1 University College London and UCLH Trust, 2 The Meyerstein Institute of Oncology, Middlesex Hospital, UCLH Trust, 3 The Middlesex Hospital, The Institute of Urology & Nephrology (St Peter's Hospital) and 4 Department of Medicine, Paediatric Endocrinology Division, Middlesex Hospital, London, UK
![]() |
Abstract |
---|
![]() ![]() ![]() ![]() ![]() ![]() |
---|
Key words: adolescent/cancer/consent/sperm banking
![]() |
Introduction |
---|
![]() ![]() ![]() ![]() ![]() ![]() |
---|
Alongside this is increasing awareness of the potential for fertility preservation offered by improvements in assisted reproduction technology. Here we explore the very real difficulties of bringing together these medical fields to benefit young people with cancer, focusing specifically on consent.
The legal framework
Obtaining consent in early adolescence remains a contentious topic, with confusing legal precepts and advice (Bahadur and Hindmarsh, 2000). These have implications for the patient, parents or legal guardian and their involvement in the decision making process towards obtaining consent.
In England and Wales, persons over the age of 16 years can give consent to treatment according to the Family Law Reform Act 1969 s8. The consent of people under 16 years is legally valid if their doctor considers that they are competent to make an informed and wise decision (Anonymous, 1985; Age of Legal Capacity (Scotland) Act 1991 s2,(4); Alderson, 2000; Hedley, 2000). The 1989 Children Act, and similar acts for Scotland and Northern Ireland, state that children deemed to be competent can `refuse medical or psychiatric examination'. The United Nations Convention on the rights of the child emphasizes the best interests and welfare of the child, which includes adults listening respectfully to the child's views `on all matters affecting the child' (United Nations, 1989, Article 12). Although this convention was ratified by the British Government in 1991, English law has since become more ambivalent about minors (Alderson, 2000
).
Alongside this, the field of assisted human reproduction is governed by statute in the UK (HFE Act, 1990) including strict guidelines on the requirements for informed consent in respect of the storage of gametes and embryos and their use. Substituted consent is specifically excluded and there is a requirement to provide verbal and written information and an offer of independent counselling. The exclusion of substituted consent may be subject to further consideration under the UK Human Rights Act 1998, if this proves to be a hindrance in genuine cases to freezing and utilization of genetic material. The onus is upon those storing gametes and embryos to ensure that an informed and effective consent is in place before embarking on the cryopreservation procedure. The provider(s) of gamete or embryos thus always retains the right to control of their genetic material, the fate of which can be altered by a variation of consent which can occur at any time. Clearly, no gametes or embryos can therefore be obtained or frozen if the patient(s) has not understood the issues. In practice counselling by counsellors and support staff often follows on from the consultation with the oncologist at which the disease and treatment side effects have been revealed to the patient. This counselling seeks to enable the patient to consider the side effects with regard to fertility and the availability of facilities for gamete preservation.
Consent, assent and proxies
Storing spermatozoa gives patients future autonomy and choice by which they may form a family should they be both rendered infertile and survive. Particular difficulties of information and consent arise in those who have reached an age where sperm storage is physically possible (puberty) but are not yet deemed legally competent.
The transition through puberty includes significant biological developmental, emotional and cognitive changes. Combining these with the prospect of a serious disease such as cancer and the need to grasp the legal formalities can be daunting for those at any age but particularly the early adolescent patient. How absolute the consent has to be to fulfil the criteria of an informed consent is a moot point, which would apply equally to adult patients. It should be borne in mind that freezing ejaculated spermatozoa is a preventative process to overcome or alleviate potentially damaging side-effects of the treatment. It is not itself a treatment but a process which concerns two parts: the storage and the subsequent use. For most cancer patients the latter is the reason for storing spermatozoa but the choice of option at that stage by the patient and his future partner will be determined by a number of other factors which are unknown at the time of freezing. These include their prevailing semen quality, post-thaw sperm quality, whether further information on the genetic damaging effect of treatment is available, who the partner may be, her age and whether she is prepared for a more intrusive form of assisted conception technique. Fully informed consent is therefore not realistically possible.
Normally consent models refer to treatment, but as stated above the freezing of spermatozoa is preventative and normally requires no surgical intervention. The consent model which appears most appropriate to the needs of early adolescent cancer patients considering the storage of spermatozoa is that covered in the Gillick case (Anonymous, 1985). Significant remarks in relation to overriding a Gillick competents' decision have recently been recorded (Yate et al., 2000
), although its application to freeze spermatozoa appears unlikely. Interestingly, in the USA the concept of `assent' has been developed. Early adolescents are considered `to assent' (or, its converse, `dissent') when they have sufficient competence to have some appreciation of a procedure, but not enough to give fully informed consent. The age of assent is currently estimated as being twelve (Anonymous, 1977
; Sigman and O'Connor, 1991
; Committee on Bioethics, 1995
).
