title: Challenges in the Ethical Review of Peer Support Interventions.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: School of Medicine, University of Western Sydney, Sydney, Australia Institute of Metabolic Science, Cambridge University Hospitals, NHS Foundation Trust, Cambridge, England dsworkster@gmail.com.
authors: David
authors: D
authors: Simmons
authors: Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.
authors: Christopher
authors: C
authors: Bunn
authors: Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
authors: Fred
authors: F
authors: Nakwagala
authors: Department of Medicine, School of Medicine, University of Alabama, Birmingham, Alabama.
authors: Monika M
authors: MM
authors: Safford
authors: San Diego State University College of Health and Human Services and the Institute for Behavioral and Community Health, San Diego State University Research Foundation, San Diego, California.
authors: Guadalupe X
authors: GX
authors: Ayala
authors: Global Health and Society Unit, SPHPM, Monash University, Melbourne, Australia.
authors: Michaela
authors: M
authors: Riddell
authors: Department of Public Health and Primary Care, University of Cambridge, Cambridge, England.
authors: Jonathan
authors: J
authors: Graffy
authors: Peers for Progress, American Academy of Family Physicians Foundation, Leawood, Kansas Department of Health Behavior and Health Education, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
authors: Edwin B
authors: EB
authors: Fisher
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D003920:Diabetes Mellitus; D026724:Ethical Review / Q000592:standards*; D017041:Ethics Committees / Q000592:standards*; D006801:Humans
keywords: diabetes; ethics; ethics review committees; global research; peer support