Participant Commentary: Ethical Issues in Longitudinal Research with At-Risk Children and Adolescents
"Although many considerations are involved in this
case, four broad areas deserve comment: researcher obligations,
the role of informed consent, developmental factors; and
options of action available to researchers who discover that
minors may be in jeopardy."
Researcher Obligations
Who are the interested parties? What are Judy's
responsibilities to each? How might each conflict?
The interested parties include the students, parents, Ms.
Rosen and Judy's funders. She holds different responsibilities
to each party, which, at times, conflict. For example, Judy
promises the students that she will keep their responses secret
and will not disclose their information to anyone. The students
trust Judy not to violate that promise.
On the other hand, parents give permission for their
children to participate in research with the understanding that
Judy will act to maximize potential benefits and will not cause
harm to the children, in accordance with the principles of
beneficence and nonmaleficence (National Commission, 1979). In
designing her research protocol and consent procedures, it is
imperative that Judy consider parental expectations. Parents of
at-risk youth may view any contact with professionals as a
means of gaining assistance for their children and may
erroneously assume that benefit will come from participation;
that assumption may influence parental consent (Fisher, 1993;
Thompson, 1992). In addition, parents may believe that the
researcher's responsibility to act in the interests of the
youth requires the researcher to disclose information that
suggests that a student is in jeopardy; however, research
protocols do not always correspond to this belief. Although
Judy is obligated to keep the participants in her study from
foreseeable harm, the parents may also feel that she is
obligated to inform them of potential dangers to the students
(i.e., excessive engagement in risky behavior).
Ms. Rosen, as a principal or school administrator, seeks
information that will help the school as a whole and assist her
in making administrative decisions. She seeks some disclosure
of information; however, unlike the parents, she does not
require unique identifiers or student names.
Judy is obligated by her sense of scientific integrity to
conduct sound research. However, Judy's proposal is supported
by grants; she is obligated by more than scientific virtue to
conduct the best study possible. Her grant sources require her
to conduct a thorough, scientifically valid study that,
ideally, finds significant results.
It is apparent that Judy's obligations to these parties
conflict. In sum, Judy is obligated to protect confidentiality,
as she promised the students, as well as to protect them from
harm. Appropriately, parents trust her to act in the best
interests of the youth and may expect good, or at least no
harm, to come from the interaction. Parents may also assume
that information pertinent to youths' welfare will be fully
disclosed; here, Judy's responsibilities to parents may
conflict with her promise to her participants. In addition,
Judy's relationship with funders obligates her to obtain
meaningful, valid results. Providing a referral or intervention
for a child or teen in jeopardy may damage the validity of
Judy's study, compromising her obligation to her funders.
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What is informed consent?
The requirement of informed consent for participation in
research was first iterated in the Nuremberg Code (1949),
following the Nazi atrocities in World War II. Informed consent
is a means of protecting participant autonomy and providing
protection for those with diminished autonomy, an extension of
the ethical principle of respect for persons (National
Commission, 1979). The provision of consent to participate in
research implies that an individual has made a voluntary and
informed decision to participate. That is, the decision to
participate must be made by a person with the rational as well
legal capacity to decide; the person must be adequately
informed; and the decision must not be coerced.
The following information must be disclosed to the
participant: an explanation of the purpose of the research,
anticipated duration of involvement; the procedures involved;
potential risks, discomforts, benefits, alternatives;
assurances of confidentiality; and identification of whom to
contact with questions (ß46.116; Department of Health and
Human Services [DHHS], 1991). In addition, participants must
understand that participation is voluntary and that refusal
will not penalize them in any way and will not result in a loss
of benefits (ß46.116). In research on minors, parents' or
guardians' permission is required, as well as the child's
assent. In other words, both parent and child must be informed
of the voluntariness, risks and benefits of participation in a
way that is appropriate to the individual's developmental and
educational level (ß46.408). Although parents must
provide permission, minors have absolute veto power (Tymchuk,
1992).
When is informed consent required, and how may it be
sought?
