Using diagnostic archives without consent

The use of samples held in a Pathology diagnostic archive for research is governed by a requirement for consent, or by a requirement to fulfil one of the exemptions to the need for consent. Consent for research should be taken separately from the consent taken for diagnostic testing. The use of archival material without consent can be justified in certain circumstances. Here are some of the considerations that should be made before deciding on the use of any human samples without consent: 

  • Would a reasonable person be distressed if they were to discover that their tissues had been used for the proposed research? (See Using information about people in health research).
  • Would a reasonable person, if asked, object to their tissue being used for the proposed research?
  • Tissue samples held in archives may be very rare.
  • The time and resource required to prospectively build up a similar collection of the same quality and with the same degree of characterisation.
  • Consent is not in place because patients were not asked; this is different from consent not being in place because patients did not wish their tissues to be used for research.
  • Tissue samples are usually accompanied by information about the donor; this information is subject to a duty of confidence. Pathologists should ensure that the use of tissues without consent does not threaten a disclosure of confidential information outside of the clinical care team. To guard against this, samples should be anonymised (e.g. robustly coded) on release from the archive.
  • What are the risks of the research uncovering an unknown pathology or unknown details of pathology? How should this be handled? Is it really appropriate to feedback details at this stage or not?


In England
, Wales and Northern Ireland
In certain circumstances archival tissue can be legally used in research without consent, or outside the terms of the original consent. These legal exceptions are as follows:

1. The samples were taken from a living person and the samples are anonymised to the researcher and an NHS Research Ethics Committee (NHS REC) has approved this; i.e. the approval must be project-specific and must include the use of the samples without consent. For this exemption to apply an NHS REC must be convinced that the use of the samples is ethical and appropriate.

2. Samples that have been in the archive since before the Human Tissue Act 2004 came in to force (i.e. before 1st September 2006) can be used for research without consent. However, such samples should be anonymised to guard against any breach in confidentiality.


In Scotland
 
In Scotland the legal need for consent applies only to tissue removed from the deceased for research or bodily material if it is held with the intention of analysing its DNA.  The legal exemptions to the need for consent in both of these instances are as follows:

1. Tissue from the deceased – Consent must be in place, unless the tissue was collected before 1st September 2006. Samples collected prior to this date can be legally used without consent, for research. In the case of whole organs released by the Procurator Fiscal, there is an additional legal requirement for NHS Research Ethics Committee approval; no matter when the samples were collected.

2. Bodily material held with the intention of analysing its DNA – Consent should be explicit and in place unless:

a. Samples were taken from the living, and are robustly anonymised to the researcher (e.g. by coding) and an NHS REC has approved this; i.e. the approval must be project-specific and must include the analysis of DNA without consent, or
b. Samples were collected prior to 1st September 2006.