Case Study: Policy into Action

Implementation of the Genome-Wide Association Studies (GWAS) Policy

Client: National Institutes of Health (NIH), Office of the Director, Office of Extramural Research (OER)

Project Duration: July – December 2007

Ripple Effect Contact: Janelle Jobe, jjobe@rippleeffect.com

Challenge

The process of policy implementation is multi-directional, disjointed, frequently interrupted, and unpredictable.  The National Institutes of Health (NIH) developed the Genome-Wide Association Studies (GWAS) Policy, which calls for NIH funded researchers to submit genetic data into a centralized repository.  The purpose of the policy is to facilitate broad and consistent access to GWAS data in order to speed the translation of basic genetic research into new therapies, technologies and procedures that benefit the public health.  Turning such policy into action can be a daunting task, considering the internal and external complexities involved.

NIH had approximately six months to prepare for implementation with the policy effective date slated for 2008.  Office of Extramural Research (OER) leadership sought the assistance of Ripple Effect to provide project management support of the policy development, public comment process, policy finalization, implementation and the transition of activities to governance.

Solution

An Implementation Committee was established comprised of members from the NIH Office of the Director and the 27 Institutes and Centers. Ripple Effect developed a project plan that identified key objectives, timeline, audiences and resources.  The project plan removed the critical unknowns of implementation: the order of actions, whom to include, what to pay attention to, the needs and role of each audience; which can vary over the life of the policy implementation process.  The key objectives of the implementation plan were to have sufficient training resources available to prepare the NIH staff and materials to educate the scientific community and general public about the policy.

NIH staff internal operational processes were reviewed to determine the various resources and materials needed to institutionalize the GWAS Policy.   Ripple Effect developed and facilitated the creation of 50+ products, including materials tailored specifically to the general public, researchers and Institutional Review Boards (IRBs), covering:

• Policy guidance (e.g., frequently asked questions, case studies, templates)
• Communications and outreach (e.g., controlled correspondence, presentations, brochures, and web content)
• Electronic systems (e.g., SharePoint site, QVR reporting)
• Training plans and instructional materials (i.e., for NIH staff, researchers and IRBs)

Ripple Effect facilitated some 40 meetings of the Implementation Committee to coordinate activities, convene with subgroups discuss policy related issues, review products and monitor project progress.  We orchestrated the simultaneous activities undertaken by the Committee and subgroups to ensure that they contributed to the successful implementation.

Achievements

• Enabled NIH OER to conduct training, and provide instructional materials to the NIH staff and the public on the GWAS policy.
• Crafted clear and consistent communications that were frequently transmitted to the NIH staff, the scientific community and the public.
• Developed a Microsoft SharePoint site which fostered information sharing among committee members and archived key deliverables for future reference.