Policy & Regulations for Human Subjects Research

POLICY

Overview
Colorado School of Mines requires all research involving human subjects, whether or not the research is funded by external sponsors, to be approved in advance by an authorized external Institutional Review Board (IRB) or by the Mines Human Subjects Administrator, or in his/her absence, the Senior Vice President for Research and Technology Transfer (VPRTT).

Human subjects protection is a professional and institutional responsibility, which requires education, conscious research planning, and peer review. Mines faculty or students engaged in research involving human subjects, whether such work is conducted on or off campus, are required to comply with all controlling State of Colorado and federal regulations governing human subject research. All Mines researchers contemplating research involving human subjects, including those categories of research that may be eligible for exemption from IRB oversight, must make themselves familiar with applicable compliance requirements as specified by the United States Department of Health and Human Services (DHHS), its Office of Human Research Protections (OHRP), or other federal agency. Regulations and policy guidance may be accessed at: www.hhs.gov/ohrp

Faculty members who violate this policy may be subject to discipline pursuant to the Faculty Handbook policies and procedures, and penalties prescribed by applicable federal and State law.

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Identifying human subjects research
There are two (2) different categories of human subjects research performed on the Mines campus: sponsored research and non-sponsored research.

Sponsored Research
Sponsored research projects are managed by the Office of Research Administration (ORA). All proposals submitted to ORA by an investigator (the principal investigator or PI) undergo a review by an ORA proposal analyst. During this review, the PI and the proposal analyst determine whether or not the project will involve human subjects. If it has been determined that human subjects will be utilized, the proposal is flagged and either the PI or ORA contacts the human subjects team to make them aware of the proposed project and what may be required if the project receives funding.

Non-Sponsored Research
Non-sponsored projects are studies conducted by faculty and/or students that are not supported by an outside source of funding. These projects are referred to as investigator-initiated studies and typically consist of academic studies, quality assurance, or student projects. When a faculty member determines that he or she would like to conduct a non-sponsored project, he or she is required to contact the human subjects team to seek review of the project prior to its commencement.

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REGULATIONS

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