Share thisMedical research compliance offices have long struggled with managing the inefficiencies of paper based operations. Printing, copying, and storage of protocols and related documents account for a large percentage of most IRB and IACUC budgets. Add to that the difficulties associated with document version tracking, outdated databases, and overworked staff and you have an industry well suited to the benefits of web-based automation.
National Institutes of Health grants in 2002 and 2003 allowed many Institutional Review Boards to build or buy software designed to resolve the inefficiencies of the paper world. Many of those IRBs are now nearing completion of their initiatives. Institutions such as Baylor College of Medicine, Boston University, and the University of Maryland were among the first to take the plunge. As the results of these projects become known, many Institutional Animal Care and Use Committees are preparing to evaluate the benefits of automation.
What to Look For in an Application
A well-designed application should automate the management of human or animal protocols. This includes protocol creation, submission, routing, review, feedback, and approval. Other actions such as management of renewals, amendments, and closures should be facilitated.
For auditing purposes, all versions of documents should be stored and accessed via a central screen. Every action that takes place within the process should be date, time, and user stamped. System access must be secure and data should be encrypted to protect sensitive personal health information.
An effective software package should automate as much as possible in order to eliminate the need to manually check each document for required content. It also must be flexible enough to quickly modify routing paths and business rules as organizational or regulatory requirements change. The end result should be a system that allows organizations to comply with increasingly stringent regulations and process a growing volume of protocols without adding staff and stretching already tight budgets.
Case Study
One large medical research organization found that the processes surrounding submission, routing, and management of protocols became daunting. The program reviewed approximately 800 human and 400 animal protocols annually. The school employed eleven professionals in the IRB office and one in the IACUC office. Four committees reviewed human protocols and one committee reviewed animal protocols. The paper-based system was bogging the office down.