Before proceeding with any student-driven research activities, determine whether the project needs to be reviewed by the IRB or if it qualifies as a class project. Use the HRP-310 WORKSHEET: Human Research Determination to help you make that determination and/or consult with the HSPP staff for assistance.
Although many studies are developed and conducted primarily by student researchers, it is expected that human research activities are appropriately mentored by a faculty or staff adviser. MSU Denver's IRB only reviews protocols where a faculty or staff member is identified as the Principal Investigator.
Student researchers are encouraged to take an active role in the development of the IRB submission package to learn about ethical conduct of human subject research and IRB oversight. The HRP-103: Investigator Manual and other researcher materials can be valuable resources in educating new researchers on IRB review and requirements. However, official IRB correspondence and the use of IRBNet is limited to the Principal Investigator. Student researchers may not register with IRBNet or submit materials to the IRB.
As Principal Investigator of student research projects, faculty/staff are expected to:
- Teach student researchers how to design and conduct an ethical research study.
- Guide student researchers in the development of their protocol and submission materials.
- Read and approve all IRB application materials created by or developed with student researchers.
- Submit research projects to the HSPP through IRBNet.
- Be the primary contact for the HSPP/IRB.
- Provide contact information for the PI to participants in the consent process/form.
- Ensure all of the appropriate materials are included and that the required information is complete.
- We provide Researcher Materials that guide you through the process and aid you in developing a complete submission package
- Supervise the research to ensure it is implemented as it was approved by the Institutional Review Board.
- Immediately inform the HSPP/IRB if they or the student researcher encounters unanticipated problems or adverse events.
- Maintain data and document security according to the approved protocol.
- Submit any proposed amendments for review and approval before the changes are implemented in the research.
- Be aware of IRB approval expiration dates and submit for continuing review or closure before approval expires.
- Ensure that all researchers maintain current and appropriate CITI certification.
The Principal Investigator on any IRB-approved human research assumes primary responsibility for the ethical conduct of the research and for meeting all IRB requirements.
Review of Student Research
The HSPP and IRB are very cognizant of the need to support student research activities. However, student-driven research cannot be held to any different standard of ethical conduct or oversight. In order to support MSU Denver student research, the HSPP/IRB responds to all research review requests in a timely manner. Protocols that receive the fastest approval are those that provide clear and consistent information about all procedures involved and include all necessary supporting materials and documentation. Proposed research activities that are not fully explained and/or well designed cannot be approved by the IRB and will require additional information or revisions.
There have been times that students have run out of time and were not able to conduct their studies, which posed problems for both the students and faculty. It is worth the time and effort to complete the submission materials correctly the first time. In addition, for many students the first submission to the IRB can be an important opportunity to learn about the ethical requirements of human subjects research. This can carry through to future research endeavors. Student researchers and their faculty/staff mentors are encouraged to consult with the HSPP in the development of their submission package and throughout the IRB review process for guidance and assistance.