Informed Consent for HPV Vaccination: A Relational Approach
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- Gottvall, M., Tydén, T., Larsson, M. et al. Health Care Anal (2015) 23: 50. doi:10.1007/s10728-012-0237-9
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The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent’s choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.
KeywordsHPV vaccinationInformed consentRelational autonomySchool nursingSweden
Human papillomavirus (HPV) is one of the most common sexually transmitted infections (STI) in the world, and some HPV types have been shown to cause cervical cancer . Therefore, vaccination against cervical cancer (HPV vaccination) is part of the national child vaccination program for girls in several countries. Some countries have a school-based HPV vaccination program [13, 18, 23, 28], while others administer the vaccine through health facilities . The effect of the vaccine is optimised if administered before sexual debut; consequently, the target population in most countries is girls between 10 and 14-years-old [21, 25]. In Sweden, all girls 10 to 12-years-old will be offered the vaccine Gardasil through a school-based program starting in 2012.
According to Swedish law (1983:47), a parent or guardian has ‘the right and responsibility to decide on issues regarding the child’s personal affairs’. Thus, a child younger than 18 years old needs the consent of a parent or guardian for medical interventions. However, the law also states that as the child grows older and becomes more mature, his or her wishes should be taken more into consideration. This is in accordance with the UN Convention on the Rights of the Child, which includes a devotion to the best interests of the child (Article 3), a child’s right to good quality health care (Article 24), and a child’s right to privacy and personal integrity (Article 16) .
In accordance with this, adolescent clinics in Sweden that focus on STI prevention and contraception are accessible to minors without parental knowledge and consent. This can be compared to the legal situation in the United States, where all states allow minors to consent for their own health care in some circumstances, e.g., family planning services and treatment of STIs . Also in Great Britain, a minor who can demonstrate his or her capacity to sufficiently understand the proposed intervention has the right to give informed consent in certain circumstances [3, 30].
Introducing HPV vaccine as part of a school-based program has been shown to cause conflicts of interest for school nurses . For example, it can be a difficult task for the health care staff to decide if a child is mature enough to make an informed choice. A British study found that school nurses were uncomfortable in assessing a child’s competence to make a decision of her/his own in a school-based HPV vaccination program .
The nurses found it problematic to override the parents’ wishes regarding HPV vaccination as they believed it could damage the relationship between schools and parents . It has also been reported that school nurses were unwilling to vaccinate without parents’ permission, but were prepared to contact parents who had not returned the consent form and to negotiate with those who had refused consent for vaccination of their child . Further, the nurses acknowledged the child’s right to vaccination and prevention of HPV infection, but they found the guidelines governing consent to be confusing.
To our knowledge, no studies thus far have investigated the perceptions of Swedish school nurses or other health care staff regarding informed consent for HPV vaccination, with a focus on the, sometimes, fine line between the parents’ responsibility and the minor’s integrity and autonomy.
The professional obligation for a school nurse is to promote the children’s well-being, protect them from harm and respect their integrity. A possible dilemma in school nursing is balancing the child’s integrity and best interest with the parents’ right to make autonomous choices on behalf of their children. The concept of autonomy is well-established in Western bioethics. In order to reject medical paternalism, not only the ethical principle of well-being, but also the principles of autonomy and self-determination have been promoted.
Autonomy can be seen in various ways; e.g., as a right or as a competency . It can also be part of a view of the human nature (i.e., as human beings we have a capacity of and often want to govern our own lives). Based on this view on the human condition, the Self within Western moral philosophy has (from Descartes and onward) been considered as individualistic, isolated and ahistorical; something that Ho calls an “acontextual notion of identity” . This implies, she argues, the refutation of intimate relationships, based on collectivity and particularity. The favored ideals are independence and control. The individual is seen as separated from others and in right of free choices, without undue pressure from other people .
One way to achieve autonomous decisions in medical practice is the procedure of obtaining informed consent from either the patient or the guardian of the patient. According to Beauchamp and Childress’s classic definition, informed consent consists of disclosure and understanding of information, voluntariness and consent .
The critique against the traditional philosophical view on autonomy has mainly concerned the individualistic approach it assumes, where the moral agent is seen as independent and isolated. According to Donchin , autonomy has been identified with non-interference. She develops an alternative model, in which the relational aspects of autonomy are highlighted, in order to better deploy the care providers’ relational capacities and enhance the autonomy of the patients. Such relational care differs from “generalized beneficence”, which can be defined as “disinterested” in that it concerns doing good to “undifferentiated others” . A relational approach, on the other hand, requires shared activity based in the integrated lives of the care provider and the patient.