If a patient is unable to produce semen by masturbation, the possibility of preserving testicular tissue arises (Bahadur and Ralph, 1999). Two issues are at stake. Where the patient is pre-pubertal, and therefore the testicular tissue does not contain `gametes' as defined by the Human Fertilisation and Embryology Authority (HFEA), the legal, practical and ethical considerations are covered by the Children's Act 1989 and the Tissues Act 1961. Under these circumstances parental consent is essential (Bahadur et al., 2000
). Secondly, where in the opinion of the medical practitioner, `gametes' are present and the patient has reached Tanner grade 2 maturity, then under the provisions of the UK HFE Act, consent must come from the patient (Tanner, 1989
; Deech, 1998
).
A `family rule' model (Foreman, 1999) of consent for early adolescents has recently been developed. The `family rule' is a framework for obtaining ethical consent for medical interventions for children. The rule proposes that informed consent in children can be regarded as shared between children and their families, the balance being determined by implicit, developmentally based negotiations between child and parent a `family rule' for consent. It is claimed that consistent and operating procedures for ethically obtaining consent can be defined by this model and could be used as a unifying framework in developing new professional guidelines. It is felt that a `guideline based' approach to gaining consent may offer a greater individuality than a `rights based' approach.
When practitioners seek consent they usually want to perform some action and the subject therefore consents to experiencing an event. However, there are two broad classes of consent: consenting to an event and consenting to a rule and for children the most important rule is that set by their family. This `family rule' is likely to promote the welfare of that child. The child's development requires repeated renegotiation of the rule's application from infant to adulthood. Acceptance of consent by the family rule implies that parents may inhibit their children's right to consent and thus diffuses the autonomy of consent. Whilst this model does seem appropriate to medical intervention it should be noted that any coercive influence affecting a decision on sperm donation by normal ejaculation and cryopreservation could be seen as contrary to the requirements of the HFE Act 1990 for autonomous consent. The specific requirement for autonomous consent in UK law may be opened to scrutiny and reinterpretation like all aspects of the HFE Act 1990 and its Code of Practice, under the new HR Act 1998 which comes into force in October 2000.
Provided that the consent is given freely by the adolescent patient there are clearly merits in involving family members when early adolescent patients seek to bank spermatozoa. These merits may include parental help in simplifying complex language or relating a life situation to a context that they know to be familiar to their child. At home, the discussion may continue bringing closeness, openness and perhaps even a focus on positive life prospects in the face of the illness.
An agreement from an early adolescent by way of consent, assent, proxy consent or parent's permission often disguises the difficulties and complexities involved in the whole process. Guidelines for good practice are open to debate (Fleming et al., 1994). The basic abilities required to give consent are developed by 2 years of age with understanding of basic requests and behaviour to others (Kagan, 1981; Nelson and Gruendel, 1981
). By age seven, emotional factors are more important than developmental factors in predicting comprehension of medical procedures (Berryman, 1978
; Turnbull and Turnbull, 1985
), and the use of appropriate techniques can significantly improve younger children's comprehension of medical procedures. However, this comprehension in children is limited when compared to adolescents (Weithorn and Campbell, 1982
); children between six and twelve can understand, for example, psychiatric hospitalization in general (Roth and Roth, 1984
). This fits the modal age at which UK patients, parents and practitioners think children can make decisions about surgery (Alderson and Montgomery, 1996
), and the age of assent. On the other hand, early adolescents are perceived to lack the social independence needed to make a fully autonomous decision, being vulnerable to external pressures, and benefiting from firm guidance (Steinberg and Silverberg, 1986
; Turner et al., 1993
; Shucksmith et al., 1995
).
Current practice
No information at present exists about how adolescents with cancer (Foley, 1989; Shields and Johnson, 1992
) are normally treated or processed for sperm banking. Here we highlight the type of issues in relation to fertility preservation faced in the clinician's consulting room (before referral) and those faced at our sperm storage laboratory (after referral).
Before referral
Before referral for sperm storage the adolescent patient should be informed of:
After referral
After referral for sperm storage the early adolescent patient should be:
The staff member with responsibility for that patient should:
|
|
|
![]() |
Discussion |
---|
![]() ![]() ![]() ![]() ![]() ![]() |
---|
It should be remembered that in the UK, the statutory storage period for spermatozoa can be extended, for medical reasons, from the 10 year limit up to when a patient is 55 years old (HFEA, No. 1540, 1991). Adolescent cancer patients would qualify under these circumstances. Our offer of counselling, care and follow-up remains for all this period. From the financial perspective we offer this facility to all cancer patients on the UK National Health Service without charge and with no annual maintenance charge levied to patients. This considerably lessens the pressure on patients to reach a hasty decision on a year by year basis, which may be counterproductive, especially when they have several decades of life ahead of them.
![]() |
Conclusion |
---|
![]() ![]() ![]() ![]() ![]() ![]() |
---|
There is a minimal risk to the adolescent in giving consent for storing spermatozoa produced non-surgically which is to be cryopreserved and possibly used several decades later. They make apparently adult-like decisions (Sigman and O'Connor, 1991) and, in so doing, demonstrate their maturity and understanding of the subject of sperm storage in relation to their disease, their treatment, their rights and their prospect of genetic continuity. Persons taking such consent should be reflective of the process and methods by which it is taken.
