Risk management Consent in assisted conception

Transcription

1 The Obstetrician & Gynaecologist /toag ;8: Risk management Risk management Consent in assisted conception Authors Robert Sawers / Sue Avery Key content: The Human Fertilisation and Embryology Act 1990 specifies the conditions and ways in which human gametes and embryos may be used or stored in the UK. The HFEA Code of Practice covers issues of consent and quotes the relevant paragraphs of the Act for each section. The cornerstone of the regulation of assisted reproduction in the UK is the formal consent to the use and storage of gametes and embryos. This is recorded on forms HFEA (00)6 (for sperm and embryos) and (00)7 (for eggs and embryos). Learning objectives: To learn about the general principles of consent in assisted conception. To learn about the standard forms in use. To learn about the different types of consent, including that required for treatment, use and storage of gametes and embryos, embryo transfer, gamete donation and research. Ethical issues: What is the legal position when one partner withdraws their consent to treatment? Keywords consent / embryos / Human Fertilisation and Embryology Act 1990 / oocytes / sperm Please cite this article as: Sawers R, Avery S. Consent in assisted conception. The Obstetrician & Gynaecologist 2006;8: Author details Robert Sawers FRCOG Consultant Gynaecologist The Fertility Centre, Priory Hospital, Edgbaston, Birmingham B5 7UG, UK rsawers@doctors.org.uk (corresponding author) Sue Avery PhD Director Assisted Conception Unit, Birmingham Women s Hospital, Birmingham B15 2TG, UK 245

2 Risk management 2006;8: The Obstetrician & Gynaecologist Introduction When this article was originally suggested, the 200th anniversary of the battle of Trafalgar was being celebrated. The carnage in the battle was immense and the surgeons were fully occupied. It is impossible to contemplate the conditions for patients and doctors in that era without comparing them to our own. Nelson had lost his right arm eight years before Trafalgar at the attack on Santa Cruz de Tenerife in A piece of grapeshot or musket ball struck his right arm just above the elbow and it shattered the bone so badly that amputation was essential. There is no record of the consent to operation which was sought or given, or how long was spent explaining the possible serious or frequently occurring complications. Written consent might have been difficult to obtain in the circumstances. In our supposedly more sophisticated and less fatalistic society, we demand to control our own destinies as far as possible and, understandably, we wish to make informed choices in all our dealings with each other and the world around us. When we have an illness or affliction, therefore, we want to know what remedies are available, the likely outcomes and what might go wrong. This seems entirely reasonable but problems arise when treatment is not actually essential, there is a range of choices, perhaps with unpredictable outcomes, or where the subtleties of treatment are hard to grasp without expert knowledge. Assisted reproduction presents many additional issues, since at least two parties are likely to be involved, decisions could affect many generations and, where there are stored gametes, consent has to cover a number of different what-if scenarios. It is hardly surprising that a considerable body of ethical debate, regulation and law has arisen around this area of medicine. This brief article endeavours to summarise the current situation with regard to consent in assisted reproduction in the UK. General principles In many ways, law is the antithesis of scientific medicine. Medicine is supposedly based on commonality of experience, where the frequency of an occurrence suggests a fundamental truth. This is referred to as evidence-based medicine. Law, on the other hand, appears to be based largely on case reports and the opinions of previous pundits. It is, therefore, difficult for the medical and scientific brain to dip into the minefield of opinions and counter-opinions and not be confused. To understand the rules under which we work it is, however, necessary to consider briefly some of the general issues concerning consent. Consent to medical treatment is governed by several basic principles: autonomy, or selfdetermination; capacity, which is the ability to decide; validity, which may include the way in which consent is given, as well as the adequacy of the information upon which the consent is based; and therapeutic purpose, which may include issues of public policy and statutory limits. The principle of autonomy is expressed in many judgements but a classic original statement from runs Every person being of adult years and sound mind has a right to determine what shall be done with his own body. A patient s capacity to consent is not absolute but depends on the gravity of the decision to be made. The court applies a three-stage test. 2 The patient must be able to: comprehend and retain the relevant information believe it weigh it up so that they can arrive at a choice. A decision to refuse medical treatment does not have to be sensible, rational, or well considered, 3 providing the patient is deemed to be capable. To be valid, consent must be given voluntarily, the person giving consent must have the necessary capacity and be appropriately informed and the consent must not have been withdrawn. The way in which the adequacy of information has been judged has evolved in recent years. An often quoted case known as Bolam, 4 referring to medical negligence, used the yardstick of a responsible body of medical opinion. However, in the case of Sidaway v Board of Governors of the Bethlehem Royal Hospital (1985) 5 the House of Lords stated that it was open to the courts to decide whether information about a particular risk was so obviously necessary that it would be negligent not to provide it, even if a responsible body of medical opinion would not have done so. It is now clear that the courts will be the final arbiter of what constitutes responsible practice, although the standards set by the health professions for their members will be influential. 