UGA and Children's Sign MOU to Streamline IRB Review Process

UGA and Children's Health of Atlanta (Children's) recently signed an Institutional Review Board (IRB) Memorandum of Understanding (MOU). This MOU represents an agreement between these two organizations to cooperate regarding IRB review and oversight of Human Subjects Research taking place at each institution's respective sites. The intent is bi-directional, to reduce IRB barriers for Children's researchers who are working on protocols at UGA sites and UGA researchers working on protocols at Children's sites. UGA and Children's are also both participating institutions of the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement. SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status.

An important initiative of the Georgia CTSA is to enhance efficiency, breakdown administrative barriers, and accelerate the pace of quality science, IRB reciprocity, and collaboration among Georgia CTSA institutions and partners. The Georgia CTSA achieved expanded IRB reciprocity across Georgia CTSA partner institutions. Additionally, Georgia CTSA is working to ensure Material Transfer Agreements, Intellectual Property (IP) agreements, and other cooperative agreements.

Meredith Capasse, CIP, Manager of HPP & Research Regulatory Affairs at Children's comments, "The MOU allows both IRBs to operate more efficiently. It allows one IRB to review a study instead of two which helps to cut down on duplicative work for IRBs. For study teams, only one submission is required instead of two which allows researchers to devote more time to doing actual research instead of regulatory submissions."

Institutional Review Boards are established to protect the rights and welfare of human research subjects. The charge of each IRB is to assure both in advance and by periodic review, that humans participating as research are protected. IRBs use a group review process of research protocols and related materials, including informed consent documents and investigator brochures, to ensure protection of the rights and welfare of human subjects of research.

According to Kim Fowler, CIP, CIM, Director of Human Subjects, Office of Research at the University of Georgia, "We are optimistic that this agreement will facilitate the continued advancement of the mission of the Georgia CTSA by streamlining the review process for research collaborations between UGA and Children's. We hope to see more researchers take advantage of the partnership in 2020 and look forward to working more with our colleagues at Children's."

View Georgia CTSA's partner reciprocity webpage for more details.

Upcoming Events

    View All Events

    Latest News

    Training

    Georgia CTSA at UGA: Henry Young, PhD Improving Medication Use & Enhancing Care Communication

    In 2013, Henry Young, PhD joined the University of Georgia (UGA) as the Kroger Associate Professor in Community Pharmacy. For the Georgia Clinical & Translational Science Alliance (Georgia CTSA) he is a co-director of the Integrating Special...