Federal guidelines (ß46.101; DHHS, 1991) stipulate
that all research involving human subjects requires informed
consent from participants. The exception is research examining
normal educational practices such as a comparison of the
effectiveness of instructional methods or curriculum
techniques. As Judy's research does not fall under the umbrella
of educational research, she is not exempt from consent
requirements.
Parental consent for minors' participation in research may
be sought either actively, whereby parents and guardians are
informed of the proposed research procedures and must respond
in order for their child to participate, or passively, whereby
parents are sent letters describing the research and are to
respond only if they do not want their child to participate. It
has been argued that passive consent does not respect parental
autonomy in that the researcher can never be certain that the
parent received the information or that failure to respond
reflects an informed agreement to allow the child to
participate (Fisher, 1993). Parental permission may be
differentiated from child assent, which refers to the child's
agreement to participate and protects his or her developing
autonomy (Tymchuk, 1992); both permission and assent are
necessary in research with minors.
How may the rights of parents and minors conflict?
As the principle of respect for persons requires autonomous
decisions about whether to engage in treatment (National
Commission, 1979), the requirement of parental permission until
age 18 presumes that youth need parental protection because
they are not autonomous, or able to make rational decisions on
their own. Youths' lack of autonomy may be challenged on two
grounds: 1) parents do not always act in the best interests of
their children, as is evident in cases of child abuse; and 2)
many adolescents are cognitively able to make reasoned
decisions (Brooks-Gunn and Rotheram-Borus, 1994). The
developmental literature provides a wealth of information about
the cognitive capacities of adolescents to consent. Minors
below the age of 11 generally do not have the intellectual
ability and volition to give informed, voluntary and rational
consent; by mid-adolescence, however, teens are able to
consider treatment alternatives, risks and benefits, and
provide rational and voluntary consent comparable to that of
adults (Grisso and Vierling, 1978; Weithorn, 1983; Weithorn and
Campbell, 1982).
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Developmental Factors
How important are developmental factors in decision making? Does Judy's responsibility vary with the age of the participants?
The developmental status of the participants must be
carefully considered at least twice in the research plan:
first, when planning research and weighing minor
vulnerabilities with proposed research protocols; and second,
when making decisions about reporting and referring minors who
may be in need of assistance. When planning research with
children and youth, an investigator's assumptions about
development and vulnerability are crucial to the
decision-making process. Children do not become less vulnerable
in a linear fashion over the course of development; Thompson
(1992) has argued that vulnerability differs by domain, and not
merely developmental status. In other words, the risks and
benefits associated with different domains of research risk
must be evaluated according to the age of the child, as
children of different ages may not be equally vulnerable to
certain risks.
As the process of weighing protocol risks with developmental
factors can be quite complex, Thompson (1992) has offered a few
developmental guidelines. With increasing age, the self-concept
becomes more coherent and integrated. Therefore, threats to
self-concept become more stressful; however, the range of
coping skills increases as well, permitting greater adaptive
functioning in the face of adversity. These developments
suggest that although participation in some types of
psychological research may be more stressful for teens than
children, they may also have developed coping resources to
adapt. As children grow older, they are increasingly able to
infer the attitudes and motives of others and develop a greater
understanding of individual rights, which serves to balance
their views of authority, thus making them less susceptible to
coercion. With increasing age, youth are able to take a greater
responsibility for their own participation in research,
suggesting that perhaps they should be afforded a greater role
in consent procedures and decisions regarding reporting and
referring.
Second, developmental knowledge must be used to assist
investigators in making decisions outside the original
protocol, as when a researcher discovers that a participant is
in jeopardy. Consider Judy's case: Her data are based on
surveys and interviews, therefore she is not manipulating
variables with the potential to harm children. However, she may
learn that a child is in jeopardy. Should her reaction vary
depending upon the age of the child? Some experimentation and
risk is developmentally appropriate for teenagers, but what
about fourth and sixth graders? It is imperative that Judy be
aware of the developmental literature and use this literature
to make decisions. For example, we know that by age 16, 50-60
percent of youth have engaged in sexual intercourse; the exact
percentage varies by sex and ethnicity (Hofferth and Hayes,
1987). If a participant substantially younger (e.g., aged
11-13) reports sexual activity, that may signal special needs
and difficulties, which Judy must attend to. If Judy believes
that the child may need treatment or intervention, how should
she decide what to do?
