Research analysis of human DNA and RNA

Clarification of the provisions of the Human Tissue Act 2004 in relation to genetic research involving DNA and RNA in terms of consent and licensing. 

 

Consent

It is always best practice to obtain consent and it is an offence under Section 45 of the Human Tissue Act 2004 to hold bodily material with the intention of analysing its DNA without 'qualifying consent'. Unlike other parts of the Human Tissue Act 2004, this offence applies to the whole of the UK (including Scotland). There are however certain exceptions to this (which are explored in more detail below).

Bodily Material is any tissue or sample that has come from a human body and contains human cells, this includes gametes, and hair and nails from the living and deceased. It excludes embryos outside the body, established cell lines and extracted cellular components where no whole cells remain (i.e. extracted DNA or RNA).

The offence does not apply if the results of the analysis are to be used for 'excepted' purposes, including those highlighted below which could relate to research:

  • Medical diagnosis or treatment of that person
  • The tissue is from a living person, it is anonymised and an NHS Research Ethics Committee (NHS REC) has approved this/approval is pending; i.e. the approval must be project-specific and must include the use of the samples without consent.
  • The research involves adults unable to consent for themselves and certain circumstances apply e.g. for the purposes of a clinical trial under UK Clinical Trial Regulations
  • It is an existing holding (i.e. sample collected pre 1st Sept 2006)

During passage of the Act in parliament, it was heavily argued that extracted DNA and RNA should not come under the consent provisions of the Act, hence the offence relates only to bodily material. Research involving extracted DNA or RNA does not legally require consent since neither is classed as bodily material. That said, when using extracted DNA or RNA (where its analysis is being used to provide information about DNA) it is obviously good practice to obtain consent (especially if feeding back information to participants); to anonymise the samples (where this is possible); and to seek approval from an NHS REC (where appropriate).


Explicit consent for genetic analysis

  1. England, Wales, Northern Ireland
    If consent to use material has been obtained under the Act for a scheduled purpose, other than anatomical examination or public display, it is not necessary to obtain separate consent where that use involves DNA analysis. Therefore if consent for research is in place, explicit consent for DNA analysis is not required.

    Good practice would dictate that the spirit in which the Act was implemented should be followed, hence when genetic analysis is being conducted, explicit consent for this should be obtained where the offence applies.

  2. Scotland
    In Scotland, only Section 45 of the Human Tissue Act 2004 is applicable therefore explicit consent for DNA analysis is required.


Anonymised in this context means:

All necessary reasonable steps are taken to prevent identifying the person donating the sample, by the person conducting the analysis (e.g. robustly coded). This does not mean that samples must be permanently unlinked. The code can be retained by anyone who is not conducting the analysis. 

 

Licensing

Storage of relevant material for research requires an HTA licence unless it is stored for a specific NHS REC approved project. Relevant material is any tissue or sample that contains human cells. Therefore the storage of extracted DNA or RNA (where no whole cells remain) does not require a licence. 

 

Guidance used in this scenario

Consultation with the Human Tissue Authority (HTA)

HTA's Codes of Practice and Standards

HTA's Consent and DNA

HTA's Definition of relevant material

MRC Research and Human Tissue Legislation Series: Consent

MRC Research and Human Tissue Legislation Series: Licensing

MRC Research and Human Tissue Legislation Series: Scotland

MRC Research and Human Tissue Legislation Series: DNA Analysis

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