6 It is not sufficient that a patient should request some form of treatment. That treatment must have some therapeutic purpose, i.e. to save lives or to ensure improvement or prevent deterioration in physical or mental health. 7 Public policy and statutory limits in the definition of acceptable therapeutic purpose with regard to assisted reproduction have evolved considerably in the 15 years since the Human Fertilisation and Embryology Act was passed. There is no legal requirement in most instances for consent to be in written form, although, clearly, this may provide useful evidence of consent. Courts will decide the validity of consent using the criteria outlined above and, while standard forms are 246

3 The Obstetrician & Gynaecologist 2006;8: Risk management clearly very helpful, issues like the adequacy of information provided may still be questioned. Assisted reproduction is one area, however, where consent forms are a legal requirement with regard to the use and storage of gametes and embryos. 8 The Human Fertilisation and Embryology Act 1990 and the Code of Practice The Human Fertilisation and Embryology Act 1990 (HFE Act) 8 specifies the conditions and ways in which human gametes and embryos may be used or stored in the UK. The Act is implemented by the Human Fertilisation and Embryology Authority (HFEA). The Code of Practice of the HFEA 9 covers issues of consent and quotes the relevant paragraphs of the Act for each section. Emphasis is placed on the provision of adequate information and of time for patients to consider the implications of treatment before giving consent. These points may seem obvious but the complexity of the issues and the fact that at least two parties are involved make them particularly important. It is not possible here to quote large sections of the HFE Act or the Code of Practice and these are readily available. This article, however, is intended to be a practical guide. The consent process Information It will be clear that the process of consent is much more than signing a piece of paper. It really begins with the centre s information sources, which include booklets, internet sites and consultations. It is essential that these should be comprehensive, accurate and specific to the treatment under consideration and to the particular centre, i.e. providing up-to-date statistics on a centre s performance. Where statutory limits or obligations exist, these must be clearly stated. The person or persons obtaining consent must be appropriately trained to do so. The consent trail in assisted reproduction Box 1 lists the most commonly used consent forms and Figure 1 shows the stages of the process at which they are usually completed. The timing varies in different clinics but adequate time must be allowed for consideration of the relevant information at each stage. Consent to disclosure of identifying information Under the HFE Act 1990, disclosure of identifying information about any patient attending a licensed centre was not permitted and correspondence had to be addressed to the patient, who might then pass it on to the general practitioner or others. This was, presumably, never the intention of the Act and an amendment was passed in which allowed communication with permission. A standard form was provided by the HFEA, originally known as Consent to disclosure of identifying information (Appendix B) Acknowledgement of information received Consent to treatment involving egg retrieval and/or egg or embryo replacement (Appendix E) Consent to use and storage of eggs and embryos (00)7 Consent to use and storage of sperm and embryos (00)6 Consent to operation of egg collection Consent to embryo transfer Additional consent Consent to egg sharing Consent to posthumous registration of father Annex A and now amended to Appendix B (of the Code of Practice). This allows both partners to specify persons to whom information may be disclosed, including external inspectors, and to exclude certain persons or information. Acknowledgement of information received It is helpful to complete a checklist of information given and received. This should include details of the written information given, whether counselling has been offered and issues regarding welfare of the child have been explained, as well as practical details such as charges which may be incurred. It is wise to include specific reference to the risks of ovarian hyperstimulation syndrome (OHSS), the possibility of cancellation of the cycle and the dangers of multiple pregnancy. It should be signed by the patients and the person giving the information. It serves not only to ensure that the necessary areas have been covered, but also reduces the risk of misunderstanding and acrimony if the outcome is not as desired. Consent to treatment There is a standard form in common use, dating from the time of the Voluntary Licensing Authority but updated and given as an example in Appendix E of the Code of Practice, which covers the process of ovarian stimulation, collection and mixing of gametes, and the associated use of any drugs or Box 1 Consent forms in common use Figure 1 The consent trail 247

