Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups.
genetics
genomics
human subjects research
institutional review boards (IRBs)
investigators
mental illness
research ethics
Journal
Ethics & human research
ISSN: 2578-2363
Titre abrégé: Ethics Hum Res
Pays: United States
ID NLM: 101738005
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
entrez:
20
11
2019
pubmed:
20
11
2019
medline:
14
4
2020
Statut:
ppublish
Résumé
Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been viewed as different from other health information. Psychiatric research has been scrutinized based on concerns about the impact of psychiatric illness on individuals' abilities to make decisions. This study compared four stakeholder groups' attitudes toward research safeguards. Psychiatric genetic researchers and institutional review board chairs received structured surveys. Individuals with mental illness and family members participated in semistructured interviews. Paired sample t-tests were used to compare mean ratings of importance of safeguard procedures for genetic versus nongenetic research on physical versus mental illnesses. All groups provided higher ratings for the importance of safeguards for genetic research and for mental illness. Individuals with mental illness and family members rated the importance of safeguards more highly than researchers and chairs did. Results of generalized linear models showed significant effects of gender and ethnicity.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
12-22Informations de copyright
© 2019 by The Hastings Center. All rights reserved.
Références
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, DC: U.S. Government Printing Office, 1979).
Roberts, L. W., “Ethical Dimensions of Psychiatric Research: A Constructive, Criterion-Based Approach to Protocol Preparation: The Research Protocol Ethics Assessment Tool (RePEAT),” Biological Psychiatry 46 (1999): 1106-19.; Lidz, C. W., et al., “How Closely Do Institutional Review Boards Follow the Common Rule?,” Academic Medicine 87, no. 7 (2012): 969-74.
Hudson, K. L., “Genomics, Health Care, and Society,” New England Journal of Medicine 365 (2011): 1033-41.; Lowrance, W. W., and F. S. Collins, “Ethics. Identifiability in Genomic Research,” Science 317 (2007): 600-602.
Lowrance and Collins, “Ethics. Identifiability in Genomic Research”; McGuire, A. L., and R. A. Gibbs, “Genetics. No Longer De-identified,” Science 312 (2006): 370-71.; Kristman, V. L., and N. Kreiger, “Information Disclosure in Population-Based Research Involving Genetics: A Framework for the Practice of Ethics in Epidemiology,” Annals of Epidemiology 18, no. 4 (2008): 335-41.; Kaye, J., “The Tension between Data Sharing and the Protection of Privacy in Genomics Research,” Annual Review of Genomics and Human Genetics 13 (2012): 415-31.
McGuire, A. L., et al., “Confidentiality, Privacy, and Security of Genetic and Genomic Test Information in Electronic Health Records: Points to Consider,” Genetics in Medicine 10, no. 7 (2008): 495-99.; Green, M. J., and J. R. Botkin, “‘Genetic Exceptionalism’ in Medicine: Clarifying the Differences between Genetic and Nongenetic Tests,” Annals of Internal Medicine 138, no. 7 (2003): 571-75.
Kass, N. E., “Participation in Pedigree Studies and the Risk of Impeded Access to Health Insurance,” IRB: A Review of Human Subjects Research 15, no. 5 (1993): 7-10.; Khan, A., et al., “Informed Consent for Human Genetic and Genomic Studies: A Systematic Review,” Clinical Genetics 86, no. 3 (2014): 199-206.; Lebowitz, M. S., and W. K. Ahn, “Blue Genes? Understanding and Mitigating Negative Consequences of Personalized Information about Genetic Risk for Depression,” Journal of Genetic Counseling 27, no 1 (2018): 204-16.; Wolf, S. M., et al., “Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations,” Journal of Law Medicine & Ethics 43, no. 3 (2015): 440-63.
Simon, C. M., et al., “Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives,” Journal of Empirical Research on Human Research Ethics 6, no. 4 (2011): 53-67.; Goldenberg, A. J., et al., “IRB Practices and Policies regarding the Secondary Research Use of Biospecimens,” BMC Medical Ethics 16 (2015): 32; Gliwa, C., et al., “Institutional Review Board Perspectives on Obligations to Disclose Genetic Incidental Findings to Research Participants,” Genetics in Medicine 18, no. 7 (2016): 705-11.; Lee, D. C., et al., “Variations in Institutional Review Board Reviews of a Multi-center, Emergency Department (ED)-Based Genetic Research Protocol,” American Journal of Emergency Medicine 31, no. 6 (2013): 967-69.
Ruiz-Canela, M., J. I. Valle-Mansilla, and D. P. Sulmasy, “What Research Participants Want to Know about Genetic Research Results: The Impact of ‘Genetic Exceptionalism’,” Journal of Empirical Research on Human Research Ethics 6, no. 3 (2011): 39-46.
