- Email: [email protected]
Ethics and Research With Vulnerable Children
EDITORIAL
Ethics and Research With Vulnerable Children Gail A. Edelsohn,
I
n this issue of the Journal, Horwitz et al.1 address important questions regarding the prevalence of mental health problems and the receipt of mental health services of very young children who became involved with the child welfare system owing to an investigation of child maltreatment. The investigators use the extensive database from the National Survey of Child and Adolescent Well-Being (NSCAW II), a longitudinal study of children referred to child welfare agencies. Direct interviews were conducted with caregivers and child welfare workers of 1,117 children 12 to 36 months of age. Sociodemographic characteristics, social services involvement, and health and developmental data on children and caregivers were collected. The outcomes measurements were scores higher than the clinical cutpoints of the Brief Infant Toddler Social Emotional Assessment (BITSEA) scales (for children 12 to 18 months) and the Child Behavior Checklist (CBCL; for those 19 to 36 months of age). Horwitz et al. found that nearly 35% of the younger children scored high on the problem scale of the BITSEA and slightly more than 20% scored low on social competence. Among the toddlers, 10% scored in the clinically significant range of the CBCL. The investigators also found that black children were less likely to have high scores on the BITSEA problem scale and that children living with a depressed caregiver were more likely to have higher scores on the CBCL. Only a disappointingly low 2.2% of children identified with mental health problems received direct clinical services; when parental skill training was counted toward mental health services, the rate increased to a still low 19.2%. This article, which focuses on the prevalence of mental health problems and related services in young children at risk, highlights several ethical questions relevant to the field of child behavioral health: Are there special considerations around informed consent for vulnerable populations? How can needed research focused on vulnerable
children in high-risk families be conducted while maintaining the highest ethical standards? How may the ethical principles of beneficence and justice be considered in light of these findings? The ethical conduct of research and informed consent have been inextricably intertwined, tracing their common historical roots to the development of the Nuremburg Code of 1947 and later the Belmont Report in 1979. Informed consent is comprised of three elements: information sharing, 2) decision-making capacity, and 3) voluntarism, meaning the ability to decide freely, without coercion to participate in research.2,3 Because a child lacks the developmental capacity to fully understand and evaluate the information and come to an informed decision, the parent or legal guardian is asked to give permission on the child’s behalf, a process that is very similar to informed consent. Children possessing a level of cognitive maturity, typically around 7 years of age, are considered capable of assenting to participate. Assent is an active declaration of agreement to participate, not simply the absence of objection. Obtaining parental permission and child assent demonstrates respect for the parent and the child and recognizes the autonomy of a research participant. Autonomy is an ethical principle closely related to the concept of voluntarism, because respect for autonomy recognizes that individuals have the right to make their own decisions. Children and their parents who are involved with child welfare may be considered especially vulnerable with regard to choosing freely to participate in research without coercion. The threat of unintended coercion is relevant, because caregivers may perceive that their decision of whether to participate in research could have a bearing on their receipt of benefits, decisions by child welfare regarding findings of maltreatment, placement determinations, or access to services. A review of caregiver permission forms has
JOURNAL 566
www.jaacap.org
M.D., M.S.P.H.
