Education and Training (Clause 1 and Schedule 1)

1.      We welcome the decision to allow tissue from living patients to be used, without consent, in education and training, whether or not this is undertaken in the course of providing services to patients. We shared the concerns of a number of bodies about the practicability of distinguishing ‘on-the-job’ training from other forms of education and training. Training doctors is essential for safe and effective patient care and must not be compromised by the practical difficulties imposed by anonymising tissue or obtaining consent from individual patients.

2.      Nonetheless, patients should be informed about this use of tissue, and it is important that information leaflets, or other means of explaining the issues to patients can be produced and made widely available. We also hope that as a matter of good practice, clinicians will anonymise any material or seek patients’ consent before retaining tissue for teaching or training purposes, wherever it is reasonably practicable to do so.

3.      We note that consent will still be needed where tissue is to be used in education or training in research techniques. We believe that this needs further clarification and explanation. It will not be immediately clear whether consent is needed where, for example, tissue is used for both clinical training, and training in research techniques. It may be helpful for the Bill to make clear that consent is needed only where tissue is to be used solely for education or training in research techniques.

Research (Clause 1 and Schedule 1)

4.      We see the proposed changes as an excellent compromise between the need to respect individual patients’ autonomy and privacy, and the need for research to be undertaken without unnecessary bureaucracy.

Mentally incapacitated adults (Proposals for a new Clause, not yet included)

5.      We welcome the recognition that this legislation needs to address the issues raised by patients who lack capacity.  We agree in principle that a best interests test should be applied and that this issue can be dealt with in Regulations. However, these Regulations will need to specify how best interests are to be judged. We hope that any regulations will draw on the work undertaken on the Mental Capacity Bill and will be amended, if necessary to maintain compatibility with the legislation when it is passed.

6.      As far as research is concerned, the Government has suggested that regulations could make provision for research (other than clinical trials) that involves incapacitated adults. We believe that this will be essential if tissue is to be retained or used for research in the period between the implementation of the Human Tissue legislation and 2007, when it is expected that most of the provisions of the Mental Capacity legislation will be implemented.

Code of Practice on Consent (Clauses 26.3 and 27)

7.      We welcome the requirement now placed on the Human Tissue Authority to include consent in its Code of Practice. This will be a document of considerable importance and will need to address a range of issues, including the time span for which consent might endure; the amount of information which should be provided; and whether consent for use of tissue in research must be obtained on each occasion it is proposed to use the tissue.

Court order to waive consent in the public interest (Clause 7.3)

8.      We welcome this amendment. It is not clear whether the regulations would set out a public interest test of some sort, or whether judgement would be wholly at the discretion of the court. If the former is the case, any criteria for defining or justifying use of tissue in ‘public interest’ would need very careful drafting to ensure that they do not exclude unforeseen needs for use of tissue, while remaining truly for use as a ‘last resort’.