Problem Solving Assignment 1 After reading the chapter on ethics and the assigned Lind and Neutel articles, please examine the attached Informed Consent developed for adults who were interested in participating in an intervention program, which was going

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DOI: 10.1191/0969733003ne632oa

2003 10: 504Nurs Ethics Candace Lind, Beverly Anderson and Kathleen Oberle

Ethical Issues in Adolescent Consent for Research

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ETHICAL ISSUES IN ADOLESCENT CONSENT FOR RESEARCH

Candace Lind, Beverly Anderson and Kathleen Oberle

Key words: adolescents; children; consent; empowerment; relational narrative; research

Different opinions are expressed in the literature regarding when children and adoles- cents can start to make decisions to participate in research and give informed consent. Nurses are frequently involved in research, either as investigators or caregivers, and must therefore have a thorough understanding of consent and related issues. In this article the issues are explored from a Canadian perspective. The argument is put forward that ado- lescents may be capable of a greater involvement in the research consent process than is the norm. Increasing adolescents’ involvement in research has the potential to enhance their growing autonomy and capabilities. Adolescents appreciate being treated with respect and dignity by adults. This can be achieved in an environment in which protec- tion from harm does not also mean prevention from decision making. The use of empow- ering processes by nurses to enhance adolescent involvement will provide benefit to adolescents in their transition to adult levels of responsibility.

Introduction There are different opinions in the literature regarding when children can start to make decisions to participate in research and give informed consent. Nurses are frequently involved in research, either as investigators or caregivers, and must therefore have a thorough understanding of consent and related issues. Nursing roles could include protecting adolescent rights,1 advocacy to help to ensure that adolescent voices are heard, and policy development for children as human research participants.2 As client advocates, nurses have an important leadership role in facilitating the meaningful involvement of children and adolescents in research. The purpose of this article is to provide an overview of issues in ethics and law regarding adolescent consent to taking part in research in Canada, and to make recommendations for change. Although this article is primarily about adolescent consent to participate in research, there is some discussion of other consent situations. Adolescence has been broadly considered to extend from puberty to relative independence from parental control,3 which could include the ages of approximately 10 to 18. Therefore the term ‘adolescence’ as used in this article will refer to those who are 10–18 years of age.

Nursing Ethics 2003 10 (5) © 2003 Arnold 10.1191/0969733003ne632oa

Address for correspondence: Candace Lind, 5204 Vallance Crescent NW, Calgary, Alberta T3A 0T6, Canada. E-mail: [email protected]

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Ethical issues in adolescent consent for research 505

Consent In health research and treatment the ethical principle of autonomy demands that consent should be informed, and that elements of voluntariness, capacity and comprehension should be present for consent to be valid. To ensure that the indi- vidual is fully informed, the Nuremberg Code requires that the person seeking consent should include a number of elements in the explanation of procedures. These include describing the nature, duration and purpose of the procedure, its methods and means, all reasonably expected inconveniences and hazards, and any effects on the person from involvement in the process.4

It is on the elements of capacity and voluntariness that an adolescent’s ability to consent can be questioned, particularly in the research setting. Whereas it is generally accepted that younger children do not have decision-making capabili- ties, the picture is much less clear with adolescents.1 Questions arise about whether they have the capacity to understand what is being presented. Volun- tariness implies that individuals understand the thing to which they are con- senting. Is it possible for voluntary consent to be obtained in the absence of full understanding? In addition, voluntariness could be jeopardized if an individual feels vulnerable, and one may question whether an adolescent child is particu- larly vulnerable to parental or other authority.5 Specific situations of particular vulnerability could also occur when an adolescent is under duress from mental or physical illness or anxiety. It is therefore important to reflect on the conditions under which adolescents could give informed consent.

Common law and legislation There is considerable confusion across Canadian jurisdictions concerning the extent to which adolescents are permitted to be involved in the research consent process. This lack of clarity reflects a general uncertainty about adolescents’ devel- opmental capabilities. Nurses need to be aware of the legislation in their own area, as it may vary considerably even within national boundaries. To illustrate the kinds of inconsistencies that may be present we offer a snapshot of this issue in Canada.

