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What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders
  1. Fiona Wood,
  2. Lucy Morris,
  3. Myfanwy Davies,
  4. Glyn Elwyn
  1. Department of Primary Care and Public Health, School of Medicine, Cardiff University, Cardiff, UK
  1. Correspondence to Fiona Wood, Department of Primary Care and Public Health, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4XN, Wales, UK; wood{at}cardiff.ac.uk

Abstract

Objective The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12–13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians.

Design Qualitative study using semi-structured interviews.

Participants A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation.

Results Overriding the parents' wishes was perceived as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine.

Conclusions While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting.

  • Minors/parental consent
  • informed consent

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Introduction

This article is concerned with the issue of how health professionals handle consent in relation to vaccination for human papillomavirus (HPV). In particular we examine how situations are managed when there is a difference of opinion between adolescent girls and their parents or guardians. The Family Law Reform Act 1969 gives the right to consent to treatment (but not to refuse) for anyone aged between 16 and 18 years.1 Although competence is assumed in those over 16 years old, in 1985 Lord Fraser established in the Gillick ruling that children under 16 years who can demonstrate their capacity to sufficiently understand the proposed intervention will have the capacity to consent.2 This is described as the young person being ‘Gillick competent’.

The UK government's sexual health strategy has promoted accessibility of sexual health services to under 16 year olds,3 and the administration of the HPV vaccine is one area where confusion over whose rights prevail is likely to occur. Decisions need to be made about whether the vaccine should be made available without parental consent and what the implications might be in terms of negative reactions from parents. The issues around HPV vaccination are particularly sensitive for three reasons: it is a vaccination for a sexually transmitted infection, the girls are young when they receive the vaccination (12–13 years) and there is still considerable resistance among parents to some types of vaccines.4 Recognising and tacking the uncertainty around this topic for HPV will have implications for the future introduction of vaccines for similar sensitive health issues, for example, other sexually transmitted viruses such as herpes and HIV.5

HPV is a common sexually transmitted viral infection that causes cervical cancer. There are a number of types of HPV infection. In the UK prevalence of HPV types 16 and 18 peaks in the late teens and early 20s following onset of sexual activity,6 7 and has been suggested to be about 40% in this age group.8 In the UK, the Department of Health has introduced a primary prevention programme to prevent cervical cancer and, from September 2008, girls aged 12–13 years became the first cohort to receive the HPV vaccine within a school setting.9 Two prophylactic HPV vaccines have shown excellent effectiveness against persistent HPV infection type 16 and 18: Cervarix and Gardasil. The Department of Health has opted to use Cervarix, but Gardasil has the added advantage of also preventing genital warts caused by HPV types 6 and 11. This decision that has come as a disappointment to many working within sexual health,10 and has raised the possibility of a two-tier population as more wealthy parents or girls may opt to pay for the Gardasil vaccine themselves.

Although a relatively high acceptance for the HPV vaccine has been anticipated,11–14 there has been some opposition to the national vaccination programme during its development. In particular parents have voiced anxiety that administering the vaccine may lead to increased sexual activity and promiscuity.15 In addition parents have raised concerns regarding the side effects and safety of the vaccine.11 15 The vaccination programme information leaflet and consent form encourages discussion between parents or guardians and their daughters regarding whether or not to accept the vaccine. However, the form only has space for the adult to sign, which suggests that those responsible for drafting the form believe a parent's signature is required before vaccination may proceed. Difficult situations may therefore arise if adolescent girls seek vaccination without parental consent. Similarly there may be occasions when the parents wish their daughter to be vaccinated but the girl refuses. Table 1 illustrates four potential scenarios regarding consent for the HPV vaccine, although other scenarios might emerge if either parent or daughter were ambivalent about whether or not the vaccination should proceed.

Table 1

Potential scenarios arising from parental and daughter consent or refusal to vaccinate

Guidance available to health professionals

For health professionals facing the scenario of an adolescent providing consent and parents refusing consent, there has been a clear precedent set with the ruling that competent girls under the age of 16 years may receive confidential advice for contraception without parental consent.2 A further ruling in 2006 upheld the guidance that, in some circumstances, contraceptive and abortion advice and treatment can be offered to young people without parental consent or knowledge.16 Additional guidance is available to health professionals relating to consent in children and adolescents.17–19 In summary, if a child is aged less than 16 years, they may accept treatment without parental consent if their competence to understand the decision can be established. There is no lower age limit in place. In guidance in Wales relating specifically to the HPV vaccination20 the message is: ‘for girls under 16 years of age who demonstrate Gillick competence, and who are appropriately informed, consent from parents/guardians is not required’. It is perhaps worth noting that while the HPV vaccine may not necessarily be medical ‘treatment’: it may reasonably be viewed as a medical ‘intervention’ so the same principles of consent that apply to contraception could be extended to vaccination.