Valle-Mansilla, J. I., “Genomic Research with Human Samples. Points of View from Scientists and Research Subjects about Disclosure of Results and Risks of Genomic Research. Ethical and Empirical Approach,” Revisa de Derecho y Genoma Humano 34 (2011): 205-24.; Edwards, K. L., et al., “Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants’ Genomic Results,” Public Health Genomics (2018): 1-9.
Appelbaum, P. S., “Ethical Issues in Psychiatric Genetics,” Journal of Psychiatric Practice 10, no. 6 (2004): 343-51.; Gershon, E. S., “The Challenges of Genetic Tests for Human Behavior,” Israel Journal of Psychiatry and Related Sciences 39, no. 4 (2002): 206-16.; Appelbaum, P. S., “Law & Psychiatry: Genetic Discrimination in Mental Disorders: The Impact of the Genetic Information Nondiscrimination Act,” Psychiatric Services 61, no. 4 (2010): 338-40.; Hoge, S. K., and P. S. Appelbaum, “Ethics and Neuropsychiatric Genetics: A Review of Major Issues,” International Journal of Neuropsychopharmacology 15, no. 10 (2012): 1547-57.
National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (Rockville, MD: National Bioethics Advisory Commission, 1998); Michels, R., “Are Research Ethics Bad for Our Mental Health?,” New England Journal of Medicine 340, no. 18 (1999): 1427-30.; Humphreys, K., J. C. Blodgett, and L. W. Roberts, “The Exclusion of People with Psychiatric Disorders from Medical Research,” Journal of Psychiatric Research 70 (2015): 28-32.
Roberts, L.W., “The Ethical Basis of Psychiatric Research: Conceptual Issues and Empirical Findings,” Comprehensive Psychiatry 39, no. 3 (1998): 99-110.
Catania, J. A., et al., “Survey of U.S. Boards that Review Mental Health-Related Research,” Journal of Empirical Research on Human Research Ethics 3, no. 4 (2008): 71-79.; Wolf, L. E., et al., “IRB Chairs’ Perspectives on Genomics Research Involving Stored Biological Materials: Ethical Concerns and Proposed Solutions,” Journal of Empirical Research on Human Research Ethics 3, no. 4 (2008): 99-111.; Klitzman, R., et al., “Psychiatrists’ Views of the Genetic Bases of Mental Disorders and Behavioral Traits and Their Use of Genetic Tests,” Journal of Nervous and Mental Disease 202, no. 7 (2014): 530-38.; Hoop, J. G., et al., “Psychiatrists’ Attitudes regarding Genetic Testing and Patient Safeguards: A Preliminary Study,” Genetic Testing 12, no. 2 (2008): 245-52.; Hoop, J. G., et al., “Psychiatrists’ Attitudes, Knowledge, and Experience regarding Genetics: A Preliminary Study,” Genetics in Medicine 10, no. 6 (2008): 439-49.; Meiser, B., et al., “Attitudes to Genetic Testing in Families with Multiple Cases of Bipolar Disorder,” Genetic Testing 12, no. 2 (2008): 233-43.; DeLisi, L. E., and H. Bertisch, “A Preliminary Comparison of the Hopes of Researchers, Clinicians, and Families for the Future Ethical Use of Genetic Findings on Schizophrenia,” American Journal of Medical Genetics Part B: Neuropsychiatric Genetics 141, no. 1 (2006): 110-15.
Nwulia, E. A., et al., “Ethnic Disparities in the Perception of Ethical Risks from Psychiatric Genetic Studies,” American Journal of Medical Genetics Part B: Neuropsychiatric Genetics 156B, no. 5 (2011): 569-80.; Fong, M., K. L. Braun, and R. M. Chang, “Native Hawaiian Preferences for Informed Consent and Disclosure of Results from Research Using Stored Biological Specimens,” Pacific Health Dialog 11, no. 2 (2004): 154-59.; Platt, J., et al., “Public Preferences regarding Informed Consent Models for Participation in Population-Based Genomic Research,” Genetics in Medicine 16, no. 1 (2014): 11-18.
Edwards, et al., “Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards”; Wolf et al., “IRB Chairs’ Perspectives on Genomics Research”; Roberts, L. W., and J. P. Kim, “Giving Voice to Study Volunteers: Comparing Views of Mentally Ill, Physically Ill, and Healthy Protocol Participants on Ethical Aspects of Clinical Research,” Journal of Psychiatric Research 56 (2014): 90-97.; Edwards, K. L., et al., “Genetics Researchers’ and IRB Professionals’ Attitudes toward Genetic Research Review: A Comparative Analysis,” Genetics in Medicine 14, no. 2 (2012): 236-42.
Roberts and Kim, “Giving Voice to Study Volunteers.”
Edwards, et al., “Genetics Researchers’ and IRB Professionals’ Attitudes toward Genetic Research Review.”
