Human Tissue Act 2004
Human Tissue Authority Consultation on Draft Codes of Practice 1- 5
Response from The Wellcome Trust and the Medical Research Council
4 October 2005
1. Introduction
1.1 Please find attached comments from the Wellcome Trust and the Medical Research Council on the Human Tissue Authority’s (HTA) draft Codes of Practice. Overall, we support the tone and content of these Codes. We believe that the Codes achieve a good overall balance, presenting workable guidelines without being too prescriptive.However, there are a limited number of issues within the Codes that give cause for concern.We have addressed these below in the order in which they appear in the Codes. This paper is supplemented by our responses to the HTA’s online questionnaire.
2. General Comments
2.1 The Human Tissue Act 2004 (“the Act”) regulates the removal, storage and use of human tissue for scheduled purposes. The most common use for human tissue is for clinical diagnosis and treatment.This use is not regulated by the Act.It would be helpful if this was explicitly stated within the Codes, particularly the Code relating to consent.
2.2 It should also be made much clearer in the Codes, again, particularly the Code on consent, that the Act does not apply to tissue that is greater than one hundred years old, and that the consent requirements do not apply to imported tissue or to existing holdings.
2.3 Although the status of the Codes is explained in the introduction to the Codes and on the face of the Human Tissue Act, there is currently no explanation as to how the licensing regime will affect the status of the Codes.In particular, will it be a condition of licence that the licensee complies with these Codes, or obtains the same agreement from the people to whom they distribute tissue? If this is likely to be the case, it puts a very different complexion on the status of these Codes and this fact should be made clear in the consultation process.
2.4 It is not clear in the draft Codes which statements reflect legal requirements and which are statements of good practice.This must be clarified.
2.5 We support the inclusion of a model consent form in the Code on Post Mortem Examination and would encourage the HTA to develop further model documentation, particularly model consent forms.The current proliferation of consent forms, which are often unclear and overly wordy, does create difficulties for professionals and patients alike. The HTA could play a very important role in taking a lead in developing consent materials that are clear, concise and fit for purpose, especially in relation to consent to future undefined research, a subject on which there is particular confusion and uncertainty.
2.6 We welcome the HTA’s decision to keep consent broad but we are also aware that some Research Ethics Committees (RECs) take a different view to consent – ie that ‘consent’ that is either general or enduring cannot be sufficient consent.We recognise that the operation of RECs is not formally the responsibility of the HTA, but we would urge the Authority to work with the Central Office for Research Ethics Committees (COREC) to encourage RECs to adhere to the principles outlined in the Act.
3. Future Work
3.1 We would strongly recommend that the HTA states the areas in which it intends to produce Codes in the future. This will greatly facilitate those responding to these consultations since it will enable commentators to be aware that certain issues will be dealt with elsewhere. It is more difficult to comment without this overview.
3.2 We believe there is a need for general overarching guidance on the Act.This could give guidance on matters of general relevance, including the definition and interpretation of key terms.This document would build on the work of the Department of Health in their summary briefing paper on the Human Tissue Act.1
3.3 We would also recommend that Codes are produced on the following:
• each of the scheduled purposes, especially:
o public display
o the use of tissue for the treatment and diagnosis of third parties
o research and public health monitoring – this Code will be important to clarify the definition of research, and related terms such as audit and public health monitoring.
• licensing
• import/export
3.4 If and when the Human Tissue (Scotland) Bill completes its passage through the Scottish Parliament, guidance on the difference between that Act and the Human Tissue Act will be critical.
4. Code 1: Consent
4.1 When to seek consent – paragraph 54
Paragraph 54 states “The following sections refer generally to clinical settings but, in all cases, the effect of the Act and the Code are generally the same for other circumstances and the following guidance will apply.” This emphasis on the clinical setting in this paragraph and generally through out all of the Codes is overly narrow and neglects to deal with the non-clinical circumstances in which tissue is obtained.This is of particular concern in relation to research since the Code obscures the differences that can arise between the clinical and research situations.As a minimum, it would be helpful if the Code made clear that circumstances and requirements may differ for research.
4.2 Information to be given – paragraph 60
The standard for information to be given in a clinical setting is stated as being that which a “responsible body of medical opinion” would give, otherwise known as the “Bolam Principle”. However, recent case law would suggest a movement away from this interpretation of the law.It would be helpful if this was noted.
