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\nBoston Medical Center and the three schools on the Boston University Medical Campus (the Chobanian & Avedisian School of Medicine, BU School of Public Health, and the Goldman School of Dental Medicine) are committed to performing human research in order to advance our understanding of health and disease. This research must be conducted according to the highest ethical standards and in compliance with all regulatory requirements. The Office of Human Research Affairs (OHRA)<\/strong> is responsible for the oversight of this human research to assure that we meet those ethical and regulatory expectations. OHRA accomplishes this through its robust Human Research Protection Program (HRPP). The two main elements of the HRPP are<\/strong>:<\/p>\n- \n
- the Institutional Review Board (IRB)<\/a> which must review and approve all human studies, and<\/li>\n
- an array of investigator educational programs<\/span> offered primarily by our Clinical Research Resources Office<\/a> (CRRO).<\/li>\n<\/ul>\n
More information about these two important elements can be found on their websites. Other important elements of our HRPP include:<\/strong><\/p>\n
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- Investigator certification\/recertification<\/a> which is required of all members of human research teams.<\/li>\n
- Quality assurance assessments<\/a> which are reviews of recently-approved studies and are designed to assure that the studies are being conducted in compliance with regulations and local policies.<\/li>\n
- For-cause audits<\/span><\/a> of studies suspected of non-compliance.<\/li>\n
- The Clinical Research Times<\/a><\/em>, our monthly newsletter that keeps human researchers up to date on what\u2019s new at our office, changes in regulations or policies, and available funding opportunities.<\/li>\n
- The Clinical Research Data Warehouse<\/a> whose research team provides patient data from the BMC data warehouse to investigators for IRB-approved studies. Our research team creates data files for investigators that can be used, for example, to determine if we have enough patients with a given medical problem to make a study feasible. For observational studies, the data from the data warehouse may provide all the data that a study needs.<\/li>\n
- Our robust Community Engagement Program<\/a> is designed to support our belief that partnering with the community early on and throughout the research process is necessary to identify and address community health needs and priorities more effectively.<\/li>\n
- Funding Opportunity Announcements<\/a>: Announcements about research funding opportunities are sent to the faculty on the Medical Campus when the funding source puts a limit on the number of applications from individual institutions.\u00a0 A faculty review committee oversees selection of priority research proposals when necessary. In order to successfully assure that\u00a0all ethical and regulatory expectations are met, we work closely with other institutional programs and offices that support clinical research including:\n
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- The BMC and BU Grants and Contracts Offices;<\/li>\n
- Conflict of Interest Committee; and<\/li>\n
- Cancer Clinical Trials Office<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- Quality assurance assessments<\/a> which are reviews of recently-approved studies and are designed to assure that the studies are being conducted in compliance with regulations and local policies.<\/li>\n
- an array of investigator educational programs<\/span> offered primarily by our Clinical Research Resources Office<\/a> (CRRO).<\/li>\n<\/ul>\n
- the Institutional Review Board (IRB)<\/a> which must review and approve all human studies, and<\/li>\n