Canadian common law is based on precedent and can be overridden by defin- itive legislation. Common law takes the starting point that all persons, including minors, can be legally and mentally capable of providing consent.6 However, there is a tacit recognition of developmental capacities and it is generally assumed that an individual must reach the age of majority to give valid consent, otherwise it must be obtained from a proxy, usually the parent. Canadian common law rec- ognizes the rights of a mature minor on case-by-case decisions made regarding capacity to consent.6,7 Once children can show sufficient understanding to enable them to understand procedures, the parental right to act as proxy terminates.6

Common law is relatively nonspecific on the topic of children’s consent. There- fore, to ensure that the individual has reached the developmental stage to enable comprehension several Canadian provinces have established statutory ages of consent for medical treatment.6 New Brunswick defines the age of consent for treatment to be 16 years, whereas in the province of Quebec it is 14 years.

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Elsewhere in Canada there is little definitive legislation. Ontario, Saskatchewan and Prince Edward Island have not adopted a general statute on consent to treat- ment by minors, but instead have dealt with the subject under condition-specific regulations.

Most of the legislation is about consent for treatment. There is even less clar- ity regarding children’s consent to participate in research. Legislation is essen- tially lacking in most jurisdictions,8 and there is limited clarity and consistency about decision-making authority for mature minors’ involvement in research.9 The default position appears to be that consent for research may be given at the same age as that required for consent to treatment. In Canada, only Quebec has legislated consent for research involvement; research consent is allowed by minors over 14 years of age, in the absence of serious risks to their health.7

Ethics, consent and assent The ethical principles involved in research in general have been stated to include respect, beneficence, nonmaleficence and justice.4,10 Ethics underlying the consent process in research has typically been described as including the principles of autonomy, respect and veracity.4,11,12 A focus on the quality of a research partic- ipant’s understanding and consent derives from the principle of autonomy, which arises from recognition that all people have unconditional worth and the right to self-determination.13 Informed consent is a person’s autonomous authorization to participate in research.13 Ethical issues can arise with respect to consent for research if there is a question about the potential participant’s ability to make autonomous decisions. Concerns centre primarily on capacity and vulnerability.

Recognizing that children and adolescents may have limited capacity and deci- sion-making abilities, some have suggested that the standard for anyone under the age of majority should be assent, not consent. Discussions of assent have arisen from the recognition of an ethical requirement to acknowledge the rights and responsibilities of children.12,14 Assent is a concept that addresses the need for a middle ground between autonomous consent and no involvement in a con- sent process. It has been defined as the process of concurring with someone to agree to treatment or involvement in research, but it does not entail a demon- stration of understanding or reasoning ability.14,15 Assent is usually used when referring to minor children and, while consent as a term has legal status, assent does not.

Ethical issues in adolescent consent Capacity to consent

Consent and assent processes for research should have stringent guidelines to clarify under what circumstances it is appropriate to use each process. For an adolescent to be capable of giving full consent knowledge, voluntariness and competence are required.15 Although mature minors may be allowed to consent to medical treatment if they have the capacity to consent, in the case of research

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participation the threshold for establishing competency for involvement is higher than that required for treatment because there is not necessarily a direct benefit for the participant.16,17

Involvement of adolescents in decisions about research participation is neither routine nor standardized in practice. Although it is generally accepted that ado- lescents’ wishes should be respected, in practice there are barriers to their full involvement in the research process.9 These barriers include a widespread reluc- tance to recognize adolescents as persons with decision-making capabilities, a con- cern about liability if their wishes were followed (due to lack of clarity in the law about their decision-making authority), and a general confusion regarding the moral weight and basis of the assent and dissent they provide.9 There is great variability in the literature regarding beliefs about adolescent capabilities of con- senting to treatment or involvement in research. Some authors state that they are capable of full consent and others state that the closest one should come to allow- ing adolescent involvement in the consent process is assent with parental consent.18–20

Societal beliefs about adolescent capabilities have arisen from adult perceptions. Lowden stated that childhood belongs to children least of all, and its study remains largely a study of adults’ attitudes to and practices concerning children.21 Even when the criterion of competency is met, a child’s right to exercise control over his or her own destiny has been negated by the courts.21 Adult beliefs regard- ing children’s rights influence children’s opportunities for self-determination.21 However, one could question whether it is ethically correct for adolescents to be considered still the property of their parents.1,22 This is implied when there is evi- dence that an adolescent is capable of consent, yet the weight of consent remains with the parent while the adolescent is only requested to assent.

