Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience

Developmental Cognitive Neuroscience

Volumn 32, Issue , 2018, Pages 143-154

  Clark, Duncan B ^a   Fisher, Celia B ^b   Bookheimer, Susan ^c   Brown, Sandra A ^d   Evans, John H ^d   Hopfer, Christian ^e   Hudziak, James ^f   Montoya, Ivan ^g   Murray, Margaret ^h   Pfefferbaum, Adolf ⁱ   Yurgelun Todd, Deborah ^j  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b FORDHAM UNIVERSITY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^f FLETCHER ALLEN HEALTH CARE   (United States)

^g NATIONAL INSTITUTE ON DRUG ABUSE   (United States)

^h NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM   (United States)

ⁱ SRI INTERNATIONAL   (United States)

^j UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

more..

Author keywords

Adolescence; Clinical oversight; Ethics; Magnetic resonance imaging; Substance use

Indexed keywords

AUTOMUTILATION; BIOETHICS; COGNITIVE DEVELOPMENT; DANGEROUS GOODS; HUMAN; NEUROIMAGING; NEUROLOGIC DISEASE; OBSERVATIONAL METHOD; OBSERVATIONAL STUDY; PRACTICE GUIDELINE; REVIEW; SUBSTANCE USE; ADOLESCENT; ADOLESCENT DEVELOPMENT; BRAIN; CHILD; CLINICAL TRIAL; COGNITION; FEMALE; GROWTH, DEVELOPMENT AND AGING; MALE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; PHYSIOLOGY; PROCEDURES; TRENDS;

ADOLESCENT; ADOLESCENT DEVELOPMENT; BIOETHICS; BRAIN; CHILD; COGNITION; FEMALE; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; NEUROIMAGING;

EID: 85023613039     PISSN: 18789293     EISSN: 18789307     Source Type: Journal    
DOI: 10.1016/j.dcn.2017.06.005     Document Type: Review

References (48)

