Joseph Ali1, Stephanie R Morain2, P Pearl O'Rourke3, Benjamin Wilfond4, Emily C O'Brien5, Christina K Zigler6, Karen L Staman6, Kevin P Weinfurt6, Jeremy Sugarman7. 1. Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: jali@jhu.edu. 2. Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. 3. Harvard Medical School, Boston, MA, USA. 4. Treuman Katz Center for Pediatric Bioethics, Seattle, WA, USA; Seattle Children's Research Institute, Seattle, WA, USA; University of Washington School of Medicine, Seattle, WA, USA. 5. Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA. 6. Duke University School of Medicine, Durham, NC, USA. 7. Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins School of Medicine, Baltimore, MD, USA.
Abstract
BACKGROUND: Ethical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or depression) in general clinical research have been described; however, pragmatic clinical trials (PCTs) raise new contextual challenges. METHODS: We use our experience with the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program, which is a component of the Helping End Addiction Long-Term (HEAL) Initiative, to provide examples of research studying nonpharmacologic interventions for pain that collect sensitive data. Members of the PRISM Ethics and Regulatory Core and Patient-Centered Outcome Core Working Group discussed and refined considerations and recommendations. RESULTS: PCT researchers can help identify the extent of their ethical obligations to monitor and respond to signals of potential behavioral and mental health risks by understanding and aligning stakeholder expectations; considering characteristics of the trial and study population; defining triggers, thresholds, and responsibilities for action; identifying appropriate response mechanisms and capabilities; integrating responses with health systems; and addressing privacy. Based on such an assessment, researchers should proactively identify if, when, and how a response will be triggered. Doing so necessitates that stakeholders understand their roles in managing such risks. Finally, consent forms and other study disclosures should clearly state what if any responses might be taken. CONCLUSION: Early and ongoing bi-directional communication with relevant stakeholders is critical to identifying and meeting the ethical challenges for PCTs when managing and responding to behavioral and mental health data that potentially signal elevated risk to individuals.
BACKGROUND: Ethical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or depression) in general clinical research have been described; however, pragmatic clinical trials (PCTs) raise new contextual challenges. METHODS: We use our experience with the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program, which is a component of the Helping End Addiction Long-Term (HEAL) Initiative, to provide examples of research studying nonpharmacologic interventions for pain that collect sensitive data. Members of the PRISM Ethics and Regulatory Core and Patient-Centered Outcome Core Working Group discussed and refined considerations and recommendations. RESULTS: PCT researchers can help identify the extent of their ethical obligations to monitor and respond to signals of potential behavioral and mental health risks by understanding and aligning stakeholder expectations; considering characteristics of the trial and study population; defining triggers, thresholds, and responsibilities for action; identifying appropriate response mechanisms and capabilities; integrating responses with health systems; and addressing privacy. Based on such an assessment, researchers should proactively identify if, when, and how a response will be triggered. Doing so necessitates that stakeholders understand their roles in managing such risks. Finally, consent forms and other study disclosures should clearly state what if any responses might be taken. CONCLUSION: Early and ongoing bi-directional communication with relevant stakeholders is critical to identifying and meeting the ethical challenges for PCTs when managing and responding to behavioral and mental health data that potentially signal elevated risk to individuals.
Authors: Deven McGraw; Sarah M Greene; Caroline S Miner; Karen L Staman; Mary Jane Welch; Alan Rubel Journal: Clin Trials Date: 2015-09-15 Impact factor: 2.486
Authors: P Pearl O'Rourke; Judith Carrithers; Bray Patrick-Lake; Todd W Rice; Jeremy Corsmo; Raffaella Hart; Marc K Drezner; John D Lantos Journal: Clin Trials Date: 2015-09-15 Impact factor: 2.486
Authors: Jonathan A Finkelstein; Andrew L Brickman; Alexander Capron; Daniel E Ford; Adrijana Gombosev; Sarah M Greene; R Peter Iafrate; Laura Kolaczkowski; Sarah C Pallin; Mark J Pletcher; Karen L Staman; Miguel A Vazquez; Jeremy Sugarman Journal: Clin Trials Date: 2015-09-15 Impact factor: 2.486
Authors: Catherine Gliwa; Ilana R Yurkiewicz; Lisa Soleymani Lehmann; Sara Chandros Hull; Nathan Jones; Benjamin E Berkman Journal: Genet Med Date: 2015-11-19 Impact factor: 8.822