Challenges in the ethical review of peer support interventions

David S Simmons, Christopher Bunn, Frederick Nakwagala, Monika M Safford, Guadalupe Ayala, Michaela Anne Riddell, Jonathan Graffy, Edwin B Fisher

Research output: Contribution to journalArticleOther

2 Citations (Scopus)

Abstract

PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the ?4+1 ethical framework? (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees? reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of ?light touch? consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.
Original languageEnglish
Pages (from-to)S79 - S86
Number of pages8
JournalAnnals of Family Medicine
Volume13
Issue numberSupplement 1
DOIs
Publication statusPublished - 2015

Cite this

Simmons, D. S., Bunn, C., Nakwagala, F., Safford, M. M., Ayala, G., Riddell, M. A., ... Fisher, E. B. (2015). Challenges in the ethical review of peer support interventions. Annals of Family Medicine, 13(Supplement 1), S79 - S86. https://doi.org/10.1370/afm.1803
Simmons, David S ; Bunn, Christopher ; Nakwagala, Frederick ; Safford, Monika M ; Ayala, Guadalupe ; Riddell, Michaela Anne ; Graffy, Jonathan ; Fisher, Edwin B. / Challenges in the ethical review of peer support interventions. In: Annals of Family Medicine. 2015 ; Vol. 13, No. Supplement 1. pp. S79 - S86.
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abstract = "PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the ?4+1 ethical framework? (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees? reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of ?light touch? consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.",
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Simmons, DS, Bunn, C, Nakwagala, F, Safford, MM, Ayala, G, Riddell, MA, Graffy, J & Fisher, EB 2015, 'Challenges in the ethical review of peer support interventions', Annals of Family Medicine, vol. 13, no. Supplement 1, pp. S79 - S86. https://doi.org/10.1370/afm.1803

Challenges in the ethical review of peer support interventions. / Simmons, David S; Bunn, Christopher; Nakwagala, Frederick; Safford, Monika M; Ayala, Guadalupe; Riddell, Michaela Anne; Graffy, Jonathan; Fisher, Edwin B.

In: Annals of Family Medicine, Vol. 13, No. Supplement 1, 2015, p. S79 - S86.

Research output: Contribution to journalArticleOther

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AU - Simmons, David S

AU - Bunn, Christopher

AU - Nakwagala, Frederick

AU - Safford, Monika M

AU - Ayala, Guadalupe

AU - Riddell, Michaela Anne

AU - Graffy, Jonathan

AU - Fisher, Edwin B

PY - 2015

Y1 - 2015

N2 - PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the ?4+1 ethical framework? (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees? reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of ?light touch? consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.

AB - PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the ?4+1 ethical framework? (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees? reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of ?light touch? consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.

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SP - S79 - S86

JO - Annals of Family Medicine

JF - Annals of Family Medicine

SN - 1544-1709

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Simmons DS, Bunn C, Nakwagala F, Safford MM, Ayala G, Riddell MA et al. Challenges in the ethical review of peer support interventions. Annals of Family Medicine. 2015;13(Supplement 1):S79 - S86. https://doi.org/10.1370/afm.1803