2 OPINION nd
Writing for the PRO position: Judith Lewis, PhD, RN, FAAN
PRO I
believe that informed consent should be required for routine newborn screening and for the storage of blood samples. The American Heritage Dictionary (n.d.) defines informed consent as “consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of relevant medical facts and risks involved.” The gold standard for medical and surgical procedures is informed consent. Informed consent refers to the process of providing the patient with information about the proposed procedure including, but not limited to: • benefits of the proposed procedure • risks of the proposed procedure • alternatives to the proposed procedure Although many believe that signing a consent form constitutes informed consent, informed consent is a process of education and that process is the key to a patient’s ability to provide consent for a procedure. It is not current practice to require informed consent for routine newborn screening, as it is seen as a routine part of newborn care. Although it is possible to opt out of newborn screening for a variety of reasons, how does a patient know of their right to refuse screening if they are not informed that screening will occur? All too often, a parent first learns that their newborn underwent newborn genetic testing when they are informed of screening results that require further diagnostic testing. Because newborn screening is a medical procedure, should not it be subject to the practice of informed consent? There are
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Should Informed Consent be Required for Routine Newborn Screening and for the Storage of Blood Samples? risks, including infection and bruising, to the process of obtaining the blood sample, and the parent has a right to know of these risks and that these tests are being performed. The American Academy of Pediatrics (AAP) (2013) suggests that presymptomatic genetic testing for a variety of conditions not be performed on children because of their inability to provide informed consent. Yet newborn screening falls outside these guidelines. Mothers also are not informed that their child’s blood spots are stored and used for research. Although these samples are deidentified, they are collected and stored without consent. One of the fundamental principles of the protection of human research subjects is Newborn screening tests should that they provide informed consent to be research sub- be subjected to the same jects. Clearly this does not happen. A class action lawsuit standard of care as any other in Texas resulted in an order genetic tests. to destroy thousands of such samples because they were obtained without consent of the donors (Root, 2010). When an adult signs a consent form for venipuncture, there is a part of the form that states the lab may retain blood samples and use them for a variety of purposes. When I’ve crossed out this section of the form, the lab technician is usually shocked, and I’ve been told I have no right to do so. In the case of newborn screening, the mother does not have the benefit of knowing ahead of time that her infant’s DNA is collected and stored. This is an unacceptable violation of the rights of human subjects. Another potential danger of obtaining DNA samples without consent is the possibility of discovering mis-paternity. If the mother is not aware that DNA samples are being retrieved, she is not aware that a de facto paternity test is being performed. This can have significant social and legal consequences in later life for the mother, putative father, biological father, and the child. The standard of care in genetic testing includes pretest counseling, testing, and posttest results delivery with counseling. Newborn screening tests should be subjected to the same standard of care as any other genetic tests. Judith Lewis is Professor Emerita at Virginia Commonwealth University in Richmond, VA. Dr. Lewis can be reached at [email protected] The author declares no conflicts of interest. References American Academy of Pediatrics (AAP) Committee on Bioethics, Committee on Genetics; American College of Medical Genetics, Social, Ethical, and Legal Issues Committee. (2013). Ethical and policy issues in genetic testing and screening of children. Pediatrics, 131(3), 620-622. Informed consent. (n.d.). The American Heritage® Stedman’s Medical Dictionary. Retrieved from: Dictionary.com website:http://dictionary.reference.com/browse/informed consent. Accessed: February 14, 2014. Root, J. (2010). Texas Officials Agree to Destory Babies’ Blood Samples After Settling Lawsuit. Texas Civil Rights Project. Retrieved from: www.texascivilrightsproject.org/1822/texas-officials-agree-todestroy-babies-blood-samples-after-settling-lawsuit/. Accessed February 17, 2014. September/October 2014
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
2 OPINION nd
Second Opinion columns are coordinated by Kathleen Leask Capitulo and Judy Beal. Dr. Capitulo can be reached via e-mail at: DrKatieRN@ hotmail.com. Dr. Beal can be reached via e-mail at: [email protected]
Writing for the CON position: Carole Kenner, RN, FNAP, FAAN Writing forPhD, the CON position: Xxx
