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Osteoarthritis Initiative Biospecimen Access Policy Statement
Updated February 18, 2015
The goal of the Osteoarthritis Initiative (OAI) is to provide an open research resource to aid in the identification and evaluation of biomarkers as candidates for surrogate endpoints for osteoarthritis. Biospecimens have been collected from OAI study participants at the baseline and at 12-month, 18-month (a limited number of subjects), 24-month, 30-month (a limited number of subjects), 36-month, 48-month, and 72-month follow-up visits. At present, biospecimens for the entire cohort from the baseline and 12-month, 18-month, 24-month, 30-month, 36-month, and 48-month follow-up visits are available for use. These biospecimens include serum, plasma, urine, and DNA (see OAI website for details, http://www.oai.ucsf.edu/datarelease/About.asp). Policies and procedures have been developed for access to these specimens and are posted on the NIAMS website (http://www.niams.nih.gov/Funding/Funded_Research/Osteoarthritis_Initiative/default.asp) and OAI Online (http://www.oai.ucsf.edu/datarelease/default.asp). Interested investigators are encouraged to apply for use of these limited resources.
NIAMS has assembled a group of individuals who serve as reviewers of proposals that are submitted to NIAMS for use of the OAI biospecimens. This rotating group is known as the Biospecimen Review and Allocation Committee (BRAC) Two or three BRAC members will be asked to review submitted proposals and make recommendations to NIAMS with regard to biospecimen allocation and use. Review criteria include significance, approach, innovation, investigator qualifications, plans for data sharing, and research environment, as well as the potential for the proposed research to contribute to the understanding of osteoarthritis or treatment of disease.
Any scientist (U.S. or International) may apply for access to the OAI biospecimens. Investigators must provide proof of funding for proposed analyses prior to gaining access to the biospecimens. Any data generated from the use of these biospecimens must be made accessible to the public through the OAI Online website. To fully understand the details of the OAI study, including the numbers and phenotypes of the participants, as well as the procedures for sample collection, interested scientists should refer to the OAI protocol and operations manuals posted on the OAI Online website (http://www.oai.ucsf.edu/datarelease/default.asp).
Application forms and detailed instructions can be downloaded from the NIAMS or OAI Online websites. Completed applications should be submitted as PDF files by email to OAIBiospecimens@kai-research.com by the appropriate deadlines. Applications will be reviewed three times per year.