4 Risk management 2006;8: The Obstetrician & Gynaecologist anaesthetics. Although there is overlap with the statutory HFEA forms and the more recent operation consent forms, Appendix E does contain detail which is not present elsewhere. Most versions of the form in current use specify whether ICSI (intracytoplasmic injection) is to be used and the number of embryos, subject to regulation, to be transferred. In recent years, the general form for consent to surgery has been expanded to detail the intended benefits of the procedure, as well as serious or frequently occurring risks, which in egg collection include failure to collect eggs, pain, bleeding and infection. It would be helpful to develop a single form to cover all of these aspects. Consent to the use and storage of gametes and embryos The cornerstone of the regulation of assisted reproduction in the UK is the formal consent to the use and storage of gametes and embryos. This is recorded on forms HFEA (00)6 (for sperm and embryos) and (00)7 (for eggs and embryos), 11 which are issued and regularly revised by the HFEA. While the 1990 Act does not specify the use of these forms, it does, as already mentioned, specify that this consent must be in written form and that it details the issues to be covered. 8 These include the purpose for which gametes and embryos are to be used and/or stored, i.e. within permitted limitations, to treat an individual, to treat an individual with a named partner, to treat others, or for research. It must also specify the duration of storage up to the maximum period of time and what is to be done with gametes or embryos if the person or persons giving the consent die or become incapable of varying or revoking the consent. The usual maximum storage period for gametes is 10 years and for embryos 5 years. These periods may be extended on request, depending on the circumstances and in accordance with conditions laid out in the Code of Practice, usually provided the person for whom they are stored, or who will be treated, will be no older than 55 years at the expiry of the storage period. Additional forms are provided for this (HFEA 009). HFEA 009 also provides for consent to storage only, without the additional consent to use. This is particularly important in the case of post-pubertal boys undergoing cytotoxic therapy, who may wish to store sperm. In these cases the 1990 Act is clear that there can be no substitution of parental consent and thus minors wishing to store sperm must be assessed for Gillick competence according to the Fraser guidelines. 12 Consent to a storage period does not impose an obligation to store but it must be clear to patients under what circumstances embryos might be removed from storage before this period has expired: this is a matter of contractual agreement, whether implied or clearly defined. Patients should also be made aware of the opportunities that might exist to extend the storage period and their own obligations in terms of keeping the clinic informed of their address so that contact can be maintained. Where the consent of both contributors to embryos is needed, it must be practically compatible, rather than identical, especially with regard to the fate of stored embryos, in case either partner dies or becomes unfit to give or vary consent. A common error is for both parties to state that embryos should continue in storage for the purpose given above, where this purpose is treatment with the female partner; clearly, this would not be possible if something happened to her. Under the current interpretation of the HFE Act (1990), the consent of both gamete providers is required for embryos to remain in storage and the withdrawal of consent by one party renders storage illegal. If patients wish to terminate the storage of their gametes or embryos they may do this by withdrawing consent to continued storage or by specifically requesting that the storage be terminated. There is no requirement for a specific consent for disposal of embryos either before or at the time of expiry of the legal storage period. The recent case of Natalie Evans 13 illustrates the problems that can arise. Ms Evans had had medical treatment that resulted in her being unable to produce viable oocytes. Before this, she and her partner had had embryos stored following IVF (in vitro fertilisation) treatment. When their relationship broke up her partner withdrew his consent to embryo storage. Ms Evans argued unsuccessfully through the courts that she should be allowed to use the embryos, as they were her only chance of having children with her own genes. The High Court examined the requirements of the 1990 Act in relation to Ms Evans claim that there was an incompatibility between the effect of the Act and the Human Rights Act 1998, and that her rights under Articles 8, 12 and 14 of the Act had been infringed. She also pleaded that the embryos were entitled to protection under Articles 2 and 8. In addition, she sought an injunction requiring her partner to restore his consent and a declaration that he had not, and could not, vary his consent. These claims were dismissed. The consent had been given in good faith and under the understanding that it could be withdrawn, although in the belief by both partners that the relationship would continue, and it would be inequitable to prevent either party from withdrawing their consent. The judge also ruled that an embryo was not a person with protected rights under the Convention and the applicant s right to family life had not been engaged. The judge accepted that the 1990 Act interfered with the private lives of both parties but that it was proportionate. The judge also used the example of a man rendered infertile in similar circumstances, such as testicular cancer, where no one would suggest that his partner could not withdraw her 248

