RT Journal Article
SR Electronic
T1 Challenges in the Ethical Review of Peer Support Interventions
JF The Annals of Family Medicine
JO Ann Fam Med
FD American Academy of Family Physicians
SP S79
OP S86
DO 10.1370/afm.1803
VO 13
IS Suppl 1
A1 Simmons, David
A1 Bunn, Christopher
A1 Nakwagala, Fred
A1 Safford, Monika M.
A1 Ayala, Guadalupe X.
A1 Riddell, Michaela
A1 Graffy, Jonathan
A1 Fisher, Edwin B.
YR 2015
UL http://www.annfammed.org/content/13/Suppl_1/S79.abstract
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.