and clinicians about CRIS, including the right to opt-out

Consent - 2 options

Ethics approval for CRIS as a research data repository

1. Opt-in model

Action:

Implement and initiative across SLAM asking clinicians to consent all current and past patients for their records to appear available for research

2. Opt-out model

Actions:

Anonymise all data

Implement a communications programme to inform patients and clinicians about CRIS, including the right to opt-out

✓x

Ethics approval for CRIS as a research data repository

Consent option 2: opt-out model

Actions:

Anonymise all data

1. Remove identifier fields not relevant for research, e.g. first name, last name, etc.

2. Truncate / modify identifier fields relevant for research, e.g. date of birth, ethnicity, postcode

Ethics approval for CRIS as a research data repository

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Anonymise all data

1. Remove identifier fields not relevant for research, e.g. first name, last name, etc.

2. Truncate / modify identifier fields relevant for research, e.g. date of birth, ethnicity, postcode

Source Record85 ethnic categories

CRISNHS 16 (+1) categories

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Anonymise all data

1. Remove identifier fields not relevant for research, e.g. first name, last name, etc.

2. Truncate / modify identifier fields relevant for research, e.g. date of birth, ethnicity, postcode

Source RecordFull postcode

CRIS Super Output Area

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Anonymise all data

1. Remove identifier fields not relevant for research, e.g. first name, last name, etc.

2. Truncate / modify identifier fields relevant for research, e.g. date of birth, ethnicity

3. Mask all identifiers from case notes (events) and correspondence

Fernandes et al. [2013] Development and evaluation of a de-identification procedure for a case register sourced from mental health electronic records, BMC Medical Informatics and Decision Making.2013, 13:71

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Anonymise all data

1. Remove identifier fields not relevant for research, e.g. first name, last name, etc.

2. Truncate / modify identifier fields relevant for research, e.g. date of birth, ethnicity

3. Mask all identifiers from case notes (events) and correspondence

Fernandes et al. [2013] Development and evaluation of a de-identification procedure for a case register sourced from mental health electronic records, BMC Medical Informatics and Decision Making.2013, 13:71

Deidentify all data

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Deidentify all data

Additional Caldicott requirements to safeguard the data:

1. Patient-led oversight committee to manage all access to CRIS

2. Researchers must have a contractual obligation to the Trust

3. Approvals are project-specific

4. All use is audited

5. All patient-level data exported from CRIS must remain within SLAM (SLAM firewall)

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Deidentify all data

Implement a communications programme to inform patients and clinicians about CRIS, including the right to opt-out• Leaflets and posters – on line and hard-copy• IoP and SLAM service user group presentations• Open days at main SLAM sites• Drop-in clinics• Videos explaining CRIS security and functionality

(+ additional Caldicott requirements)

Ethics approval for CRIS as a research data repository

2. Opt-out model

Actions:

Deidentify all data

Implement a communications programme to inform patients and clinicians about CRIS, including the right to opt-out

CRIS Security Model Approvals

SLaM Caldicott

SLaM Executive

Ethics as an anonymised data source for secondary analysis

✓✓ ✓

Deliverables

(+ additional Caldicott requirements)

Generlisability of CRIS security model

Through the NIHR funded D-CRIS programme, CRIS has been developed at four other specialist mental health care providers with Dementia Biomedical Research Units:

• Cambridgeshire & Peterborough

• Oxford Health

• Camden and Islington

• West London

✓

Contact details

CRIS applications and general enquiries – andrea.fernandes@slam.nhs.uk

CRIS communications and training – megan.pritchard@kcl.ac.uk

Anything else – matthew.broadbent@kcl.ac.uk