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Regulatory Knowledge & Support

Regulatory Knowledge & Support

Because Clinical and Translational Research is cross-disciplinary and inter-institutional, barriers to promising translational investigations are often posed by varied and conflicting policies, guidelines and interpretations of research regulations, both within and among collaborating institutions. The Regulatory Knowledge and Research Ethics Program will promote protection of human subjects and facilitate regulatory compliance while decreasing redundant and burdensome barriers to the conduct of research.

Goals

Goals

  • Increase inter-institutional collaboration in human subjects research oversight, working toward greater integration and more streamlined processes
  • Provide researcher-focused, integrated regulatory support for investigators
  • Develop and implement a curriculum for research education and training, integrating ethics, regulations, human subject protections, good clinical practice and responsible conduct of research
  • Foster interdisciplinary research to clarify, address and resolve ethically important issues and the alternative ways to address research regulations as they arise in human research, clinical care and professional conduct
  • Establish a research subject advocate to work with investigators and trainees to ensure that human subject protections are given the highest priority in research studies

Services

Services

Coordinated IRB Review

As key partners in the CTSI of Southeast Wisconsin, the IRBs work together to make the IRB review process between institutions more efficient. A pathway for considering a coordinated IRB review has been developed for research that will be conducted at more than one institution.

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NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

Children's Hospital of WisconsinMarquette UniversityMSOEUWMVersitiVA Medical Center