Moreover, it should be noted that, if we allow adolescents to consent, but not to dissent, then that effectively gives them no decision-making powers at all. Dis- sent is generally defined as an objection to participation14 and it could be argued that, if assent is to be honoured, we have an ethical duty also to honour dissent. If we do not, we are inconsistent and therefore untrustworthy.23 By present stan- dards for adolescents, the right to consent appears not to be balanced by the right to withhold consent.21 As Dickenson suggested, ‘it looks suspiciously like the right to vote in a one-party state’ (p. 51).24

Adolescents have often been marginalized from decision making, although it has been shown that many are capable of much fuller involvement.25,26 In a study conducted to examine the relationship of understanding of research participation to anxiety, control and stage of cognitive development in children and adoles- cents, knowledge of research participation was found to be related more to emo- tional aspects (control and trait anxiety) than to factors such as age or cognitive development.27 In another study using the test of understanding, which is the one most consistent with the law of informed consent, 14-year-old adolescents did not differ from adults in their ability to understand. The researchers suggested that capacity needs to be determined by specific questions, on a case-by-case basis; it cannot be assessed globally.28

The responsibilities given to children who are aged over about 11 years when babysitting have been used to provide a contrast to considerations of adolescents’ capacity to consent to take part in research. There are marked inconsistencies in

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the way the maturity of children is appreciated for these two different tasks. They are considered mature enough by society to supervise younger children in poten- tially dangerous situations, yet they are judged too immature to consent to their own involvement in research. This suggests that sometimes the issues are not about capacity; they are about power and control, and poor communication.18

Vulnerability

Another concern raised about adolescent involvement in research is that they could be considered as ‘captive subjects’ when they are in positions of depen- dence on adults, which could be abused.19 Free consent may not be possible when others hold the balance of power.7,29 Vulnerability has been defined as the inca- pacity to protect one’s own interests. This may arise from being a junior/subor- dinate member of a hierarchical group.29,30 Adolescents may be vulnerable, depending on the context within which their consent to participation in research is obtained. Positions of dependence and vulnerability could be experienced in any controlled setting, but if an adolescent is in a crisis, his or her ability to give consent may be particularly impeded.15 However, the belief that adolescents are highly vulnerable and easily influenced is not necessarily supported by empiri- cal evidence.14 It should be noted, too, that adults who are hospital inpatients could also be considered to be dependent, and hence vulnerable, but their rights to provide consent are not invalidated unless there are other confounding cir- cumstances (for example, if they have been found to be incompetent).

Research and empowerment of adolescents

There is conflict in the literature regarding the underlying ethical foundations that guide whether or not children and adolescents ought to be involved in research. Although there is considerable discussion about adolescents’ rights, these rights may not be realized if they can be overridden by adult decisions. A utilitarian perspective for ethical reasoning would direct that decisions regarding research participation should be made on the basis of the greatest good for the greatest number of people.13 A communitarian perspective would suggest that the person ought to do what is best for the community. Conflict between these perspectives may arise in discussions about research participation and what we ought to do. Using only universal principles of ethics to make decisions about adolescent par- ticipation in research may not help nurses to decide about individual cases.

There is a need to rethink the taken-for-granted assumptions of adolescent incompetence and to consider the ethical foundations for decisions about adoles- cent involvement in research. Nurses have traditionally considered themselves to be patient advocates. Moral concepts for nurses include advocacy, accountability, collaboration and caring.31 Nursing advocacy roles extend to nurses’ involvement in research (both their own and others’), and they have a professional responsi- bility to understand the research process and act as patient advocates when needed. This nursing role could extend to advocating for adolescents’ views to be heard by health professionals and parents.29

A generalization that all members of a ‘special population’ are incompetent or

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vulnerable is unfair, unrealistic and disrespectful.30 Those who are competent, yet have their decisions overridden by others, can suffer substantial injury to their sense of self.32 Adolescents, also, are not a homogeneous population and should not be treated accordingly.2 Although universal principles are helpful in provid- ing a structure for guiding decisions, they cannot assist in decision making in all cases because individuals are not all the same, neither are contexts.

