Code E: Consent

39.    The giving of consent is a positive act. The HT Act requires that consent must be sought for the removal, storage and use of human tissue for certain scheduled purposes, including research in connection with disorders, or the functioning, of the human body, subject to the exceptions set out later in this Code.

40.    Although the HT Act deals with removal of tissue from the deceased, consent to treatment and examination (and the removal of tissue from the living for research) is covered by the common law and the Mental Capacity Act 2005 (MC Act) and in Northern Ireland the Mental Capacity Act (Northern Ireland) 2016 where appropriate; these are not covered in this Code of Practice. Trusts should have local policies in place for seeking consent to treatment and the legal position is set out in the Department of Health and Social Care’s guidance.

41.    Guidance for healthcare professionals in Wales is available in the Welsh Assembly Government’s Reference guide to consent for examination and treatment. The MC Act does not apply in Northern Ireland (provisions around treatment in the NI MCA have not yet commenced); the Department of Health (Northern Ireland) published its own reference guide to consent for examination, treatment or care in 2003. This guidance is based on mental health and capacity case law.

42.    To give consent, the individual (or the person with parental responsibility) should understand the nature and purpose of what is proposed and be able to make an informed decision. They should be told of any ‘material' or ‘significant' risks inherent in the way the sample will be obtained, how the tissue will be used and any possible risks or implications of its use, such as genetic tests. Where consent was not given while the person was alive, their nominated representative or a relative may give consent (please see Code of Practice A for more information).

43.    Establishments should also provide appropriate and clear information on the activities for which they are seeking consent. The information might be in the form of leaflets or information sheets, or might be contained within the consent form. Many establishments have policies on consent that include the use of standard documentation. Such documentation should make reference to the HT Act and the role of the HTA and be reviewed to ensure that it is consistent with the relevant HTA Codes of Practice.

44.    Where appropriate, information should be available in widely spoken languages and in a variety of formats, such as video, audio or Braille and in line with other relevant legislation, including the Equality Act 2010.

45.    To facilitate the use of valuable human tissue in research, donors should be advised of the potential value of giving their generic consent to future research. It is still important, however, that consent is valid. If the intention is to store the tissue for an as yet unknown research purpose or as part of a research tissue bank then this should be explained, setting out the types of research that may be involved, any wider implications and the circumstances under which the tissue will be disposed of.

46.    While obtaining broad or generic consent offers the widest benefit for future research, the seeking of such consent should be supported by safeguards and assurances for donors. For example, if a donor expresses objections to specific types of research, these must be respected, and donors should be provided with information about how future research will be approved within the scope of the consent they have given. A donation may not proceed if a donor places conditions on their consent which cannot be met or guaranteed. Further guidance on ‘Conditions on consent’ can be found in paragraphs 45-48 of Code A.

47.    If identifiable tissue is to be used for research, donors should be informed about any implications this may have. For example, they may be contacted by researchers, given feedback, or be asked for access to their medical records. Donors should be asked whether the consent they are giving is generic (for example, for use in any future research project), or specific (for one research project only). If it is the latter, detailed information about the research project should be provided, in line with good practice. Depending on the nature of the research, researchers may need to consider how they deal with a later loss of mental capacity. Certain safeguards, which are outlined in paragraph 54, need to be in place where the possibility of research involving adults who lack capacity is being explored.

48.    To ensure transparency on areas of public concern, for example where research is known or is likely to involve the commercial sector, genetic testing or the use of human tissue in animals, these should be covered in the information used to support the consent process. Where there is an expectation that samples may be exported for use abroad, the HTA also advises that donors are provided with adequate information as part of the consent process.

49.    Research tissue banks may charge for providing human tissue samples to researchers, including those working for private companies, so that their running costs are recovered and the viability of the bank is maintained. Where cost recovery, or any other charging mechanism, is in place it is important that research tissue banks are able to satisfy themselves that the information provided to potential donors is sufficient to ensure they understand that their tissue may be shared, subject to a fee being charged. The HTA also recommends that research tissue banks ensure transparency by providing easily accessible information about how and why they charge, and to whom they will supply tissue samples. This is important to ensure that the consent sought from donors to the research tissue bank is fully informed.

50.    Subject to the exceptions set out later in this Code, consent must be obtained from volunteers, for example, employees or students, to use their tissue for research.

51.    Consent may be withdrawn at any time, whether it is generic or specific. Withdrawal should be discussed at the outset when consent is being sought. The implications and practicalities of withdrawing consent should be made clear; for example, withdrawal of consent cannot be effective where tissue has already been used.