1. Beauchamp, T.L., Childress, J.F., Principles of Biomedical Ethics. 3rd ed., 1989, Oxford University Press, New York.
2. Berge, J., Sundell, K., Ojehagen, A., Hoglund, P., Hakansson, A., Parental awareness of substance use among adolescents in a junior high school sample. J. Drug Issues 45:3 (2015), 263–278.
3. Borgelt, E., Anderson, J.A., Illes, J., Managing incidental findings: lessons from neuroimaging. Am. J. Bioeth. 13:2 (2013), 46–47.
4. Brown, S.A., Brumback, T., Tomlinson, K., Cummins, K., Thompson, W.K., Nagel, B.J., De Bellis, M.D., Hooper, S.R., Clark, D.B., Chung, T., Hasler, B.P., Colrain, I.M., Baker, F.B., Prouty, D., Pfefferbaum, A., Sullivan, E.V., Pohl, K.M., Rohlfing, T., Nichols, B.N., Chu, W., Tapert, S.F., The National Consortium on Alcohol and NeuroDevelopment in Adolescence (NCANDA): a multi-site study of adolescent development and substanceuse. J. Stud. Alcohol Drugs 76 (2015), 895–908.
5. Clark, D.B., Winters, K.C., Measuring risks and outcomes in substance use disorders prevention research. J. Consult. Clin. Psychol. 70:6 (2002), 1207–1223.
6. Clark, D.B., Pollock, N., Bukstein, O.G., Mezzich, A.C., Bromberger, J.T., Donovan, J.E., Gender and comorbid psychopathology in adolescents with alcohol dependence. J. Am. Acad. Child Adolesc. Psychiatry 36:9 (1997), 1195–1203.
7. Cole, C., Petree, L.E., Phillips, J.P., Shoemaker, J.M., Holdsworth, M., Helitzer, D.L., ‘Ethical responsibility’ or ‘a whole can of worms’: differences in opinion on incidental finding review and disclosure in neuroimaging research from focus group discussions with participants, parents, IRB members, investigators, physicians, and community members. J. Med. Ethics 41:10 (2015), 841–847.
8. Cramer, S.C., Wu, J., Hanson, J.A., Nouri, S., Karnani, D., Chuang, T.M., Le, V., A system for addressing incidental findings in neuroimaging research. Neuroimage 55:3 (2011), 1020–1023.
9. Del Boca, F.K., Darkes, J., The validity of self-reports of alcohol consumption: state of the science and challenges for research. Addiction 98:s2 (2003), 1–12.
10. Delaney-Black, V., Chiodo, L.M., Hannigan, J.H., Greenwald, M.K., Janisse, J., Patterson, G., Huestis, M.A., Ager, J., Sokol, R.J., Just say I don't: lack of concordance between teen report and biological measures of drug use. Pediatrics 126:5 (2010), 887–893.
11. Dempsey, A.F., Singer, D.D., Clark, S.J., Davis, M.M., Adolescent preventive health care: what do parents want?. J. Pediatr. 155 (2009), 689–694.
12. Di Pietro, N.C., Illes, J., Disclosing incidental findings in brain research: the rights of minors in decision-making. J. Magn. Reson. Imaging 38 (2013), 1009–1013.
13. Duncan, R.E., Vandeleur, M., Derks, A., Sawyer, S., Confidentiality with adolescents in the medical setting: what do parents think?. J. Adolesc. Health 49 (2011), 428–430.
14. Fisher, C.B., Goodman, S.J., Goodness-of-fit ethics for non-intervention research involving dangerous and illegal behaviors. Buchanan, D., fisher, C.B., Gable, L., (eds.) Research with High Risk Populations: Balancing Science, Ethics, and Law, 2009, APA Books, Washington, DC, 25–46.
15. Fisher, C.B., Higgins-D'Alessandro, A., Rau, J.M., Kuther, T.L., Belanger, S., Referring and reporting research participants at risk: views from urban adolescents. Child Dev. 67 (1996), 2086–2100.
16. Fisher, C.B., Hoagwood, K., Boyce, C., Duster, T., Frank, D.A., Grisso, T., Macklin, R., Levine, R.J., Spencer, M.B., Takanishi, R., Trimble, J.E., Zayas, L.H., Research ethics for mental health science involving ethnic minority children and youth. Am. Psychol. 57:12 (2002), 1024–1040 (PMID: 12613155).
17. Fisher, C.B., Relational ethics and research with vulnerable populations. Reports on Research Involving Persons with Mental Disorders That May Affect Decision-Making Capacity, Vol. 2, 1999, National Bioethics Advisory Commission, Rockville, MD, 29–549 Commissioned Papers by the National Bioethics Advisory Commission, Retrieved October 26, 2009, from http://www.bioethics.gov/reports/past_commissions/nbac_metal2.pdf.
18. Fisher, C.B., Participant consultation: ethical insights into parental permission and confidentiality procedures for policy relevant research with youth. Lerner, R.M., Jacobs, F., Wertlieb, D., (eds.) Handbook of Applied Developmental Science, Vol. 4, 2002, Sage, Thousand Oaks, CA, 371–396.
19. Fisher, C.B., Adolescent and parent perspectives on ethical issues in youth drug use and suicide survey research. Ethics Behav. 13:4 (2003), 303–332 PMID: 15000093.
20. Fisher, C.B., Confidentiality and disclosure ion non-intervention adolescent risk research. Appl. Dev. Sci. 17:2 (2013), 88–93.
21. Fisher, C.B., Decoding the Ethics Code: A Practical Guide for Psychologists. 4th ed., 2017, Sage Publications, Thousand Oaks, CA.
22. Ford, C.A., Millstein, S.G., Halpern-Felsher, B.L., Irwin, C.E., Influence of physician confidentiality assurances on adolescents’ willingness to disclose information and seek future health care: a randomized controlled trial. JAMA 278:12 (1997), 1029–1034.
23. Gillon, R., Medical ethics: four principles plus attention to scope. Br. Med. J. 309:184 (1994), 184–188.