Adolescents under 18 years of age may not necessarily refuse treatment (in England and Wales) that is intended to save their lives or prevent serious harm. However, strong caution is advised in instances where health professionals intend to overrule the refusal of a competent adolescent. The harm caused by violating a young person's choice must be balanced against the harm caused by failing to treat.19 21 Some practitioners and ethicists are disturbed by the apparent contradiction, enacted in the Family Law Reform Act,1 that young people have the right to consent to treatment, but not the power to withhold consent, as it suggests that the right to consent in reality represents only a right to agree with a doctor.22

Despite the guidance, there is evidence that healthcare professionals feel uncomfortable vaccinating adolescent girls for HPV without parental consent.23–25 There has been no research exploring other stakeholders' views (including head teachers and those involved in the development and delivery of the vaccination programme) on the process of consent for HPV vaccination. In particular, it is not known how situations will be managed when there is a difference of opinion between daughters and their parents or guardians regarding the vaccine and who should be able to ascertain if a girl is competent to provide consent for this vaccine. We therefore set out to explore the views of key stakeholders about how the process of consent should proceed where a potential conflict exists between parents and an adolescent daughter.

Method

Setting

We conducted semi-structured interviews with 14 professionals involved in the development of HPV vaccination programme in Wales. Typically, respondents held senior positions in their individual profession or organisation and were from a range of backgrounds including medicine, education, children's advocacy, public health, nursing and academic research. A second phase of ‘implementer interviews’ was then conducted to further explore the issue of how professionals would proceed without parental consent. For this second phase 11 semi-structured interviews were conducted with school nurses of varying seniority and general practitioners (GPs).

Sampling and recruitment

The main stakeholders in the area of HPV vaccine policy were identified through discussions with colleagues working in the field of HPV. Searches were made on a number of websites, for example the National Public Health Service for Wales website http://www.publichealthwales.wales.nhs.uk. The sample was supplemented by snowball sampling: during interviews respondents were asked if they knew of any other professional who may be relevant to the study. The snowball sampling process continued until respondents were not able to suggest any stakeholders who had not already been interviewed. All stakeholders who were approached agreed to be interviewed. The method used to identify respondents in the second phase of ‘implementer’ interviews was similar to that used to the first phase—a website search of local health services and snowball sampling. This method identified a number of school nurses and GPs who had a particular interest in teenage health and sexual health. Initial contact was made with potential respondents usually by email or telephone followed up by a letter. Five respondents who were approached declined to be interviewed: two because they felt they did not know enough about the topic and three due to time pressures. We stopped data collection when respondents were not providing any further fresh insights: a point of theoretical saturation.26

Data collection

All interviews were conducted by LM, an academic GP. The semi-structured interviews were based on an interview guide consisting of six broad topic sections: the nature of their involvement with the HPV vaccination programme, views on potential problems with implementing the programme, the process of consent within the programme, issues of conflicting consent between parents and child, who can decide competence, and support available for professionals when dealing with the process of consent. Each section contained more detailed questions and the interviewer pursued emerging issues as well. Interviews were audio-recorded and transcribed.

Analysis

Data were analysed using thematic content analysis.27 This method of analysis is essentially a process of categorising data according to a thematic framework (or coding scheme) and key themes are summarised.27 The thematic framework was applied to the data using the coding software package NVivo8.28 Interpretations were discussed between all authors.

Ethical considerations

Ethical review was sought and granted. Respondents were provided with an information sheet and signed a consent form prior to the interview. Transcripts were anonymised. Protecting the identity of ‘elite’ respondents poses problems when researching a specialist field. To aid concealment of individual identities, we have not provided details of respondents' professional details alongside ID number for data extracts. However, respondents R1–R14 are policy-makers, and respondents R15–R25 are HPV vaccine implementers.

Results

Twenty-five respondents agreed to participate in the study. We discuss the results in four parts, all of which relate to table 1: (1) dealing with a lack of parental consent (daughter consents/parents refuse); (2) problems in establishing Gillick competency (daughter consents/parents refuse); (3) situations when a vaccine would be withheld (daughter consents/parents refuse); and (4) dealing with instances where girls withhold consent (daughter refuses/parents consent).

