Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.
Behavioral health
Common data elements
Ethics
Mental health
Pain
Pragmatic clinical trials
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
01
10
2021
revised:
02
12
2021
accepted:
05
12
2021
pubmed:
10
1
2022
medline:
1
4
2022
entrez:
9
1
2022
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 34998990
pii: S1551-7144(21)00387-6
doi: 10.1016/j.cct.2021.106651
pmc: PMC8844235
mid: NIHMS1771451
pii:
doi:
Substances chimiques
Analgesics, Opioid
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106651Subventions
Organisme : NCCIH NIH HHS
ID : U24 AT009676
Pays : United States
Organisme : NCCIH NIH HHS
ID : U24 AT010961
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
Références
Clin Trials. 2015 Oct;12(5):520-9
pubmed: 26374682
Psychiatr Serv. 2013 Dec 1;64(12):1195-202
pubmed: 24036589
Qual Life Res. 2018 Jul;27(7):1885-1891
pubmed: 29569016
Genet Med. 2016 Jul;18(7):705-11
pubmed: 26583685
J Comp Eff Res. 2016 Nov;5(6):561-567
pubmed: 27586855
Pain. 2018 Sep;159 Suppl 1:S85-S90
pubmed: 30113952
JAMA. 2018 Jul 10;320(2):129-130
pubmed: 29896636
Clin Trials. 2015 Oct;12(5):449-56
pubmed: 26374678
Am J Bioeth. 2016;16(4):62
pubmed: 26982930
Clin Trials. 2015 Oct;12(5):457-66
pubmed: 26374685
J Gen Intern Med. 2020 Mar;35(3):775-783
pubmed: 31659663
Am J Bioeth. 2020 Jan;20(1):6-18
pubmed: 31896322
Clin Trials. 2016 Dec;13(6):671-676
pubmed: 27311638
Appl Transl Genom. 2016 Feb 01;8:33-5
pubmed: 27047758
Pain Med. 2019 Dec 1;20(12):2336-2345
pubmed: 31807788
Int Psychogeriatr. 2019 Nov;31(11):1665-1674
pubmed: 30782232
Learn Health Syst. 2020 Aug 28;5(4):e10245
pubmed: 34667872
Front Psychiatry. 2021 Apr 12;12:643609
pubmed: 33912086
Lancet. 2007 Mar 10;369(9564):874-877
pubmed: 17350458
J Empir Res Hum Res Ethics. 2016 Apr;11(2):129-34
pubmed: 26994734
Am J Bioeth. 2016;16(4):65-6
pubmed: 26982932
JAMA. 2013 Sep 25;310(12):1229-30
pubmed: 24065005
J Law Med Ethics. 2008 Summer;36(2):271-9, 211
pubmed: 18547194
J Gen Intern Med. 2017 Sep;32(9):990-996
pubmed: 28550609
Clin Trials. 2015 Oct;12(5):436-41
pubmed: 26374676
JCO Clin Cancer Inform. 2020 Oct;4:947-957
pubmed: 33112661
J Pain. 2017 Sep;18(9):1139-1149
pubmed: 28528981
Am J Bioeth. 2016;16(4):67-8
pubmed: 26982933
Med Care. 2013 Aug;51(8 Suppl 3):S73-9
pubmed: 23774513
Learn Health Syst. 2020 Jul 14;5(2):e10238
pubmed: 33889738
Psychiatry Res. 2011 Jun 30;188(1):58-64
pubmed: 21339006
J Gen Intern Med. 2020 Dec;35(12):3436-3442
pubmed: 32815061
J Abnorm Psychol. 2020 Jan;129(1):64-69
pubmed: 31868389
Hastings Cent Rep. 2013 Jan-Feb;Spec No:S4-S15
pubmed: 23315895
Med Care. 2003 Nov;41(11):1284-92
pubmed: 14583691
Mayo Clin Proc. 2016 Jul;91(7):955-70
pubmed: 27344405
Healthc (Amst). 2016 Sep;4(3):138-41
pubmed: 27637816
Hastings Cent Rep. 2013 Jan-Feb;Spec No:S16-27
pubmed: 23315888
Hastings Cent Rep. 2004 Jan-Feb;34(1):25-33
pubmed: 15098404