Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience
Observational neuroimaging studies with children and adolescents may identify neurological anomalies and other clinically relevant findings. Planning for the management of this information involves ethical considerations that may influence informed consent, confidentiality, and communication with pa...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2018-08-01
|
| Series: | Developmental Cognitive Neuroscience |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1878929317300622 |
| _version_ | 1819162168309841920 |
|---|---|
| author | Duncan B. Clark Celia B. Fisher Susan Bookheimer Sandra A. Brown John H. Evans Christian Hopfer James Hudziak Ivan Montoya Margaret Murray Adolf Pfefferbaum Deborah Yurgelun-Todd |
| author_facet | Duncan B. Clark Celia B. Fisher Susan Bookheimer Sandra A. Brown John H. Evans Christian Hopfer James Hudziak Ivan Montoya Margaret Murray Adolf Pfefferbaum Deborah Yurgelun-Todd |
| author_sort | Duncan B. Clark |
| collection | DOAJ |
| description | Observational neuroimaging studies with children and adolescents may identify neurological anomalies and other clinically relevant findings. Planning for the management of this information involves ethical considerations that may influence informed consent, confidentiality, and communication with participants about assessment results. Biomedical ethics principles include respect for autonomy, beneficence, non-maleficence, and justice. Each project presents unique challenges. The Adolescent Brain and Cognitive Development study (ABCD) collaborators have systematically developed recommendations with written guidelines for identifying and responding to potential risks that adhere to biomedical ethics principles. To illustrate, we will review the ABCD approach to three areas: (1) hazardous substance use; (2) neurological anomalies; and (3) imminent potential for self-harm or harm to others. Each ABCD site is responsible for implementing procedures consistent with these guidelines in accordance with their Institutional Review Board approved protocols, state regulations, and local resources. To assure that each site has related plans and resources in place, site emergency procedures manuals have been developed, documented and reviewed for adherence to ABCD guidelines. This article will describe the principles and process used to develop these ABCD bioethics and medical oversight guidelines, the concerns and options considered, and the resulting approaches advised to sites. Keywords: Ethics, Adolescence, Magnetic resonance imaging, Clinical oversight, Substance use |
| first_indexed | 2024-12-22T17:23:57Z |
| format | Article |
| id | doaj.art-2e836158776741a383749c2f2b2cce2d |
| institution | Directory Open Access Journal |
| issn | 1878-9293 |
| language | English |
| last_indexed | 2024-12-22T17:23:57Z |
| publishDate | 2018-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Developmental Cognitive Neuroscience |
| spelling | doaj.art-2e836158776741a383749c2f2b2cce2d2022-12-21T18:18:46ZengElsevierDevelopmental Cognitive Neuroscience1878-92932018-08-0132143154Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experienceDuncan B. Clark0Celia B. Fisher1Susan Bookheimer2Sandra A. Brown3John H. Evans4Christian Hopfer5James Hudziak6Ivan Montoya7Margaret Murray8Adolf Pfefferbaum9Deborah Yurgelun-Todd103811 O’Hara Street, Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA 15215, United States; Corresponding author.441 East Fordham Road, Dealy Hall, Fordham University, Bronx, NY 10458, United StatesDepartment of Psychiatry and Biobehavioral Sciences, UCLA School of Medicine, Los Angeles, CA 90095, United StatesDepartment of Psychology and Psychiatry, UC San Diego, 9500 Gilman Drive (MC 0043), La Jolla, CA 92093, United StatesDepartment of Sociology, UC San Diego, 9500 Gilman Drive (0533), La Jolla, CA 92093, United StatesDepartment of Psychiatry, University of Colorado, Denver School of Medicine, 12469 E 17th Place (Bldg 400), Mail Stop F478, Aurora CO 80045, United StatesUHC Campus, St. Joe’s Room 3213, Box 364SJ 3, 1 South Prospect, Burlington, VT 05401, United StatesOffice of the DTMC Director, National Institute on Drug Abuse, 6001 Executive Boulevard, Bethesda, MD, United StatesOffice of the Director, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Rockville, MD, United StatesNeuroscience Program, SRI International, 333 Ravenswood Ave., Menlo Park, CA 94025, United StatesDepartment of Psychiatry, University of Utah School of Medicine, 501 Chipeta Way, Salt Lake City, UT 84108, United StatesObservational neuroimaging studies with children and adolescents may identify neurological anomalies and other clinically relevant findings. Planning for the management of this information involves ethical considerations that may influence informed consent, confidentiality, and communication with participants about assessment results. Biomedical ethics principles include respect for autonomy, beneficence, non-maleficence, and justice. Each project presents unique challenges. The Adolescent Brain and Cognitive Development study (ABCD) collaborators have systematically developed recommendations with written guidelines for identifying and responding to potential risks that adhere to biomedical ethics principles. To illustrate, we will review the ABCD approach to three areas: (1) hazardous substance use; (2) neurological anomalies; and (3) imminent potential for self-harm or harm to others. Each ABCD site is responsible for implementing procedures consistent with these guidelines in accordance with their Institutional Review Board approved protocols, state regulations, and local resources. To assure that each site has related plans and resources in place, site emergency procedures manuals have been developed, documented and reviewed for adherence to ABCD guidelines. This article will describe the principles and process used to develop these ABCD bioethics and medical oversight guidelines, the concerns and options considered, and the resulting approaches advised to sites. Keywords: Ethics, Adolescence, Magnetic resonance imaging, Clinical oversight, Substance usehttp://www.sciencedirect.com/science/article/pii/S1878929317300622 |
| spellingShingle | Duncan B. Clark Celia B. Fisher Susan Bookheimer Sandra A. Brown John H. Evans Christian Hopfer James Hudziak Ivan Montoya Margaret Murray Adolf Pfefferbaum Deborah Yurgelun-Todd Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience Developmental Cognitive Neuroscience |
| title | Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience |
| title_full | Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience |
| title_fullStr | Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience |
| title_full_unstemmed | Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience |
| title_short | Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience |
| title_sort | biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents the abcd experience |
| url | http://www.sciencedirect.com/science/article/pii/S1878929317300622 |
| work_keys_str_mv | AT duncanbclark biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT celiabfisher biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT susanbookheimer biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT sandraabrown biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT johnhevans biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT christianhopfer biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT jameshudziak biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT ivanmontoya biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT margaretmurray biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT adolfpfefferbaum biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience AT deborahyurgeluntodd biomedicalethicsandclinicaloversightinmultisiteobservationalneuroimagingstudieswithchildrenandadolescentstheabcdexperience |