![]() |
Acknowledgments |
---|
![]() |
Notes |
---|
![]() |
References |
---|
![]() ![]() ![]() ![]() ![]() ![]() |
---|
Alderson, P. (2000) The rise and fall of children's consent to surgery. Paediatric Nursing, 12, 68.
Alderson, P. and Montgomery, J. (1996) Health Care Choices: Making Decisions About Children. Institute for Public Policy Research, London.
Anonymous (1985) Gillick v W. Norfolk and Wisbech ANA. All England Law Reports, 402.
Anonymous (1977) Report and Recommendations: Research Involving Children. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Washington, USA.
Bahadur, G. (2000) Fertility issues for cancer patients. Mol. Cell. Endocrinol., 169, 12, 117122.[ISI][Medline]
Bahadur, G., and Ralph, D. (1999) Gonadal tissue cryopreservation in boys with paediatric cancers. Hum. Reprod., 14, 1117.
Bahadur, G., and Hindmarsh, P. (2000) Age definitions, childhood and adolescent cancers in relation to reproductive issues. Hum. Reprod., 15, 227.
Bahadur, G., Chatterjee, R., and Ralph, D. (2000) Testicular tissue cryopreservation in boys. Ethical and legal issues, case report. Hum. Reprod., 15, 14161420.
Berryman, J. (1978) Discussing the ethics of research on children. In van Eys, J. (ed.) Research on Children: Medical Imperative, Ethical Quandaries, and Legal Constraints. University Park Press, Baltimore, pp. 85104.
Children's Act (1989) The Stationery Office, London, SW8 5DT, ch. 41.
Committee on Bioethics (1995) Informed consent, parental permission, and assent in paediatric practice. Paediatrics, 95, 314317.[Abstract]
Deech, R. (1998) Human Fertilisation and Embryology Authority. Brit. Med. J., 316, 1095.
Family Law Reform Act (1969) HMSO, London.
Flaming, G.V., O'Connor, K.G. and Sanders, J.M. (1994) Paediatricians' views of access to health services for adolescents. J. Adolesc. Health, 15, 473478.[ISI][Medline]
Foley, M.K. (1989) Children with cancer: ethical dilemmas. Semin. Oncol. Nurs., 5, 109113.[Medline]
Foreman, D.M. (1999) The family rule: a framework for obtaining ethical consent for medical interventions from children. J. Med. Ethics, 25, 491496.[Abstract]
Hedley, M. (2000) Treating children: whole consent counts? Curr. Paediatrics, 10, 216218.
HFE Act (1990) The Stationery Office, London, SW8 5DT, ch. 37.
HFEA (1991) The Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991. Statutory Instruments. No. 1540.
Human Rights Act (1998) The Stationery Office, London, SW8 5DT, ch. 42.
Kagan, J. (1981) The Second Year: The Emergence of Self-awareness. Harvard University Press, Cambridge, MA.
Nelson, K. and Gruendel, J. (1981) Generalised event representation: basic building blocks of cognitive development. In Brown, A. and Lamb, M. (eds) Advances in Development Psychology. Lawrence Erlbaum, Hillsdale, NJ, pp. 131158.
Richards, M.A., Stockton, D., Babb, P. and Coleman, M.P. (2000) How many deaths have been avoided through improvements in cancer survival? Br. Med. J., 320, 895898.
Roth, E. and Roth, L. (1984) Children's understanding of psychiatric hospitalisation. Am. J. Psychiat., 141, 10661070.[Abstract]
Shields, J.M. and Johnson, A. (1992) Collision between law and ethics: consent for treatment with adolescents. Bull. Am. Acad. Psychiat. Law, 20, 309323.
Shucksmith, J., Hendry, L. and Glendinning, A. (1995) Models of parenting implications for adolescent well-being within different types of family contexts. J. Adolescence, 18, 253270.[ISI]
Sigman, G. and O'Connor, C. (1991) Exploration for physicians of the mature minor doctrine. J. Pediat., 119, 520525.[ISI][Medline]
Steinberg, L., and Silverberg, S. (1986) The vicissitudes of autonomy in early adolescence. Child Development, 57, 841851.[ISI][Medline]
Tanner, J.M. (1989) Foetus into man: physical growth from conception to maturity, 2nd edn. Castlemead, London.
Tissues Act (1961) The Stationery Office, London, SW8 5DT.
Turnbull, A.P., and Turnbull, H.R. (1985) Developing independence. J. Adolesc. Health Care, 6, 108119.[Medline]
Turner, R., Irwin, C., Tschann, J. and Millstein, S. (1993) Autonomy, relatedness, and the initiation of health risk behaviours in early adolescence. Health Psychol., 12, 200208.[ISI][Medline]
United Nations (1989) UN Convention on the Rights of the Child; Second UK Report. The Stationery Office, London SW8 5DT.
Weithorn, L. and Campbell, S. (1982) The competency of children and adolescents to make informed treatment decisions. Child Development, 53, 15891599.[ISI][Medline]
Yate, R.M., Milling, M.A.P. and McFadzean, W. (2000) Treatment without consent: a medicolegal precedent. Lancet, 356, 69.
Submitted on May 18, 2000; accepted on September 29, 2000.