Professional Standards Authority and Human Tissue Authority

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1 Professional Standards Authority and Human Tissue Authority Notes of joint seminar on consent, 11 December 2012 The notes below summarise the case study discussions only. Case study 1 Qualifying Relationships 1. A man dies in hospital from an AIDS-related illness, after two weeks in intensive care. During the period of his hospitalisation, he is visited daily by his partner, whose details he has provided as his next of kin. Following his death, the intensivist who was looking after him approaches the partner requesting permission to undertake a post mortem examination, to find out more about the cause of his death. The partner gives full and informed consent and the post mortem is undertaken. A few days later, the brother of the deceased makes a formal complaint, claiming that the person who gave consent was not the man s partner, but merely his flat mate and friend, and that he should have been approached as the person at the top of the hierarchy. Discussion questions: a) How does the consent taker know that they are getting consent from the most appropriate person and what should they do when there is doubt? b) To what lengths should they go to check, and how might they do this? c) What is the status in law of next of kin, and how should it be handled if the next of kin is not the appropriate person to give consent under the Act? d) What procedures should hospitals have in place to avoid a situation like the one described? 2. A key issue in the discussion of this case study was that the concept of next of kin does not have legal force, and does not determine who can give consent for a post mortem. In the situation where a deceased person has not recorded their wishes and has not nominated a representative to consent or otherwise, the person who can give consent is determined by the qualifying relationship hierarchy set out in the Human Tissue Act

2 2004. There was widespread agreement that this is not well enough understood by the public. 3. The groups discussed what would be reasonable steps for health professionals to take in the circumstances described. All agreed that there was a limit to what could be expected in terms of investigating, triangulating or double-checking of information, given the time-pressures and demands on health professionals. Some felt that in this case study, reasonable steps had been taken. Others felt that other sources of confirmation of the status of the partner might have been consulted. Examples included from the deceased s general practitioner, or their medical records. However, particularly in London, it was felt that GPs would not have any relevant records or knowledge, and there was also the problem of accessing information from such sources for example at the weekend. Some felt that GPs should specifically record information to assist the decision about who qualified in these circumstances. 4. It appeared to many that there was a mismatch between the information that hospitals were recording for example at admission, and the information that would be required in this specific situation of trying to determine who was the person qualified to give consent under the legislation. Therefore there was scope for improvement in the kind of information being asked at admission. There was some discomfort at the idea of having to ask legalistic questions at times of distress, but having these points clarified could avoid greater problems at a later stage. 5. However, more than anything the groups felt that this case study highlighted the need to ensure that people s wishes were made clear in life, rather than being fought over by relatives after death. As noted above, it was felt that hospitals could support this by ensuring that the relevant questions were asked at an earlier stage, noting in particular that the patient in this case study had been in intensive care for two weeks. Some felt that it demonstrated the value of advance health directives, so that wishes could be clearly recorded before death. This was particularly the case where a patient had a chronic disease. The groups felt that there would be value in wider public discussion of the importance of people planning for the difficult decisions at end of their life when they were still in good health. Case study 2 post mortem on a still born child 6. At 32 weeks, a mother delivers a still born child. It is her first child and she is naturally distraught, as is the father of the baby. She is

3 approached by the obstetrician who would like there to be a post mortem examination of the baby, to understand why it died. She and her partner agree to meet with the obstetrician and a paediatric pathologist to discuss the benefits of a post mortem and what that means, so that they can consider whether or not to consent for it to take place. During the meeting, it becomes obvious that the mechanics of the post mortem are going to be too distressing for the mother and that a detailed explanation of what is involved is likely to put her off giving her consent. The clinicians want to avoid losing this valuable opportunity to find out why the baby died and possibly to avoid a future pregnancy loss for the mother. Discussion questions: a) How open should the consent takers be in their description of the process? b) Explaining the detail of a post mortem examination may put the parents off; how can this be balanced against the need to obtain full and informed consent? c) What practical things could be done to make it easier for the parents? d) How should a disagreement between the two parents be handled? 7. The crux of this case study was the extent to which consent can be considered properly informed, if the consent giver (in this case, the parents of the still born child) would find details of the procedure too distressing to hear. As a general observation, the groups agreed that the welfare of the living was paramount in this case, and should be the primary concern of clinicians and other professionals rather than the clinical interest of the case. 8. It was acknowledged that seeking consent in these circumstances was a difficult task, requiring great sensitivity and skill. Some felt that trained bereavement officers were often better able to handle this situation than doctors. Skill was involved in judging how much detailed information bereaved couples were able to hear about the post-mortem process at a time of acute distress, when a decision was needed quickly on whether a post-mortem was to go ahead. One group commented that 24 hours was too little time for the decision to be made. It was felt essential that parents understood the potential benefits of the post-mortem, although some cited evidence that in relatively few cases did a post-mortem in these

