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 institutional review board (IRB) review. The study or project will be reviewed by the 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 IRB has the responsibility and authority to review, approve, disapprove or require changes to 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. 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), Subpart A, 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 according to the Common Rule.
SIUE will comply with the requirements set forth in 45 CFR 46.114 regarding cooperative research projects. When research covered by SIUE's assurance is conducted at or in cooperation with another entity, all provisions of SIUE's assurance will remain in effect for that research. SIUE may, for the purpose of meeting a sponsor's requirements and the IRB review requirements, rely upon approval by a single IRB or another institution's IRB to avoid 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.
SIUE shall provide required education as required.
Approved by Chancellor effective 8/2/23
This policy was issued on August 2, 2023, replacing the March 5, 2021 version.
Document Reference: 1M9
Origin: GR 13/14-10; OC 1/31/19; GR 19/20-13; GR 22/23-09
