PT  - JOURNAL ARTICLE
AU  - Simmons, David
AU  - Bunn, Christopher
AU  - Nakwagala, Fred
AU  - Safford, Monika M.
AU  - Ayala, Guadalupe X.
AU  - Riddell, Michaela
AU  - Graffy, Jonathan
AU  - Fisher, Edwin B.
TI  - Challenges in the Ethical Review of Peer Support Interventions
AID  - 10.1370/afm.1803
DP  - 2015 Aug 01
TA  - The Annals of Family Medicine
PG  - S79--S86
VI  - 13
IP  - Suppl 1
4099  - http://www.annfammed.org/content/13/Suppl_1/S79.short
4100  - http://www.annfammed.org/content/13/Suppl_1/S79.full
SO  - Ann Fam Med2015 Aug 01; 13
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.