Consent requirements - Part 3: Tissue from the living
When is consent required?
113. Under the HT Act, consent from the living is needed for storage and use of tissue for:
- obtaining scientific or medical information which may be relevant to any person including a future person
- public display
- research in connection with disorders, or the functioning, of the human body (but see paragraphs 117-123), and
114. Under the HT Act, consent from the living is not needed for storage and use of tissue for [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_6#sch1]
- clinical audit
- education or training relating to human health (including training for research into disorders, or the functioning, of the human body)
- performance assessment
- public health monitoring
- quality assurance
115. Consent to treatment and examination is covered by the common law and the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1 ] where appropriate. Trusts should have local policies in place for obtaining consent to treatment and the legal position is set out in the Department of Health's guidance [www.dh.gov.uk/consent]. Guidance for healthcare professionals in Wales is available in the Welsh Assembly Government's Reference guide to consent for examination and treatment [www.wales.nhs.uk/consent]. The DHSSPS (Northern Ireland) has published its own Reference guide to consent for examination, treatment or care [www.dhsspsni.gov.uk/consent-referenceguide.pdf]. See also the GMC guidance on consent and decision making in Consent: patients and doctors making decisions together [www.gmc-uk.org/guidance/ethical_guidance/consent_guidance/index.asp].
Tissue may be taken in a variety of circumstances, for example:
- in the course of diagnostic procedures, e.g. taking a blood or urine sample, tissue biopsy, cervical screening, etc
- in the course of treatment, e.g. removing tissue (organs, tumours, etc.) during surgery
- when removed specifically for the purpose of research
116. Although consent for treatment and examination is dealt with under the common law and consent for scheduled purposes is dealt with under the HT Act, the consent for each activity may be obtained at the same time. It is still important to explain clearly the activity for which consent is being obtained, including the risks and wider implications. Further guidance on this issue in respect of obtaining consent for donation may be found in the code of practice on Donation of solid organs for transplantation.
Consent exception for research in specific circumstance
- 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
- the material is used for a specific research project with ethical approval
118. Data about the tissue does not have to be permanently or irrevocably unlinked, and may be pseudonymised where, for example, a system of coding is used.
119. 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 (e.g. coded by a laboratory accession number) 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 it is given ethical approval by a recognised research ethics committee.
Applying for ethical approval for research
120. The HTA's remit does not include ethical approval of research on human tissue, which must be applied for using the guidance provided by the National Research Ethics Service (NRES) [www.nres.npsa.nhs.uk/rec-community/guidance/] and the GMC [www.gmc-uk.org/guidance/ethical_guidance/index.asp]. For the consent exception to apply ethical approval can only be given by a recognised research ethics committee which is either:
- a Research Ethics Committee (REC) established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments [www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727]; or
- 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 [www.opsi.gov.uk/si/si2004/20041031.htm].
See the code of practice on Research for further information on ethics committees.
121. 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 National Information Governance Board for Health and Social Care (NIGB) [http://www.nigb.nhs.uk/].
122. Researchers intending to use patient data in research should be aware that such information is subject to the common law duty of confidentiality and the requirements of the Data Protection Act 1998 [www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1].
123. In general, obtaining consent is preferable to developing complex systems for keeping samples unlinked.
Who may give consent?
Adults who have capacity to consent
125. Surplus tissue is often an important source of material for research and consent procedures may include an agreement to its use. The HT Act [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb1-l1g44] makes it lawful to dispose of surplus tissue. See the code of practice on Disposal of human tissue for further guidance.
Adults who lack capacity to consent
127. Under the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_2#pt1-pb1-l1g1] a person aged 16 and over is unable to make a particular decision if they cannot do one or more of the following things:
- understand the information given to them that is relevant to the decision
- retain that information long enough to be able to make the decision
- use or weigh up the information as part of the decision-making process
- communicate their decision by any means
Full guidance on how the MC Act defines capacity and how it should be assessed is given in chapter 4 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm].
128. The provisions of the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] should be considered together with general principles governing capacity to consent to medical procedures. Guidance is available from the Office of Public Guardian website [www.publicguardian.gov.uk/mca/mca.htm] and in the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. There is separate guidance for Wales [http://new.wales.gov.uk/topics/health/nhswales/healthservice/mentalhealthservices/mentalcapacityact/?lang=en] and for Northern Ireland [www.dhsspsni.gov.uk/public_health_consent]. The Adults with Incapacity (Scotland) Act 2000 [www.opsi.gov.uk/legislation/scotland/acts2000/asp_20000004_en_1] governs adults who lack capacity in Scotland.
129. The MC Act governs decision-making on behalf of adults (aged 16 and over) who lack capacity if unable to make a decision in relation to a matter at the relevant time because of an impairment of, or disturbance of, the mind or brain, whether permanent or temporary (see paragraph 55). For the purposes of the MC Act, unlike the HT Act, an adult is a person aged 16 or over. The MC Act only applies to persons aged 16 or over.
130. There are detailed provisions contained in the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] concerning decisions made on behalf of adults lacking capacity. All decisions must be made in the person's best interests, as laid out in chapter 5 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. Also, certain categories of people have a legal duty to have regard to the MC Act code of practice, when working with or caring for individuals who lack or may lack capacity to make decisions for themselves, as laid out in chapter 6 [www.publicguardian.gov.uk/mca/code-of-practice.htm].
131. The MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1] defines persons who lack capacity, see chapter 4 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm], and contains a set of key principles and a checklist to be used in ascertaining best interests, see chapter 5 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm]. The first core principle of the MC Act is that an adult must be assumed to have capacity to make a decision for themselves, unless it is established that they lack capacity to make the particular decision at the time the decision needs to be made [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_2].