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Options for Action
At least four options are available to Judy and other
researchers confronted with similar decisions about how to
handle minor participants in danger: maintaining
confidentiality, reporting, directly intervening and referring
the participant to outside sources of assistance (Fisher,
Higgins, Rau, Kuther and Belanger, in press).
Maintain confidentiality -- take no action.
When scientists discover that participants are in potential
jeopardy, a no-action stance is common. This response reflects
a concern for confidentiality as well as a commitment to
scientific validity, which may be threatened by humanitarian
actions (Fisher et al., in press; Fisher 1993). Taking no
action is supported by ethical guidelines that stress
maintaining confidentiality of information derived from
research in order to protect participants' right to privacy
(APA, 1992; DHHS, 1991; National Commission, 1979). Sharing
information about minor participants with parents may, at
times, have adverse consequences, especially if the parents
react to the disclosure with punitive measures. In addition,
acting to assist the participant may threaten the internal
validity of a study and jeopardize the trust and participation
of other participants.
This tension between the investigator's commitment to
scientifically valid designs and the humanitarian obligation to
protect participant welfare has been referred to as the
"scientist-citizen dilemma" (Veatch, 1987). It has been argued
that the interests of researchers and participants diverge, as
researchers seek to produce scientifically generalizable
knowledge rather than participants' well-being (Scott-Jones,
1994). Many investigators do not acknowledge a humanitarian
obligation to their participants outside the provision of
informed consent.
Reporting
Unlike the guidelines articulated by the federal government
(DHHS, 1991) or American Psychological Association (1992), the
Society for Research in Child Development (SRCD)'s Ethical
Standards for Research with Children support taking action when
a researcher encounters information suggesting that a minor is
in danger
When, in the course of research, information comes to the
investigator's attention that may jeopardize the child's
well-being, the investigator has a responsibility to discuss
the information with the parents or guardians and with those
expert in the field in order that they may arrange the
necessary assistance for the child (SRCD, 1993, p. 339).
In applied research contexts such as Judy's case, where
information suggests delinquent behavior, substance abuse or
sexual promiscuity on the part of minors, SRCD's professional
guidelines (1993) could be interpreted as encouraging Judy to
report the problem to adults who could assist the youths.
(Fisher et al., in press) In some cases, the investigator's
obligation to protect the immediate welfare of participants may
outweigh his or her obligation to produce scientifically valid
results, thus supporting the reporting of information obtained
in research. In addition, federal, state and local laws must be
considered in weighing the decision to report information
obtained in research, especially in the case of child abuse,
where researchers may be mandated reporters. (See Liss,
1994.)
The decision to report information obtained in research must
be carefully considered, especially if error is possible.
Reporting may have a negative impact upon the youth and his or
her family. For example, child abuse carries a negative social
stigma and legal consequences (Scott-Jones, 1994).
Investigators must recognize that reporting and referring
practices may be affected by their own assumptions about
participants, especially if participants are members of
vulnerable populations, such as low-income minority youth. In
fact, increased surveillance rather than a higher rate of
occurrence may promote greater reporting in groups considered
to be of low status (e.g., low income, minority and single
parent families; Scott-Jones, 1994). Without carefully
considering the evidence and potential consequences of
reporting information, researchers are in danger of
over-reporting suspected problems.
Investigator competence is at the forefront of issues to
consider in decisions about whether to report research-derived
information. In many cases, investigators are trained in
research methodology and may not be clinically trained or
equipped to assess the extent of participant problems such as
child abuse, substance abuse and depression, or to determine
whether treatment is necessary. Although the scientists may
recognize that their opinions must be taken with the proverbial
grain of salt, as they are not clinicians, their reports are
likely to be taken quite seriously (Scott-Jones, 1994).
Therefore, they should exercise restraint in reporting
suspected problems, and in fact, SRCD's ethical principles
recognize this danger: Because the investigator's words
may carry unintended weight with parents and children, caution
should be exercised on reporting results, making evaluative
statements, or giving advice (SCRD, 1993, p. 339).
