Policy responses and statements

Name of organisation:

Scottish Executive Health Department

Name of policy document:

Human Tissue (Scotland) Act 2006 - Hospital Post-Mortem Authorisation Forms and Information Leaflets

Deadline for response:

26 May 2006

Background: Comments were invited on the content of the standard post-mortem authorisation forms to be used across Scotland under the Human Tissue (Scotland) Act 2006 ('the 2006 Act') when it comes into operation on 1 September 2006.

The development of these forms responds to the wish for consistency of approach expressed by both families and health professionals as a result of past experience, when local forms of very different types were in use. NHS Quality Improvement Scotland's clinical standards on hospital post-mortem examinations anticipated the introduction of these forms, and there has been general support for prescribing them in Regulations to emphasise the mandatory nature of their use. The Department shall therefore use the powers available to Scottish Ministers under section 52 of the 2006 Act.

The Department is aware, however, of the large amount of work already undertaken on the development of local forms, and wishes to provide an opportunity to reflect the best of that thinking in the national forms.

The forms are based on those developed by the Review Group on Retention of Organs at Post-Mortem and published in its Phase 3 Report (November 2003), and many organisations may have been involved in their gestation at that stage. The adult and child forms were then piloted through focus groups which included parent or family support groups, pathologists and staff from Intensive Care Units. This was to ensure that they would command the support of both relatives and health professionals and take full account of the practical needs of families and hospital staff. The content of the forms has been further adapted to make sure they are fully consistent with the provisions of the 2006 Act.

Apart from general comments, there were a number of specific issues on which views were invited.

COMMENTS ON
SCOTTISH EXECUTIVE HEALTH DEPARTMENT
HUMAN TISSUE (SCOTLAND) ACT 2006: HOSPITAL POST-MORTEM AUTHORISATION FORMS AND INFORMATION LEAFLETS

The Royal College of Physicians of Edinburgh is pleased to respond to the Scottish Executive on its consultation on the Human Tissue (Scotland) Act 2006: Hospital Post-Mortem Authorisation Forms and Information Leaflets.

The College’s general response is favourable, recognising the extensive consultation that has taken place to develop the compromise between legal requirements and sensitivity to those involved in authorisation.  In answer to the specific questions posed:

Question 1

According to the UK Advisory committee on Genetic Testing in 1998, non-specific consent for genetic testing is not “informed” and is therefore invalid.  Under this view, the statement on the current consent forms would therefore be meaningless.  In discussing research genetic testing in 2001, the MRC came to a similar conclusion, as did the Human Genetics Commission in 2002.  To provide a similar standard for diagnostic testing, in line with clinical practice as defined in the Joint Committee on Human Genetics consultation paper on Consent and Confidentiality, the form should include words to confirm the intended purpose of the genetic testing, and it should cover the issue of implications for relatives, sometimes referred to as “shared genetic heritage”.  This could also, or alternatively, only, appear in the information sheet.  If it only appeared in the information sheet, then the Genetic Testing section  (section 4) should appear in the Basic as well as the Advanced leaflets (currently it is only in the Advanced leaflet).

In our view, it would be reasonable to use phrasing such as:-

“I/we authorise genetic testing on this material for medical diagnosis/audit/education/ training/research.”  [Please delete according to your wishes].  “I am aware that genetic testing may provide information which is important to relatives.”

It is highly unlikely that DNA analysis for medical diagnosis or research currently envisaged would require the use of whole organs.  Normally, sufficient DNA can be extracted from samples of organs for medical diagnosis or research.  DNA from fresh samples from organs may be of better quality than that extracted from tissue blocks or slides, and therefore sampling for the explicit purpose of DNA testing should be included in the consent process.

Question 2

Similar information about genetic disorders may be obtained from miscarriages by performing an external examination, as may be obtained from stillbirths.  Miscarriages are more likely to be due to genetic disorders, and therefore it could be argued that examination of these is of greater value.  Of course, a full post mortem including genetic testing is of more value than external examination alone.

Question 3

There is no justification for splitting education and training.

Question 4

The explanation on withdrawal of authorisation in the information leaflet is quite clear, and there does not seem to be any need to include provision for withdrawal on the authorisation form.

Question 5

The expression ‘your child’ should be retained.

Question 6

We agree with the approach taken.

Comments on the Genetics in the Information Sheet

There is a problem with the Genetic testing section of the information sheet.  As currently worded, it would prevent all meaningful genetic testing, as all genetic testing (including “simple tests for diagnosis”) such as chromosome tests may reveal information which has major implications for the whole family (for example, a translocation may be detected).  As discussed earlier, all the guidance documents indicate that persons consenting to genetic tests should be aware of this possibility before consent can be said to be “informed”.  We would suggest revision of this section along the following lines:

4   Genetic testing

Genetic tests vary from the examination of chromosomes (often from a blood or skin sample) to tests of specific genes causing specific diseases.  If such a test is positive, it may have implications for the rest of the family.  Under the Human Tissue Act 2004, someone may commit an offence if he has bodily material and intends that human DNA in the material will be analysed without consent, as set out in that act.  There are certain specific exceptions to this.