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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 – [email protected]
CRIS communications and training – [email protected]
Anything else – [email protected]