52.    If a donor gives consent for their tissue to be stored or used for more than one scheduled purpose and then withdraws consent for a particular scheduled purpose, such as research, this does not necessarily mean that the sample or samples have to be removed or destroyed. However, the samples may no longer be stored or used for the particular purpose for which consent has been withdrawn. In addition, if a donor withdraws consent for samples to be used in any future projects, this does not mean that information and research data should be withdrawn from any existing projects.

53.    Research establishments may wish to seek consent to obtain the equivalent of ‘healthy volunteer’ blood, or other, samples from their own staff or students. A reliance on this mechanism of donation poses potential risks to staff or students who are also donors; for example, there is a risk of people feeling pressured or coerced to donate. At a minimum, in addition to meeting all other required regulatory standards, establishments that wish to obtain samples from their staff or students should put systems in place to ensure the following:

a)    a confidential coding system, so that donors cannot readily be identified by their colleagues;
b)    donors should be able to withdraw their consent at any time, without any reason, without their decision having any negative effect on their relationship with colleagues or their conditions of employment or enrolment;
c)    donors of samples with desirable biological characteristics should not be unfairly targeted;
d)    donation thresholds should be established, and donation quantities monitored, such that donors do not donate excessively;
e)    where donations are likely to be repeated, appropriate consent should either be sought afresh or reconfirmed, depending on whether the information needed to support the consent process has changed. In addition, establishments need to consider other risks, such as whether the lifestyle or medical history of the donor has changed since their previous donation. This may be important to protect both research staff (for example with regard to exposure to potential infectious risks) and donors (such as where their health status precludes donations).

In consideration of these issues, establishments may wish to seek separate employment law or other legal advice when considering whether or not to involve their staff or students as donors.

54.    Not all adults whose human tissue may be used in research have the capacity to consent themselves. However, medical research involving adults who lack mental capacity can lead to innovations in healthcare which could substantially improve their health and quality of life, and that of others with similar conditions. It is therefore important that these adults are given the opportunity to participate in such research. However, certain safeguards need to be in place to ensure that this vulnerable group are protected when they do participate in research. Specialist RECs are required to approve such research and more information about these arrangements can be found on the Health Research Authority’s (HRA) website. For detailed information about medical research involving adults who cannot consent, refer to the guidance on the HRA’s website and MC Act and Mental Capacity Act Code of Practice. In Northern Ireland, reference should be made to the Mental Capacity Act (Northern Ireland) 2016 and the NI Mental Capacity Act Code of Practice (Only certain provisions have been commenced to date, but research provisions within the NI Act (Part 8 of the Act) were commenced in October 2019).

55.    It is important for those involved in research to be aware that, in addition to the consent provisions of the HT Act, they will need to adhere to other legal requirements such as the UK General Data Protection Regulation (UK GDPR), Data Protection Act 2018 and the common law duty of confidentiality.

56.    The consent requirements of the HT Act are not retrospective. This means that legally it is not necessary to seek consent under the HT Act to store or use an ‘existing holding’ for a scheduled purpose. An existing holding is material from the living or deceased that was already held at the time the HT Act came into force on 1 September 2006.

57.    Although there is no statutory requirement for consent for storage or use of tissue that is an existing holding, it does not mean that all such human tissue can be used freely and without regard to issues of consent or other ethical considerations. If practical, the consent of the participant should be sought and the views of the deceased person or of their relatives.¹ (if known) must be respected.

 58.    Ethical approval may be required for research involving existing holdings and, as for any case where ethical review is being considered, reference should be made to the guidance produced by the HRA.

59.    Although existing holdings are exempt from the consent provisions in the HT Act, the HTA's licensing requirements may still apply where material is being stored or used for a scheduled purpose.

60.    It should be noted that consent is normally required to use identifiable patient data in research. In cases where researchers do not have consent to use identifiable patient data for research, they should refer to the HRA. Obtaining consent may be preferable to developing complex systems for keeping samples unlinked.

61.    Whatever the date the tissue was donated for research, if more than 100 years have elapsed since a person’s death, consent to undertake research on their tissue is not required under the HT Act.

62.    In terms of research, the consent provisions of the HT Act do not apply to imported material. However, the HTA considers it good practice for there to be mechanisms in place to provide assurance that the tissue has been obtained with valid consent. Specific guidance on import (and export) is set out later in this Code (see paragraphs 98-114).

63.    There is a further statutory consent exception for the use and storage of human tissue for research, where all of the following criteria apply:

a)    the tissue is from a living person; and
b)    the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come; and
c)    where the material is used for a specific research project approved by a recognised REC.