Dealing with a lack of parental consent

Only three respondents expressed the view that there was no, or minimal, ethical dilemma for professionals in situations where there was no signed parental consent for the HPV vaccine. All three of these respondents were involved in the development of the vaccination programme rather than its implementation. For these respondents, consent could fairly unproblematically be dealt with under the Gillick guidelines.

R13: I do think that if there is a situation where parents, perhaps for religious reasons or whatever, do not want their daughter to have the vaccine and the girl does want to have it, then I think we need to look at how her rights can prevail and, I think, for me it's a parallel with the Gillick contraception.

R2: It's pretty straightforward. The principles of consent for those who are under sixteen are all very well worked out.

R3: We prefer for twelve and thirteen year olds to have parental consent, but we will recognise that they can, obviously if they fully understand it, make decisions in their own right.

A further four respondents expressed the view that although the Gillick guidelines were helpful in situations where parents and daughter disagreed about whether they should have the vaccine, parents should also be informed that the girl had given consent for herself and, where possible, their agreement for vaccination sought.

R14: I think you'd probably need to make some contact with the parents, just to make sure because I can understand that they would be perhaps rightfully a little bit irritated that they had never been told. Yeah, although the girl can consent on the day, I think the parents do need to be involved.

R9: At least get the parents' acknowledgement that this is what you plan to do and have a discussion about it. Because if you were to immunise a Gillick competent girl and her parents were dead against the vaccination, the ripples that that would cause in the school, you know “the nurse immunised my daughter even though we were against it”. It doesn't really matter what the law would say, you've undermined confidence in the service. There are consequences. And so I think it would be very unwise to simply say “This girl is Gillick competent, I'm not going enter into discussion with the parents and I'm going to vaccinate her now.”

In particular, one head teacher felt very uneasy about overriding lack of parental consent with consent from a Gillick competent child. Even though he was aware that legislation existed to establish consent from the girl, he felt that the family's relationship with the school could be damaged. Professional anxiety about administering the vaccine against parental preference may be related more to the need to work with parents pragmatically rather than a principled defence of parental decision-making.

R10: I would feel very uncomfortable about that because what we are trying to do is build up relationships with parents here. I am asking parents to support the college in terms of rules, regulations, etc., and here I am then saying to parents, “Well in this case tough, what you say really does not count.” It puts us in a very awkward position. I think all I could do is say to them “Well this is what the law allows these days.”

Nearly all respondents also reflected on some of the practical difficulties of establishing parental consent for a school-based vaccination programme. Such difficulties included children forgetting to take the form home to their parents or not returning the form to school, and parental ambivalence about the vaccine.

Respondents reflected that these problems made it more difficult to assess whether there was genuine parental objection to the vaccine or merely a lack of parental engagement with the process. Four respondents felt that clarification on the reason for lack of parental consent would need to be established before the person administering the vaccine could decide whether the vaccine could be given. In the following extract the respondent has incorrectly referred to the Fraser guidelines (which specifically address the dilemma of providing contraceptive advice to girls without the knowledge of their parents) rather than the Gillick guidelines (which more broadly refer to children under 16 years having the legal capacity to consent to medical treatment and examination if they can demonstrate competence).29

R8: If I know that this particular twelve year old girl is at risk of contracting an illness for which there is an injection that will prevent this illness then it is most definitely in her interest to give it to her, even if her parents don't agree, because she is Fraser competent, she understands and she can agree to her own medical treatment. So in that case I would go ahead and give it to her and get her to sign the consent form. If on the other hand I just think that her parents have not read the form right or just think that they haven't really understood, then that is a different scenario, and it would be worth following it up, making sure they received the pack and making sure they have read it. You see the reality is that if you are a parent of a twelve year old and they will shove the form under your nose at breakfast time and you know they are trying to get two children off to school, they are trying to get to work. You know life is too fraught, so you need to know the circumstances as to why the consent form is not signed, is there an ideological reason, is there a cultural reason, is there a disorganisation reason?

Problems with establishing Gillick competency

Although all respondents recognised that the Gillick guidelines were relevant, they still felt that in a school-based vaccination programme there were significant problems in establishing whether girls could be assessed as Gillick competent. These concerns particularly reflected the views of school nurses, nurse educators and GPs within the sample. One major problem, expressed by a range of respondents (including the school nurses), was that school nurses would not be comfortable in assessing Gillick competence. These opinions related to issues of professional limitations and time restrictions given the constraints that the school nurses were working within.

R17: If everybody is given 30 seconds to get in and out, you can't reasonably expect a nurse to make a decision in that time. Yes or no? They would have to make some sort of later appointment to speak to the young person and have a serious chat, which in itself then would single them out from, you know if there was a mass queue.