5 The Obstetrician & Gynaecologist 2006;8: Risk management consent to undergo treatment with embryos created using his sperm. The Court of Appeal also dismissed the case. 14 Arden LJ pointed out that motherhood could not be forced on the applicant and, likewise, fatherhood should not be forced on her partner. The case then progressed to the European Court of Human Rights (ECHR) 15 and, on the day before the embryos were to be destroyed, the ECHR requested the British Government to take steps to prevent their destruction. The ECHR also found against Ms Evans, although there was dissenting opinion in relation to Article 8, the right to respect of private and family life. Two judges felt that there should be protection for people of either sex whose only chance of having their own children lies with stored embryos and that in those circumstances the other party should not be able to withdraw consent. There has not been a case yet where it has been the male partner who has lost his fertility and where judgement has been made about whether a woman should undergo treatment and pregnancy against her will. Under the current law there remains an imbalance between the rights of males and females in cases where one partner no longer wishes to be treated with the other s gametes. If a couple separate there is still the biological potential for the female partner to continue with treatment if the male partner withdraws from treatment but allows storage to continue. In the reverse situation, the female partner would have to be prepared to assume the status of an egg donor so the embryos could be transferred to another woman. The best known case relating to death and gametes storage is that of Diane Blood. 16 Sperm were removed from Mrs Blood s husband and stored while he was in a coma and thus unable to give consent. Thus, the removal and storage were both illegal. After a long court battle Mrs Blood was permitted to take the stored sperm to Belgium for treatment under legislation permitting the free movement of goods in Europe. Largely as a result of Mrs Blood s case, the law relating to posthumous conception and fatherhood has been changed. However, valid consent to the use or storage of gametes remains essential. The Deceased Fathers Act 2003 allows for the situation where a woman may want to conceive the child of her husband or partner after his death; for example, if the man had sperm stored before cancer treatment. The law now allows the deceased man s name, surname, occupation and place of birth (not in Scotland) to be entered in the birth register and on the birth certificate as the father of the child. This registration does not, however, give the child any legal rights such as inheritance or nationality. As a result of this, yet another consent form has been introduced. Birth registration can only take place if the man concerned has given consent to his details being placed on the register. It also requires some forward thinking, as couples must, therefore, be given the opportunity to complete this form before storage. Consent to embryo transfer The general principles governing embryo transfer, such as the number to be transferred, the procedures and the outcome possibilities (including multiple pregnancy and its attendant risks) should be explained at an early stage. A clear written record should be completed of the following: the oocytes collected; the method and results of fertilisation; the number to be transferred and by whom; and the fate of any remaining embryos or gametes. This should be signed by the patients and the person giving the explanation. It is good practice for this to be done by the embryologist, who is probably best placed to explain the early progress of the embryos. Consent to gamete donation Consent to gamete donation is obtained using the same storage and use forms as for treatment. The law regarding consent is the same, whether the consent is for the patient s own treatment or for donation, i.e. only the gamete provider can give consent. Donors do not relinquish their rights on donation but retain them up until the point that embryos are transferred to the recipient s body. This includes the right to vary or withdraw consent at any time. Withdrawal of consent by the gamete provider will take precedence over the wishes of any other party in relation to storage. In practice, this means that embryos created using donated eggs or donated sperm must be removed from storage if the donor withdraws consent, even if the recipient wishes them to remain. It is essential that all parties clearly understand this. In the case of egg sharing, where a woman undergoing treatment for herself opts to donate some eggs from that cycle for the treatment of others, the sharer needs to complete two consent forms for storage and use (HFEA (00)7). One form refers to her own use and a separate form specifies her wishes in relation to the donated oocytes and any resulting embryos. 17 The implications of gamete donation, especially egg sharing schemes, need to be clearly set out in the nature of a contract, to avoid disagreement or litigation over division of eggs or charges incurred. Before April 2005 there was no obligation for gamete donors to allow identifying information to be released to any resulting children and gamete donation was, therefore, largely anonymous. The regulations have since changed and identifying information will be available to children prospectively. The couple having treatment will 249

