Instructors

Step 1: Check if your students need HPRB review
Step 2: Complete required online training (CITI)
Step 3: Understand the basics of the HPRB process
Step 4: Understand methodological issues that impact HPRB proposals
Step 5: Plan ahead for review time
Step 6: Provide your electronic signature to submit your students’ proposals
Step 7: Advise students on responding to HPRB questions/concerns (stipulations)
Step 8: Understand students’ on-going responsibilities once approved

Here are the biggest changes (aside from our online submission system, Mentor)

1. **** Instructors will submit student proposals for HPRB review *****
This is probably the biggest change impacting you as an instructor. You will now be the one to initiate submission when you provide your electronic signature. Before that point, you will be able to comment on student proposals within Mentor. Once students believe they have a final version, you will need to review their materials and provide an electronic signature.

Your electronic signature indicates that you:

• have consulted with students on their methods and materials,
• have reviewed and approved the proposal and all final versions of required documents,
• will help students navigate any unforeseen issues, once their projects are approved, and
• will oversee students’ on-going HPRB responsibilities related to the project

2. Optional diagnostic pre-survey
This pre-survey within Mentor will help you and your students determine if their projects meet the federal definition of Human Subjects Research (HSR) and require HPRB approval and, if so, which kind of review is likely: exempt, expedited, or full board.

If relevant, the pre-survey also helps students decide if their projects constitute Quality Improvement (QI), which is not considered HSR and will not need HPRB review. This affects primarily student projects in Nursing and health-related fields.

3. Changes for quality improvement (QI) projects (Nursing)
Investigators who believe their projects to be QI should review this QI information page and take our diagnostic pre-survey through Mentor. Projects qualifying as QI will no longer routinely be reviewed by the PLU HPRB. QI projects—even those that will be presented or published—are not intended to contribute to generalizable knowledge, and as such are not considered “research” according to the federal definition. Investigators conducting QI projects should work with administration or the IRB at the research site (e.g., hospital or other health care agency).

4. HPRB proposal form revisions
We have taken this opportunity to revise our form with a goal of minimizing stipulations. The online survey format allows for branching logic questions, so there is no longer a one-size-fits-all proposal. Depending on how students respond, they may led in different directions and asked to provide different kinds of information. Some questions have been changed to a yes/no or multiple-choice format, with explanations required for only some responses. The form also students to access explanations and examples for certain questions and terms, either by hovering over the text or clicking the information button (little blue “i”) next to the item. This means that there is less text to sift through for each question and less need to rely on documents external to the form for more detailed instructions or explanations.

5. More research will be reviewed as exempt
The Mentor pre-survey includes questions relevant to the different exemption categories. There is no longer a separate exempt form to be completed. If the HPRB determines a project to be exempt, further HPRB review or oversight will not be required, unless there are changes in the nature or scope of the project. Exempt reviews will have quicker review times.

6. Template revisions and additions
All consent documents have changed, so be sure that students use current versions. We have also added new templates (e.g., for anonymous online surveys, parental consent for work with children, debriefing)

7. Supplemental forms for certain kinds of research
Certain kinds of research will require completion of a supplemental form (part of the online proposal). Currently, there are supplemental forms for research with children and research with international/non-English-speaking populations.

8. New post-approval responsibilities for investigators
Mentor will send out automatic notifications before expedited or full board approval expires. Investigators are responsible for submitting a request for continuation or project completion report.