R12: I think the people who administer the vaccination are going to have to be obviously Gillick trained. You are going to have to get the nurse to, before she starts the programme, to say that she's happy to make decisions on competence. The people who are administering it have to have the capability of being able to assess competence and, if they don't, well then they shouldn't be giving the vaccinations.

The young age of the girls was also considered a barrier to establishing consent in a school setting. Three of the nine nurses were very uncomfortable with assessing Gillick competence in such circumstances. One other nurse felt that they might receive some professional protection by careful documentation of the Gillick assessment and consent-taking process.

R20: What I wouldn't like to do is if I had a twelve or thirteen year old child sat in front of me, because assessing maturity under the Fraser guidelines is slightly different.

R19: I would feel very uncomfortable vaccinating without written consent because it's so controversial at the moment. I would want some form of documentation about the discussion I had with the girl.

Situations in which the HPV vaccine would be withheld

Four school nurses explained that they would not give the vaccine if parental consent had not been given. In two of these instances the nurses told us that they were following a policy of their Health Trust, but in the other two cases the nurses suggested that they were acting on their own discretion. The two senior nurses felt that their staff were capable of deciding competence but their junior colleagues contradicted this and were more reluctant to take responsibility for such decisions.

R24: From the nurse's point of view, because we use a directive which says it must be parental written consent, we would not have been able to give it. So I would probably have brought that child to a clinic situation where it would have been a doctor who would probably have been able to accept the child's consent.

R18: Well, if the consent form has not come back and it hasn't been signed, then they don't have it. They don't have it. We have had children come in with consent forms that they have given to their parents but the parents have not signed them, “Yes, my mother wants me to have this”, and it would be easy for us to say ok, sign it, but from a legal stand point I don't think it would be a good idea to do that. [Interviewer: So would you take the parents' verbal consent over the phone?] No.

Dealing with instances where girls refuse the HPV vaccine

None of the respondents suggested that a girl should be vaccinated against her consent. Forcing the HPV vaccine onto a girl was generally considered to be assault and an unimaginable situation. However, unlike the opposite situation where parents refuse and daughters wanted the vaccine, respondents did not reference any legal framework. One respondent did allude to the fact that if girls could be judged competent to consent for the vaccine then they should, in principal, be judged to be competent to refuse it. Respondents felt that the few cases they had either personally dealt with or had heard reports of where parents had consented to the vaccine and girls refused were mostly related to needle phobias, ‘attention-seeking’ and fear of the process rather than fear of the vaccine side effects or safety. Girls' refusals were therefore considered to be emotional responses and a consequence of immaturity.

R22: We did have one young girl who has got lots of problems, who refused and refused, and we got her grandmother in, grandmother wagged her finger at her and made her sit down, she sat down and had the injection. She was attention-seeking that one. There are problems: needle phobics or vaccine phobics or attention seekers.

Respondents who worked at policy level stated that in such circumstances a letter would probably be sent home to parents simply stating that their daughter had refused the vaccine.

R2: Well you can't give a reluctant thirteen year old a vaccine (laughs). Practically, it's not possible because if they physically refuse to have it then you can't force them to have it, that's an assault even though the parents may consent. So, the girl needs to be persuaded, even if she doesn't agree with it herself, she needs to be persuaded that it's in her interests to receive a vaccine.

R5: Well if we decide that they can make that decision to have it, then you have to partly accept the decision that they do not. I think you have just got to put it on hold and say, well perhaps we can revisit this again at another time. I don't think you can actually physically force the girl to have it.

The school nurses in the sample, however, described a number of measures that they would employ to persuade girls to have the vaccine including reassuring them, asking a colleague to hold the girl comfortingly, asking them to return at the end of the session, and asking the parent or guardian to come to the school to reassure the girl. The difference between these two approaches suggests there may be a contrast between the official respect for autonomy from the policy-makers and the more practical steps to inform and gain consent from those delivering the vaccine.

R23: I certainly wouldn't give it, because we have nervous girls and I mean we are used to dealing with this, and you say ok, if you really don't want it off you go, but then they say well I know I really should have it. And you say “Just put your courage in the nurse.” So no, if the parent had signed and it wouldn't matter if the parent shouted down the phone “Tell her she has got to have it”, we don't operate that way.

