David Simmons1, Christopher Bunn2, Fred Nakwagala3, Monika M Safford4, Guadalupe X Ayala5, Michaela Riddell6, Jonathan Graffy7, Edwin B Fisher8. 1. School of Medicine, University of Western Sydney, Sydney, Australia Institute of Metabolic Science, Cambridge University Hospitals, NHS Foundation Trust, Cambridge, England dsworkster@gmail.com. 2. Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland. 3. Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. 4. Department of Medicine, School of Medicine, University of Alabama, Birmingham, Alabama. 5. 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. 6. Global Health and Society Unit, SPHPM, Monash University, Melbourne, Australia. 7. Department of Public Health and Primary Care, University of Cambridge, Cambridge, England. 8. 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.
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.
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.
Authors: Juliana C N Chan; Yi Sui; Brian Oldenburg; Yuying Zhang; Harriet H Y Chung; William Goggins; Shimen Au; Nicola Brown; Risa Ozaki; Rebecca Y M Wong; Gary T C Ko; Ed Fisher Journal: JAMA Intern Med Date: 2014-06 Impact factor: 21.873
Authors: Monika M Safford; Susan Andreae; Andrea L Cherrington; Michelle Y Martin; Jewell Halanych; Marquita Lewis; Ashruta Patel; Ethel Johnson; Debra Clark; Christopher Gamboa; Joshua S Richman Journal: Ann Fam Med Date: 2015-08 Impact factor: 5.166
Authors: David Simmons; A Toby Prevost; Chris Bunn; Daniel Holman; Richard A Parker; Simon Cohn; Sarah Donald; Charlotte A M Paddison; Candice Ward; Peter Robins; Jonathan Graffy Journal: PLoS One Date: 2015-03-18 Impact factor: 3.240
Authors: Edwin B Fisher; Guadalupe X Ayala; Leticia Ibarra; Andrea L Cherrington; John P Elder; Tricia S Tang; Michele Heisler; Monika M Safford; David Simmons Journal: Ann Fam Med Date: 2015-08 Impact factor: 5.166
Authors: Tiwonge K Mtande; Charles Weijer; Mina C Hosseinipour; Monica Taljaard; Mitch Matoga; Cory E Goldstein; Billy Nyambalo; Nora E Rosenberg Journal: J Med Ethics Date: 2019-06-12 Impact factor: 2.903