OF THE
AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012
EDITORIAL
shown that the NSCAW II research team took considerable effort to ensure that caregivers understood that participation was completely voluntary and that the benefits or services being received would not be affected.4 The second ethical dilemma focuses on the challenge to undertake research in vulnerable children and ensure that the highest ethical research standards are maintained. One approach is to apply an analysis of ethical dimensions of psychiatric research protocols using an assessment tool such as the one developed by Roberts.5 Another is turning to the federal regulations that provide some protections regarding confidentiality and limiting exposure to study risks for children. When studying potentially stigmatizing conditions (such as mental health problems) or illegal behaviors (such as antisocial behaviors and substance use), researchers often obtain a Certificate of Confidentiality that guards the privacy of participants by protecting against compulsory legal demands such as court orders and subpoenas for identifying information of research participants. Particularly important in studies of children and adolescents is the issue of mandated reporting of abuse and neglect. A Certificate of Confidentiality may be worded to allow the voluntary disclosure of child abuse and neglect information in keeping with child protective service regulations and protecting against other disclosures. This exception to disclosure must be clearly communicated and specified in the consent form. The levels of risk to a child participant are defined by federal regulations in relation to potential benefits to the individual; these levels are minimal risk, greater than minimal but with direct benefit to the child, and minor increase over minimal risk yet likely to yield generalizable knowledge of vital importance for the understanding of the disorder or the condition. The third ethical issue involves the application of ethical theory and principles as a lens through which to view the findings and draw some policy implications. Although there are some competing ethical theories, principle-based ethics, as formulated by Beauchamp and Childress6 as a way to connect moral decision making to pragmatic principles, is perhaps the most familiar.7,8 Principle-based ethics is founded on four principles: autonomy, beneficence, nonmaleficence, and justice. These four principles pervade profes-
sional ethical guidelines and are incorporated, among others, into the Code of Ethics of the American Academy of Child and Adolescent Psychiatry (AACAP).9 Two ethical principles, beneficence and justice, are particularly pertinent with respect to this study’s findings. Beneficence, or acting to benefit others, can be extended from the caretaking of individuals to larger populations and is reflected in AACAP’s Code of Ethics, Principle II, Promoting the Welfare of Children and Adolescents.9 The study’s finding of a very low reported rate of mental health services received by vulnerable children is in stark contrast to the goal of beneficence. Beneficence in this study should also be considered with respect to meeting the multiple needs of children, as reflected by the roughly 40% of subjects who were found to have severe to moderate delays in daily living skills. Recognizing the relation between maternal depression and child psychopathology, the concept of beneficence would extend to providing treatment to the depressed caregivers and their children. The principle of beneficence could be invoked in support of policy recommendations that would enhance a variety of resources to meet the needs of children involved with child welfare.10 The principle of justice refers to treating people fairly and is applied to research settings so the burden of risk on subjects should not fall disproportionately on a vulnerable population such as children, prisoners, disabled individuals, or members of minority groups. However, there are also ethical concerns of ignoring the needs of a vulnerable population, such as at-risk children in the child welfare system, and failing to study the prevalence of their mental health problems and how to address them.5 The overrepresentation of black children in child welfare and a lower threshold for their placement are possible explanations for the finding that black children were less likely to have high problem scores. The disproportionate rate of black children in the child welfare system highlights racial and ethnic disparities that are contrary to the principle of justice, or of treating individuals or groups equitably. The concept of justice has been extended to embrace “distributive justice,” referring to the fair distribution of health resources with access to services and not being so burdensome that those in need are excluded.10 Interestingly, there were no differences in any type of service use for children with and without mental health prob-
JOURNAL OF THE AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012
www.jaacap.org
567
EDELSOHN
lems. Horwitz et al.1 discuss this finding in view of less than optimal targeting of services overall. There are many evidence-based interventions appropriate for young children involved with child welfare that include foster and biological parents. However, these interventions are not widely available to the populations who might benefit the most from them. These are but a few of the ethical challenges facing researchers in the area of child maltreatment. A key lesson learned from NSCAW II is that the ethical standards can be observed and adhered to while protecting participants and maintaining a viable research project. Perhaps the NSCAW II will serve as a model and encourage researchers to conduct further investigations this area. It is important that researchers strive to advance the field by improving the ways in which we asses, intervene, and treat at-risk chil-
dren and simultaneously being held accountable to the highest ethical standards. & Accepted April 2, 2012. Dr. Edelsohn is with Community Care Behavioral Health Organization, Pittsburgh, PA. Dr. Edelsohn thanks the American Academy of Child and Adolescent Psychiatry Ethics Committee for its support of her work on this article. She also acknowledges Mary Bruce Webb, Ph.D., Director, Division of Child and Family Development Office of Planning, Research and Evaluation, Administration for Children and Families, for providing additional information on the National Survey of Child and Adolescent Well-Being (NSCAW II) informed consent protocols. Disclosure: Dr. Edelsohn reports no biomedical financial interests or potential conflicts of interest. Correspondence to Gail A. Edelsohn, M.D., M.S.P.H., Community Care Behavioral Health Organization, 1 East Uwchlan Avenue, Suite 311, Exton, PA 19341; e-mail: [email protected] 0890-8567/$36.00/©2012 American Academy of Child and Adolescent Psychiatry http://dx.doi.org/10.1016/j.jaac.2012.04.001
REFERENCES 1. Horwitz SM, Hurlburt MS, Heneghan A, et al. Mental health problems in young children investigated by US child welfare agencies. J Am Acad Child Adolesc Psychiatry. 2012;572-581. 2. Hoop JG, Smyth AC, Roberts LW. Ethical issues in psychiatric research in children and adolescents. Child Adolesc Psychiatric Clin N Am. 2008;17:127-148. 3. Roberts LW. Informed consent and the capacity for voluntarism. Am J Psychiatry. 2002;159:705-712. 4. National Survey of Child and Adolescent Well-Being (NSCAW). NSCAW II Combined Waves 1-2, Restricted Release Version, Appendix—Volume I. Ithaca, NY: Cornell University; 2011. 5. Roberts LW. Ethical dimensions of psychiatric research: a constructive, criterion -based approach to protocol preparation. The Research Protocol Ethics Assessment Tool (RePEAT). Biol Psychiatry. 1999;46:1106-1119. 6. Beauchamp TL, Childress JF, eds. Principles of Biomedical Ethics. 5th edition. New York, NY: Oxford University Press; 2001.
