Human Subjects Research

Getting Started

All human subject research projects must be reviewed by Mines’ Human Subjects Research committee prior to the commencement of any research activities. The Human Subjects Research committee meets every two weeks to review all submitted applications, modification requests, and general questions. The committee will review each application to determine if it qualifies for one of the seven categories of exemptions under 45 CFR 46.101(b). If the application meets one of the exemptions but there are minor concerns or missing documents, the committee will work with the investigators to modify their application. Incomplete applications are returned to researchers with the missing or incomplete parts identified.

During review of any applications, the Human Subjects Research committee focuses on the following:

• subject recruitment strategy
• protection of the research data obtained and subject identities, or other personally identifiable information
• procedures for obtaining informed consent, including the informed consent form
• data collection, use, and disclosure
• evaluation of risk towards the subjects
• applicable compliance requirements

Researchers should allow a minimum of two weeks for an exempt review. Providing more details 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.

Application for Exemption of Human Subjects Research

The human subjects research application is automated though OneAegis.

Once signed into OneAegis, researchers will be able to:

• Submit a new application for human subjects research exemption;
• Submit an amendment to an existing application or study;
• Submit an inquiry of any type;
• Complete the steps for an annual check in when notified.