Notice Number: NOT-HL-14-028

July 22, 2014

Peter G. Kaufmann, PhD

National Heart Lung and Blood Institute (NHLBI)

6701 Rockledge Drive
Rockledge II, MSC 7936
Bethesda, MD 20892-7936

Response to Request for Information: Collaborative Translational Research Consortium to Develop T4 Translation of Evidence-based Interventions

Dear Dr. Peter G. Kaufmann,

Members of the Office of Special Education and Rehabilitative Services at the Department of Education,

The American Occupational Therapy Association (AOTA) represents over 145,000 occupational therapists, occupational therapy assistants and students of occupational therapy. We appreciate the opportunity to submit commentsregarding a collaborative translational research consortium to develop T4 translation of evidence-based interventions.

As the national association representing occupational therapy, a profession dedicated to maximizing independence and function for people across the lifespan, AOTA supports the National Heart Lung and Blood Institute’s (NHLBI) efforts to promote evidence-based preventive interventions and treatments.

1) The organizational structure and overall governance of the Consortium, including what type of institutions or organizations should be included for effective implementation of T4 translational research

AOTA agrees that medical centers, health management systems, third party payers, and professional associations should be involved in the consortium. In terms of sustaining evidence-based practice, other organizations may also be helpful. For example, licensing and certification boards may be willing to accept evidence-based practice (EBP) research or documentation of adhering to current clinical practice guidelines. Similarly, professional organizations may be willing to develop or change their board and specialty certification criteria to include EBP research or documentation of adhering to current clinical practice guidelines. Alternatively, special recognition of a certain percentage of clinicians or practices who implement current guidelines or best practices could be developed to incentivize clinicians’ participation.

2) How the Consortium would develop, prioritize and implement clinical protocols, including plans for establishing criteria for review and evaluation of potential T4 protocols as well as development and integration of ancillary studies

No comment.

3) Optimal methods for managing data from many sites

Would REDCap or similar software be sufficient to manage data from multiple sites?

4) Issues of informed consent for conducting T4 translational research, including potential issues in IRB clearance.

It would be most advantageous and efficient if institutions and organizations could agree to a standard IRB (or several formats) prior to the grant award.

5) The anticipated personnel and expertise needed for research and administration of such a Consortium and estimated range of related costs.

Some of the CTSAs may be able to offer clues about the infrastructure and budgetary scope of the proposed T4 consortium. It would be helpful to include some communication software/social media into the budget to enhance communication and collaboration.

We appreciate this opportunity to submit comments and welcome opportunities to partner with NHLBI to disseminate opportunities and resources in order to increase evidence-based preventive interventions into daily clinical practice.

Sincerely,

Susan H. Lin, ScD, OTR/L

Director of Research

American Occupational Therapy Association