6 Risk management 2006;8: The Obstetrician & Gynaecologist remain the legal parents of the children and the donors will have no legal responsibilities towards the children. Nevertheless, this has had considerable impact on the recruitment of sperm donors and the availability of donated sperm would appear to have decreased below the level of the availability of donated eggs. Consent to research The consent forms HFEA (00)6 and (00)7 include options to donate gametes or embryos for research. However, it is important to understand that this is not sufficient permission to use them in any research project. It is necessary to obtain specific consent for a specific project. In addition, there are requirements laid down by the HFEA in relation to the information that should be given to patients before obtaining their consent for research. 18 Central to this is the condition that gametes and embryos used and created for research will not be transferred in treatment and that treatment will not be affected. It must be clear whether embryos or gametes may be stored for any future (secondary) research, and whether this might include genetic research. In that case it must be clear whether any information directly relating to the patients or their offspring is likely to be obtained, whether it could be available to them and, if so, would they wish to receive it. The Central Office for Research Ethics Committees (COREC) has published guidance on the structure of both patient information and consent in relation to research 19 and this clearly applies as much to research in this field as to any other and is not negated in any way by the HFE Act (1990). Other types of consent Many of the different types of consent in assisted reproduction are really a contract between the patients and the treating centre. In addition to those outlined above, other types of consent may be required, often with regard to risks or potential complications. Clinics will usually draw up their own forms, with legal advice, to be used in addition to the statutory forms. In the case of egg sharing there are contractual issues relating to the number of oocytes to be donated and the consequences, financial and otherwise, of withdrawing from the arrangement. These must be made clear to the patients. Surrogacy is a particularly difficult area and all parties should always be advised to seek specialised legal advice. Where patients are funding their own treatment, any issues relating to payment and treatment, such as the consequences of failing to pay for sperm or embryo storage, are contractual issues and obligations on both sides must be clear before treatment commences. Conclusion Assisted conception is unusual in that consent must be obtained, not only for procedures to be carried out on patients, but to the use of cells obtained as a result. The HFE Act was designed firstly to ensure that human gametes and embryos are treated with respect and, secondly, to ensure that individuals retain control over their genetic material, whether it is to be used in treatment, donated to others, or for research. As with all treatments, effective consent depends on the quality of any information given. There are specific requirements laid down in legislation and regulation for both consent and information. In addition to the legal requirements and the spirit of best practice, as noted above, much of the consent process forms the basis of a contract between the patient and the treating centre. In most medical treatment we would not be content with a failure rate of 60% or more per operation and, yet, this is what patients undergoing treatment for subfertility have to expect and tolerate. A clear pathway of information, acknowledgement and consent is vital to managing expectations, maintaining trust and avoiding litigation. Lord Nelson may have had little choice in the removal of his arm but the choices open to people receiving assisted conception are complex and there is usually more time to consider them. It is important that both patients and service providers understand the implications and limitations of proposed treatment, their responsibilities towards each other and to the embryos being created and that these are clearly recorded. References 1 Schloendorff v. Society of New York Hospital (1914) 105 NE Re C [1994] 1 Al1 ER Re T (Adult: Refusal of Treatment) [1992] 3 WLR 782, 800A. 4 Bolam v. Friern Hospital Management Committee [1957] 2A11ER Sidaway v. Board of Governors of the Bethlehem Royal Hospital [1985] AC Department of Health. Reference Guide to Consent forexamination or Treatment. London: Department of Health; section [ 7 Re F [1990] 2 AC 1, Human Fertilisation and Embryology Act 1990 (c. 37). London: The Stationery Office, 1990 [ _en_1.htm] 9 Human Fertilisation and Embryology Authority. Code of Practice. 6th Edition. [ hfea/code_of_practice_sixth_edition_-_final.pdf] 10 Human Fertilisation and Embryology (Disclosure of Information) Act 1992 (c. 54). London: The Stationery Office, [ 11 Human Fertilisation and Embryology Authority. Consent to storage. [ 7E09BA9F/hfea/hs.xsl/1339.html] 12 Gillick v. West Norfolk and Wisbech Area Health Authority [1985] 3 All ER Evans v. Amicus Healthcare and Others [2003] EWHC 2161 (Fam). 14 Evans v. Amicus Healthcare Ltd and Others [2004] EWCA Civ Evans v. the United Kingdom [2006] ECHR 6339/ Human Fertilisation and Embryology Authority, ex parte Blood [1997] 2 A11ER Human Fertilisation and Embryology Authority. Code of Practice. 6th Edition. Sections [ 3F57D79B-1E67E076/hfea/Code_of_Practice_Sixth_Edition_-_final.pdf] 18 Human Fertilisation and Embryology Authority. Code of Practice. 6th Edition. sections [ 1E67E076/hfea/Code_of_Practice_Sixth_Edition_-_final.pdf] 19 Central Office for Research Ethics Committees. Guidelines for Researchers. Information sheets & consent forms. Version 2.0, [ Sheets_and_Consent_Forms.doc] Further reading Hockton, A. The Law of Consent to Medical Treatment. London: Sweet & Maxwell;