Murat Soncul - Governance and Ethics when using Clinical Information for Research
1. Governance and ethics when using
clinical information for research
Dr Murat Soncul, Head of Information Governance
Consent, Ethics and Data Security Workshop
12 June 2014
Bioinformatics and Biostatistics at the NIHR Biomedical Research Centre for Mental Health
2. www.slam.nhs.uk
- Why do we need clinical information in medical research?
- How to use of clinical information in medical research
- Consent and what if consent is not practicable?
- Health Service (Control of Patient Information) Regulations
(section 251 support)
- Summary
Objectives
3. www.slam.nhs.uk
- To identify prevalence of disorders
- To identify causes of diseases
- To measure outcomes of treatment
- To assess long-term and/or unexpected effects of treatment
- To identify contributing factors in healthcare and outcomes
- To monitor diseases
- Variations by time and place
Introduction
Why do we need clinical information in research?
5. www.slam.nhs.uk
Research must sometimes use data
without informed consent while retaining identifiers
Consent
What if consent is not practicable?
Large scale study
Full coverage of cohort is essential
Exclusion of those who do not consent would introduce bias
Identifiers are required to link different datasets
Identifiers contain useful information
Contact for consent is likely to cause distress
6. www.slam.nhs.uk
The NHS Act 2006 and the Regulations enable the common law duty of
confidentiality to be temporarily lifted so that confidential patient information
can be transferred to an applicant without the discloser being in breach of the
common law duty of confidentiality.
In practice, this means that the person responsible for the information
(the data controller) can, if they wish, disclose the information to the applicant
without being in breach of the common law duty of confidentiality.
They must still comply with all other relevant legal obligations
e.g. the Data Protection Act 1998.
Approval also provides reassurance that that the person(s)
receiving the information has undergone an independent review
of their purposes and governance arrangements.
Section 251 of the NHS Act (2006)
Health Service (Control of Patient Information) Regulations
7. www.slam.nhs.uk
Research (and other activities such as health service audits,
evaluations) with a medical purpose that is in the public
interest,
Should clearly demonstrate that consent is not practicable,
Access to identifiers must be temporary,
Must be compliant with the Data Protection Act .
In other words…
9. www.slam.nhs.uk
Fair processing:
‘No surprises’ – The need to inform patient what you are doing with their data
- Patient public engagement
- Clear and easy to understand information materials
- Demonstrate an exit strategy
In line with data subjects rights:
- Access to personal data
- Enable dissent / opt-out
Secure processing:
- Demonstrate compliance with NHS security and
governance standards
Data protection principles
10. www.slam.nhs.uk
The key purpose of the CAG
To promote and protect the interests of the patient whilst at the same time
facilitating appropriate use of confidential patient information for purposes
beyond direct patient care.
CAG provides independent expert advice
on whether applications to access
patient information without consent
should or should not be approved.
Confidentiality Advisory Group (CAG)
11. www.slam.nhs.uk
Summary
• Access identifiable clinical information with informed consent
• Anonymised clinical information can be accessed without consent
• When consent is not practicable and identifiable patient information is
required for research, audit and service evaluation with medical purpose
that is in the public interest, seek support to temporarily set aside the
common law of duty of confidentiality and access identifiers, provided that:
There is an exit strategy
Access is deemed reasonable in public/patient opinion
Patients are sufficiently informed and have opportunity to opt-out
Conditions of the Data Protection Act are met for
secure access, storage and destruction
