Consent arrangements: Should consent be sought?

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Introduction

It is always best practice to obtain consent wherever this is practicable. However within the legal frameworks there are mechanisms to provide exemption to this where consent is not practicable or would be inappropriate, both in relation to confidential patient information and human tissue samples in research. The legal situation in this regard is complex and can be misunderstood; this station will therefore outline the legal exemptions to the need for consent. 

Data
Obtained anonymised or robustly pseudonymised/linked anonymised data may be used without consent. What this means is that it should be impossible for the recipient of the data (the researcher) to identify individuals, either through the data provided or by linking it with other data.

For the research use of confidential identifiable data, consent must be sought unless there are robust justifications for the use of such information without consent. It is recognised in law that there are certain circumstances where seeking consent may not be practicable for ethical or financial reasons, for example:

  • If using information from deceased persons, consent may not have been obtained before death, and it may be insensitive to contact relatives for their permission; or
  • Where the benefits of the research to society outweigh the risks to the individual, in terms of the individual's right to privacy and confidentiality and the public interest in maintaining trust in a confidential service (in terms of NHS data); or
  • Where the cost of seeking consent is prohibitive to conducting the research that would have great benefit to society, this may be the case in very large-scale epidemiological studies.

Whether identifiable information can be accessed and used for research purposes without consent depends on the following:

  • Whether identifiable information is really necessary – sometimes a staggered approach can be used to minimise the identifiability of the data.
  • Whether consent is really unfeasible.
  • The role of the person requiring access to the identifiable information.
  • Whether the research is medical research (and therefore a medical purpose) or another type of research.

There are many considerations, both legal and ethical, which need to be viewed in context before a decision can be made as to whether it is reasonable not to seek consent for the use of identifiable information in research. This complex issue is explained in the 1st and 2nd resources below.

Access by researchers and decisions taken by ethics or advisory committee members should be justifiable. In rare circumstances these parties may need to be legally accountable for their decisions.

In England and Wales, the Confidentiality Advisory Group (CAG) of the Health Research Authority (HRA) can approve the temporary use of identifiable NHS patient information without consent, under Section 251 of the NHS Act 2006. The 3rd resource below gives more information on the role of the Confidentiality Advisory Group (CAG) - see also Section 251 approval for further details.

In Northern Ireland, Medical Directors of individual Trusts are responsible for making decisions on the research use of confidential identifiable data without consent, on a case-by-case basis. There is also Privacy Advisory Committee (PAC) in Northern Ireland, for more information see 'Northern Ireland' in Central NHS and other data approvals.

For access to patient information held within one NHS board in Scotland, advice should be sought from the individual Caldicott Guardian. For access to patient information in more than one NHS Board in Scotland applications can be made to the Public Benefit and Privacy Panel for Health and Social Care (4th resource). Similarly applications should be made to the Public Benefit and Privacy Panel for access to central NHS and other government data. Advice on Public Benefit and Privacy Panel applications should be sought and made via the electronic Data Research and Innovation Service (eDRIS) (5th resource below). This service provides a single entry point for publicly held data. See 'Scotland' in Central NHS and other data approvals for further details. 

The use of identifiable data without consent is a complex area and open to different legal interpretations. This issue has been addressed by many organisations and research groups, a selection of guidance documents and discussion papers are available in the 6th - 11th resources below, some of which are summarised in the 1st resource.

Tissues
The legal situation for the use of tissue samples in research is slightly more straightforward.

In England, Wales and Northern Ireland the Human Tissue Act 2004 sets out the legal framework for regulating the storage and use of human organs and tissues from the living and the removal, storage and use of human organs, tissue and cells from the deceased.

When considering whether consent is legally required, it is first important to understand whether the human material is covered by the Human Tissue legislation mentioned above (further information in 12th resource below) and if any exemptions apply (below).

Exemptions to the need for consent for the use of tissue samples are:-

If relevant material

  • From living person (when sample taken); and
  • Anonymous; and
  • Research project is approved by an NHS Research Ethics Committee

OR

Existing holdings

  • Samples collected before 1st September 2006

These exemptions may be of particular relevance to the research use of archival specimens held within Pathology diagnostic collections.  Although now many prospectively collected pathology specimens will be obtained with explicit, generic consent for research, those samples held in Pathology without consent for research may be made available to researchers provided that one of the consent exemptions can be met.

If you are unsure when and how human tissue legislation enables researchers to carry out research without consent then further understanding can be gained by completing the MRC e-learning Research and Human Tissue legislation (13th resource below).

It is worth noting that where tissue samples are referred to in the legislation as anonymous it does not mean that these are irreversibly unlinked. Coded samples are classed as anonymous by the Human Tissue Authority provided that the investigator does not, and is not likely to come into possession of, information that will identify the donor. See Anonymisation and coding for further guidance.

It should be noted that these legal requirements are a minimum, it is good practice to obtain consent wherever it is practical to do so, and Research Ethics Committees will review what is appropriate.  The Human Tissue Authority Codes of Practice and Standards are available in the 14th resource below.

Human tissue legislation differs in Scotland from the rest of the UK. In Scotland the legislation in place is the Human Tissue (Scotland) Act 2006 which sets out provisions for the use of organs, tissues and samples (including skin, nails and hair) from the deceased. Only one section of the Human Tissue Act 2004 applies in Scotland and that is section 45 regarding DNA analysis. The 15th - 17th resources below summarise the legal requirements in England, Wales and Northern Ireland; and in Scotland.

For the use of embryos in research there are strict requirements, which are regulated by the Human Fertilisation and Embryology Authority (HFEA), see the HFEA's Code of Practice in the 18th resource below for further guidance.

Data and Tissues
Some studies will require access to both data and tissues where researchers would wish to link the two. If in England or Wales, Section 251 approval from the HRA Confidentiality and Advisory Group (CAG) should be sought either to facilitate the matching with historically collected tissue samples and data or to identify the cohort in order to seek their consent for more recent data and tissue collection.

In Scotland, if seeking central NHS and other government data applications need to be made to the Public Benefit and Privacy Panel via eDRIS (4th resource below). In Northern Ireland, for access to Health and Social Care data advice should be sought from the Privacy Advisory Committee (see Central NHS & Government Data and Central NHS and other data approvals).

Resources