Hostname: page-component-76fb5796d-wq484 Total loading time: 0 Render date: 2024-04-26T01:08:10.563Z Has data issue: false hasContentIssue false

Optimizing Ethics Engagement in Research: Learning from the Ethical Complexities of Studying Opioid Use in Pregnancy

Published online by Cambridge University Press:  27 July 2022

Seema K. Shah
Affiliation:
LURIE CHILDREN’S HOSPITAL AND DEPARTMENT OF PEDIATRICS, NORTHWESTERN UNIVERSITY, CHICAGO, ILLINOIS, USA
Marielle Gross
Affiliation:
DEPARTMENT OF OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE SCIENCES, UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE, PITTSBURGH, PENNSYLVANIA, USA
Camille Nebeker
Affiliation:
SCHOOL OF PUBLIC HEALTH AND UC SAN DIEGO RESEARCH ETHICS PROGRAM, UNIVERSITY OF CALIFORNIA, SAN DIEGO, LA JOLLA, CALIFORNIA, USA

Abstract

Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.

Type
Independent Articles
Copyright
© 2022 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Anderson, E. and McNair, L., “Ethical Issues in Research Involving Participants with Opioid Use Disorder,” Therapeutic Innovation and Regulatory Science 52, no. 3 (2018): 280284.CrossRefGoogle ScholarPubMed
Morgridge Institute, “Infants with Prenatal Substance Exposure,” available at <https://morgridge.org/research/bioethics/prenatal-substance-exposure/> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Department of Health and Human Services, National Institutes of Health, HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD), available at <https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-036.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
NIH Office of Science Policy, Bioethics Research, available at <https://osp.od.nih.gov/clinical-research/bioethics-research/> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Porter, K. M., Danis, M., Taylor, H. A., Cho, M. K., and Wilfond, B. S., Clinical Research Ethics Consultation Collaborative Repository Group, “The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative,” The American Journal of Bioethics 18, no. 1 (2018): 3945; R. R. Sharp, H. A. Taylor, M. A. Brinich, M. M. Boyle, M. Cho, M. Coors, M. Danis, M. Havard, D. Magnus, and B. Wilfond, “Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations,” Academic Medicine 90, no. 5 (2015): 615–620; See generally M. A. Danis, E. Largent, C. Grady, D. Wendler, S. C. Hull, S. Shah, J. Millum, and B. Berkman, Research Ethics Consultation: A Casebook (New York: Oxford University Press 2012).CrossRefGoogle Scholar
Sugarman, J. and Bredenoord, A. L., “Real-time Ethics Engagement in Biomedical Research: Ethics from Bench to Bedside.” EMBO Reports 21 (2020): e49919.Google ScholarPubMed
Levine, C., “Has AIDS Changed the Ethics of Human Subjects Research?Journal of Law, Medicine & Ethics 16, no. 3-4 (1988): 167173.Google ScholarPubMed
Office for Human Research Protections, Federalwide Assurance (FWA) for the Protection of Human Subjects, available at <https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Department of Health and Human Services, Basic HHS Policy for Protection of Human Research Subjects, §45 C.F.R. §46.103.Google Scholar
Petrella, B. L., “Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!Current Protocols in Microbiology 39 ( 2015): 1A.5.11A.5.16.CrossRefGoogle Scholar
Collaborative Institutional Training Initiative (CITI) Program, available at <https://about.citiprogram.org/en/homepage/> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Levine, supra note 8 at 3.Google Scholar
Eckstein, L., Rid, A., Kamuya, D., and Shah, S. K., “The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19),” Clinical Infectious Diseases 73, no. 11 (2021): 21262130.CrossRefGoogle ScholarPubMed
Kimmelman, J., “Why IRBs Should Protect Bystanders in Human Research,” Bioethics 34, no. 9 (2020): 933936; S.K. Shah, J. Kimmelman, A. D. Lyerly, et al., “Bystander Risk, Social Value, and Ethics of Human Research,” Science 360, no. 6385 (2018): 158-159; C. Nebeker, J. Harlow, R. E. Giacinto, R. Orozco-Linares, C. S. Bloss, and N. Weibel, “Ethical and Regulatory Challenges of Research using Pervasive Sensing and Other Emerging Technologies: IRB Perspectives,” AJOB Empirical Bioethics 8, no. 4 (2017): 266-276; C. Nebeker, T. Lagare, M. Takemoto, et al., “Engaging Research Participants to Inform the Ethical Conduct of Mobile Imaging, Pervasive Sensing, and Location Tracking Research,” Translational Behavioral Medicine 6, no. 4 (2016): 577-586.CrossRefGoogle ScholarPubMed
