In 2011, Helen, Caryn, and their colleagues reviewed exempt and expedited protocol submission materials to determine if all regulatory requirements were satisfied. Through this research, the team sought to develop measurable standards that could be used in the evaluation of research protocols.
Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference. How has your research since evolved?
Helen Panageas (HP): We have implemented a process to evaluate the quality of reviews of expedited projects.
We have been having some difficulty transitioning to full-board protocol reviews because not all studies are equal in their level of complexity. Hence, we have decided that the project must evolve in order to capture the complexity of a research protocol, in addition to ensuring that all regulatory requirements have been satisfied.
Adding a rating for complexity will help us stratify the types of protocols we are looking at and what areas of our initial indicators we should focus on. We also used our initial findings to develop training and education sessions for our reviewers.
AA: What challenges have you faced in implementing this research?
Caryn Diuguid (CD): Our challenge lies in identifying a metrics system that we can use to quantify our findings. We are still determining what methodology to use to finalize a specific metric; therefore we have been unable to measure the quality of protocols approved by the institutional review board (IRB). We are considering basing our metrics on scores for each required element and the complexity of a project. If there is anyone out there that thinks they can help us with this… please email us!
AA: What is one principle that has guided you in your research?
HP: Continuous improvement. We ultimately would like to develop a tool that can objectively measure the quality of a research protocol. We hope that this tool can be used to assist research teams and IRB staff training.
Thank you for sharing, Helen and Caryn! We hope that you will consider submitting an abstract for the 2012 AER Conference.