In recent years, the research community has made an effort to increase patient and participant engagement. Including participants in implementation and dissemination of research results has allowed voices to be heard at every stage of the research process.
Even with the benefits of including patient and participant communities, there are novel regulatory and ethical questions potentially impacting IRB review. When does the IRB need to step in and review the study design and implementation? What potential obligations or risks may arise if a sponsor works closely with patient advocacy groups? Should the IRB play a role in scrutinizing possible conflicts of interest?
To learn more about patient engagement and the IRB, read the full article on Advarra’s website.