Perelman School of Medicine at the University of Pennsylvania

AEREO: The Consortium to Advance Effective Research Ethics Oversight

Projects

AEREO has a number of projects underway, as well as several in development. 

In Progress:

  • An interview study to better understand how stakeholders define and evaluate IRB quality and effectiveness 
  • A systematic review of existing tools available to evaluate IRB quality and effectiveness
  • A scoping review of the conceptual literature on definitions of IRB quality and effectiveness
  • A study assessing the sorts of changes IRBs require and recommend for proposed research, and whether these changes are likely to advance outcomes of interest related to participant protection and other goals
  • An interview study to learn how institutions accredited by AAHRPP satisfy accreditation standards related to quality, efficiency, and effectiveness of the human research protection program (HRPP)
  • A pilot project to explore whether and how a model of IRB precedent could work
  • An assessment of approaches to the revised Common Rule's new requirement that consent include a concise summary of key information
  • A study to examine IRB approaches to noncompliance and unanticipated problems

In Development:

  • A mixed methods study to learn what patients want from research ethics oversight of patient-centered outcomes research and comparative effectiveness research
  • An effort to develop a data dictionary to allow HRPPs to evaluate themselves in a consistent way across sites
  • A study to better understand the circumstances in which consent waiver is requested and granted
  • An examination of the role of lay/community members serving on IRBs
  • An evaluation of IRB approaches to requiring "additional safeguards" for vulnerable populations

We are currently seeking funding to advance this work. 

Do you have an idea for empirically evaluating IRB and HRPP effectiveness?

We want to hear it. Please contact AEREO Chair Holly Fernandez Lynch to set up a meeting.