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IntroductionThe federal government mandates that universities have the ultimate responsibility to ensure that any research conducted on or off campus, including collaborative research with other institutions, is conducted in compliance with University, local, state, federal and funding agency regulations. It is also the responsibility of the institution to ensure that the rights and welfare of human subjects, the welfare of animals, the rights of the investigator, the environment and the community are protected. At Iowa State University, the Vice President for Research and Economic Development (VPR) is authorized to provide this oversight for the institution. At Iowa State University it has been a tradition that support and implementation for the research compliance committees (covering human subjects research, animal related research, biohazards, and radioactive materials and devices) were the responsibility of personnel in individual offices. To eliminate the need for duplicate submissions and to create a unified and integrated program, the VPR created the Office of Research Assurances (ORA) in December of 2001. Committee administrators who provide support for the compliance committees are now part of the ORA. To assist the VPR office with compliance of its mandate, the ORA plans, develops, modifies, implements and monitors a comprehensive compliance program for research administration. The ORA also develops and implements short- and long-term strategic plans to enhance the compliance program for research administration. The ORA assesses and improves the quality of existing research compliance program operations at institutional, departmental and project levels. The ORA also develops and implements research compliance policies and procedures, as needed. These internal controls are combined with education, training, effective communication and teamwork to fulfill this mission and responsibility. |