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IRB Approval

MOST is conducted in accordance with U.S. Dept. of Health & Human Services Protection of Human Subjects regulations (45 CFR part 46) and the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Research data and image sets available for public use are de-identified in accordance with regulation 45 CFR 164.514(e) relating to limited datasets.

Study participants were recruited and enrolled at clinical centers at the University of Alabama at Birmingham and University of Iowa under local IRB approval and with informed consent given prior to inclusion in the study.

Research data and images are managed at the SF Coordinating Center, UCSF Department of Epidemiology and Biostatistics. Collaborating investigators at the Boston University Clinical Epidemiology Research and Training Unit conduct radiograph reading and analysis.

Federalwide Assurances (FWAs) are held by Institutional Review Boards at the four MOST centers.
FWA00000068 University of California, San Francisco
FWA00000301 Boston University
FWA00005960 University of Alabama at Birmingham
FWA00003007 University of Iowa

For more information, see the NIH publications:
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
Research Repositories, Databases, and the HIPAA Privacy Rule