Scientific And Administrative Plans For The Osteoarthritis Initiative Public-Private Consortium Appendix A

- Prospectus -

Scientific and Administrative Plans for the
Osteoarthritis Initiative Public-Private Consortium

Appendix A -Terms and Definitions

As the Initiative involves an array of organizations and disciplines with different interests and backgrounds, the Osteoarthritis Initiative Steering Group deemed it valuable to develop uniform terminology to aid the understanding and communication about the Initiative. These are the terms and definitions that are used in this document (below) and accompanying figures.

Osteoarthritis Initiative. Identifies the research activities conducted by a public-private Consortium that will create research resources to enable the identification, evaluation, and validation of biomarkers of osteoarthritis.

Sponsors. This refers to the companies and organizations including the National Institutes of Health that support the Osteoarthritis Initiative through scientific input and financial resources. Public Sponsor means governmental organizations, such as the NIH, and Private Sponsor means non-governmental organizations, such as pharmaceutical companies and private, nonprofit organizations. In the project models, the private sponsors and NIH are jointly identified as "the Consortium" where reference is made to the administration and management of research activities for the Osteoarthritis Initiative.

Osteoarthritis Initiative Public-Private Consortium. The collective of the public and private sponsors. When an agreement is reached on the scientific project(s) to be pursued, the NIH, pharmaceutical/biotechnology companies and other sponsors will form a formal consortium - the Osteoarthritis Initiative Public-Private Consortium. All Sponsors, including NIH, will contribute to the fiscal support of the project. This group of fiscal sponsors is distinct from the Osteoarthritis Initiative Steering Group - the large and open group that has contributed ideas and recommendations for the scientific goals of the project.

Contractors. Universities, medical centers, contract research laboratories, private companies, or other groups that conduct research activities under contract to the NIH are termed "contractors." Contractors are subject to the terms of the agreements with NIH including the reporting of data and technologies.

Osteoarthritis Initiative Steering Group. Advisors that have composed the steering group include representatives of the private industry, federal agencies that conduct research or provide intellectual or financial support of research (NIH, U.S. Food and Drug Administration, and National Center for Health Statistics), academic research community, professional research organizations, and voluntary health organizations.