In addition, reporting can violate confidentiality, which
has long been regarded as the cornerstone of ethical research.
If there is potential for reporting , consent and assent
procedures must be modified to include this possibility; the
obligation to report changes the nature of informed consent and
voluntary participation (Scott-Jones, 1994). For example, if
the investigator plans to report abuse, then informed consent
and assent require a statement to that effect, so that parents
and participants are forewarned. This requirement applies to
high risk behavior with minor participants as well.
Intervention
Intervention is an option that may be considered by
researchers in Judy's position. In this case, Judy would teach
the students coping skills relevant to their particular
vulnerabilities. For example, students having difficulties with
violence would learn skills such as anger management and
conflict mediation. There are two problems with this option: 1)
This intervention is not appropriate for every problem
encountered (e.g., what skills would be taught in cases of
sexual promiscuity?); and 2) intervention would create a dual
relationship between Judy and the participants. The ethical
guidelines of the American Psychological Association (1992)
suggest that professionals refrain from entering into multiple
relationships, which may impede objectivity and interfere with
a professional's duty. If she intervened, Judy would be
entering into a therapeutic relationship with her participants,
perhaps creating conflicting roles.
Referral
Referrals may be appropriate in cases where an investigator
obtains information suggesting that an adolescent research
participant would benefit from medical, social or psychological
services, but not from the reporting of the risk status to
parents or guardians (Fisher et al., in press). The provision
of referral information is an attempt to balance the teen's
right to confidentiality with his or her need for treatment. In
school-based research, students may be referred to sources
within the school, such as the school psychologist or
counselor, without violating promises to parents, as these
sources of assistance are available to all who attend the
school. Provision of a blanket referral could be standard
procedure in school-based research; for example, all
participants could be provided with a list of local sources of
help for common problems such as anxiety, substance abuse and
risk of pregnancy. Referral information could be provided for
services that adolescents can obtain in normal circumstances
without parental consent (i.e., contraception and family
planning at a local clinic). However, the provision of referral
information is sometimes not enough to protect the participant;
the researcher's obligations may be extended depending upon the
law, the situation at hand and what the he or she deems
appropriate.
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What should Judy do?
Should Judy suspect that an adolescent research participant
is having difficulties, she should first consider whether the
difficulties are within the range of normative developmental
phenomena for the participant's age. In addition, she should
interview the youth to see whether concern is warranted. This
step is especially important when the information is derived
from survey techniques such as depression, anxiety or risk
questionnaire inventories. Such indices usually offer a cut-off
score to indicate risk. High scores are indicative of risk, but
they are not proof, as identification is not perfect
(Brooks-Gunn and Rotheram-Borus, 1994). Because the teen has
provided assent and the parent consent, Judy should contact the
teen directly to determine whether her suspicions have
merit.
If Judy's suspicions are confirmed, the teen must be
referred for clinical services. Depending upon the problem,
that may or may not require disclosure to parents and their
consent. Disclosure to parents violates confidentiality, but
failure to provide clinical intervention may not be in the
child's best interests (Brooks-Gunn and Rotheram-Borus, 1994).
For example, a referral without parental disclosure would be
appropriate when services are available to teens without
parental permission. For example, referral would be appropriate
when a teen has a sexually transmitted disease and can obtain
services from a local clinic, unless the teen is engaging in
abnormally early sexual activity. However, if a teen has a
serious or life-threatening problem such as HIV, the parents
must be notified regardless of the participant's wishes. Here,
the researcher must assist the youth in obtaining treatment
because early treatment increases the length of life and must
disclose the information to parents in order to facilitate the
pursuit of treatment, which is expensive and often requires
hospitalization (Brooks-Gunn and Rotheram-Borus, 1994).
Ideally, the researcher should anticipate the need for
treatment or intervention and should make provisions for
reporting and referring in the initial protocol. In the
consent/assent forms, Judy could have included a statement
explaining the possibility of discussing any medical or
psychological condition with a parent. If such a statement was
not included in the consent/assent form, as in Judy's case,
then the researcher must discuss the problem and potential
solutions with the teen, as well as the advisability of
discussing the problem with parents. The investigator is
responsible for working with the participant on a plan for
seeking treatment. Depending upon the problem, if the teen
refuses to tell his or her parents, the researcher must
disclose out of her clinical responsibility to ensure
participant welfare, unless there is reason to believe that the
parent would not act in the teen's best interest.