Ethics based on a relational narrative is suggested as a means of providing case- by-case assessment of capacity and vulnerability based on context.33 A relational narrative is the means by which a nurse would, through the development of a relationship and trust with the adolescent, have conversations about the research and the adolescent’s potential involvement. This demonstrates valuing and respect for the inclusion of the adolescent in the decision-making process and could occur within the context of the nurse acting as investigator or as clini- cian/advisor.1 The engagement process may have the effect of levelling power differentials, thus providing adolescents with a greater voice. Such an approach is consistent with what has been described as a postmodern turn in nursing ethics,33 that is, a move beyond rational objectivity in ethics towards focusing on the interpretation and negotiation of meanings in the social world.34,35 The ‘good’ in this case does not depend on an ethical universalism based on principles or laws, but on a constructed contextual meaning of the good, developed in an inter- subjective relational narrative process.33 This suggests that there is an ethical place between an objective and a subjective stance that is interrelational,35 and focused on engagement as the means of co-authoring a relational narrative34 such that it may lead to an understanding of the other’s uniqueness.33 Engagement with patients, as a way of demonstrating nursing’s caring, is thus understood as a fun- damental part of nursing itself.

An effort by adults to increase an adolescent’s perception of inner control could potentiate positive health behaviours and, by giving a voice to adolescents through empowering strategies, could help to equalize the power in the researcher–adolescent relationship. By induction, then, one could conclude that the role that adolescents ought to have in the research consent process is in giv- ing consent to the best of their ability. This ability should be assessed by the nurse and the adolescent in partnership, through a relational intersubjective process and could range from assent to consent. Those who are not competent to consent for themselves are still owed respect, justice and inclusiveness to participate in the assent process in whatever way they can.12,36 It is important for nurses to involve adolescents in the consent process as fully as possible to give them the message that we are supporting their developing autonomy and that we respect and value their contributions.37 As the role of parents is unclear in law, it is recommended that they should be included in the consent process.9 A family risks suffering harm through the responsibility of caring for any injury incurred by a young per- son and so should have a role in the decision making.8 Ethically, however, the heavier weight of consent should be the competent adolescent’s. Dissent should be respected as a refusal. It is not morally acceptable to force an adolescent’s involvement in research. The welfare and integrity of each person, regardless of age, remains paramount in human scientific investigations.

Consent to involvement in research must be a more stringent process than

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consent to treatment. This is not necessarily because of higher levels of risk, but because what we are asking of research participants is to help us to further advances in health care for groups of children, adolescents or all of society. If we use a liberal view of individual rights, then adolescents should be involved in research. The duty that we owe our adolescents is a duty of minimal risk and full disclosure in a consent process. Adolescents appreciate being valued and treated with respect and dignity by adults. The use of empowering processes, such as relational engagement, will provide benefit to adolescents in their transition to adult levels of responsibility.

There is also a role for nursing educators to re-examine their teaching content on adolescent capabilities. Examining and challenging some of the assumptions that educators have about adolescents will help to open up new possibilities for the continuing development of a relational ethic to guide nursing care.

Candace Lind, Beverly Anderson and Kathleen Oberle, University of Calgary, Canada.

References 1 Dickey SB, Deatrick J. Autonomy and decision making for health promotion in adolescence. Pediatr Nurs 2000; 26: 461–67.

2 Bragadottir H. Children’s rights in clinical research. Image J Nurs Sch 2000; 32: 179–84. 3 Hamachek DE. Development and dynamics of the self. In: Adams JF ed. Understanding ado- lescence: current development in adolescent psychology, third edition. Boston, MA: Allyn and Bacon, 1976: 145–75.

4 Fry ST, Veatch RM. Case studies in nursing ethics, second edition. Sudbury, MA: Jones and Bartlett, 2000.

5 Scherer DG, Reppucci ND. Adolescents’ capacities to provide voluntary informed consent: the effects of parental influence and medical dilemmas. Law Hum Behav 1988; 12: 123–41.

6 Hesson K, Bakal D, Dobson KS. Legal and ethical issues concerning children’s rights of con- sent. Can Psychol 1993; 34: 317–28.

7 Rozovsky LE. The Canadian law of consent to treatment, second edition. Toronto: Butterworth, 1997.

8 Weisstub DN, Verdun-Jones SN. Biomedical experimentation involving children: balancing the need for protective measures with the need to respect children’s developing ability to make significant life decisions for themselves. Health Law Can 1999; 19(3): 72–87.

