weekone 20161029200346sss_590_online_week_1_article_ch3_lind__anderson__oberle_ethical_issues informed_consent__1__assignment x
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 to be evaluated as well.
Identify and discuss at least three strengths that can be seen in the Informed Consent document, and also briefly discuss how this Informed Consent could be strengthened in order to provide participants with a good quality Informed Consent. Please be specific and thorough in your discussion.
Format Structure
- This assignment represents a short paper, please review attachments for guidance
- Full Student Names are to be placed in the header of the paper.
- The short paper written discussion should be double spaced, organized, and address the salient points in this assignment.
- The paper should have page numbers, and be well organized.
- Length: 2 pages maximum
- include reference and cover page
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Nursing Ethics
http://nej.sagepub.com/content/10/5/504
The online version of this article can be found at:
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: candace@fekete.com
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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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Ethical issues in adolescent consent for research 507
Nursing Ethics 2003 10 (5)
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
508 C Lind et al.
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Ethical issues in adolescent consent for research 509
Nursing Ethics 2003 10 (5)
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.
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SSS 590 – Online – Paired Problem-solving Assignment # 1
INFORMED CONSENT
You have been selected to participate in a Career Counseling program that addresses adult indecision in selecting a job or a career. For quality assurance, the project evaluates the impact of the method of counseling on participants’ job decision-making.
The Career Counseling is operated by the Giant Inc. [Project Director: Bob Brown]. The evaluation of the impact of the Career Counseling services is conducted by the National Catholic School of Social Service at the Catholic University of America [Evaluator: Sam Simpson, PhD}
Your participation in this project is voluntary and you may withdraw from the services or evaluation at any time and for any reason.
Workshop on Career Decision making
In return for the opportunity to receive free instruction in career decision making as a part of a research project, I agree that if I am selected for instruction I will:
Attend Career Counseling sessions;
Devote time to “homework” to be completed between sessions;
Complete evaluation forms given to me.
In the event that I am not scheduled to receive instruction, I understand that I will receive monetary compensation when I am asked to complete the evaluation forms.
I also affirm that:
The purpose of the Career Counseling program has been explained to me;
I have been given an opportunity to ask questions for which I have received satisfactory
answers;
I understand that all evaluation forms, which I complete for this project, will remain
completely confidential and that my anonymity will be protected.
_______________________________ Address ____________________________
Participant’s Name – PRINT ____________________________
Phone ____________________________