24. Gur, R.E., Kaltman, D., Melhem, E.R., Ruparel, K., Prabhakaran, K., Riley, M., Yodh, E., Hakonarson, H., Saterthwaite, T., Gur, R.C., Incidental findings in youths volunteering for brain MRI research. Am. J. Neuroradiol. 34 (2013), 2012–2015.
25. Hiriscau, I.E., Stingelin-Giles, N., Stadler, C., Schmeck, K., Reiter-Theil, S., A right to confidentiality or a duty to disclose? Ethical guidance for conducting prevention research with children and adolescents. Eur. Child Adolesc. Psychiatry 23 (2014), 409–416.
26. Hoop, J.G., Smyth, A.C., Roberts, L.W., Ethical issues in psychiatric research on children and adolescents. Child Adolesc. Psychiatr. Clin. North Am. 17 (2008), 127–148.
27. Houghton, C., Young people's perspectives on participatory ethics: agency, power and impact in domestic abuse research and policy making. Child Abuse Rev. 24 (2015), 235–248.
28. Illes, J., Desmond, J.E., Huang, L.F., Raffin, T.A., Atlas, S.W., Ethical and practical considerations in managing incidental findings in functional magnetic resonance imaging. Brain Cogn. 50 (2002), 358–365.
29. Illes, J., Kirschen, M.P., Edwards, E., Stanford, L.R., Bandettini, P., Cho, M.K., Ford, P.J., Glover, G.H., Kulynych, J., Macklin, R., Michael, D.B., Wolf, S.M., Incidental findings in brain imaging research: what should happen when a researcher sees a potential health problem in a brain scan from a research subject. Science 311:5762 (2006), 783–784.
30. Kennedy, D., Neuroscience and neuroethics. Science, 306(5695), 2004, 373.
31. Kirschen, M.P., Jaworska, A., Illes, J., Subjects’ expectations in neuroimaging research. J. Magn. Reson. Imaging 23 (2006), 205–209.
32. Kumra, S., Ashtari, M., Anderson, B., Cervellione, K.L., Kan, L., Ethical and practical considerations in the management of incidental findings in pediatric MRI studies. J. Am. Acad. Child Adolesc. Psychiatry 45:8 (2006), 1000–1106.
33. Lefaivre, M., Chambers, C.T., Fernandez, C.V., Offering parents individualized feedback on the results of psychological testing conducted for research purposes with children: ethical issues and recommendations. J. Clin. Child Adolesc. Psychol. 36:2 (2007), 242–252.
34. Lehrer, J.A., Pantell, R., Tebb, K., Shafer, M.A., Forgone health care among U.S. adolescents: associations between risk characteristics and confidentiality concern. J. Adolesc. Health 40 (2007), 218–226.
35. Lloyd-Richardson, E.E., Lewis, S.P., Whitlock, J.L., Rodham, K., Schatten, H.T., Research with adolescents who engage in non-suicidal self-injury: ethical considerations and challenges. Child Adolesc. Psychiatry Ment. Health 9:37 (2015), 1–14.
36. Lothen-Kline, C., Howard, D.E., Hamburger, E.K., Worrell, K.D., Boekeloo, B.O., Truth and consequences: ethics, confidentiality, and disclosure in adolescent longitudinal prevention research. J. Adolesc. Health 33 (2003), 385–394.
37. Milstein, A.D., Research malpractice and the issue of incidental findings. J. Law Med. Ethics 36:2 (2008), 356–360.
38. Nelson, C.A., Incidental findings in magnetic resonance imaging (MRI) brain research. J. Law Med. Ethics 36:2 (2008), 315–319.
39. O'Sullivan, C., Fisher, C.B., The effect of confidentiality and reporting procedures on parent-child agreement to participate in adolescent risk research. Appl. Dev. Sci. 1 (1997), 185–197.
40. Phillips, J.P., Cole, C., Gluck, J.P., Shoemaker, J.M., Petree, L.E., Helitzer, D.L., Schrader, R.M., Holdsworth, M.T., Stakeholder opinions and ethical perspectives support complete disclosure of incidental findings in MRI research. Ethics Behav. 25:4 (2015), 332–350.
41. Richardson, H.S., Incidental findings and ancillary-care obligations. J. Law Med. Ethics 36:2 (2008), 256–270.
42. Royal, J.M., Peterson, B.S., The risks and benefits for incidental findings in MRI research scans. J. Law Med. Ethics 36:2 (2008), 305–314.
43. Scott, N.A., Murphy, T.H., Illes, J., Incidental findings in neuroimaging research: a framework for anticipating the next frontier. J. Empirical Res. Hum. Res. Ethics 7:1 (2012), 53–57.
44. Seki, A., Uchiyama, H., fukushi, T., Sakura, O., Tatsuya, K., Incidental findings of brain magnetic resonance imaging study in a pediatric cohort in Japan and recommendation for a model management protocol. J. Epidemiol. 20:s2 (2010), s498–504.
45. Shoemaker, J.M., Cole, C., Petree, L.E., Helitzer, D.L., Holdsworth, M.T., Gluck, J.P., Phillips, J.P., Evolution of universal review and disclosure of MRI reports to research participants. Brain Imaging Behav., 6(3), 2016, e00428.
46. Ethical Challenges in the Behavioral and Brain Sciences. Sternberg, R.J., Fiske, S.T., (eds.), 2015, Cambridge University Press, New York, NY.
47. Sullivan, E.V., Lane, B., Kwon, D., Meloy, M.J., Tapert, S.F., Brown, S.A., Colrain, I.M., Baker, F.C., DeBellis, M.D., Clark, D.B., Nagel, B.J., Pohl, K.M., Pfefferbaum, A., Structural brain anomalies in health adolescents in the NCANDA cohort: relation to neuropsychological test performance, sex, and ethnicity. Brain Imaging Behav., 2016 in press.
48. Wolf, S.M., The challenge of incidental findings. J. Law Med. Ethics 36:2 (2008), 216–218.