Promoting Harmonization in Clinical and Translational Research Through Template Forms and Policy Guidelines

A key feature of AzTransNet is working to develop template forms and guidelines on approaches to IRB activities as well as complex business practices that can pose barriers to collaboration in biomedical research.

In translational research, it is often critical to have multiple institutions collaborate. This is due to the fact that translational research is a multi-faceted process that covers a broad range of scientific, regulatory and clinical disciplines not typically found in any single organization. Consequently, an extensive range of organizations are called on to play a role in translational research, from universities to non-profit research organizations to hospitals and medical centers to community health organizations to physician practice groups, often in collaboration with bioscience industry partners.

Given the diverse and broad biomedical research landscape in Arizona, multi-institutional collaboration is particularly needed for success at all stages of translational research - from basic research to preclinical development to clinical activities involving human subject research.

The need for advancing multi-institutional collaborations in translational research, unfortunately, often runs up against the realities of business requirements for organizations to work together. Unlike individual organizations pulling together teams across different departments or schools, multi-institutional collaborations face specific business-related barriers that can slow down or even frustrate efforts to work collaboratively across organizations. These barriers often have little to do with the substance of the collaborative work and much to do with more issues of how organizations operate and manage their affairs from insurance to credentialing qualified researchers to cost sharing to management of intellectual property.

Activities to Date:

Through the efforts of the Arizona Translational Research Pathway Program, policy guidelines and template forms were developed for:

Ongoing Activities:

Work is underway to development policy guidelines and template forms for:

Biorespository informed consent document and HIPAA authorization form.
Biorespository template clinical trial agreement provisions, material transfer agreements, and policies on the business aspects of biorepository research.