Consequently, the basic conviction in theories on relational autonomy is that “persons are socially embedded and that agents’ identities are formed within the context of social relationships and shaped by a complex of intersecting social determinants, such as race, class, gender, and ethnicity” . According to this position, individuals might have interests related to other persons that are close to them. They may not necessarily regard this as a restriction of their autonomy; rather they might see it as a voluntary and even emotionally preferred involvement of the close ones in their lives.
Today we see an increased interest in family centered care in health care research [15, 20, 24]. However, there are worries that involvement of the family might challenge professional authority and/or intervene in the patient’s decision making in a problematic way; i.e., place ‘undue pressure’ upon her .
For most patients the relations with their close relatives or significant others are of great importance. The family is part of the individual’s identity and relational self. A broad conception of the family suggests that a family contains people who are emotionally or psychologically close to one another . However, when it comes to parents’ right to decide over their children, the family is defined by law, as it is the biological or adoptive parent, i.e., the legal care takers, that can decide on behalf of the child. This does not mean that other individuals could not be part of the broader “family” and relational context the patient is part of and situated in.
The core concept in a framework of relational autonomy is that individuals are seen as interdependent and embedded in social contexts. Arguably, relational autonomy can be linked to a deliberative approach to ethics; a communicative model where ethical decisions are made in a democratic dialogue  and through negotiations. Furthermore, this theoretical starting point makes it possible to explore the role of the family in a school nursing context, as well as how autonomy should be regarded when it comes to children and decisions concerning their health and future welfare.
The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones.
Materials and Methods
This study is based within a wider investigation of Swedish school nurses’ perceptions of a school based vaccination program against HPV. The study was qualitative, using focus group interviews, and was carried out soon before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy.
We chose focus groups interviews, as this method is particularly suited when studying attitudes, knowledge, and experiences of groups with an expected moderate knowledge regarding the topic at stake. The group process in focus groups can help people to explore and clarify views in new ways. However, a weakness of the group dynamics is that the articulation of group norms may silence individual voices of dissent . Nonetheless, more active participants can also break the ice for shier participants, which may lead to a more meaningful discussion. In this case, the interaction was good and led to rich discussions in all groups. The groups were homogenous and in general, the school nurses had similar opinions.
School nurses (n = 70), from five strategically chosen municipalities, were invited to participate. The strategic choice was made in order to get a mix of larger, smaller, urban and rural municipalities. Thirty school nurses were interviewed in five focus groups. School nurses from the same municipality were grouped together. Each group consisted of four to eight female school nurses. The median age of the school nurses was 48 (range 35–60), and 19 of them had worked for 5 years or more as a school nurse.
A semi-structured interview guide on the school nurses’ perceptions of HPV vaccination and obtaining informed consent was used. The interview guide covered a wide range of questions in relation to school based vaccination against HPV, such as the nurses’ general views on HPV vaccine, how they regarded the fact that only girls are to be vaccinated, cultural factors as well as views on information and consent. The questions on consent were developed in light of the theoretical framework described above, in that they covered topics such as the parents’ role, the minors’ right to self-determination, and possible ethical dilemmas in the consent process. In the present article, the results regarding informed consent are presented; the remaining results are presented elsewhere .
The coordinating school nurse in each municipality was asked to contact school nurses in her municipality and distribute the informational letter about the study. On the day of the focus group interviews the nurses again received written and verbal information about the study. The interviews were led by a female moderator (MG) and were supported by a female observer (ATH or CS). The interviews lasted between one and one and a half hour and were audio-recorded with the permission of the participants. Thereafter, the interviews were transcribed verbatim.
Example of the content analysis
Condensed meaning unit
Well, we can’t break the law, then we have to get guidelines about it. We, ourselves, can’t just decide this and that.
We can’t break the law, but we need guidelines
Have to follow the law
Basically, I think a 15-year-old should be allowed (to decide about vaccination)
A 15-year-old should be allowed to decide about vaccination
15 years as age limit for consent
The project was presented to the Regional Ethical Review Board; however, according to Swedish regulations, permission for the study was not needed from the board. Ethical requirements, as outlined in the Declaration of Helsinki , were fulfilled.
The categories and subcategories that emerged through the content analysis
Complexity of consent and autonomy
Problems with obtaining consent
Disagreement between child and parent
No doubt about needing parents’ consent
Adolescent minors’ consent could be discussed
Striving for dialogue
Negative consequences for the child
Feelings of inadequacy
Complexity of Consent and Autonomy
No Doubt About Needing the Parents’ Consent
It’s totally their responsibility [the parents’] (Nurse 4, Group 1).
It has to be according to the law. The children are minors, from a juridical point of view (Nurse 4, Group 4).
