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By Stephen Shortell; Julie Schmittdiel; Margaret Wang; Rui Li; Robin Gillies

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The National Institutes of Health (NIH) was initially created as the Marine Hospital Service (MHS) in 1798 to service merchant seamen. In 1902, the Biologics Control Act was passed by Congress to regulate vaccines and antitoxins that reorganized the MHS into the Public Health and Marine Hospital Service (PH-MHS). In 1912, the PH-MHS became the Public Health Service (PHS) and began to research diseases that were related to the pollution of water supplies. With the passage of the Ransdell Act in 1930, the organization became known as the National Institute of Health and was tasked with promoting public funding for medical research.

Consequently, internal control structures of universities are under pressure to change and be in alignment with federal (or sometimes private) regulatory strictures that are attached to research funds (see Olswang and Lee 1984). The passage of the Patriot Act of 2001 and the Bioterrorism Preparedness and Response Act of 2002 ushered in a Regulatory Change and Organizational Responses • 7 new era of federal oversight that increased the number of guidelines over research universities. As of 2004, the Department of Health and Human Services, Office of the Inspector General had started to audit universities on their security and safety measures over the use and storage of select agents.

Congress 2002). S. S. Congress 2002). The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) have a list of select agents, 14 • Compliance for Public Research Organizations pathogens, and toxins that are considered regulated by the Patriot Act amendment (Youngers and Norris 2004). In 2007 Congress passed the Homeland Security Chemical Facility Anti-Terrorism Standards, which targeted how research centers and research universities accounted for specific chemicals that were over a certain threshold amount.

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