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Non-consensual DNA analysis

This page provides guidance on when DNA analysis may be used, for obtaining scientific or medical information about the person whose body manufactured the DNA, even if their consent has not been obtained. This page also provides information about how establishments can apply to the HTA to carry out non-consensual analysis of DNA.

Issued 11 May 2007

Introduction

In most circumstances it is an offence to analyse DNA without what the Human Tissue Act (HT Act) calls ‘qualifying consent’.

However, there are exceptions. This policy explains how the Authority may in exceptional circumstances, provided that it is satisfied that certain conditions have been met, make a direction that DNA analysis may be used for obtaining scientific or medical information about the person whose body manufactured the DNA even if their consent has not been obtained.

This is a key aspect of the consent requirements affecting DNA; use of DNA where the specific conditions (explained below) apply is exempted from the ‘qualifying consent’ required for DNA testing for other purposes under the HT Act.

This policy does not apply to Scotland as there are corresponding but different  provisions in paragraphs 9(4) and (5) of the Act covering Scottish applications, which will be made to the Court of Session.

The conditions for exemption

The conditions under which the Authority can make a direction to allow non-consensual analysis of DNA - as set out in paragraph 9(2) and (3) of Schedule 4 of the Act - are laid out below. In order for an applicant to apply for and be granted an exemption from qualifying consent, the HTA must be satisfied that all the provisions of either 9(2) or 9(3) are met as appropriate. These are the two conditions:

Conditions under 9(2)  - “not reasonably possible to trace the person”

If the Authority is satisfied -

a) that bodily material has come from the body of a living person.

b) that it is not reasonably possible to trace the person from whose body the material has come (“the donor”).

c) that it is desirable in the interests of another person, (including a future person), that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the donor, and

d) that there is no reason to believe -

I. that the donor has died,
II. that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or
III. that the donor lacks capacity to consent to the use of the material for that purpose

it may direct that this paragraph apply to the material for the benefit of the other person.

Conditions under 9(3) – “reasonable efforts have been made to get the donor to decide”

If the Authority is satisfied -

a) that bodily material has come from the body of a living person,

b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come (“the donor”),

c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,

d) that there is no reason to believe -

I. that the donor has died,
II. that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
III. that the donor lacks capacity to consent to the use of the material for that purpose, and

e) that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph,

it may direct that this paragraph apply to the material for the benefit of the other person.

Guidance for applicants

Guidance is set out as follows, to deal with instances where ‘qualifying consent’ is not required for DNA analysis on the grounds that the HTA is satisfied that it is:

  • Part A: not reasonably possible to trace that person (the donor), or
  • Part B: the HTA is satisfied that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material to obtain scientific or medical information about the donor.

Guidance is provided to avoid scenarios where stakeholders may unjustly take advantage of the exception - for example, to use the samples for paternity testing on the pretext of carrying out the analysis for the benefit of another person’s health care - or vice versa where stakeholders may be unwittingly disadvantaged through unawareness of not being able to benefit from it.

It is essential to be aware that the provisions do not apply where there is an express refusal to consent, however unreasonable, or where the analysis is for the purpose of medical research.

The principles on which this guidance is based are that:

  • it should be practicable for the sector and the Authority;
  • that the outcome should not involve unreasonable risk or exposure for the Authority;
  • it should be compatible with the Act and the Codes of Practice.

Satisfying the Authority

Part (A) – The ‘not reasonably possible to trace’ scenario

The ‘not reasonably possible to trace’ provision applies where for instance a relative is missing, or is known to have moved abroad and contact has been lost.

Essentially, the exception in the HT Act provides a last resort option for a relative who requires information about, for example, a genetic condition known to affect the untraceable donor. It does not apply to a case where the donor has consented or refused consent.

Based on advice from the Department of Health, the Authority estimates that the likely number of applications for the ‘untraceable relative’ scenario to be a handful a year.

To apply for the exception process to be invoked, a formal application should be made to the Authority for its consideration (see the application process further on).
 
The declaration from the applicant should confirm that all the conditions as set out under 9(2), as laid out above have been met.

In order for the Authority to be satisfied that reasonable efforts have been made to trace the donor, the following steps should have been followed (in sequential order):

  • All usual forms of contact with the donor must have been attempted in the form of phone calls and letters – at least 1 phone call must have been made and 1 letter (by regular postal delivery) sent.
  • If such attempts at contact fail, a recorded letter from the applicant seeking to make use of the results of a DNA analysis should be sent to the last known address of the potential donor. This may be considered as reasonable efforts to trace the donor about whether they consent to the use of their bodily material for DNA analysis.
  • All written evidence of attempted contact must be furnished with the declaration (see application process). This should include the final letter sent by recorded delivery - which will have been returned to sender if the relative was indeed not residing at the last known address.
  • Under the Royal Mail postal services, if an item is not collected for redelivery within 7 calendar days, the mail is returned to sender with a note explaining the reason why it could not be delivered. This notification should be sent to the Authority together with the letter itself.
  • The contents of the letter should indicate as a minimum the following:

(a) confirmation that there has been no decision from the donor stating a specific refusal to consent 

(b) the detail of the analysis to be performed;

(c) an account of the repeated attempts to seek contact (documenting the number of phone calls and letters sent) with the potential donor for permission to carry out the DNA analysis;

(d) an explanation that the recorded letter has been sent as a final attempt, following the series of prior unsuccessful attempts at contact;

(e) a statement that unless a response is heard to the contrary from the potential donor, the individual or researcher will make an application to the Human Tissue Authority for the exemption to be invoked, based on the fact that reasonable efforts have been made to trace the donor – it will be for the HTA to decide whether it is satisfied that all the conditions laid down in paragraph 9(2) have been met;

(f) whether or not it is the intention of the applicant to use the bodily material for paternity testing purposes;

(g) a clause which makes clear that if the potential donor is in fact residing at this last known address and it is not the intention of the individual to provide bodily material for the intent of DNA analysis, they should contact the sender immediately, with a copy of the letter sent to the Authority, indicating that this is the case.