CON I
believe that informed consent should not be required and that storing of newborn blood should occur without consent from parents. Newborn screening started in the 1960s when the linkage between mental retardation and Phenylketonuria became known. A simple blood test afforded the opportunity for early detection and treatment of an otherwise devastating metabolic condition. Such screening, now expanded to other conditions, provides a means for early detection of problems that may affect a child’s survival or lifelong health problems (Centers for Disease Control and Prevention [CDC], 2014). Every state requires newborns to be tested for potential genetic conditions such as congenital hypothyroidism, cystic fibrosis, and phenylketonuria. The New England Newborn Screening Program (2014) requires tests for 30 common disorders. In Massachusetts, parents can opt out if they object to the testing, mainly for religious reasons. However, there are ethical, social, legal, and associated financial implications of any newborn screening. These issues include (Baily, 2014): • Is this a type of diagnostic test that is so routine that no informed consent is needed?; • Are the outcomes in line with the potential costs for statemandated screening?; and • Should blood from such tests be stored for future testing without parental consent or knowledge? Many experts have argued over the years that because newborn screening test are state-mandated, no actual informed consent is needed. Rather, parents need to be educated about the tests, and healthcare providers should be certain that parents
September/October 2014
Coordinated by Judy Beal, DNSc, RN, FNAP, FAAN have thorough explanations if the results show that the baby has a potential problem requiring further diagnostic testing. The rationale for this point of view has been promotion of public health and improved outcomes for newborns. Even the opt out for parents has been considered as controversial at times because some of the conditions covered by newborn screening are so devastating that some authorities question the parents right to make this decision. Parents may not have enough information to fully understand why the tests are important, thus denying their baby the test if informed consent was required (Hofher & Oglesbee, 2014). These questions have increased as newborn screening tests have expanded. Other related questions are the costs associated with expanded The rationale for not requiring screening with some states requiring many more tests than parental consent has been the recommended 30 tests and promotion of public health and at what cost, because many of the extra conditions are very improved outcomes for newborns. rare or have no form of treatment. Each state determines what tests are mandated (DeLuca, Zanni, Bonhomme, & Kemper, 2013). The U.S. Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) helps guide states as to what tests should be conducted. With improved technology, more and more genetic conditions have the potential of being discovered and treatments may follow. This expansion in genetic knowledge has led to the storing of dried blood taken for newborn screening to be used for later testing (DeLuca et al., 2013). Rationale for storage is promotion of health and better quality of life for individuals and families. Should informed consent be required for such storage? In my opinion, if the frame of public health promotion is used for newborn screening and no informed consent is needed then it would follow that no consent is needed for the blood storage. Nurses must become more familiar with the newborn screening tests, the use of the blood after the initial testing is done, and the long-term consequences of these actions in order to educate parents about this screening process. In addition, nurses need to conduct research studies to examine parent perceptions of screening and storage of blood in relationship to informed consent. ✜ Carole Kenner is Chief Executive Officer, Council of International Neonatal Nurses, Inc. (COINN) in Boston, MA. Dr. Kenner can be reached at [email protected] The author declares no conflicts of interest. DOI:10.1097/NMC.0000000000000062 References Baily, M. A. (2014). Newborn Screening. The Hastings Center. Retrieved from: www.thehastingscenter. org/Publications/BriefingBook/Detail.aspx?id=2268. Accessed February 2, 2014. Centers for Disease Control and Prevention. (2014). Newborn screening. Retrieved from: www.cdc.gov/ newbornscreening/. Accessed February 2, 2014. DeLuca, J., Zanni, K. L., Bonhomme, N., & Kemper, A. R. (2013). Implications of newborn screening for nurses. Journal of Nursing Scholarship, 45(1), 25-33. Hofherr, S., & Oglesbee, D. (2014). Newborn screening by tandem mass spectrometry and molecular confirmation. In W. E. Highsmith, Jr. (Ed.), Molecular diagnostics (pp. 209-222). New York: Springer. New England Newborn Screening Program. (2014). Routine disorders. Retrieved from: www. umassmed.edu/nbs/screenings/disorders/routine.aspx. Accessed February 2, 2014. MCN
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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Writing for the PRO position: Judith Lewis, PhD, RN, FAAN