Roberts, L. W., et al., “Views of the Importance of Psychiatric Genetic Research by Potential Volunteers from Stakeholder Groups,” Journal of Psychiatric Research 106 (2018): 69-73.
Ibid.; Roberts, L. W., et al., “Perspectives of Psychiatric Investigators and IRB Chairs regarding Benefits of Psychiatric Genetics Research,” Journal of Psychiatric Research 106 (2018): 54-60.
Erby, L. H., et al., “The Rapid Estimate of Adult Literacy in Genetics (REAL-G): A Means to Assess Literacy Deficits in the Context of Genetics,” American Journal of Medical Genetics A, 146A, no. 2 (2008): 174-81.; Warem, J., Jr., M. Kosinski, and S. D. Keller, “A 12-Item Short-Form Health Survey: Construction of Scales and Preliminary Tests of Reliability and Validity,” Medical Care 34, no. 3 (1996): 220-33.; Derogatis, L. R., BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual, 4th ed. (Minneapolis, MN: National Computer Systems, 1993).
Roberts et al., “Perspectives of Psychiatric Investigators and IRB Chairs regarding Benefits of Psychiatric Genetics Research.”
Roberts, L.W., et al., “Do Human Subject Safeguards Matter to Potential Participants in Psychiatric Genetic Research?,” Journal of Psychiatric Research 116 (2019): 95-103.
Roberts, L. W., et al., “Influence of Ethical Safeguards on Research Participation: Comparison of Perspectives of People with Schizophrenia and Psychiatrists,” American Journal of Psychiatry 161 (2004): 2309-11.; Roberts, L. W., et al., “Schizophrenia Research Participants’ Responses to Protocol Safeguards: Recruitment, Consent, and Debriefing,” Schizophrenia Research 67 (2004): 283-91.; Roberts, L. W., and B. Roberts, “Psychiatric Research Ethics: An Overview of Evolving Guidelines and Current Ethical Dilemmas in the Study of Mental Illness,” Biological Psychiatry 46 (1999): 1025-38.; Dunn, L. B., P. J. Candilis, and L. W. Roberts, “Emerging Empirical Evidence on the Ethics of Schizophrenia Research,” Schizophrenia Bulletin 32 (2006): 47-68.
National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders.
McGuire et al., “No Longer De-identified”; Khan et al., “Informed Consent for Human Genetic and Genomic Studies”; Hoop, J. G., “Ethical Considerations in Psychiatric Genetics,” Harvard Review of Psychiatry 16, no. 6 (2008): 322-38.; Biesecker, B. B., and H. L. Peay, “Ethical Issues in Psychiatric Genetics Research: Points to Consider,” Psychopharmacology 171, no. 1 (2003): 27-35.
Edwards et al., “Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards.”
Roberts and Kim, “Giving Voice to Study Volunteers”; Roberts et al., “Influence of Ethical Safeguards on Research Participation.”
Trinidad, S. B., et al., “Research Ethics. Research Practice and Participant Preferences: The Growing Gulf,” Science 331, no. 6015 (2011): 287-88.
Edwards et al., “Genetics Researchers’ and IRB Professionals’ Attitudes toward Genetic Research Review.”
Green and Botkin, “‘Genetic Exceptionalism’ in Medicine”; Bains, W., “Genetic Exceptionalism,” Nature Biotechnology 28, no. 3 (2010): 212-13.
McGuire et al., “Confidentiality, Privacy, and Security of Genetic and Genomic Test Information in Electronic Health Records”; Ruiz-Canela et al., “What Research Participants Want to Know.”
McGuire et al., “Confidentiality, Privacy, and Security of Genetic and Genomic Test Information in Electronic Health Records”; Biesecker, B. B., and H. L. Peay, “Genomic Sequencing for Psychiatric Disorders: Promise and Challenge,” International Journal of Neuropsychopharmacology 16, no. 7 (2013): 1667-72.
Roberts et al., “Schizophrenia Research Participants’ Responses to Protocol Safeguards.”
Roberts, L. W., and J. P. Kim, “Attunement and Alignment of People with Schizophrenia and Their Preferred Alternative Decision-Makers: An Exploratory Pilot Study Comparing Treatment and Research Decisions,” Journal of Psychiatric Research 71 (2015): 70-77.
Kim, J. P., and L. W. Roberts, “Demonstrating Patterns in the Views of Stakeholders regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry,” AJOB Empirical Bioethics 6, no. 2 (2015): 33-42.
Nwulia et al., “Ethnic Disparities in the Perception of Ethical Risks from Psychiatric Genetic Studies”; Ngui, E. M., T. D. Warner, and L. W. Roberts, “Perceptions of African-American Health Professionals and Community Members on the Participation of Children and Pregnant Women in Genetic Research,” Public Health Genomics 17, no. 1 (2014): 23-32.