64.    There may be occasions when a clinician involved in research may also have access to a secure database that would permit identification of a sample used in research and the identity of the patient whose material is being used. Providing the research material is not identifiable to the researcher (if it has been coded by a laboratory accession number, for example) and the researcher does not seek to link the sample to the patient, it will still be regarded as non-identifiable and the research will be permissible without consent if approved by a recognised REC.

65.    The HTA’s remit does not include ethical approval of research on human tissue, which must be applied for as described in the guidance available from the HRA. Ethical approval which qualifies for exemptions under the HT Act can only be given by a recognised REC, which is either:

a)    a REC recognised or established by, or on behalf of, the HRA under the Care Act 2014 or any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by, or on behalf of, the Welsh Ministers or the Department of Health in Northern Ireland; or
b)    an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA) to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

66.    Further information about the link between ethical approval and the licensing and consent exceptions is provided in Annex B.

67.    For the purposes of the HT Act, recognised RECs include all RECs within the Research Ethics Service of the four UK countries (although the HTA does not license storage of tissue for research in Scotland). Within the UK Research Ethics Service, the term ‘favourable opinion’ is used to mean ethical approval. Details of all recognised committees and general information about ethical approval can be found on the HRA’s website. The HRA is the regulator responsible for ethical review arrangements in health research.

68.    A university ethics committee is not, for the purpose of the consent exception, considered to be a recognised REC. Therefore, consent is still required for tissue to be used in a research project approved by a university ethics committee, even if it uses tissue from the living and the researcher is not in possession, and not likely to come into possession, of information identifying the participant.

69.    Recognised RECs can consider all applications relating to research involving the use of human tissue, even where this is conducted outside the NHS.
 

70.    Anyone holding ‘bodily material’ without the qualifying consent of the person/s concerned, intending to analyse the DNA and use the results, may be breaking the law. It is an offence to analyse DNA without qualifying consent unless it is for an excepted purpose. The offence attracts a fine, a term of imprisonment of up to three years, or both. Although the HT Act does not generally apply to establishments in Scotland, the offence of non-consensual analysis of DNA applies to the whole of the UK, including Scotland.

71.    ‘Bodily material’ differs from ‘relevant material’ as it includes hair and nails from the living as well as the deceased. It also includes gametes (human sperm and eggs).

72.    DNA itself (as opposed to the bodily material from which it originates) is not considered to be relevant material under the HT Act. Its storage is therefore not subject to licensing.

73.    In this section, the guidance also applies to RNA analysis where it is to be used to provide information about DNA.

74.    The results of DNA analysis can be used for research without consent, providing the bodily material from which the DNA is extracted:

a)    is from a living person; and
b)    the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come; and
c)    the material is used for a specific research project which has received ethical approval from a recognised REC.

75.    Although no offence will be committed in this situation, the HTA recommends that consent is sought where it is practical to do so. Information about ethical approval from recognised RECs is provided in paragraphs 65-69 and 86-88
 

76.    If appropriate consent has previously been obtained to use samples for research under the HT Act, and there is a subsequent intention for the research to include the analysis of DNA, as long as the consent does not rule-out DNA analysis, then the original consent will suffice as ‘qualifying’ consent for use in England, Wales and Northern Ireland. However, where samples are being prospectively collected for research involving DNA analysis, it should be made clear to the donor that their bodily material will be used for this purpose.

 77.    The DNA analysis offence in the HT Act applies only to bodily material; however, it is possible to extract human DNA from acellular materials, such as serum, for analysis. It follows that the offence does not extend to acellular materials from which DNA can be extracted and analysed.

78.    Even though an offence would not be committed, the use, without consent, of acellular material for DNA analysis for a purpose other than an excepted purpose, appears contrary to the purpose and intention of the DNA offence set out in the HT Act. As this does not fall within the scope of the HT Act or the remit of the HTA, there was a concern that a regulatory gap existed.

79.    Working together to address this concern, the HTA, HRA and Devolved Administrations have agreed a position on the regulatory oversight of proposed research using DNA extracted from acellular material. The ethical issues in the use of this material are the same as for those using bodily material and, therefore, the HRA and the Devolved Administrations expect researchers intending to extract human DNA from acellular material for research analysis to submit their proposals for ethical review by a recognised REC.

Throughout the Codes, the term ‘relatives’ should be taken to include a spouse or partner and, in cases where there are no relatives, close friends of the deceased person. Decisions regarding consent should be made according to the hierarchy of qualifying relationships as set out in the HT Act.