7. Dell ML, Kinlaw K. Theory can be relevant: an overview of bioethics for the practicing child and adolescent psychiatrist. Child Adolesc Psychiatric Clin N Am. 2008;17:1-9. 8. Bloch S, Green SA. An ethical framework for psychiatry. Br J Psychiatry. 2006;188:7-12. 9. American Academy of Child and Adolescent Psychiatry Code of Ethics with Annotations. Washington, DC: AACAP; 2012. http:// www.aacap.org/page.ww?section⫽system&name⫽Search⫹ Results&indexId⫽default&hitsStart⫽1&query⫽Code⫹of⫹Ethics&x⫽ 2&y⫽4. Accessed on March 30, 2012.. 10. Cooper JL, Banghart P, Aratani Y. Addressing the Mental Health Needs of Young Children in the Child Welfare System: What Every Policymaker Should Know. New York: National Center for Children in Poverty, Columbia University; 2012. http://www.nccp.org/publications/pub_968.html. Accessed on March 30, 2012.
JOURNAL 568
www.jaacap.org
OF THE
AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012
Ethics and Research With Vulnerable Children Gail A. Edelsohn,
I
n this issue of the Journal, Horwitz et al.1 address important questions regarding the prevalence of mental health problems and the receipt of mental health services of very young children who became involved with the child welfare system owing to an investigation of child maltreatment. The investigators use the extensive database from the National Survey of Child and Adolescent Well-Being (NSCAW II), a longitudinal study of children referred to child welfare agencies. Direct interviews were conducted with caregivers and child welfare workers of 1,117 children 12 to 36 months of age. Sociodemographic characteristics, social services involvement, and health and developmental data on children and caregivers were collected. The outcomes measurements were scores higher than the clinical cutpoints of the Brief Infant Toddler Social Emotional Assessment (BITSEA) scales (for children 12 to 18 months) and the Child Behavior Checklist (CBCL; for those 19 to 36 months of age). Horwitz et al. found that nearly 35% of the younger children scored high on the problem scale of the BITSEA and slightly more than 20% scored low on social competence. Among the toddlers, 10% scored in the clinically significant range of the CBCL. The investigators also found that black children were less likely to have high scores on the BITSEA problem scale and that children living with a depressed caregiver were more likely to have higher scores on the CBCL. Only a disappointingly low 2.2% of children identified with mental health problems received direct clinical services; when parental skill training was counted toward mental health services, the rate increased to a still low 19.2%. This article, which focuses on the prevalence of mental health problems and related services in young children at risk, highlights several ethical questions relevant to the field of child behavioral health: Are there special considerations around informed consent for vulnerable populations? How can needed research focused on vulnerable
children in high-risk families be conducted while maintaining the highest ethical standards? How may the ethical principles of beneficence and justice be considered in light of these findings? The ethical conduct of research and informed consent have been inextricably intertwined, tracing their common historical roots to the development of the Nuremburg Code of 1947 and later the Belmont Report in 1979. Informed consent is comprised of three elements: information sharing, 2) decision-making capacity, and 3) voluntarism, meaning the ability to decide freely, without coercion to participate in research.2,3 Because a child lacks the developmental capacity to fully understand and evaluate the information and come to an informed decision, the parent or legal guardian is asked to give permission on the child’s behalf, a process that is very similar to informed consent. Children possessing a level of cognitive maturity, typically around 7 years of age, are considered capable of assenting to participate. Assent is an active declaration of agreement to participate, not simply the absence of objection. Obtaining parental permission and child assent demonstrates respect for the parent and the child and recognizes the autonomy of a research participant. Autonomy is an ethical principle closely related to the concept of voluntarism, because respect for autonomy recognizes that individuals have the right to make their own decisions. Children and their parents who are involved with child welfare may be considered especially vulnerable with regard to choosing freely to participate in research without coercion. The threat of unintended coercion is relevant, because caregivers may perceive that their decision of whether to participate in research could have a bearing on their receipt of benefits, decisions by child welfare regarding findings of maltreatment, placement determinations, or access to services. A review of caregiver permission forms has
JOURNAL 566
www.jaacap.org
M.D., M.S.P.H.