9 Baylis F, Downie J, Kenny N. Children and decisionmaking in health research. IRB Rev Hum Subjects Res 1999; 21(4): 5–10.

10 Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. Can Med Assoc J 1997; 156: 1153–57.

11 Hall JK. Nursing ethics and law. Philadelphia, PA: Saunders, 1996. 12 Bartholome WG. A new understanding of consent in pediatric practice: consent, parental

permission, and child assent. Pediatr Ann 1989; 18: 262–65. 13 Beauchamp TL, Childress, JF. Principles of biomedical ethics, fifth edition. New York: Oxford

University Press, 2001. 14 Broome ME, Stieglitz KA. The consent process and children. Res Nurs Health 1992; 15: 147–52. 15 Pieranunzi VR, Freitas LG. Informed consent with children and adolescents. J Child Adolesc

Psychiatr Nurs 1992; 5(2): 21–27. 16 Brock DW. What is the moral authority of parents to make decisions for their children regarding

research participation? Providence, RI: Brown University, 1998. 17 Dickens BM. The legal challenge of health research involving children. Health Law J 1998; 6

(special edition): 131–48. 18 Koren G, Carmeli DB, Carmeli YS, Haslam R. Maturity of children to consent to medical

research: the babysitter test. J Med Ethics 1993; 19: 142–47. 19 Pearn JH. The child and clinical research. Lancet 1984; ii: 510–12.

510 C Lind et al.

Nursing Ethics 2003 10 (5) at CATHOLIC UNIV OF AMERICA on December 5, 2014nej.sagepub.comDownloaded from

Ethical issues in adolescent consent for research 511

Nursing Ethics 2003 10 (5)

20 Ross LF. Health care decision making by children. Is it in their best interest? Hastings Cent Rep 1997; 27(6): 41–45.

21 Lowden J. Children’s rights: a decade of dispute. J Adv Nurs 2002; 37: 100–107. 22 Thurber FW, Deatrick JA, Grey M. Children’s participation in research: their right to con-

sent. J Pediatr Nurs 1992; 7: 165–170. 23 Leikin SL. Minors’ assent, consent, or dissent to medical research. IRB Rev Hum Subjects Res

1993; 15(2): 1–7. 24 Dickenson D. Suffer the children act. Nurs Stand 1993; 7(35): 50–52. 25 Browne BW. Imagine Chicago: a study in intergenerational appreciative inquiry. In: Ham-

mond SA, Royal C, eds. Lessons from the field: applying appreciative inquiry, revised edition. Plano, TX: Thin Book, 2001: 76–89.

26 Hall J. The Banana Kelly experience: strength-based youth development. In: Hammond SA, Royal C, eds. Lessons from the field: applying appreciative inquiry, revised edition. Plano, TX: Thin Book; 2001: 114–25.

27 Dorn LD, Susman EJ, Fletcher JC. Informed consent in children and adolescents: age, mat- uration and psychological state. J Adolesc Health 1995; 16: 185–90.

28 Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Dev 1982; 53: 1589–98.

29 Bricher G. Children in the hospital: issues of power and vulnerability. Pediatr Nurs 2000; 26: 277–82.

30 Weisstub DN, Arboleda-Florez J, Tomossy GF. Establishing the boundaries of ethically per- missible research with special populations. Health Law Can 1996; 17(2): 45–63.

31 Bishop A, Scudder J. Nursing ethics: holistic caring practice, second edition. Sudbury, MA: Jones and Bartlett, 2001.

32 Appelbaum PS, Roth LH. Clinical issues in the assessment of competency. Am J Psychiatry 1981; 138: 1462–67.

33 Gadow S. Relational narrative: the postmodern turn in nursing ethics. Sch Inq Nurs Pract 1999; 13(1): 57–69.

34 Gadow S. Clinical epistemology: a dialectic of nursing assessment. Can J Nurs Res 1995; 27(2): 25–34.

35 Kvale S. Interviews: an introduction to qualitative research interviewing. Thousand Oaks, CA: SAGE, 1996.

36 Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-council pol- icy statement: ethical conduct for research involving humans. Canada: MRCC, NSERCC, SSHRCC, 1998.

37 Dickey SB, Kiefner J, Beidler SM. Consent and confidentiality issues among school-age chil- dren and adolescents. J Sch Nurs 2002; 18: 179–86.

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