Human Subjects Research
OVERVIEW
The protection of human subject’s in research is a professional and institutional responsibility. Mines faculty and students engaged in research involving human subjects (conducted on or off campus), are required to comply with all applicable State of Colorado and federal regulations governing human subject research and privacy, and Mines’ institutional policy on Human Subjects Research. This is true even if the research is eligible for exemption under IRB oversight under the federal regulations.
All investigators and students working on a human subject’s research project are required to complete online training in advance of starting the research. Additional training and review obligations could be required for expedited or full board approved projects.
Mines’ faculty and students engaged in human subjects research are encouraged to contact Mines’ Human Subjects committee with any questions. 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.
Identifying human subjects research
- A systematic investigation designed to develop or contribute to generalizable knowledge;
- involving collecting information about a living individual;
- involving intervention or interaction with the individuals or is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) and private (behavior that occurs in a context in which an individual can reasonably expect privacy); and
- the results of which will be published.
Exempt Research
- Research conducted in established or commonly accepted educational settings, involving normal education practices.
- Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.
- Research involving collection or study of existing data, documents, records, or pathological or diagnostic specimens.
- Research studying, evaluating, or examining public benefit or service programs.
- Research involving taste and food quality evaluation or consumer acceptance studies.
Final determination of exemption status is made by the Human Subjects committee, and a study must be approved by the Human Subjects committee prior to research commencing. An approval letter will be provided by the Committee. Research that does not meet the criteria for exemption under 45 CFR 46.101(b), must follow the external review process (as follows).
External Review Process
COMRIB, and other external review boards, have associated fees to their review process. The investigator is expected to pays all necessary fee(s) for their IRB application review; however, these fees are allowable costs on sponsored projects.
In limited circumstances, Mines may be able to enter into a reciprocity agreement with another academic IRB engaged in the same research project. Mines follows this process for multi-site studies in which our faculty are collaborating with other faculty on human subjects research projects that have IRB approval from another IRB in good standing with OHRP (Office for Human Research Protections). To qualify for this type of IRB approval, the Mines faculty member must be listed as a Co-PI on the application to the external IRB.