Informed consent, capacity to consent and other issues issues

When dealing with an adolescent age group it is important to appreciate that it is a scenario whereby some participants will be old enough to provide informed consent whilst others can only provide informed assent with the supplement of parental consent.

The definition of informed consent is detailed in the Belmont Report (1978), the specification of which sets the standards for informed consent in research.

The report maintains that participants:

 Are given opportunity to choose whether or not they want to participate as a matter of moral respect for persons.

 That their decision should be guided by appropriate information

 Are given assurance of their comprehension of the information

 Are given affirmation of the voluntary nature of their participation

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 Are not coerced or undue influence controls the persons decision making

 Are given the opportunity to ask questions

 Information should include nature of the proposed study, purposes, risks, benefits, and alternatives to participation involving medical treatment.

(Belmont Report 1978) Informed consent in the UK is defined by the Economic and Social Research Council as “giving sufficient information about the research and ensuring that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision on their possible involvement” (ESRC 2010). However, there are many conflicting guidelines about when adolescents should be able or competent to be sole providers of this consent.

In the UK 18 years old is considered to be the legal age of majority, when individuals 18 years or above are able to provide their own informed consent.

This is also considered the legal termination of adolescence in England, Wales and Northern Ireland. As such it is difficult to involve adolescents in non-clinical research until they reach the age of majority (BMA 2001).

However for medical research the GMC (2007) states that “a young person may have the capacity to consent depending on their maturity and ability to understand what is involved”. This viewpoint is the result of the landmark ruling of Gillick v.s. Wisbech (1985) which established that individuals under 18 may give informed consent to medical treatment or research if they are deemed cognitively competent. This stance has now been adopted by the Department of Health (2001a) and the NCB (2004) who state that anyone aged 16 or over can consent to their involvement in research. The Medical Research Council (2004) discusses the varying age differences between consent for medical treatment and research, and in particular the differences between Scottish Law and the rest of the UK. Scotland are more liberal in their laws and provide young people aged 16 and above with the legal capacity to consent to involvement in treatment and research. This also applies to under 16’s providing that they have been deemed competent by a medical practitioner to make this decision. However in England, Wales and Northern Ireland there is “no legal statute governing people under the age of 16 to give consent for medical treatment or research” (MRC 2004). Hull (2000) reinforces

27 this sentiment asserting that “the law relating to research on children (defined by law as those under 18 years) has never been clearly established”.

This demonstrates a lack of consensus on the age of consent for young participants in low risk medical research (GMC 2007). More pragmatic assessments of the risks associated with individual studies may help decisions to be made regarding the appropriate age of consent for adolescent participants. The first issue for consideration is: Is the young person capable of giving fully informed consent having appreciated the risks and potential benefits? According to the ruling made in the hearing of Gillick vs. Wisbech (1985) if the adolescent has “sufficient understanding and intelligence to understand what is proposed then it is they and not their parents whose consent is required by law”. This refers to medical decision making and in the context of this specific benchmark lawsuit refers to the administration of the contraceptive pill to patients younger than 16 years old. However currently, this approach to obtaining consent does not include medical or general research with adolescents. The issue is also difficult to regulate as

“competence is socially constructed” and where cultural ‘norms’ differ in relation to the maturation of adolescents in different countries (Willow 2002).

The second issue is what is the probability that the participant will be at risk?

Minimal risk is defined as “the probability and magnitude of physical and mental harm that is normally encountered in the daily lives or in the routine medical, dental or psychological examination of healthy persons” (46 CFR part 46 303 Committee of Human Rights Policy, OHSR 2005) and the ethical framework from the ESRC (2010) outlines additional facets which contribute to this issue.

Alderson (2007) suggests that the situation of young patients with long term health problems and their ability to consider these issues may differ from healthy people of the same age.

“Young patients with chronic conditions have to consent to a lifetime of prescribed treatment regimens. When they show an understanding of their serious condition and potential treatment choices, it is no longer viable to speak of general incapacity below the age of 7, 10 or 14 as many commentators still do”.

28 In response to these perceived problems, Burke et al. (2005) describe a process of risk mitigation where the assessment and conclusion of minimal risk research and the provision of age-appropriate information and resources could result in adolescent participants in low-risk studies being able to provide consent on their own behalf.

In support of this are studies which have tested the competency levels of early and middle adolescents. One view is that many adolescents are competent before the age of 16 and indeed 18, to make these decisions. Weithorn (1983) tested this theory investigating children’s competency at 14 years old.