That’s the instructions we’ve got. There’s nothing we can do about it (Nurse 4, Group 2).
Adolescent Minors’ Consent Could be Discussed
The nurses compared HPV vaccination with other things that 15-year-olds are allowed to do, such as engaging in sex, getting prescriptions for hormonal contraceptives and even undergoing an abortion, without parental consent in some cases. Therefore, they felt that decisions about one’s own body should be up to the individual at the age of 15. Some of the nurses also expressed that they would be willing to help 15- or 16-year-old girls to get vaccinated without parental consent, although they identified it as an ethical dilemma.
Yes, if it was possible, if the law didn’t exist, then I definitely think that 15-year-olds should make their own decisions (Nurse 2, Group 4).
I know what I would have done, but I don’t want to say it… If they are in high school and are 16-years-old, then I think they should be able to decide, even if the parents say no. And then I would probably help them to get vaccinated without the parents’ consent. I would work undercover, so to say. I wouldn’t give them the shot myself, but I would give them a phone number and the name of someone they could go to (Nurse 3, Group 2).
Striving for Dialogue
The school nurses also described how they already worked in order to create this joint agreement on what should be decided and how they were prepared to continue this work also when it concerned consent to HPV vaccination
It would be difficult for me to deprive the parents of their role, I must say. I think… it’s important that the parents participate (Nurse 1, Group 5).
Well, then we will have to do as we already do, and the parents will have to be present. Participate, simply enough./—/For a while you can go on and negotiate, back and forth (Nurse 4, Group 4).
And it will be something like… you tell [the child] that now it’s time, and you must bring this [the consent form] home, because your mum and dad must decide for you (Nurse 4, Group 1).
Problems with Obtaining Consent
The nurses also believed that they sometimes did not have time to contact parents who did not return the consent form.
Slightly troublesome, forms are lost and so on (Nurse 6, Group 4).
School-based vaccination is voluntary/—/We might get those who don’t answer, but for how long should we be chasing them? (Nurse 5, Group 3)
The nurses also believed that some immigrant parents had a tradition of listening more to authorities; therefore, they thought that more information and recommendations should come from a physician or from The National Board of Health and Welfare.
Well, about the information… parents who aren’t Swedish… They should [get it] in their own language, yes, but… it’s another culture (Nurse 5, Group 4).
Some of the nurses also expressed a concern that girls from certain cultures risked being discriminated against, as their parents might not consent to the HPV vaccination as it protects against a sexually transmitted disease, which might be apprehended as a sensitive issue.
If the doctor says something, you do it (Nurse 3, Group 1).
I think of these immigrant girls, if the parents say no and the girl wants to have the shot… That would be really tough for me (Nurse 1, Group 3).
Are we discriminating them then, if they don’t get a ‘yes’ from their parents and so they don’t get the same [as the other girls]? That could be a dilemma (Nurse 3, Group 2).
Disagreement Between Child and Parent
Negative Consequences for the Child
Some nurses further mentioned that the disagreement between the child and the parent could also go in the opposite direction, i.e., the parents wanting their daughter to have the vaccination but the girl refusing to take it. That was also something they had experienced when it concerned other vaccinations.
They can get contraceptive pills and have an abortion without the parents’ knowledge, but we are not allowed to give them a shot that would protect them (Nurse 5, Group 3).
In such cases, the nurses did not believe that the girl should be vaccinated against her own consent, even though her parents supported it.
They [the girls] forget their consent-forms on purpose and so on. Someone might even fill in ‘no’ before their parents sign it (Nurse 3, Group 4).
We won’t force them (Nurse 4, Group 4).
Feelings of Inadequacy
I would feel bad about it myself if I had a girl in front of me who wanted the vaccination and I had a flat refusal from the parents. That would be really difficult for me (Nurse 2, Group 2).
I agree, I would find it really hard, if they [the girls] really wanted the vaccine (Nurse 5, Group 2).
The school nurses in this study all agreed that parental consent was necessary in order to vaccinate 11-year-old girls, but they also expressed concerns about the consent procedure as well as a complexity in the questions of autonomy for minors. The need for parental consent was expressed with reference to the law, but there also seemed to be some confusion about what the law states, since many school nurses believed that no minor could execute self-determination in medical issues; therefore, they saw the law as a barrier to vaccinate even 15 to 16-year-old girls without parental consent. In fact, the Swedish law (1983:47) states, in accordance with the UN Convention on the Rights of the Child, that as the child grows older and becomes more mature, his or her wishes should be taken into consideration. A British study found that school nurses can find the guidelines governing consent to be confusing . Our study further displayed an uncertainty among the school nurses of what such guidelines actually state.