OF THE
AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012
EDITORIAL
shown that the NSCAW II research team took considerable effort to ensure that caregivers understood that participation was completely voluntary and that the benefits or services being received would not be affected.4 The second ethical dilemma focuses on the challenge to undertake research in vulnerable children and ensure that the highest ethical research standards are maintained. One approach is to apply an analysis of ethical dimensions of psychiatric research protocols using an assessment tool such as the one developed by Roberts.5 Another is turning to the federal regulations that provide some protections regarding confidentiality and limiting exposure to study risks for children. When studying potentially stigmatizing conditions (such as mental health problems) or illegal behaviors (such as antisocial behaviors and substance use), researchers often obtain a Certificate of Confidentiality that guards the privacy of participants by protecting against compulsory legal demands such as court orders and subpoenas for identifying information of research participants. Particularly important in studies of children and adolescents is the issue of mandated reporting of abuse and neglect. A Certificate of Confidentiality may be worded to allow the voluntary disclosure of child abuse and neglect information in keeping with child protective service regulations and protecting against other disclosures. This exception to disclosure must be clearly communicated and specified in the consent form. The levels of risk to a child participant are defined by federal regulations in relation to potential benefits to the individual; these levels are minimal risk, greater than minimal but with direct benefit to the child, and minor increase over minimal risk yet likely to yield generalizable knowledge of vital importance for the understanding of the disorder or the condition. The third ethical issue involves the application of ethical theory and principles as a lens through which to view the findings and draw some policy implications. Although there are some competing ethical theories, principle-based ethics, as formulated by Beauchamp and Childress6 as a way to connect moral decision making to pragmatic principles, is perhaps the most familiar.7,8 Principle-based ethics is founded on four principles: autonomy, beneficence, nonmaleficence, and justice. These four principles pervade profes-
sional ethical guidelines and are incorporated, among others, into the Code of Ethics of the American Academy of Child and Adolescent Psychiatry (AACAP).9 Two ethical principles, beneficence and justice, are particularly pertinent with respect to this study’s findings. Beneficence, or acting to benefit others, can be extended from the caretaking of individuals to larger populations and is reflected in AACAP’s Code of Ethics, Principle II, Promoting the Welfare of Children and Adolescents.9 The study’s finding of a very low reported rate of mental health services received by vulnerable children is in stark contrast to the goal of beneficence. Beneficence in this study should also be considered with respect to meeting the multiple needs of children, as reflected by the roughly 40% of subjects who were found to have severe to moderate delays in daily living skills. Recognizing the relation between maternal depression and child psychopathology, the concept of beneficence would extend to providing treatment to the depressed caregivers and their children. The principle of beneficence could be invoked in support of policy recommendations that would enhance a variety of resources to meet the needs of children involved with child welfare.10 The principle of justice refers to treating people fairly and is applied to research settings so the burden of risk on subjects should not fall disproportionately on a vulnerable population such as children, prisoners, disabled individuals, or members of minority groups. However, there are also ethical concerns of ignoring the needs of a vulnerable population, such as at-risk children in the child welfare system, and failing to study the prevalence of their mental health problems and how to address them.5 The overrepresentation of black children in child welfare and a lower threshold for their placement are possible explanations for the finding that black children were less likely to have high problem scores. The disproportionate rate of black children in the child welfare system highlights racial and ethnic disparities that are contrary to the principle of justice, or of treating individuals or groups equitably. The concept of justice has been extended to embrace “distributive justice,” referring to the fair distribution of health resources with access to services and not being so burdensome that those in need are excluded.10 Interestingly, there were no differences in any type of service use for children with and without mental health prob-