Part (B) – The ‘reasonable efforts to get the donor to decide’ scenario

The ‘reasonable efforts to get the donor to decide’ provision applies to a situation where the relative has neither refused nor consented to DNA analysis to be carried out on his/her bodily material, but has simply not responded to requests by the applicant for a decision to be made about whether such an analysis be carried out.

Based on advice from the Department of Health, the Authority estimates that the likely number of applications for this exemption to be rarer than the ’untraceable scenario’ with therefore very few cases to be processed by the HTA.

In this case, notice of the application must be given to the potential donor and this must be verified by the applicant. The application process is not a substitute for the need to ask the donor for their consent in the first place.

The ‘reasonable efforts to get the donor to decide’ scenario allows for the kind of situation where, for instance, the analysis of a person’s tissue could yield information vital to their relatives – such as to predict the likelihood of a genetic condition in a relative, or to help diagnose and treat a condition. 

A formal application should be made to the Authority (see the application process below), requesting that consideration if made for the exception to be invoked.
 
The declaration should take into account whether all the conditions as set out under 9(2) as laid out above have been met.

For the Authority to be satisfied that reasonable efforts have been made to get the donor to make a decision, the following steps should have been followed (in sequential order):

  • All usual forms of contact with the donor must have been attempted in the form of phone calls and letters requesting them to come to a decision – at least 1 phone call must have been made and 1 letter (by regular postal delivery) sent. As a final attempt, a letter under recorded postal delivery should be sent to the donor.
  • As one of the Conditions under 9(3) indicates (see paragraph 7) above, one of the requirements is that notice of the application must be given by the applicant to the ‘donor’. This should be formally set out in writing and sent with the letter (see above) by recorded postal delivery to the donor.
  • The contents of each letter should indicate as a minimum the following:

(a) confirmation that there has been no decision from the donor stating a specific refusal to consent 

(b) the detail of the analysis to be performed;

(c) an account of the repeated attempts to seek contact with the potential donor getting them to make a decision to consent or otherwise;

(d) in the signed letter, an explanation should be provided that this letter has been sent as a final attempt, following a series of prior unsuccessful attempts at contact;

(e) a statement that unless a response is heard to the contrary from the potential donor, the individual or researcher will make an application to the Human Tissue Authority for the exemption to be invoked, based on the fact that reasonable efforts have been made to make the donor come to a decision to consent– it will be for the HTA to decide whether it is satisfied that all the conditions laid down in paragraph 9(3) have been met;

(f) whether or not it is the intention of the applicant to use the bodily material for paternity testing purposes.

  •  If such attempts at contact fail in the final instance, the Authority will consider it reasonable if a letter under recorded postal delivery from the applicant seeking to make use of the results of a DNA analysis is sent to the last known address of the potential donor. This may be considered as reasonable efforts to make the donor come to a decision about whether they consent to the use of their bodily material for DNA analysis.
  • All written evidence of attempted contact must be furnished with the declaration. This should include the final letter sent by recorded delivery.
  • The Authority recognises that the potential donor may indeed sign to indicate receipt of the letter, regardless of whether they have come to a decision to consent or otherwise.  The Authority cannot therefore rely on the original letter being returned to the sender as its means of evidence to satisfy itself.
  • In order for the Authority to be satisfied that all possible contact was made with the potential donor for them to come to a decision – but failed – the written evidence furnished by the applicant should constitute copies of the letters that were sent, together with the notice of the application (see above).

The application process

The application process – including scrutiny of applications, decision making and any checks – will be carried out by the HTA executive.

For the Authority to be satisfied that reasonable efforts have been made to contact the potential donor, an audit trail must be in place. In order to satisfy itself, the Authority would require the following evidence:

  • An application made to the Authority for a direction to be issued – under either 9(2) or 9(3).
  • A declaration would have to be sworn before a solicitor or notary public (this will incur an expense for the applicant in terms of swearing fees, but the Authority considered this to be justified given that it needs to be satisfied that the application is genuine), signed by the declarant and witnessed, setting out that concerted attempts had been made to contact the potential donor in question.
  • The final letter and all other letters or evidence of contacts set out in the declaration.

The Authority will scrutinise each application in order to satisfy itself that all the conditions laid out in 9(2) or 9(3) have been met as appropriate.

The Authority will then makes its decision as to whether the applicant making the application may be granted the exemption, and issue its decision to the applicant in writing. It will be the applicant’s responsibility to confirm in writing when the exemption has been invoked.

If the Authority is not satisfied with the evidence, it can ask for further information or evidence to support and ultimately to refuse the application.

Performing checks

The Authority will perform checks as necessary. If, on investigation, it became clear that either it was reasonably possible to trace the donor or that reasonable efforts were not made to get the donor to make a decision on consent, and this contradicted the contents of the declaration, the Authority could refuse any application for a direction under paragraph 9(2) or 9(3) and indeed revoke any previous direction given by the Authority. If an application is refused, the applicant would be supplied with an accompanying rationale to justify the basis on which such a refusal had been made.