The American Journal of Bioethics, 15(4): 76, 2015 Copyright © Taylor & Francis Group, LLC ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265161.2015.1011003
Case Description
Navigating Parental Permission for Neonatal Research Holly A. Taylor, Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health Ellen Kuwana, Seattle Children’s Research Institute Benjamin S. Wilfond, Seattle Children’s Research Institute Ethical study recruitment is one of the most challenging aspects of medical research. Who is in the best position to recruit subjects? Are there people who should be excluded from the recruitment process? What are the advantages and disadvantages to individuals in the roles of clinician, researcher, and study coordinator being permitted or assigned to obtain consent? The case we present here, along with three accompanying commentaries, address these issues, made even more complex in the context of conducting interventional research with neonates. Robin Fiore, PhD, and Reid Cushman, PhD, from the University of Miami Miller School of Medicine, focus on the importance of minimizing therapeutic misconception, undue influence, and conflict of commitment when enrolling vulnerable populations in research studies. Leah Eisenberg, MA, JD, at the University of Arkansas Medical School, reminds researchers that parents of neonates face many difficult decisions and that the timing (prenatally or postnatally) of presenting clinical research options matters. Anita Shah, MD, MPH, Kathryn Porter, JD, MPH, Sandra Juul, MD, PhD, and Benjamin Wilfond, MD, of the University of Washington and Seattle Children’s Research Institute, address the trade-offs associated with parental permission being sought by attending physicians, researchers, or study coordinators. CASE SUMMARY A randomized, multicenter, placebo-controlled trial was established to test the efficacy of a drug on extremely premature infants. The drug at issue is already Food and Drug Administration (FDA) approved for a different purpose in children and adults. Parental permission was obtained either prenatally or postnatally, depending on
the availability of the parent. Prenatally, the standard approach was for the obstetrician caring for a hospitalized high-risk expectant mother to ask whether she was interested in being referred to a study investigator or study coordinator to discuss the study. Postnatally, however, consent had to be obtained within the first 24 hours of the child’s life. The study protocol required that the person obtaining permission postnatally could not be the attending physician of record. It came to the attention of the principal investigator at one of the trial centers that an attending physician admitting the baby was also a study investigator and obtained permission from the family to enroll the baby and initiate study procedures. After this event was discussed by the data coordinating center, the attending physician contacted the institution’s institutional review board (IRB), which confirmed that this was an acceptable practice. At another trial site, the study investigators anticipated being short-staffed for a few days and asked the coordinating center for permission to use a similar approach of allowing the attending to enroll study subjects, again with local IRB approval. The coordinating center decided to allow the local IRB to guide the approach to recruitment, but there remained uncertainty as to what was the ethically correct approach. The regulations do not specify who can obtain parental permission. These two separate events motivated the investigators to request an ethics consult to discuss the range of acceptable approaches for parental permission. To what extent might the role of the person obtaining parental permission (attending physician or trial investigator) influence the parent’s voluntariness or understanding? Who should be authorized to obtain parental permission? &
Address correspondence to Ellen Kuwana, MS, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, 1900 Ninth Avenue, M/S JMB-6, Seattle, WA 98101, USA. E-mail: [email protected]
76 ajob
Copyright of American Journal of Bioethics is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Case Description
Navigating Parental Permission for Neonatal Research Holly A. Taylor, Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health Ellen Kuwana, Seattle Children’s Research Institute Benjamin S. Wilfond, Seattle Children’s Research Institute Ethical study recruitment is one of the most challenging aspects of medical research. Who is in the best position to recruit subjects? Are there people who should be excluded from the recruitment process? What are the advantages and disadvantages to individuals in the roles of clinician, researcher, and study coordinator being permitted or assigned to obtain consent? The case we present here, along with three accompanying commentaries, address these issues, made even more complex in the context of conducting interventional research with neonates. Robin Fiore, PhD, and Reid Cushman, PhD, from the University of Miami Miller School of Medicine, focus on the importance of minimizing therapeutic misconception, undue influence, and conflict of commitment when enrolling vulnerable populations in research studies. Leah Eisenberg, MA, JD, at the University of Arkansas Medical School, reminds researchers that parents of neonates face many difficult decisions and that the timing (prenatally or postnatally) of presenting clinical research options matters. Anita Shah, MD, MPH, Kathryn Porter, JD, MPH, Sandra Juul, MD, PhD, and Benjamin Wilfond, MD, of the University of Washington and Seattle Children’s Research Institute, address the trade-offs associated with parental permission being sought by attending physicians, researchers, or study coordinators. CASE SUMMARY A randomized, multicenter, placebo-controlled trial was established to test the efficacy of a drug on extremely premature infants. The drug at issue is already Food and Drug Administration (FDA) approved for a different purpose in children and adults. Parental permission was obtained either prenatally or postnatally, depending on
the availability of the parent. Prenatally, the standard approach was for the obstetrician caring for a hospitalized high-risk expectant mother to ask whether she was interested in being referred to a study investigator or study coordinator to discuss the study. Postnatally, however, consent had to be obtained within the first 24 hours of the child’s life. The study protocol required that the person obtaining permission postnatally could not be the attending physician of record. It came to the attention of the principal investigator at one of the trial centers that an attending physician admitting the baby was also a study investigator and obtained permission from the family to enroll the baby and initiate study procedures. After this event was discussed by the data coordinating center, the attending physician contacted the institution’s institutional review board (IRB), which confirmed that this was an acceptable practice. At another trial site, the study investigators anticipated being short-staffed for a few days and asked the coordinating center for permission to use a similar approach of allowing the attending to enroll study subjects, again with local IRB approval. The coordinating center decided to allow the local IRB to guide the approach to recruitment, but there remained uncertainty as to what was the ethically correct approach. The regulations do not specify who can obtain parental permission. These two separate events motivated the investigators to request an ethics consult to discuss the range of acceptable approaches for parental permission. To what extent might the role of the person obtaining parental permission (attending physician or trial investigator) influence the parent’s voluntariness or understanding? Who should be authorized to obtain parental permission? &
Address correspondence to Ellen Kuwana, MS, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, 1900 Ninth Avenue, M/S JMB-6, Seattle, WA 98101, USA. E-mail: [email protected]
76 ajob
Copyright of American Journal of Bioethics is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
