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Research, Grants and Export Control

Protection for Human Subjects - 1M9

Southern Illinois University Edwardsville (SIUE) acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects. It is the policy of SIUE that faculty, staff, and student investigator(s) of any study or project involving human subjects, regardless of the type of activity or interaction, are required to submit the project for IRB review. The study or project will be reviewed by the appropriate institutional review board (IRB) that has been established per SIUE's assurance compliance document negotiated with the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services. The IRBs have the responsibility and authority to review, approve, disapprove or require changes in appropriate research activities involving human subjects. The involvement of human subjects in studies and projects is not permitted until the IRB has completed its review and given its approval to proceed. Any data collected prior to IRB approval shall not be utilized for the project under consideration. Engaging in research activity involving human subjects or analysis of data gathered from human subjects without prior approval may result in disciplinary action per Policy 1Q5.

For all studies and projects that meet the definition of research contained in the "Common Rule," which is found in Title 45 of the Code of Federal Regulations (CFR) Section 46.102, the involvement of human subjects will not be permitted until the IRB has approved the research and protocol and informed consent has been obtained in accord with and to the extent required by the "Common Rule" Section 46.116. The IRB will consider safeguards in addition to those required in the Common Rule when the research involves children, individuals institutionalized as mentally disabled, prisoners, and other potentially vulnerable groups. The IRB's review of research on a continuing basis will be conducted at appropriate intervals but not less than every 12 months.

SIUE will comply with the requirements set forth in the "Common Rule" Section 46.114 regarding cooperative research projects. When research covered by its assurance is conducted at or in cooperation with another entity, all provisions of its assurance will remain in effect for that research. With the approval of the federal department or agency head, SIUE may, for the purpose of meeting the IRB review requirements, enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangement for avoiding duplication of effort. Such acceptance must be in writing, approved and signed by SIUE's Office of Research and Projects, and approved and signed by correlative officials of each of the other cooperating institutions. A copy of the signed agreement will be forwarded to the OHRP.

SIUE shall provide required education through the online Collaborative Institutional Training Initiative (CITI Program) offered by the University of Miami or other means as appropriate.

Approved by Chancellor effective 6/4/14
This policy was issued on September 16, 2014
Document Reference: 1M9
Origin: GR 13/14-10

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