4.3 Commercial Setting – paragraph 62
We agree that it is generally good practice to inform a patient that his/her samples will be used for research involving the commercial sector where this is known. However, we believe the following wording in paragraph 62, “Where it is known, or likely, that the samples will be used for research involving the commercial sector, this should also be made known to the individual” is overly prescriptive and fails to take account of the wide range of circumstances that may arise.The ‘commercial sector’ involvement may be incidental (e.g. the involvement may be through a particular function in the research process being outsourced, e.g. to a security service, or to a laboratory conducting a particular analysis), or may fall outside of some people’s understanding of ‘the commercial sector’ altogether (e.g. if the ‘commercial’ partner is a subsidiary of a charity involved in the research).Given this, we would recommend that this section is amended.This matter will of course be considered by the REC in relation to each individual research project in any event.We believe this is a more flexible and proportionate way of dealing with the issue.
4.4 Multiple consents – paragraph 77
The wording of line 2 is not entirely clear.We would suggest the wording “should be aware that” in line 2 is replaced with “ensure that (where necessary)”.
4.5 Existing Holdings – paragraphs 82- 86
4.5.1 Paragraph 82
We understand that the Act is expected to come into force in April 2006, not 2005 as stated in paragraph 82.
4.5.2 Paragraph 86
Whilst we agree with the sentiment of paragraph 86, that the wish to have a deceased’s tissues and organs returned should be complied with, we believe it is too categorical given the vagueness of the language used.The word “family” is too broad within the context of this paragraph, which requires further explanation, as there can be conflicting requests within a family as well as variance between the family and the deceased’s wishes.In addition, any request made by the family member must be reasonable in the sense that it must be lawful, not prohibitively expensive and not harmful or offensive to third parties, including the deceased.
4.5.3 Paragraph 87
Paragraph 87 comes under the umbrella heading of Existing Holdings, however this paragraph refers to the future removal of tissue.We presume that the first bullet point in paragraph 87 applies to the use of existing holdings in relation to which there is no consent for purposes for which consent would be required if the tissue was not an existing holding.If so, this should be made clear.
4.5.4 The second bullet point under paragraph 87 states that “research using samples of human organs or tissue must be approved by a properly constituted REC”.We understand this to refer to NHS Research Ethics Committees.This then creates problems for certain types of research that are outside of the remit of NHS RECs.Research carried out in a museum for example, or on imported material, is generally not reviewed by NHS RECs.We would recommend that the Code provides that research outside the NHS REC remit may be ethically reviewed by an alternative body constituted for that purpose.
4.5.5 Paragraph 88
The wording in paragraph 88 is overly complex and needs to be simplified. The third bullet point in this section states that tissue samples may be used for research if “there is no potential harm to the donors.”It is frequently impossible to predict with absolute certainty that there is no potential harm.We would therefore suggest that “where risk of harm is insignificant” is a more appropriate phrase.
4.5.6 It is not clear whether the “established collections” mentioned in bullet point three of paragraph 88 is the same as “existing holdings” as defined in the Act.This needs clarification.
5 Code 2: Donation of organs, tissues and cells for transplantation
5.1 We have no comments on this code.
6 Code 3: Post mortem examination
6.1 What should the discussion include? – paragraph 44
Paragraph 32 of Code 5 states that Code 3 includes the need to point out to families that not all donated material will necessarily be used. However, Paragraph 44 of Code 3, which describes what the discussion should cover, does not explicitly mention this.
7 Code 4: Anatomical examinations
7.1 Paragraph 29
We seek clarification of paragraph 29 as it does not concur with our understanding of “public display”.The wording suggests that the taking and using of images of human tissue is a form of public display of such tissue, regulated under the Act.This is at odds with our understanding of the position.Clarification on this issue is essential.
8. Code 5: Removal/collection, retention and disposal of human organs and tissue
8.1 Terminology – paragraph 13
Paragraph 13 refers to “ancient” human remains. This is a slightly misleading term as the remains may be relatively young in museum terms. A better term would be “historic”.
8.2 Organs/tissue removed from living persons – paragraph 15
8.2.1 The removal of tissue for non-clinical research is not mentioned in paragraph 15. Although less common, it is a different scenario to the three already mentioned and worthy of note to give a proper view of the range of possible scenarios.
8.2.2 It should also be made clear here that the consent requirements under the Act do not apply to imported material.
8.3 Existing Holdings – paragraph 43
8.3.1 The Act does not apply to tissue that is more than 100 years old.It would be helpful if this were reiterated here for clarity.
8.3.2 The second sentence in paragraph 43 is potentially confusing. It does not make clear that adhering to the views of the deceased or their family is not a legal requirement and it also skirts over the potential conflicts that may arise between the deceased and the deceased’s family.Given that, the final clause in this paragraph is too unconditional.
8.4 Surplus material from tissue samples – paragraphs 74-77
It is not clear whether this section applies to all tissue or only post-mortem tissue. If it does apply to all tissue, then the requirements seem excessive in some regards, particularly insofar as they demand that there is separate disposal for tissue samples, such as fluids, taken from the living and that this disposal is discussed with the patient in advance.