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| Harrison IRB takes a partnership approach while working with research sponsors that allows a more in-depth review of research, both ethically, as well as scientifically. It is our belief that IRBs should work together with sponsors and researchers to ensure that the rights of subjects are protected, while maintaining the integrity of the research. Harrison IRB has developed an extensive pre-study questionnaire to gather information from the sponsor about their research project. Prior to protocol review, we finalize an IRB review strategy that ensures the adherence of processes and procedures of both the IRB and sponsor (i.e., determining the reporting of IND safety reports by the sponsor or investigator), without compromising the adherence to federal regulations. We will clearly define the administrative actions of Harrison IRB, the reporting requirements of the investigator and any outstanding questions from the sponsor. Our proactive approach to IRB review and working with sponsors reduces minimizes questions about Harrison IRB’s activities throughout the review of the research. Harrison IRB has created internal systems to track the progress of IRB submission review and to ensure the accuracy of IRB-related documents. With these systems, we pride ourselves as a transparent organization providing various reports and study-related metrics to document our progress. Our numerous checklists and clear study guidelines minimize IRB queries, ultimately reducing the study start up timelines. As an accredited organization with AAHRPP,
our policies and procedures have been carefully reviewed and approved
to ensure that Harrison IRB exceeds the regulatory requirements for
IRB review. |
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