PRO I
believe that informed consent should be required for routine newborn screening and for the storage of blood samples. The American Heritage Dictionary (n.d.) defines informed consent as “consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of relevant medical facts and risks involved.” The gold standard for medical and surgical procedures is informed consent. Informed consent refers to the process of providing the patient with information about the proposed procedure including, but not limited to: • benefits of the proposed procedure • risks of the proposed procedure • alternatives to the proposed procedure Although many believe that signing a consent form constitutes informed consent, informed consent is a process of education and that process is the key to a patient’s ability to provide consent for a procedure. It is not current practice to require informed consent for routine newborn screening, as it is seen as a routine part of newborn care. Although it is possible to opt out of newborn screening for a variety of reasons, how does a patient know of their right to refuse screening if they are not informed that screening will occur? All too often, a parent first learns that their newborn underwent newborn genetic testing when they are informed of screening results that require further diagnostic testing. Because newborn screening is a medical procedure, should not it be subject to the practice of informed consent? There are
282
volume 39
|
number 5
Should Informed Consent be Required for Routine Newborn Screening and for the Storage of Blood Samples? risks, including infection and bruising, to the process of obtaining the blood sample, and the parent has a right to know of these risks and that these tests are being performed. The American Academy of Pediatrics (AAP) (2013) suggests that presymptomatic genetic testing for a variety of conditions not be performed on children because of their inability to provide informed consent. Yet newborn screening falls outside these guidelines. Mothers also are not informed that their child’s blood spots are stored and used for research. Although these samples are deidentified, they are collected and stored without consent. One of the fundamental principles of the protection of human research subjects is Newborn screening tests should that they provide informed consent to be research sub- be subjected to the same jects. Clearly this does not happen. A class action lawsuit standard of care as any other in Texas resulted in an order genetic tests. to destroy thousands of such samples because they were obtained without consent of the donors (Root, 2010). When an adult signs a consent form for venipuncture, there is a part of the form that states the lab may retain blood samples and use them for a variety of purposes. When I’ve crossed out this section of the form, the lab technician is usually shocked, and I’ve been told I have no right to do so. In the case of newborn screening, the mother does not have the benefit of knowing ahead of time that her infant’s DNA is collected and stored. This is an unacceptable violation of the rights of human subjects. Another potential danger of obtaining DNA samples without consent is the possibility of discovering mis-paternity. If the mother is not aware that DNA samples are being retrieved, she is not aware that a de facto paternity test is being performed. This can have significant social and legal consequences in later life for the mother, putative father, biological father, and the child. The standard of care in genetic testing includes pretest counseling, testing, and posttest results delivery with counseling. Newborn screening tests should be subjected to the same standard of care as any other genetic tests. Judith Lewis is Professor Emerita at Virginia Commonwealth University in Richmond, VA. Dr. Lewis can be reached at [email protected] The author declares no conflicts of interest. References American Academy of Pediatrics (AAP) Committee on Bioethics, Committee on Genetics; American College of Medical Genetics, Social, Ethical, and Legal Issues Committee. (2013). Ethical and policy issues in genetic testing and screening of children. Pediatrics, 131(3), 620-622. Informed consent. (n.d.). The American Heritage® Stedman’s Medical Dictionary. Retrieved from: Dictionary.com website:http://dictionary.reference.com/browse/informed consent. Accessed: February 14, 2014. Root, J. (2010). Texas Officials Agree to Destory Babies’ Blood Samples After Settling Lawsuit. Texas Civil Rights Project. Retrieved from: www.texascivilrightsproject.org/1822/texas-officials-agree-todestroy-babies-blood-samples-after-settling-lawsuit/. Accessed February 17, 2014. September/October 2014
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
2 OPINION nd
Second Opinion columns are coordinated by Kathleen Leask Capitulo and Judy Beal. Dr. Capitulo can be reached via e-mail at: DrKatieRN@ hotmail.com. Dr. Beal can be reached via e-mail at: [email protected]
Writing for the CON position: Carole Kenner, RN, FNAP, FAAN Writing forPhD, the CON position: Xxx