However this particular research has been criticised for the participant sampling of healthy, middle class cognitively normal adolescents. Since then others such as Leffert et al. (1996), Bruzzese and Fisher (2003) and Sanci et al. (2004) have championed the view that adolescents younger than 16 or 18 may have the cognitive capacity to provide their own informed consent.

In support of this is the General Medical Council guidance (GMC 2007) which acknowledges that “a young person under the age of 16 may have the capacity to consent depending on their maturity and ability to understand what is involved”. According to this guidance the decision to determine the competence of young patients/ participants is often left to authority figures such as doctors or counsellors and committees. In the case of medical treatment research it is common in the case of a minor patient (someone aged under 18 years), that the doctor will make a subjective decision regarding the patient’s capacity to consent and may, or may not consult with parents and other professionals (MRC 2004).

It would appear that until more standardised regulations are established between the relevant authorities and organisations, researchers will have to navigate the issue of adolescent consent to research participation with caution.

What is needed is a dialogue between ethics committees, researchers and the sponsors of research (who must assume liability for the risks involved) to establish good practice guidelines that ensure the highest ethical standards whilst also ensuring that the involvement of adolescent participants in research is not jeopardised (Dixon-Woods et al. 1999).

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2.4.1.1 Inconsistencies

Within the literature available it is evident that there are inconsistencies with regard to the issue of informed consent. The review of policies relating to age milestones in North America (Flicker & Guta 2008) describes a situation where conflicting regulations may appear unsound or confusing.

“A 13 year old (without parental consent) may obtain information about abortion from any number of sources, and subsequently terminate a pregnancy. However this same youth might require parental consent to participate in a formal study providing her with opportunities to make recommendations on the process and potentially improve conditions for other youth”

There are two major anomalies to the current recommended guidelines about when a person can provide consent. The first is that of emancipated minors:

people under 18 years of age who are no longer under the care or responsibility of their parents/ guardians, this may include young people who are in the army or who are married. These individuals, living independently from the power of a guardian may (in most states in the U.S and in the UK) consent to medical treatment and research involvement prior to reaching the age of majority which is deemed necessary for normal people of this age (Roddey-Holder 2008). The second is when a young person (under 18) has a child of their own and therefore can consent to their child’s inclusion in research but are still unable to consent to their own participation (McCabe 1996). Situations like this highlight the failings of the guidelines surrounding the matter of ‘age of majority’ and young people’s ability to consent to certain activities.

It is interesting that from a legal perspective, understanding ‘right and wrong’

and subsequent criminal acts that this is a very controversial area with regard to adolescents. According to Scott et al. (1995) there are two main fields of thought regarding adolescents in criminal law. Those who argue that adolescent legal treatment is unduly restrictive based on the idea that their capacity to reason and understand their behaviours is similar to that of an adult (especially by the middle adolescent stage). Opposors to this view subscribe to the more traditional paternalistic legal policies that are based on

30 the belief that adolescents make ‘poor choices’ due to immaturity and the risk taking attitudes described previously (Cauffman & Steinberg 2000).

An example of this interesting scenario occurred in the U.S in 1989. The Supreme Court extended the lower limit for the death penalty to include 16 &

17 year olds (Stanford vs. Kentucky 1989), meaning that a young person charged with murder could legally be sentenced to death but in the same country could not consent to a longitudinal study regarding their attitudes towards healthcare.

One last discrepancy applying to the issue of informed consent is when the nature of the research study and potential sensitivities of the content mean that consultation with parents is unlikely to be carried out. This was demonstrated by Webb et al. (1999) where a study of adolescents aged 13-20 was carried out within a sexual health clinic and “parental consent was not required since the majority of adolescents use the clinics for confidential healthcare”. Research that looks to investigate deviant, immoral or illegal behaviours is more likely to have difficulty recruiting if the young participants feel that their behaviour and views are likely to be divulged to adult relations.

The practice of not obtaining adult/ parental consent can on occasion be appropriate for research studies. The ESRC (2010) provide guidance on this scenario and is also examined within Subpart A of US Federal Regulations 45 CFR § 46.116 (2005). These state that “there may be circumstances where seeking consent from parents could jeopardise the research (for example research into teenage sexuality or teenage pregnancy)” (ESRC 2010) and where research would not be able to be carried out were it not for the waiver of parental consent (Tigges 2003).

These inconsistencies support the view that there is no clear point of cross-over from child to adult and that for research and industry this provides a major challenge.