Policy responses and statements

Name of organisation:: Human Tissue Authority
Name of policy document:: Codes of practice consultation
Deadline for response:: 14 November 2008

Background: The Human Tissue Authority has been holding a public consultation on eight codes of practice. Seven of the codes have been revised based on the HTA's experience of regulation over the last two years, and there is also a new code on research. This was an opportunity to have an input into the advice and guidance that the HTA provides to professionals.

The codes of practice cover the following:

Code 1- Consent
Code 2 - Donation of solid organs for transplantation
Code 3 - Post-mortem examination
Code 4 - Anatomical examination
Code 5 - Disposal of human tissue
Code 6 - Donation of bone marrow and peripheral blood stem cells for transplantation
Code 7- Public display
Code 9 - Research

The HTA is not consulting on code of practice 8 - Import and export of human bodies, body parts and tissue. This is because the code was only published in May 2007.

COMMENTS ON

HUMAN TISSUE AUTHORITY

CODES OF PRACTICE CONSULTATION

The Royal College of Physicians of Edinburgh is pleased to respond to the Human Tissue Authority on its Codes of practice consultation.

GENERAL QUESTIONS

Q1. Do you find the codes useful as a guide to the legislation?

Some of the document appears not directly relevant to Scotland, and there may be other difficulties for Wales and Northern Ireland. It is important that the public and practitioners are clear on legislative differences across the UK.

Q2. Are the codes clear and comprehensive?

In the main, these are useful practical guidance for professionals.

Q3. We have intended to set a broad framework of guidance rather than detailed prescription: have we succeeded?

Largely, and the use of good practice examples is helpful.

Q4. Have we distinguished between what must be done and what is good practice?

Largely.

Q5. Are the codes helpful in laying out clear and practical guidance for practitioners and non-professionals alike?

The guidance is more targeted at practitioners, and it may be useful to provide a summary for non-professionals in due course.

Q6. Are the structures and ordering of the codes user friendly?

Largely.

Q7. Do the codes point to other advice and guidance adequately e.g. Mental Capacity Act; Coroners Rules?

See points raised to Q1 and Q5 above. Largely adequate for professionals, but more challenging for non-professionals.

Q8. Are the best practice examples helpful in illustrating key points in the guidance?

Yes. It is unclear why best practice is not available for most/all aspects of the codes and it would be helpful to have more of same.

Q9. Are the flow charts in the appendices an effective way of presenting complex issues in the codes? Have we forgotten or omitted anything important?

Yes.

Q10. Do you have any other general comments about the codes?

No.

SPECIFIC QUESTIONS:

Code 1: Consent

Qualifying relationships (paragraphs 95-101)

Q1. Is the hierarchy causing any problems in practice?

The hierarchy is difficult in respect of “enduring family relationship”. Marriage is straightforward, but the cohabiting couple for 6 months is more of a challenge in terms of whether the views of these people should carry more weight than the children of the deceased. This would benefit from greater clarity.

There may be concerns for older people who have close friends of long standing who are better informed about their views than distant relatives. Linking this point to “nominated representatives” may be helpful

Paragraph 95 b) indicates that a child of the deceased may qualify to give consent ahead of a sibling. The College believes further guidance may be helpful in cases where a child may be asked for consent.

Q2. Do you think that other people should be added to the hierarchy of other people who can give consent?

Executors of a will or estate may be useful additions.

Adults who lack capacity to consent (paragraphs 143-153)

Q3. Does the code give enough guidance on the impact of the Mental Capacity Act on the Human Tissue Act when dealing with adults who lack capacity?

Yes – but please note the points below on different legislation across the UK.

Do you have other comments on this code?

