Perelman School of Medicine at the University of Pennsylvania

AEREO: The Consortium to Advance Effective Research Ethics Oversight

Current Projects

AEREO has a number of projects underway, as well as several in development. Make sure to check out our Publications and Completed Projects to see our work so far.

In Progress:

1. A "snapshot" of COVID-19 protocols and amendments submitted to IRBs in the first several months of the US pandemic, including approaches to IRB review and an overview of relevant ethical issues 

2. An interview study to better understand how stakeholders define and evaluate IRB quality and effectiveness 

3. A scoping review of the conceptual literature on definitions of IRB quality and effectiveness

4. 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

5. 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)

6. An effort to determine what types of QA/QI AEREO members conduct to evaluate their HRPPs, feeding into a "data dictionary" to allow HRPPs to evaluate themselves in a consistent way across sites, leading to the ability to combine and compare data for broader analysis

7. A pilot project to explore whether and how a model of IRB precedent could work to promote consistency in board decisions and flesh out ambiguous ethical and regulatory concepts

8. A survey to better understand the characteristics of unaffiliated and nonscientific IRB members and the roles they serve within boards

9. A survey to determine how IRB members understand the regulatory requirement for "additional safeguards" for research with vulnerable populations and the interface of those safeguards with participant diversity goals

10. An assessment of IRB approaches to reviewing data sharing plans

11. A conceptual project to evaluate the thresholds for raising new concerns during continuing review

12.  An assessment of how, when, and why IRBs use their discretion to invite individuals with competence in special areas (i.e., "outside experts") to assist in the review of issues that require expertise beyond what is currently available on the IRB

 

Projects in Development:
  • What information do researchers and staff need in IRB decision letters?
  • What is the best way to solicit protocol information from investigators to minimize burden and maximize the ability for boards to achieve their quality and effectiveness goals?
  • What do patients want from research ethics oversight?
 
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.