Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group
The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal ch...
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| Language: | English |
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Elsevier
2024-12-01
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| Series: | Developmental Cognitive Neuroscience |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S187892932400121X |
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| author | Jenny Kingsley Barbara Andraka-Christou Seema K. Shah Paul Spicer Sharlene Newman Pilar N. Ossorio |
| author_facet | Jenny Kingsley Barbara Andraka-Christou Seema K. Shah Paul Spicer Sharlene Newman Pilar N. Ossorio |
| author_sort | Jenny Kingsley |
| collection | DOAJ |
| description | The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal challenges due to its goal of enrolling pregnant people (including those with substance use disorder) and their newborns. Challenges not fully anticipated at the outset emerged from the rapidly changing legal landscape around reproductive rights in the United States. By embedding scholars in bioethics and law within research teams and engaging them in conversation with each other and other study personnel, we were able to address many challenges proactively and respond promptly to unanticipated challenges. In this paper, we highlight several important ethical and legal challenges that arose from the first phase of funding through the beginning of participant enrollment. We explain the methods used to address these challenges, the ethical and legal tradeoffs that arose, and the resolution of challenges through the design of the study. Based on this experience, we provide recommendations for research teams, sponsors, and reviewers to address legal risks and promote the ethical conduct of studies with pregnant people and caregivers. We highlight the importance of collaboration with bioethics and legal scholars in studies involving complex and evolving legal risks, as well as the necessity of designing robust approaches to informed consent and maintaining participant trust while navigating ethical challenges in research. |
| format | Article |
| id | doaj-art-aedbcac22ed54ff483136e0205837b84 |
| institution | OA Journals |
| issn | 1878-9293 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Developmental Cognitive Neuroscience |
| spelling | doaj-art-aedbcac22ed54ff483136e0205837b842025-08-20T02:07:34ZengElsevierDevelopmental Cognitive Neuroscience1878-92932024-12-017010146010.1016/j.dcn.2024.101460Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working groupJenny Kingsley0Barbara Andraka-Christou1Seema K. Shah2Paul Spicer3Sharlene Newman4Pilar N. Ossorio5Center for Bioethics, Children’s Hospital Los Angeles, Los Angeles, CA, United States; Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States; Correspondence to: Center for Bioethics, Children’s Hospital Los Angeles, 4650 Sunset Blvd, MS 12, Los Angeles, CA 90027, United States.School of Global Health Management & Informatics, University of Central Florida, Orlando, FL, United StatesDepartment of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Smith Child Health Outcomes, Research, and Evaluation Center, Stanley Manne Children’s Research Institute, Lurie Children’s Hospital, Chicago, IL, United StatesDepartment of Anthropology, University of Oklahoma, Norman, OK, United StatesAlabama Life Research Institute, University of Alabama, Tuscaloosa, AL, United StatesUniversity of Wisconsin Law School, Madison, WI, United StatesThe HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal challenges due to its goal of enrolling pregnant people (including those with substance use disorder) and their newborns. Challenges not fully anticipated at the outset emerged from the rapidly changing legal landscape around reproductive rights in the United States. By embedding scholars in bioethics and law within research teams and engaging them in conversation with each other and other study personnel, we were able to address many challenges proactively and respond promptly to unanticipated challenges. In this paper, we highlight several important ethical and legal challenges that arose from the first phase of funding through the beginning of participant enrollment. We explain the methods used to address these challenges, the ethical and legal tradeoffs that arose, and the resolution of challenges through the design of the study. Based on this experience, we provide recommendations for research teams, sponsors, and reviewers to address legal risks and promote the ethical conduct of studies with pregnant people and caregivers. We highlight the importance of collaboration with bioethics and legal scholars in studies involving complex and evolving legal risks, as well as the necessity of designing robust approaches to informed consent and maintaining participant trust while navigating ethical challenges in research.http://www.sciencedirect.com/science/article/pii/S187892932400121XResearch ethicsPregnancySubstance usePediatricsReproductive rightsResearch regulation |
| spellingShingle | Jenny Kingsley Barbara Andraka-Christou Seema K. Shah Paul Spicer Sharlene Newman Pilar N. Ossorio Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group Developmental Cognitive Neuroscience Research ethics Pregnancy Substance use Pediatrics Reproductive rights Research regulation |
| title | Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group |
| title_full | Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group |
| title_fullStr | Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group |
| title_full_unstemmed | Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group |
| title_short | Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group |
| title_sort | navigating ethical and legal challenges in the healthy brain and child development study lessons learned from the ethics law policy working group |
| topic | Research ethics Pregnancy Substance use Pediatrics Reproductive rights Research regulation |
| url | http://www.sciencedirect.com/science/article/pii/S187892932400121X |
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