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

The HT Act 2004 states that it is an offence to have bodily material with the intention of conducting analysis of the DNA in it without ‘qualifying consent’, with certain exceptions (see below for exceptions that relate to research).

Extracted DNA and RNA (where no whole cells remain) are not classed as bodily material in the Human Tissue Act 2004 (HT Act 2004). Bodily Material is defined as material which has come from a human body and which consists of, or includes human cells (except embryos outside the human body). This includes hair and nail, and does not specifically exclude gametes.

The offence does not apply if the results of the analysis are to be used for excepted purposes, including (specific ones identified that could relate to research):

Medical diagnosis or treatment
The tissue is from a living person, it is anonymised and the research has been approved (or approval is pending) by a NHS Research Ethics Committee
The research involves adults with incapacity and certain circumstances apply e.g. for the purposes of a clinical trial under UK Clinical Trial Regulations
It is an existing holding (pre 1 Sept 2006) and uses include:

research

Research involving just RNA or DNA does not require NHS ethical approval for the consent exemption to apply, since RNA and DNA are not classed as bodily material if no whole cells remain. During passage of the Act in parliament it was heavily argued that extracted DNA and RNA would not come under the consent provisions of the Act, hence the offence in the Act relates only to bodily material. Having said this it is obviously good practice to anonymise DNA and RNA; to ensure that consent is in place (especially if feeding back information to patients); and that ethical approval is in place.

It is clearer if this is turned on its head and we look at when consent is legally required under the HT Act 2004.

Consent is legally required for research if bodily material is:

From a living person and samples are identifiable; or
From a living person and samples are anonymised but no NHS REC approval; or
From a deceased person and collected after 1 Sept 2006 (for both anonymous and identifiable samples).

Explicit consent for genetic analysis

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.
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 from whom the material has come by the person conducting the analysis. 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 a licence unless it is stored for a specific ethically approved project, where the ethical approval has come from an NHS REC. Relevant material is defined as material that consists of or contains cells. Therefore the storage of extracted DNA or RNA (where no whole cells remain) does not require a licence.