JOURNAL OF THE AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012
www.jaacap.org
567
EDELSOHN
lems. Horwitz et al.1 discuss this finding in view of less than optimal targeting of services overall. There are many evidence-based interventions appropriate for young children involved with child welfare that include foster and biological parents. However, these interventions are not widely available to the populations who might benefit the most from them. These are but a few of the ethical challenges facing researchers in the area of child maltreatment. A key lesson learned from NSCAW II is that the ethical standards can be observed and adhered to while protecting participants and maintaining a viable research project. Perhaps the NSCAW II will serve as a model and encourage researchers to conduct further investigations this area. It is important that researchers strive to advance the field by improving the ways in which we asses, intervene, and treat at-risk chil-
dren and simultaneously being held accountable to the highest ethical standards. & Accepted April 2, 2012. Dr. Edelsohn is with Community Care Behavioral Health Organization, Pittsburgh, PA. Dr. Edelsohn thanks the American Academy of Child and Adolescent Psychiatry Ethics Committee for its support of her work on this article. She also acknowledges Mary Bruce Webb, Ph.D., Director, Division of Child and Family Development Office of Planning, Research and Evaluation, Administration for Children and Families, for providing additional information on the National Survey of Child and Adolescent Well-Being (NSCAW II) informed consent protocols. Disclosure: Dr. Edelsohn reports no biomedical financial interests or potential conflicts of interest. Correspondence to Gail A. Edelsohn, M.D., M.S.P.H., Community Care Behavioral Health Organization, 1 East Uwchlan Avenue, Suite 311, Exton, PA 19341; e-mail: [email protected] 0890-8567/$36.00/©2012 American Academy of Child and Adolescent Psychiatry http://dx.doi.org/10.1016/j.jaac.2012.04.001
REFERENCES 1. Horwitz SM, Hurlburt MS, Heneghan A, et al. Mental health problems in young children investigated by US child welfare agencies. J Am Acad Child Adolesc Psychiatry. 2012;572-581. 2. Hoop JG, Smyth AC, Roberts LW. Ethical issues in psychiatric research in children and adolescents. Child Adolesc Psychiatric Clin N Am. 2008;17:127-148. 3. Roberts LW. Informed consent and the capacity for voluntarism. Am J Psychiatry. 2002;159:705-712. 4. National Survey of Child and Adolescent Well-Being (NSCAW). NSCAW II Combined Waves 1-2, Restricted Release Version, Appendix—Volume I. Ithaca, NY: Cornell University; 2011. 5. Roberts LW. Ethical dimensions of psychiatric research: a constructive, criterion -based approach to protocol preparation. The Research Protocol Ethics Assessment Tool (RePEAT). Biol Psychiatry. 1999;46:1106-1119. 6. Beauchamp TL, Childress JF, eds. Principles of Biomedical Ethics. 5th edition. New York, NY: Oxford University Press; 2001.
7. Dell ML, Kinlaw K. Theory can be relevant: an overview of bioethics for the practicing child and adolescent psychiatrist. Child Adolesc Psychiatric Clin N Am. 2008;17:1-9. 8. Bloch S, Green SA. An ethical framework for psychiatry. Br J Psychiatry. 2006;188:7-12. 9. American Academy of Child and Adolescent Psychiatry Code of Ethics with Annotations. Washington, DC: AACAP; 2012. http:// www.aacap.org/page.ww?section⫽system&name⫽Search⫹ Results&indexId⫽default&hitsStart⫽1&query⫽Code⫹of⫹Ethics&x⫽ 2&y⫽4. Accessed on March 30, 2012.. 10. Cooper JL, Banghart P, Aratani Y. Addressing the Mental Health Needs of Young Children in the Child Welfare System: What Every Policymaker Should Know. New York: National Center for Children in Poverty, Columbia University; 2012. http://www.nccp.org/publications/pub_968.html. Accessed on March 30, 2012.
JOURNAL 568
www.jaacap.org
OF THE
AMERICAN ACADEMY OF CHILD & ADOLESCENT PSYCHIATRY VOLUME 51 NUMBER 6 JUNE 2012