Human Subjects Research
The Colorado School of Mines requires all research involving Human Subjects or data containing Private Information (regardless of funding source), to be approved in advance. For research that is exempt under 45 CFR §46.104 as determined by the Human Subjects Committee, the process will start with Mines’ human subject’s application. Approval is obtained from the Mines Human Subjects Administrator, or in his/her absence, the VPRTT. All non-exempt research activities must be approved by an authorized external Institutional Review Board (IRB). Information on the policy and procedures can be found here.
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. Regulations may be accessed here.
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’ Human Subject’s Research policy is located here. Mines’ faculty and students engaged in human subjects research are expected to review the policy in advance of commencing human subjects research at Mines and 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 Human Subjects Research review is generally triggered when the following exist:
- 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.
Research involving human subjects may be eligible for exemption from the federal regulations. General exemption categories include:
- 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
If the research study does not qualify for exemption, the Principal Investigator (PI) may choose to send the application to the external IRB that Mines has contracted with to perform the review. Currently, the external IRB for Mines is the Colorado Multiple Institutional Review Board (COMIRB). The Mines human subjects team can assist investigators with the COMIRB application process, as needed. If an investigator would like to learn more about the COMIRB submission process, they can read through the step by step instructions for submissions. Applications submitted to COMIRB have an average 4-6 weeks processing time.
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.