Although parental consent was seen as obvious for young girls, the nurses did not believe that this should apply for all minors under the age of 18. Rather, they seemed to favour competent minors’ right to autonomy, in line with findings in other contexts . From an ethical point of view, respecting the parents’ autonomy is one important ethical value. However, what makes this a dilemma for the school nurses is the fact that there are other important values at stake too, primarily the value of protecting young girls from the risk of developing cervical cancer, but also the girl’s moral right to autonomy and self-determination.
According to theories on relational autonomy [14, 15, 19] the young girl and her parents are situated in a web of relationships and the consent procedure is to be a cooperative venture, as no person is isolated, but always situated and embedded. Consequently, obtaining consent in school nursing should not be framed within an understanding of autonomy as non-interference or a strive for doing good to “undifferentiated others” . Rather, this context displays the integration of lived experiences the parents share with their children and to which the school nurse is temporarily included.
On several occasions the nurses expressed the view that obtaining consent to HPV vaccination should be seen as a joint process in which the child, the parents and the school nurse are to be involved. The school nurses described how they worked on establishing a dialogue with the parents when informed consent was needed and that they intended to do so in the case of HPV vaccination, too. This resembles the results of Stretch et al. , who found that school nurses were willing to negotiate with parents in the consent process.
However, the challenge with an approach of relational autonomy is to account for power differences in various relationships, not least when it comes to decisions within families and parents’ authority over children. It has been argued that family members may have divergent values and priorities; hence, the family’s involvement in medical decision-making could counter patient autonomy and the patient’s best interest . This concern was also expressed in our findings. In cases when the parents would consent, but the girl would refuse vaccination, the nurses were not willing to force a girl to get vaccinated even though they had parental consent, supporting the assumption that they favoured the minor’s right to autonomy.
On the other hand, in line with previous research , the nurses in our study also found it difficult to go against the parents’ wishes. They expressed concerns that could be interpreted as moral distress [5, 16] if there were disagreements between the child’s and the parents’ wishes, especially if a girl would want to get vaccinated but the parents would not support it. The nurses were also willing to help an older girl (15 to 16-years-old) to get vaccinated, without the parents’ knowledge. They compared HPV vaccination with other sexual and reproductive health services offered to minors without parental consent, such as contraceptive pills and STI treatments. This notion has also been presented by Farrell and Rome .
From a relational point of view a further challenge is to account for power differences between the school nurse and parents from less educated contexts as well as parents who belong to a minority culture. Our study showed that cultural factors might create a barrier between the nurse and the parents, e.g., when immigrant parents did not understand the information given.
Based on this view, the decision on whether to vaccinate or not needs to be set within a framework of a democratic dialogue, in which everyone who is concerned can take part and it is the strength of the argument that counts, not who is delivering it . The promising part of seeing autonomy as relational is the opportunity to promote a dialogue that can increase the power of those with limited or constrained autonomy. In this case it relates to young girls, particularly young girls from strongly patriarchal and hierarchical family traditions, and to parents from minority cultures with limited knowledge of the vaccine. The relational approach can make conflicts of interest within a family or between the school and the parents visible and promote a dialogue that could strengthen the autonomy of both child and parent, without necessarily destroying the family bonds.
Limitations and Strengths
Our study was qualitative, thus, the results cannot be generalised to a larger population. Further, the investigation took place before the school based vaccination program was launched, so the school nurses could only reason hypothetically. We do claim, however, that our investigation has captured important aspects of informed consent to HPV vaccination for adolescents, transferrable to similar settings, and that the fact that the study was done before the launching of the program could be informative for school nurses when the program actually started. Finally, our study is an example of empirical ethics , in that it is both descriptive and normative, using the empirical results as the basis for the normative ethical discussion.
The ethical dilemma in the consent process for HPV vaccination concerns the child’s best interest, the child’s right to self-determination and the parents’ right to make autonomous choices on behalf of their children. From a relational point of view, individuals have interests related to persons close to them, which opens up for a more relational view on autonomy and a dialogical approach towards how consent is to be collected in school nursing. With such an approach conflicts of interests are made visible and become possible to deal with in a dialogue involving the parents, the child and the nurse, striving to reach a decision that all parties can accept. If the school nurses focus exclusively on accepting the individual parent’s choice, other important ethical values might be lost. If they instead strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.
This study was funded by the Swedish Cancer Society and the Solsticke Foundation. We are most grateful to the school nurses who participated in the investigation. Thanks also to the Ethics of Family in Health and Social Care Research Consortium as well as to the anonymous reviewers of HCAN for helpful comments on earlier versions of the manuscript.