The Stroke Institute of Minnesota

LOGO SHOULD BE HERE

The institute’s qualified employees work on on-going and future projects within the Institute. Employees include biostatisticians, clinical trialists, research coordinators, fiscal officers, and clinician researchers

CLINICAL RESEARCH

Grants and contracts administration
The institute is committed to optimize the transdisciplinary approach to research and training, ensuring ethical conduct of research, meeting regulatory obligations, coordinating the various research projects, assuming grant fiscal responsibilities, and managing the resources and environment. The Institute’s administrative structure assists the investigators in the personnel and logistic operations. Dedicated coordinators are responsible for quality control, monitoring adherence with ethical scientific procedures, and completion of regulatory forms. This administrative core is supported by the accountant provided by the institute. These shared resources for each of the proposed projects provide greater integration and efficiency across the various studies and ensure fiscal efficiency in conduct of each project. The intramural grants are derived from the Applicant Defined Fund for amounts to be set at least yearly at the annual meeting by the Board of Directors. In case of extramural wards, the Administrative Director and designated employees work with the Principal Investigator with other key members of the project (as appropriate) to execute the tasks specified in the award maintaining fiscal and administrative compliance with the sponsoring agency. The institute’s qualified employees work on on-going and future projects within the Institute. Employees include biostatisticians, clinical trialists, research coordinators, fiscal officers, and clinician researchers.

Protection Of Human Subjects
Our research group has an emphatic policy, based on tenets of medical ethics, supporting patients’ basic right to privacy of their medical information and their right to control access to their information, with narrowly drawn exceptions made in the public interest. The duty of an investigator to preserve the confidentiality of their patients' personal, often intimate, medical information is an integral part of professional ethics. In the event data is transferred to the institute for analyses and/or archiving, patients will be coded so names and other identifiers will not be available or disclosed in any aspect of this research outcome, seminars, presentations, or publications. The following are the main pillars of human subject safety and protection in our collaborations:

	The IRBs of collaborative institutions will review and approve the proposal for the study before initiation of study.
	Researchers are required by federal law to have a study-specific HIPAA form approved by the IRB and signed by each subject or proxy as required.
	Patients will be coded and access to codes will be kept by parent institution.
	Names and other identifiers will not be disclosed in any aspect of this research outcome, seminars, presentations, or publications.
	The IRB at each institution will conduct Continuing Review of an approved study at intervals appropriate to the degree of risk, but not less than once per year. The purpose of this process is to review an entire study and determine that it’s anticipated risks and benefits are reflected in the actual experience of subjects and that safeguards in place at the time of original approval are, in fact, adequate to ensure subject safety.