Shah, S. K., “Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?Journal of Law, Medicine & Ethics 41, no. 2 (2013): 397410.CrossRefGoogle ScholarPubMed
Landeweerd, L., Townend, D., Mesman, J., Landeweerd, I. V., et al., “Reflections on Different Governance Styles in Regulating Science: A Contribution to ‘Responsible Research and Innovation,’Life Sciences, Society, and Policy 11, no. 8 (2015): epublication.CrossRefGoogle Scholar
Shah, S. K. and Porter, K., “Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favor of the Ethically Preferable Outcome,” The American Journal of Bioethics 18, no. 4 (2018): 9394.CrossRefGoogle ScholarPubMed
See Sugarman supra note 7.Google Scholar
Jao, F. Kombe, Mwalukore, S., et al., “Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenya: Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement,” Journal of Empirical Research on Human Research Ethics 10, no. 3 (2015): 264277.CrossRefGoogle ScholarPubMed
Morgridge Institute, supra note 3.Google Scholar
Bietta, E., “From Ethics Washing to Ethics Bashing: A View on Tech Ethics from Within Moral Philosophy,” Proceedings of the 2020 Conference on Fairness, Accountability, and Transparency (2020): 210219, available at <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3513182> (last visited April 28, 2022).CrossRef+(last+visited+April+28,+2022).>Google Scholar
Metz, R., “Google to Examine the Departure of a Leading AI Ethics Researcher,” CNN, December 9, 2020, available at <https://www.cnn.com/2020/12/09/tech/google-timnit-gebru-sundar-pichai-memo/index.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Ashby, M.A. and Morrell, B., “Embedded Journalists or Empirical Critics? The Nature of the Gaze in Bioethics,” Bioethical Inquiry 15 (2018): 305307.CrossRefGoogle ScholarPubMed
See Shah et al., supra note 14.Google Scholar
Miller, F. G., “Ethical Supervision?” Hastings Center Report (Nov. 27, 2017), available at <https://www.thehastingscenter.org/ethical-supervision/> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
See Ashby and Morrell, supra note 24.Google Scholar
See Miller, supra note 26.Google Scholar
Canadian Institutes of Health Research, “Ethics Action Plan: Placing Ethics at the Core of CIHR’s Business,” available at <https://cihr-irsc.gc.ca/e/49289.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Ethics at CIHR, Impact Ethics Recommendations for Governance of Research, available at <https://www.dal.ca/sites/noveltechethics/projects/past-projects/governance-of-research/ethics.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
National Human Genome Research Institute, Ethical, Legal, and Social Implications Program, available at <https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications> (last visited April 28, 2022); L. S. Parker, P. L. Sankar, J. Boyer, J. McEwen, and D. Kaufman, “Normative and Conceptual ELSI Research: What it is, and Why it’s Important,” Genetic Medicine 21, no. 2 (2019): 505-509.CrossRef+(last+visited+April+28,+2022);+L.+S.+Parker,+P.+L.+Sankar,+J.+Boyer,+J.+McEwen,+and+D.+Kaufman,+“Normative+and+Conceptual+ELSI+Research:+What+it+is,+and+Why+it’s+Important,”+Genetic+Medicine+21,+no.+2+(2019):+505-509.>Google Scholar
Greely, H. T., Grady, C., Ramos, K. M., et al., “Neuroethics Guiding Principles for the NIH BRAIN Initiative,” The Journal of Neuroscience: The Official Journal of the Society for Neuroscience 38, no. 50 (2018): 1058610588.CrossRefGoogle ScholarPubMed
NIH Office of the Director, Notice of Special Interest: Administrative Supplement for Research on Bioethical Issues, available at <https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-038.html> (last visited April 28, 2022).+(last+visited+April+28,+2022).>Google Scholar
Arnason, G., “Synthetic Biology between Self-Regulation and Public Discourse,” Cambridge Quarterly of Healthcare Ethics 26 (2017): 246256, at 252.CrossRefGoogle ScholarPubMed
Department of Health and Human Services, supra note 4.Google Scholar
American Association for the Advancement of Science (AAAS), Mission Statement, available at <https://www.aaas.org/mission/what> (last visited 28, 2022).+(last+visited+28,+2022).>Google Scholar
Grady, C. and Fauci, A.S., “The Role of the Virtuous Investigator in Protecting Human Research Subjects,” Perspectives in Biology and Medicine 59, no. 1 (2016): 122131.CrossRefGoogle ScholarPubMed