Other strategies for protecting participants' privacy could
be implemented at the assent or data collection stages. For
example, the consent form could include a statement that if
problems are identified the researcher would contact the teen
and discuss it further (Brooks-Gunn and Rotheram-Borus, 1994).
At this time, blanket referrals could be made, providing the
participant with information about a variety of available
services, as indicated earlier. Another possibility is to ask
participants directly, during data collection, if they want to
talk with someone about a particular problem or current issue
(Brooks-Gunn and Rotheram-Borus, 1994). Participants can be
informed that parents will not be told of this desire, and then
can be referred to resources within the school such as the
school counselor or psychologist, who is better equipped to
make decisions about the students' welfare. Finally, should a
researcher make a decision that is not in the initial protocol,
he or she must seek approval from the institutional review
board before taking action.
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References
- American Psychological Association. "Ethical Principles
of Psychologists and Code of Conduct." American
Psychologist 47 (1992): 1597-1611.
- Brooks-Gunn, J., and Rotheram-Borus, M. J. "Rights to
Privacy in Research: Adolescents versus Parents."
Ethics and Behavior 4 (2; 1994): 109-121.
- Department of Health and Human Services (1991).
"Protection of Human Subjects." Code of Federal Regulations,
Title 45, Part 46, revised 1991.
- Fisher, C. B. "Integrating Science and Ethics in Research
with High-risk Children and Youth." Society for Research in
Child Development: Social Policy Report 7 (4, Winter 1993):
1-26.
- Fisher, C. B.; Higgins, A.; Rau, J. M. B.; Kuther, T. L.;
and Belanger, S. "Reporting and Referring Research
Participants at Risk: Views from Urban Adolescents.
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- Gisso, T. and Vierling, L. "Minors' Consent to Treatment:
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- Hufferth, S. L., and Hayes, C. D. Risking the
Future: Adolescent Sexuality, Pregnancy and
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- Liss, M. B. (1994). "Child Abuse: Is There a Mandate for
Researchers to Report?" Ethics and Behavior 4 (2, 1994):
133-146.
- National Commission for the Protection of Human Subjects
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Subjects Research." Washington, D. C.: Government Printing
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- Nuremberg Code. Journal of the American Medical
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- Scott-Jones, D. "Ethical Issues in Reporting and
Referring in Research with Low-income Minority Children."
Ethics and Behavior 4 (2, 1994): 97-108.
- Society for Research in Child Development. "Ethical
Standards for Research with Children." In Directory of
Members. Ann Arbor: Society for Research in Child
Development, 1993, pp. 337-339.
- Thompson, R. A. "Developmental Changes in Research Risk
and Benefit: A Changing Calculus of Concerns." In B. Stanley
and J. E. Sieber , eds. Social Research on Children and
Adolescents: Ethical Issues. Newbury Park, Calif.:
Sage, 1992, pp. 31-64.
- Tymchuk, A. J. "Assent Processes." In B. Stanley and J.
E. Sieber, eds. Social Research on Children and
Adolescents: Ethical Issues. Newbury Park, Calif.:
Sage, 1992, pp. 109-127.
- Veatch, R. M. The Patient as Partner.
Bloomington: Indiana University Press, 1987.
- Weithorn, L. "Children's Capacities to Decide to
Participate in Research." IRB: A Review of Human
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- Weithorn, L. A., and Campbell, S. B. "The Competency of
Children and Adolescents to Make Informed Treatment
Decisions." Child Development 53 (1982):
1589-159
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"Although many considerations are involved in this
case, four broad areas deserve comment: researcher obligations,
the role of informed consent, developmental factors; and
options of action available to researchers who discover that
minors may be in jeopardy."
Cite this page:
" Participant Commentary: Ethical Issues in Longitudinal Research with At-Risk Children and Adolescents"
Online Ethics Center for Engineering
2/16/2006
National Academy of Engineering
Accessed: Tuesday, March 16, 2010
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