CON I
believe that informed consent should not be required and that storing of newborn blood should occur without consent from parents. Newborn screening started in the 1960s when the linkage between mental retardation and Phenylketonuria became known. A simple blood test afforded the opportunity for early detection and treatment of an otherwise devastating metabolic condition. Such screening, now expanded to other conditions, provides a means for early detection of problems that may affect a child’s survival or lifelong health problems (Centers for Disease Control and Prevention [CDC], 2014). Every state requires newborns to be tested for potential genetic conditions such as congenital hypothyroidism, cystic fibrosis, and phenylketonuria. The New England Newborn Screening Program (2014) requires tests for 30 common disorders. In Massachusetts, parents can opt out if they object to the testing, mainly for religious reasons. However, there are ethical, social, legal, and associated financial implications of any newborn screening. These issues include (Baily, 2014): • Is this a type of diagnostic test that is so routine that no informed consent is needed?; • Are the outcomes in line with the potential costs for statemandated screening?; and • Should blood from such tests be stored for future testing without parental consent or knowledge? Many experts have argued over the years that because newborn screening test are state-mandated, no actual informed consent is needed. Rather, parents need to be educated about the tests, and healthcare providers should be certain that parents
September/October 2014
Coordinated by Judy Beal, DNSc, RN, FNAP, FAAN have thorough explanations if the results show that the baby has a potential problem requiring further diagnostic testing. The rationale for this point of view has been promotion of public health and improved outcomes for newborns. Even the opt out for parents has been considered as controversial at times because some of the conditions covered by newborn screening are so devastating that some authorities question the parents right to make this decision. Parents may not have enough information to fully understand why the tests are important, thus denying their baby the test if informed consent was required (Hofher & Oglesbee, 2014). These questions have increased as newborn screening tests have expanded. Other related questions are the costs associated with expanded The rationale for not requiring screening with some states requiring many more tests than parental consent has been the recommended 30 tests and promotion of public health and at what cost, because many of the extra conditions are very improved outcomes for newborns. rare or have no form of treatment. Each state determines what tests are mandated (DeLuca, Zanni, Bonhomme, & Kemper, 2013). The U.S. Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) helps guide states as to what tests should be conducted. With improved technology, more and more genetic conditions have the potential of being discovered and treatments may follow. This expansion in genetic knowledge has led to the storing of dried blood taken for newborn screening to be used for later testing (DeLuca et al., 2013). Rationale for storage is promotion of health and better quality of life for individuals and families. Should informed consent be required for such storage? In my opinion, if the frame of public health promotion is used for newborn screening and no informed consent is needed then it would follow that no consent is needed for the blood storage. Nurses must become more familiar with the newborn screening tests, the use of the blood after the initial testing is done, and the long-term consequences of these actions in order to educate parents about this screening process. In addition, nurses need to conduct research studies to examine parent perceptions of screening and storage of blood in relationship to informed consent. ✜ Carole Kenner is Chief Executive Officer, Council of International Neonatal Nurses, Inc. (COINN) in Boston, MA. Dr. Kenner can be reached at [email protected] The author declares no conflicts of interest. DOI:10.1097/NMC.0000000000000062 References Baily, M. A. (2014). Newborn Screening. The Hastings Center. Retrieved from: www.thehastingscenter. org/Publications/BriefingBook/Detail.aspx?id=2268. Accessed February 2, 2014. Centers for Disease Control and Prevention. (2014). Newborn screening. Retrieved from: www.cdc.gov/ newbornscreening/. Accessed February 2, 2014. DeLuca, J., Zanni, K. L., Bonhomme, N., & Kemper, A. R. (2013). Implications of newborn screening for nurses. Journal of Nursing Scholarship, 45(1), 25-33. Hofherr, S., & Oglesbee, D. (2014). Newborn screening by tandem mass spectrometry and molecular confirmation. In W. E. Highsmith, Jr. (Ed.), Molecular diagnostics (pp. 209-222). New York: Springer. New England Newborn Screening Program. (2014). Routine disorders. Retrieved from: www. umassmed.edu/nbs/screenings/disorders/routine.aspx. Accessed February 2, 2014. MCN
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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