Given the seriousness of sanctions in the legislation cited within the code, it may be helpful for practitioners working across borders to first summarise all the legislation as it applies in the different nations of the UK. Alternatively, different versions for the 4 UK nations may be required.
Readers may question whether consent and authorisation amount to the same concept? The code implies they are to be treated as such.
The College believes the authority has a duty to promote the rules within these codes to the public to improve wider understanding of the importance of donation or use of human tissue and the requirements for consent.
The code (correctly) makes much of cultural sensitivity on consent, and it may be helpful to add a short section summarising the need for sensitivity.
Paragraph 46 correctly reassures patients that refusing consent will not result in denial of subsequent treatment. How will this be quality assured?
Paragraphs 48/49 – is there a conflict between recommending generic consent for tissue samples from the living and requiring specific consent from relatives of the dead?
Paragraph 59 – the timing of seeking consent is important for the patient or relative where possible and should be emphasised within the code.
Paragraph 67 – the College agrees that it need not be a doctor or nurse who seeks consent for a post mortem, providing the individual is appropriately trained and experienced and has the necessary information to hand to respond to questions from the relatives. However, by including references to nursing and technical support staff only it could imply to the wider public that obtaining consent is not a valuable use of medical time.
Paragraphs 53, 79, 136 and 137 would benefit from rewording to improve clarity.
Paragraphs 73, 77 and 100 may require additional definition eg what is an “independent translator” or how strong is “whenever possible”, and how much effort would be expected of the clinical team to try and communicate with different members of the hierarchy before skipping to the next level?
Paragraph 80 on regulations for importing organs or tissue applies to England, Wales and Northern Ireland only – the code should confirm the position in Scotland. This is an important point to prevent exploitation of vulnerable people outside the UK.
Paragraphs 85-88 – this section should emphasise that interpretation of the deceased’s wishes may not amount to the same as them having given valid consent during life (as laid out in paragraphs 42-46).
Paragraph 89 – it would be helpful to clarify the difference between a representative with legal powers (LPA) and nominated representative, and how the latter would be appointed and by whom?
Paragraph 106 implies that consent by children will never stand alone and must always be revisited with parents or others with caring responsibilities for that child after death. Does this render the consent invalid?
Paragraph 142 – should this section on surplus tissue code cross-reference to requirements under IVF treatment for surplus embryos?
Paragraph 161 – the complexities of ensuring patients understand the implications of consent for research might be helped by good practice examples, which might include the King’s College London Stem Cell Project or the Oxford University Ascend Project.
The code is complex and detailed and the College has concerns about the practicality of all relevant practitioners in terms of reading and applying all the detail, including regular updates. Can the key information be distilled to support implementation of good practice with flags to sources of more detailed advice in rare but important circumstances?
The College is concerned about how updates to the Code will be communicated in a way that alerts practitioners and the public effectively to important changes.

Code 2: Code of Practice on Donation of Organs for Transplantation

Adults who lack capacity (paragraphs 85-88 and Appendix A)

Q1. Does the Code give enough guidance on the impact of the Mental Capacity Act on the Human Tissue Act?

Yes.

Preservation of Organs in situ (paragraphs 131 -139)

Q2. Does the code provide enough guidance about the minimum steps that can be taken to preserve an organ, while a decision on consent is being established?

Yes.

Working with the coroner in cases requiring steps to be taken for organs preservation (paragraphs 140-141 and Appendix B)

Q3. Does the guidance in the code clarify the relevant roles and responsibilities of both the coroner and transplant teams?

Typo in first sentence of Appendix B, point iii – otherwise fine.

Do you have any other comments on this code?

The following comments from Code 1 also apply here
The interpretation of the deceased’s wishes may not amount to them having given valid consent during life.
A child of the deceased may qualify to give consent ahead of a sibling. The College believes further guidance may be helpful in cases where a child may be asked for consent (paragraphs 113-118).

Code 3: Code of Practice on Post Mortem Examination

Coroner’s Post Mortem Examination (paragraphs 66 – 89)

Q1. Will the code, with its expanded section on coroners’ post-mortems, be useful to coroners’ officers and help improve communication between coroners/coroners’ officers and pathologists and mortuary staff?

No comment.

Tissue or Organ Donation (paragraphs 54-59)

Q2. Should the section on tissue or organs donation be included in this code?

No comments.

Storage of tissue blocks and slides (paragraphs 66-89 and 120-123)

Q3. Is there clarity about when exemptions apply and when they do not?

No comments.

Do you have any other comments on this code?

Comments from our lay advisers draw attention to the potential conflict between the requirement in paragraph 50 to respect the differing views of relatives in relation to level of detail sought on which to make a decision, and paragraph 51 where the minimum information is spelt out in great detail. How can a practitioner obtain valid consent and protect him/herself from prosecution under the legislation in the face of such a conflict? There is a danger that information givers may feel a need to protect themselves rather than the wishes of the relatives or, indeed, it may deter requests for post mortems.

Code 7: Code of Practice on Public Display

Consent and licensing requirements (paragraphs 40-66)

Q1. Is it clear how the consent and licensing requirements apply in different respects to material from the living and the deceased?

The diagram in Appendix B is very clear.

Definition of Public Display (paragraphs 30-32 and examples throughout code)

Q2. Do the examples provide sufficient detail on how we define “public display”?

The examples strengthen the document significantly.

HTA Standards (paragraphs 67-95)

Q3. Does the section on HTA standards compliance address all pertinent issues?

Yes.

Do you have any other comments on this code?

Paragraph 18 could benefit from a diagram or decision tree illustrating the relationships between all the codes.
Paragraph 27 - the difference between scheduled purposes and licensable activities should be included in the main text rather than consigned to an Appendix.
The section on obtaining consent should be cross referenced to the code on consent.
Paragraph 67 – it may be helpful to include more detailed guidance on expectations regarding the respect to be shown for human remains or samples when on display.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[14 November 2008]