Core-004

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Linked publications & trials

Abstract

The Michigan Institute for Clinical & Health Research (MICHR) aspires to optimize the provision of research services, maximize research quality and productivity, and promote ethical research education and practices. Two key programs within MICHR that work toward these objectives are 1) Biostatistics, Epidemiology, and Research Design (BERD) and 2) Regulatory Knowledge and Support (RKS). BERD provides services for research development, design, analysis, and implementation, supporting both new and experienced investigative teams. Within RKS, the MICHR Investigator Assistance Program for Investigational New Drug and Investigational Device Exemption support and other services provide institutional resources for regulatory expertise, support, and education for clinical and translational research. We propose to develop, demonstrate, and disseminate best practices for study design and analysis, improve research compliance, and reduce barriers to the implementation and conduct of clinical and translational research, through the following aims: 1) Establish an Applied Biostatistical Sciences network that catalyzes a campus-wide community of biostatisticians and develops novel resources; 2) Use the principles of regulatory science and an adaptive Institutional Review Board to improve the efficiency, quality, and compliance of clinical and translational research; 3) Develop, demonstrate, and disseminate innovative strategies to informed consent. Accomplishing these aims will increase access to biostatistics and regulatory knowledge, promote research compliance and ethics, educate clinical and translational investigators, and ultimately enhance the conduct and impact of research.