Consent arrangements: Proposed use without appropriate consent

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Introduction

Consent is a central principle of both data and tissue legislation and it is always good practice to obtain consent wherever this is practicable. That said there are legal provisions for using identifiable data and/or tissues without consent.

Data
In general, researchers will seek consent to use data in research, or robustly anonymise data before carrying out research.

Some researchers may intend to seek consent for their research but require access to confidential identifiable data (e.g. health records) in order to identify the study population. Where this cannot be undertaken by a member of the clinical care team responsible for the patient’s care, many argue that consent for access should be sought. This issue (known as Consent for consent) is addressed in the 1st resource below.

There are situations where research needs to be carried out on identifiable data and informed consent cannot be obtained. For example, some research projects may involve tens of thousands of patients where contact with all would not be feasible, or the cost would be prohibitive. The essential nature of some of this research means that the potential public benefit from the research could outweigh issues of privacy. However the requirement of fair collection under the Data Protection Act 1998 would still stand, i.e. individuals have a right to know who holds information about them and why (see the 2nd resource below for further guidance). Fair processing information that includes research, available on demand in hospitals and GP surgeries, is a good way of meeting this requirement.

If there is a proposal to use identifiable information without consent, it is obviously worth considering whether identifiable information is absolutely necessary or whether a staggered approach can be taken to preserve anonymity e.g. disclosing postcodes in order for deprivation scoring to be assigned. This data would be returned to the holders of the data for them to match with records, clinical data and the deprivation score then reported back in place of postcode data.

Where identifiable data is necessary and consent is not possible, the following may apply:

  • In England and Wales, you may be able to use NHS patient identifiable medical information with Section 251 approval from the Health Research Authority's Confidentiality Advisory Group (HRA CAG). More information on Section 251 approval can be obtained from the 3rd resource below. Further guidance can be found on stations Section 251 approval and Which approvals are needed.
  • In Northern Ireland, Medical Directors of Trusts are responsible for making decisions on the use of identifiable patient information without consent. There is also a Privacy Advisory Committee (PAC) but it does not have the same statutory basis as HRA CAG in England and Wales. For more information, see Privacy Advisory Committees.
  • The Public Benefit and Privacy Panel for Health and Social Care advises on access to publicly held data in Scotland such as that retained by ISD.  Applications to this committee are made via the electronic Data Research and Innovation Service (eDRIS). This service provides a single entry point for publicly held data (see Privacy Advisory Committees for further details).

Tissues
The legal position for the research use of tissue samples without consent within the UK differs.

The 4th resource below outlines the requirements in England, Wales and Northern Ireland; and the 5th is for Scotland. More information can be obtained from the Human Tissue Authority (6th resource) and Scottish Executive (7th resource).

Resources