Information for Faculty Advisors of Student Researchers

Any student engaging in research that involves human participants must have a faculty or staff adviser actively engaged in overseeing the research project. Faculty advisors cannot, however, provide IRB determinations of Exemption and/or approvals for student research projects involving human participants. The student must instead submit their project to us for formal IRB review. Moreover, we cannot retroactively issue a determination on a research project already begun. Lastly, please keep in mind that students who initiate projects prior to a written IRB determination are potentially engaging in research misconduct and cannot use their data for any publications or presentations. Please help your students plan ahead with the IRB review timeline taken into account.

The three most common ways that Seattle University students engage in research during their time here are:

• As part of a course, SU students often conduct minimal-risk research overseen by the faculty member teaching the course. Course projects should fall into one of two categories: "Not Human Participant Research" or Exempt. These projects are first assessed by the faculty and then submitted to us for "bundled review."
• An SU student might serve as Primary/Principal Investigator (PI) on a research project involving human participants for an Honors, Capstone, or individualized graduate-level project. 
• An SU DNP student serves as Primary/Principal Investigator (PI) on a research project involving human participants to fulfill their programmatic requirements.

The implications for faculty advisers are different, depending on whether the proposed research projects are a required part of a specific course in which a "bundled review" coordinated by the faculty is appropriate... or are for a research project in which the student will be the designated PI. 

Student PIs will use the OneAegis portal for their submissions.  This includes DNP students, students working on their dissertations, students working on theses, and specific Honors and Capstone classes (especially at the graduate level). After students submit a protocol via OneAegis, it will be routed directly to the faculty/staff adviser (via an auto-notification email sent to your SU address). That advisor must sign an attestation regarding the advisor's role and the protocol's accuracy and completeness. Then the protocol will come to the IRB for initial processing. As part of their role, advisors must:

• Complete human subjects training and provide CITI certificates to their advisees when the project is Expedited or Full Board;
• Review all parts of the advisee’s protocol before signing, paying particular attention to the consent process, evidence of site permissions to conduct research, and evidence of a data storage plan;
• Check in with the student PI periodically during research;
• Ensure the PI submits Modification requests, Continuing Reviews, and Close-Out Reports as appropriate.

Faculty advisors, please be aware that if you go ahead and approve a submission in OneAegis that is missing significant parts of the protocol, the IRB will likely send the submission back to your student. The student will then have to make revisions and re-submit the application for your review and signature... which will significantly delay the review process.

DNP students and advisors should consult their Canvas pages, as well as Nursing's DNP guidelines, for additional information.

Bundled Reviews of Course-based Projects

Bundled reviews for minimal-risk projects undertaken to fulfill a course requirement are different in terms of intent and process from the Student PI projects described above. The fundamental difference in this case is that the classroom-based projects are first and foremost undertaken in a condensed period of time to fulfill a particular course requirement under the close supervision of the faculty teaching the course. For certain low-risk, student research projects, a faculty member may therefore coordinate the project proposals and liaise with the IRB to create a group submission.

Faculty, if the projects being undertaken for a class do not fit the basic definition of research, then you do NOT need to submit a bundled review to us. The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you are uncertain whether your student projects constitute research with human participants, please contact us. 

Faculty who wish to submit a "bundled review" of their student class projects should email us a single Excel spreadsheet at irb@seattleu.edu  The spreadsheet should contain the faculty's name and the course's name in the file title. The spreadsheet should provide a single compilation of the following information on each of the student projects:

• Student(s) Full Name
• Project Title
• Research Goal (1-2 sentences)
• Anticipated population and size
• Recruitment methods, i.e. how will the student access the population?
• Data collection methods, including student interactions with participants and location of the interactions
• Nature of the data, i.e. what will the student collect?
• What direct and indirect identifiers will the student collect?
• What potentially sensitive information, if any, will the student collect?
• Are there any risks to the participants if they participate in the study, and include an explanation for why yes or no.
• What type of informed consent will occur?
• What does the student plan to do with the data?
• What is the student's data storage plan? (This ideally will involve SU SharePoint or OneDrive and will include a plan for deleting the data in an appropriate timeframe.)
• CITI proof. (Please note that bundled course reviews are the exception to our usual policy that CITI training proof is not required for Exempt-level projects; for bundled reviews, proof is required of everyone.)

See below for sample spreadsheet template.

The IRB will evaluate each proposed project in the context of potential risks and human participant protections, then communicate determinations to the faculty member. Faculty, please be aware that if your student research projects do not fall into "Not Human Participants Research" or Exempt categories, then your students will have to submit an Expedited or Full Board submission through OneAegis. The IRB supports many types of research projects, but please note that certain projects necessitating a higher level of review may be challenging to carry out within a ten-week term.