4 circumstances yield useful information for the parents in future, although others stated the opposite to be the case. 9. Some felt that if the parents could not bear to hear all of the details of the post-mortem process, it should not go ahead, whereas others felt that health professionals and other consent-takers should be able to make a judgement on whether parents were adequately informed. One group noted that the difficulty arose in part because of the power and knowledge imbalance between professionals and patients. At the very least, the parents should be made aware of what the proposed benefits were, including what uses tissue would be put to, or what the focus of the postmortem would be; what questions would it be seeking to answer and how might it benefit the parents in future? 10. It was considered important to convey to parents that there were options about the kind of post-mortem that would be carried out, for example, a limited, and therefore less invasive, post-mortem might be possible. It was considered that professionals should routinely seek consent for the least invasive form of post-mortem which would achieve the benefits or information they were hoping to secure. 11. While it was noted that the legal position was that only one parent needed to give consent, the groups agreed that it was preferable for both parents to agree for a post-mortem to go ahead and that neither parent should be able to over-rule the other. The groups reached this position after detailed consideration of alternative views. There was concern that in some cultures fathers might be able to dominate the decision, and that in supporting couples in making a decision, health professionals would need to be sensitive to this, taking particular care to ascertain the views of both parents. Case study 3 umbilical cord blood 12. A couple are expecting their first baby and are considering whether or not to have the umbilical cord blood collected by a company that offers private cord blood collection and storage. They have heard that cord blood contains stem cells that might be useful in the future to help cure an illness. 13. The couple have arranged to have the baby at a private hospital which has an arrangement in place with a private cord blood company that allows a member of the delivery team to collect the cord blood.

5 14. They feel that before they can make a decision and sign the necessary consent forms to the collection and storage of the cord blood they need more information. The midwife, under the terms of the agreement with the cord blood company, will be providing the couple with the information they need to make an informed decision about the collection. Information about the processing and storage of the cord blood is provided by trained sales staff working for the cord blood company. Discussion questions: 1. In order to provide sufficient information for the couple to make an informed decision: a) what information should the midwife be trained to provide about the collection process? b) what information should the sales staff be trained to provide about the processing and storage? 15. In discussing this case, the groups noted that the HTA regulates the collection of umbilical cord blood in the UK under the Human Tissue (Quality and Safety for Human Application) Regulations The collection of cord blood outside the HTA licensing framework is unlawful. People collecting cord blood have to be acting either directly under the authority of an HTA licence, or under a third party agreement where a hospital or person acts for a licensed blood bank. The responsibility for compliance with HTA requirements lies with the licensed establishment. The HTA has set out to all licensed cord blood establishments the need to ensure that parents considering collecting and storing blood are fully informed of the risks and benefits (cost was also mentioned although this is not in HTA s remit). Cord blood storage is expensive and the number of parents opting to store blood is small, but the market is growing. The banks that offer cord blood storage are mostly private companies, who provide the facility for private use. However there are also NHS and Anthony Nolan cord blood banks, for use by patients anywhere in the world. 16. The groups felt that the potential uses of cord blood, the risks of collection, and arrangements for its banking and storage were little understood. Information was routinely made available to pregnant women through GP practices, hospitals and by midwives. Some thought that this information should include prompt questions for parents to ask to

6 ascertain the risks and benefits in their own specific case, and also that HTA should ensure the information was being made available in different languages. However, some felt that the NHS should have no role in the promotion of this commercial service, for example there should be no promotion within maternity units, and that awareness of the existence of the NHS cord blood bank should be more actively raised. In general it was felt that there should be wider discussion and awareness of the process and its risks and benefits. 17. There was widespread agreement on the importance of parents having balanced information on which to base a decision on whether or not to store their baby s cord blood, and this should be made available from an early stage of pregnancy. Whoever was telling parents about the benefits and risks should be presenting balanced information and should themselves be fully informed about the collection and storage process, so that parents could have any questions reliably answered and could make an informed decision about whether or not to bank the cord blood. Explanations of the process should include different options for the way that the blood is collected and stored, and associated risks, taking into account any case-specific risks. It was understood that there was some evidence of potential harm to the baby if too much blood was taken. This needed to be made clear to patients. 18. The importance of training for people undertaking this role (of explaining options, risks, benefits and costs) was recognised. For the health professionals involved, it was felt that this should be underpinned by their professional standards and codes of conduct. There was concern that sales staff working for the cord blood establishment might not have sufficient clinical understanding to explain the risks and options properly, albeit some would have clinical training and experience. Some felt that the role of sales staff should be restricted to explaining the costs, contractual matters and technical details of the collection and storage process. 19. Discussion also focussed on what were seen as inherent conflicts of interest for those giving parents advice with regard to private storage. The specific concern was that the potential benefits of cord blood banking might be overstated to parents, and any risks understated, for commercial gain in particular by non-clinical sales staff. There was especial concern that the midwife should be in this position, because of the possible conflict of interest between acting in the patient s best interest, and acting in the interest of generating business for the private cord blood bank. Some felt therefore that there was a danger of parents being pressured into agreeing to storage of the cord blood, or of making a decision based on

7 distorted or impartial advice. There was also potential conflict with a midwife s personal convictions and principles. Again, the importance of adherence to professional codes was stressed. Many felt that there was a role for independent advice for parents, coming from neither the midwife nor from sales staff, and others suggested that there should be some kind of peer support for parents in making the decision. 20. Concerns were also expressed about the fate of cord blood that was being stored by a company that failed. HTA required, as a condition of licensing, that companies should have arrangements for the transfer of blood to another storage facility in these circumstances. Discussion also covered some of the technical sides of the process of collection. HTA confirmed that screening of the blood, e.g. for genetic diseases, is routinely carried out. People were interested in whether umbilical cord blood stored in this way was used for research; HTA confirmed that at present the banks only hold the blood for future medical use, not for research. The groups were also interested in issues around the child s own future say over how the blood was stored, and how it might be used.

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