The University of Denver requires that all student investigators that wish to be the Principle Investigator (PI) on a research project submitted to the IRB (human subjects research), must have a Faculty Sponsor. This faculty member acts as an advisor and essentially assumes equal responsibility for ethical conduct of the research.
Although it is preferable, the Research Compliance Office does not require that the Faculty Sponsor on a research project is also the student's primary advisor, nor does it have to be the Chair of the student's Thesis or Dissertation Committee. However, specific Schools or departments may set their own policy regarding who may act as a Faculty Sponsor on student projects.The Faculty Sponsor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The Faculty Sponsor must support the student in the conduct of the research project after IRB approval is attained.
- Assist students in designing and planning the research project – Student research projects must be appropriate to their level of training and experience. Students must allocate time for IRB review and approval in their process, especially for projects conducted in international settings. Be sure that the student understands IRB approval must be in place before they can begin their work and that this includes recruitment of potential participants.
- Oversee preparation of the IRB application via IRBNet – A clear, complete, consistent application will move more quickly through the IRB review process. Be sure the application includes (as applicable) informed consent documents, recruitment materials, and surveys or other data collection instruments.
- Signing the IRB application via IRBNet prior to submission – Students must "share" projects and give full access to their Faculty Sponsors in IRBNet. Faculty Sponsors are required to electronically sign all student submissions in IRBNet. Faculty Sponsors are expected to have read the materials before signing as this indicates acknowledgment of their responsibility for the student application. The IRB copies Faculty Sponsors on communications with the student and may communicate directly with the faculty member if the application reflects a need for faculty involvement.
- Support students conducting research in field settings, particularly international research – Faculty Sponsors must be sure that students are aware of local customs and regulations, for the safety of their subjects and the students themselves. Provide assistance with establishing local contacts or mentorship. Establish a communication plan with students. Develop effective plans for data security.
- Monitor student research – Check in with students to ensure that research is being conducted as approved, that no problems have been encountered, and that all study modifications are submitted for IRB approval. Be sure that any adverse events or other research-related problems are reported to the IRB as soon as possible.
Required Human Subjects Training:
As the Faculty Sponsor you are required to complete the online CITI Basic Course (about 2 hours). This training is required for all human subject research personnel and is valid for 4 years. Instructions related to CITI training can be found here: EDUCATION