Human Subjects Procedure
- Getting Started
- Human Subject Regulations Decisions Charts (offsite)
- Mines Application Review and Approval
- External Review Process
|Identify research||Determine if your work involves human subjects. If you are having trouble identifying human subjects research, email the human subjects team (email@example.com) or use the OHRP decision tree.
If the project involves human subjects research, IRB approval must be obtained before any work begins.
|Identify the Type of Review Necessary||Determine which approval you need for your project; Exempt, Expedited or Full IRB board review.|
|Complete forms||Complete the appropriate form. New projects require the completion and submission of the Mines Application for Exemption Form or the COMIRB Application Form. Changes to approved protocols require completion and submission of the Modification Request Form. Incomplete applications are returned to researchers with the missing or incomplete parts identified.|
|Submit forms||Email completed Mines Exemption forms to firstname.lastname@example.org. Submit the COMIRB forms via COMIRB’s electronic submission system. Forms must be submitted at least 4-6 weeks before approval is needed.|
|Mines Review||All projects involving human subjects are reviewed by the Mines human subjects team. The team determines if your research qualifies for an exemption approval or needs to be sent to an external IRB board that will review your human subject research protocol.|
|Exempt Approval||For applications approved as exempt, an approval letter is authored by the Human Subjects Administrator and sent to the researchers.|
|Expedited or Full Board Approval||If your project is not exempt, and you submitted an exemption request, your application is returned to you. If you still wish to pursue the project, you will need to submit an application to an external review board for further review.
For projects that require an expedited or full board approval, the approval letter will come from the external IRB.
|Training||All investigators or students working on a human subjects research project are required to complete online training. Additional training and review obligations could be required for expedited or full board approved projects.|
All human subject research projects must be reviewed prior to the commencement of any research activities. The human subjects team meets once every two weeks to review all submitted applications, modification requests, and general questions. The team will review each application to see if it qualifies for one of the seven IRB exemptions. If the application could meet one of the exemptions but there are minor concerns or missing documents, the team will work with the investigators to modify their application.
During the review, the human subjects team will focus on the following:
- Detailed research design
- Detailed recruitment strategy
- Detailed plan to protect the research data and subject identities
- Detailed consent procedures
- Detailed evaluation of risk towards the subjects
The more details provided in the initial application often speeds up the review and approval process.
For applications approved as exempt, the researcher(s) is sent an approval letter from the Human Subjects Administrator. The letter identifies which exemption category the research study has been approved for and requires the researcher(s) to notify the human subjects team if there is any necessary modification to the approved application.
If the research study does not qualify for exemption, the 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 will assist all investigators that need to submit applications to COMIRB for approval. 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. 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.
Each PI, and any other investigators on the project, is required to complete the Collaborative Institutional Training Initiative (CITI) training for researchers (read about registering for the CITI course) before the project begins. The human subjects team recommends that this training be done prior to submitting an application.