Code of Practice for the use of Human Stem Cell Lines

Code of Practice for the use of Human Stem Cell Lines

The Royal Society of Edinburgh (RSE) is pleased to respond to the Medical Research Council consultation on the Steering Committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines draft code of practice for the use of human stem cell lines. This response has been compiled by the General Secretary, Professor Andrew Miller and the Research Officer, Dr Marc Rands, with the assistance of a number of Fellows with considerable experience in this area.

Overall, the draft code of practice is a good document and reasonably practicable. The different sections of the draft code of practice are now addressed below.

Ethical principles

Although section 5 is explicitly headed ‘Ethical Principles’, many principles which are essential to ethics are considered in section ‘6. Stem cell donations’. For example, 6.2 (consent), 6.3 (conflict of interest), 6.4 (conscientious objection), and 6.5 (confidentiality).  Consideration should therefore be given to moving these sections to section 5, under an ethics rubric, in case there is any implication that what is in 6. is simply discussion of technical or organisational matters.

In terms of the status of the human embryo, Section 5.1 could be better developed.  We are told (first sentence) that the human embryo ‘has a special moral status’, and then (second sentence):  ‘The position taken by many...is that the embryo, unlike an infant, does not have the full rights of a person; however its human potential gives it an intrinsic value…’. Yet an infant does not have the ‘full rights of an [adult] person’ either. Instead of contrasting ‘full rights’ with ‘some rights’ the authors contrast ‘full rights’ with ‘intrinsic value’. But the introduction of this term does not help the argument. Terms such as ‘intrinsic value’ make sense only when they are seen as half of an implied contrast between what has intrinsic value and what has extrinsic or instrumental value. Following Kant, we might say that what has intrinsic value, what is an end in itself, should never be treated only as a means. But the embryo in these cases is not being treated as an end or with intrinsic value; it is being treated as an instrumental means to research or therapy for others.

However, the derived human embryonic stem cells are cell lines like any other and do not have the special moral status of embryos, and yet the Stem Cell Steering Committee is proposing quite a heavy handed regulatory approach to their use. This will have a negative effect on the development of stem cell research, through the increased regulatory load and the need for research ethics committee approval for standard cell culture experiments.

Stem cell donations

We agree with information and consent principles, especially noting that donors should not expect a share in any benefits that may accrue from the research, nor put conditions on the use of the stem cells. This follows the principle that consent is ‘altruistic’, not constrained.

It should be noted that section 6.2.2.3 about the consent of relatives to use of tissues from deceased persons assumes that the current Human Tissue Bill will be approved, and that relatives will be given a new role in this regard.

We also agree that donors should be told the risks of discovering an abnormality and the possible consequences of feed back; for example, possible life insurance problems.

Deriving and working with stem cell lines

The issues concerning cell lines of low stability or tumorigenic origin are correctly identified, as are the proposals for cryopreservation and storage.  In terms of the disposal of material of human origin, clear guidelines should be given for the responsibility of disposal of the material where donors, or relatives, have expressed a wish for the return of material following use. It should also be explained what the ‘dignified’ disposal of material means in practice.

The UK Stem Cell Bank

The anonymised donor traceability scheme will need to be operated with care to acknowledge those donors who don’t want to be identified, should adverse health data be detected.

Depositing stem cell lines in and accessing lines from the UK Stem Cell Bank

The code of practice proposed that any derivatives of existing stem lines must be deposited in the Stem Cell Bank. However, the role of the bank is to hold a master archive stock of each cell line, rather than its derivatives. Human ES cells drift in phenotype and genotype in culture, therefore the same cell line in two different labs will not necessarily be equivalent, nor even in the same lab after different periods of culture. It is, therefore logically and logistically impractical for the bank to collect and curate all of these variants and every lab will have multiple variants of differing utility and interest. Deposition of derivative lines should be at the discretion of the scientist and should only be requested and accepted by the bank if a derivative has value above that of the original line.

Data management

In terms of computerised records, a requirement should be put in place for the automatic identification of anyone accessing the files (as a safeguard against fraudulent searching).

Annexes

In terms of Annexe 15 (the Materials Deposition Agreement), under section 6 (Governing Law and Jurisdiction), mention is only made of the agreement being governed by English law. As the authority is a UK authority, all regions of the UK should be covered by the relevant parts and therefore it will need to be valid under Scots law as well.

Additional Information

In responding to this inquiry the Society would like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject: Consent and the Law (December 1997); Cloning Issues in Reproduction, Science and Medicine (April 1998); Review of the Common Law Provisions Relating to the Removal of Gametes and of the Consent Provisions in the Human Fertilisation and Embryology Act 1990 (April 1999); Chief Medical Officer’s Expert Group on Cloning (November 1999); Preimplantation Genetic Diagnosis (March 2000) and Human Reproductive Technologies and the Law (May 2004).  

 

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