132. It should therefore always be assumed that an adult has the capacity to make a decision unless there is reason to believe otherwise.
133. Individuals may sometimes temporarily be unable to make a decision, for example people affected by trauma, illness or shock. It may therefore not be appropriate to seek consent at that time and in some cases it may be necessary to put off the decision until the person has the capacity to make it, as laid out in the MC Act [www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1]. See chapter 4 of the MC Act code of practice for further guidance [www.publicguardian.gov.uk/mca/code-of-practice.htm].
134. Some adults may have capacity to make decisions about some matters, but not others. The MC Act requires that care should be taken to ensure that patients are given every opportunity, and support where needed, to make their own decisions, see chapter 3 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm].
135. A person must not be treated as unable to make a decision unless all practicable steps to help them do so have been taken without success, nor must they be treated as being unable to make a decision merely because they make an unwise decision.
136. The ability of adults with learning difficulties, or with limited capacity to understand should not be underestimated. Where appropriate, someone who knows the individual well, such as a family member or carer, should be consulted, as they may be able to advise or assist with communication.
137. Since the MC Act came into force a person aged 18 or over may make a Lasting Power of Attorney (LPA). This allows for an attorney to make certain decisions in circumstances where the person no longer has capacity. One type is a personal welfare LPA, which provides for the appointment of a person to make certain healthcare decisions on their behalf. Where an LPA exists, it is good practice to check the detail to see if the attorney has the authority to make the decision in question. Detailed guidance on the role of the attorney is set out in chapter 7 of the MC Act code of practice [www.publicguardian.gov.uk/mca/code-of-practice.htm].
138. Storage or use of tissue from adults who lack capacity to consent is permitted in certain circumstances specified in the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 [www.opsi.gov.uk/si/si2006/20061659.htm].
139. Under the HT Act, a child is defined as being under 18 years old [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54]. Under the HT (Scotland) Act, a child is defined as being under 16 years old [www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_8#pt7-l1g60].
140. Children may consent to a proposed medical procedure or the storage and use of their tissue if they are competent to do so. In the Gillick case, the court held that a child was considered competent to give valid consent to a proposed intervention if they had sufficient intelligence and understanding to enable them fully to understand what was involved. The concept of Gillick competence does not exist in Scottish law. The legal position on obtaining consent to treatment is set out in the Department of Health's guidance [www.dh.gov.uk/consent]. Consent documents for Wales can be found at [www.wales.nhs.uk/consent] and the DHSSPS (Northern Ireland) has published its own Reference guide to Consent for examination, treatment or care [www.dhsspsni.gov.uk/consent-referenceguide.pdf].
141. If a child consents to a procedure, then this consent carries over into adulthood unless they explicitly withdraw it.
142. Under the Children Act 1989, a person who has parental responsibility [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_2#pt1-l1g2] for the child may consent on their behalf only if the child has not made a decision either way; and the child:
- is not competent to do so; or
- is competent to do so, but is unwilling to make that decision.
143. A person who has parental responsibility will usually, but not always, be the child's parent [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_2#pt1-l1g3]. See also the GMC guidance 0-18 years: guidance for all doctors [www.gmc-uk.org/guidance/ethical_guidance/children_guidance/index.asp].
144. Where there is any dispute between persons with parental responsibility or any doubt as to the child's best interests, the matter should be referred to court for approval. The need to refer cases to court does not apply to Scotland. For further guidance on court approval in cases of potential donation, see the codes of practice on Donation of solid organs for transplantation and Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation.
145. Even if the child is competent to consent, it is good practice to consult the person who has parental responsibility for the child and to involve them in the process of the child making a decision. However, it should be emphasised that, if the child is competent, the decision to consent must be the child's. Information about a competent young person should only be disclosed to the person with parental responsibility for the child with the child's consent. It is also essential to make sure that a child has consented voluntarily and has not been unduly influenced by anyone else.
Steps to take
146. 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, e.g. genetic tests. If the person concerned is not a patient, and is volunteering samples purely for research, the general principles of providing appropriate information still apply (see paragraphs 30-34 on valid consent).
147. Healthcare professionals should try to find out about the individual's needs and priorities when telling them about their options. Some people may not be interested in knowing the full details about the proposed use of the tissue and it is good practice to record this in the notes. People should nevertheless have all their options explained to them and be provided with an appropriate level of information. See GMC guidance on Consent: patients and doctors making decisions together [www.gmc-uk.org/guidance/ethical_guidance/consent_guidance/index.asp].
148. 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). If it is the latter, detailed information about the research project should be provided, in line with good practice. Researchers will need to consider how they deal with tissue samples in the event of a later loss of capacity. There are certain safeguards which need to be in place where research involving adults who lack capacity is concerned (See the code of practice on Research for further detail).
149. Donors should be told if their samples will or could be used for research involving the commercial sector. They should be given appropriate information on the range of activities and researchers which may be involved, and whether these include commercial establishments. The HTA also advises that is good practice that donors are provided with adequate information upon giving consent, should their samples be exported for use abroad (see the code of practice on Import and export of human bodies, body parts and tissue for further information [www.hta.gov.uk/guidance/codes_of_practice.cfm]).
Powers deeming consent to be in place
150. Section 7 of the HT Act allows the HTA to dispense with the need for consent in certain circumstances, as set out in paragraph 151.
151. The HTA has the power to deem consent to be in place for relevant material from someone who is untraceable, or who has not responded to requests for consent to use of their material, if that material could be used to provide information relevant to another person. This may be important where information could be obtained about the treatment and diagnosis of the applicant. The HTA has prepared guidance on the implementation of these provisions in relation to DNA analysis (see paragraphs 152-156 on Consent and the use of DNA).