Discussion

Principal findings

Our research indicates that currently there are different approaches adopted in relation to guidance on whether adolescent girls can provide consent for HPV vaccination in the absence of their parents' written consent. We found that while there was broad agreement that the guidelines on Gillick competence are relevant to situations where parental consent is absent, professionals tasked with organising and implementing the HPV vaccine school programme still have significant concerns about vaccinating without parental consent (or parental knowledge). Specifically, there were concerns relating to how those administering the vaccine can determine the reasons for absence of parental consent, how vaccination in the absence of parental consent might damage parents' relationships with the school or have wider implications on the vaccination programme in the school, how Gillick competence can be assessed within a school setting, and whether school nurses have the skills to assess Gillick competence. Some school nurse teams are implementing a policy of non-vaccination in the absence of parental consent. There also seems to be a general acceptance that the vaccine is not given in instances where the girl refuses her consent but parents give their consent.

Strengths and weaknesses of the study

We aimed to interview a wide range of stakeholders who are involved with the development and the implementation of the HPV vaccination programme. While we have achieved that aim, our data reflect views of a heterogeneous sample of health advisors, policy-makers, teachers, medical professionals and school nurses. The sample size is fairly small for qualitative study and respondents were not systematically sampled, but this was an exploratory study and respondents were selected on the basis of their views being likely to yield theoretically interesting insights.30 We had a good response rate with 25 individuals agreeing to be interviewed from the 30 individuals who we approached.

Results in context

To our knowledge, this is the first study to examine issues of consent from the prospective of a range of stakeholders. Previous quantitative research has investigated parents' attitudes to vaccinating adolescents with the HPV vaccine without parental consent.11 A qualitative study has also explored school nurses views of providing the HPV vaccine to 12–13 year old girls without parental consent and found that school nurses knew how to assess competency in under 16 year olds but were still unwilling to vaccinate if parents had refused permission.24 Our study confirms these findings. A qualitative study has also been undertaken of GP and practice nurses' views of managing conflicts between parents and their daughters with respect to vaccination decisions.25 Results from this study indicated that there was a great deal of confusion among GPs and practice nurses as to whether the parents' or the daughter's decision should be prioritised. Our study builds on this previous work, but our focus is on the interaction at the school level rather than within primary care. There has been no previous research on the views of policy-makers of how consent-conflict between parents and daughters should be managed. This is significant because we found that there are tensions between the views of policy-makers and those implementing the vaccine. Policy-makers tended to view the guidance as relatively clear and downplayed some of the ethical dilemmas. By comparison, those involved in giving the vaccine, managing the consent procedures and assessing competence suggested that the guidance was being implemented inconsistently and at times they were not clear as to how to proceed.

Implications (for policy, practice, research and education)

Although it is likely that disagreement between parents and their daughters will only happen in a minority of situations, it is these situations that may potentially cause most difficulties. Currently, there is no consistent guidance as to how to proceed if these disagreements arose. We would suggest that more details are provided to assist professionals in these potentially difficult situations. In particular we would suggest the following.

  • If parents have refused consent but the girl wishes to have the vaccine, the vaccine should be given if the girl can be assessed as Gillick competent.

  • If the girl claims that her parents have forgotten to sign the form, or says her parents are ambivalent about whether or not she has the vaccine, then she should be given the vaccine if she can be assessed as Gillick competent.

  • If the girl is ambivalent or refuses to have the vaccine, this refusal should be accepted, even if parents have consented to the vaccine. However, it is reasonable for a school nurse to advise the girl that it is in her best interests to have the vaccine or arrange for further information to be given alongside a discussion with her parents.

  • If the girl is ambivalent about having the vaccine, and her parents have not signed the consent form, then she should not be given the vaccine, but given further information and a discussion arranged with the parents.

Those administering the vaccine need to be confident in their local guidance on how to manage difficult situations and will need to ensure that they are able to assess competence in adolescents, should this be required, or be able to refer the girl to somebody who can make that decision. School nurses should have the confidence that their decisions regarding Gillick competence are supported by senior colleagues and the nursing unions. Head teachers will also need to be familiar with the guidelines and prepared for objections from parents.

The vaccine is relatively new and has raised a great deal of interest as the first vaccine that can protect against cancer but also as a vaccine against a sexually transmitted disease. The findings and recommendations of this study have implications for the possible introduction of vaccines for other sexually transmitted diseases such as herpes and HIV. Conflicting consent for this vaccine, and others like it, needs to be a negotiated process between parents, adolescents and the vaccinators, and not a process determined by a form that is subject to loss and confusion.

Acknowledgments

We would like to thank the respondents who participated in this study.

References

Footnotes

  • Funding Research costs were met by the Department of Primary Care and Public Health, Cardiff University.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the South East Wales Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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