Human Subjects Research

Research Integrity and Security

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 Research (HSR) 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).

The HSR committee meets biweekly, generally on Wednesdays. For information on the next meeting date, contact humansubjects@mines.edu.

Getting Started and Training Requirements

1. 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.

2. Training Requirements

Mines requires all project investigators complete the Social and Behavioral Research or Biomedical Research course prior to their project starting. The courses are available on the CITI platform and must be completed by all investigators, co-investigators, and student researchers.

All human subject research projects must be reviewed by Mines’ (HSR) committee prior to the commencement of any research activities. The HSR committee meets every two weeks to review applications, modification requests, and general questions. The committee reviews each application to determine if it qualifies for exemption 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 HSR 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. After review by the Human Subjects Research committee, department head signature is required to acknowledge that the proposed study meets departmental research standards and provide assurance that the principal investigator will meet institutional requirements for review and approval of the research. 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.

Mines can only approve exempt human subjects research. Mines is not registered with the Office of Human Research Protection (OHRP) for a full internal IRB. Human subjects research protocols requiring an expedited approval or full board approval must be sent to an external IRB in good standing with OHRP.

contact human subjects

Is your study funded by the NIH? If you are planning to conduct human subjects research and collect demographic data that includes sex or gender, please contact the Human Subjects Research committee: humansubjects@mines.edu.

FAQ
HSR Committee
Policy & Regulations
resources
About Research Participation
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 Research 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).

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 Research committee can assist investigators with the COMIRB application process, as needed.

  • COMIRB instructions for submissions – applications submitted to COMIRB have an average 4-6 weeks processing time.
  • COMIRB fees – 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 reliance 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.