The following topics represent the most common questions the HPRB receives about human subjects research and proposal submissions. If you have a question not covered here or elsewhere on our website, please contact the HPRB at firstname.lastname@example.org.
If you have a suggestion for adding any question(s) not addressed here, we’d appreciate your input.
DO I NEED TO SUBMIT AN HPRB PROPOSAL?
If you’re collecting information from and/or about living human beings or their private records, you should complete our diagnostic pre-survey in Mentor and/or consult with the HPRB to determine whether to submit your project.
Start with our Step-by-Step Guide. Step 1 covers this question:
The HPRB distinguishes between human subjects research and classroom research.
Please see our Classroom Research Guidelines for more information.
PROPOSAL & METHODS QUESTIONS
We use an online submission system, Mentor, for all proposal submissions. If you are a member of the PLU community, you can access Mentor using your PLU username and password.
Access Mentor here.
See Mentor Instruction Sheets here.
In Mentor, you will need to upload required materials (e.g., consent forms, recruitment scripts, debriefing documents, approvals from research sites). The most recent versions of all templates can be found here.
Before submitting an HPRB application, all researchers (and key personnel, as well as faculty supervisors) must successfully complete the Collaborative Institutional Training Initiative (CITI) online training course.
Important information about registering for CITI training for the first time can be found here.
Still have questions? Please email email@example.com.
Training is valid for four years.
Our online proposal submission system, Mentor, will let you know if your training is complete and up-to-date. Mentor will not allow you to submit your proposal without CITI certification.
Please see our website for more information about the different levels of review.
We have a pre-proposal survey in Mentor that walks you through a series of questions to help you determine the level of review. If you are new to the HPRB process, we strongly recommend you take the pre-proposal survey.
If you choose to skip the pre-proposal survey, the Mentor default is to set your project to the level of Full Board Review. If this is not the case, please edit this on the initial information page for your project. Failing to do so could result in a delay in the review process.
The informed consent process represents one of the key principles of ethical human subjects research.
Find information about the informed consent process here.
If you are conducting research with children or adolescents (minors), you also need “oral assent” and “parental permission.” More information can be found here.
It depends on what kind of study you are conducting and the level of risk involved. Please use the most recent version of our templates for:
- Signed consent forms for confidential in-person studies
- Cover letter for anonymous in-person studies (i.e., with hard copy surveys)
- Online cover letter for anonymous online studies (i.e., with online surveys)
- Parental consent for studies with minors (under age 18)
- Oral assent for studies with minors
Be sure to pay attention to specific methodological considerations if you are recording or photographing your participants, etc. You may need to get an additional signature for these purposes.
See the HPRB website for more information.
Understanding these concepts is an important part of human subjects research, and you must carefully distinguish between them in your protocol and also your informed consent sheet to enable potential participants have an accurate understanding of the nature of the data you collect.
Research projects may assure either anonymity OR confidentiality, but not both (unless there are different procedures for different groups of participants).
Anonymity is when the participants’ identities and data cannot be linked in any way. In-person surveys can be anonymous IF there is no identifying information and all participants are asked to use the same writing instruments.
With confidentiality, the researcher – but no one else – knows the identity of the participants and can link participants with specific data. Confidentiality, but not anonymity, is possible during face-to-face interviews or interactions with participants.
Read further guidance on anonymity confidentiality, and privacy [link to follow], which also offers best practices in applying these concepts.
For exempt and expedited projects, we review proposals as we receive them through the online submission system, Mentor.
For full board proposals, you must submit by the deadlines listed here.
Approximate review timelines (during Fall and Spring, excluding J-term and holidays; expect longer review times in summer). Understanding the levels of review timelines can be found here.
Review times do not take into account time for responding to stipulations.
You may not begin any aspect of your study — including advertisements or recruitment — until you have received written HPRB approval. Otherwise, you will be considered in non-compliance with Federal human subjects policies and regulations.
Ensuring that you protect your participants’ data is a hallmark of ethical research. Review guidance about data storage and security. [link to follow]
Once in your proposal, on the main protocol page, click on -> ACCESS HPRB PROPOSAL SECTIONS HERE (to edit, review, revise). This will take you to the different proposal sections that need to be completed. You can do them one by one or click on Expand All Sections to see everything at once.
Documents get uploaded at the bottom of the main protocol page in Mentor. This includes the recruitment script, consent document, surveys, debriefing, and/or letter from research site outside of PLU.
The HPRB website has step-by-step instructions and detailed explanations for what needs to be included: .
Be sure to pay attention to specific methodological considerations if you are doing online surveys, research with vulnerable populations, recording or paying your participants, etc. See the HPRB website for more information.
Track changes may be on (it is the default setting). Turn it off by clicking on the little document icon with the pencil. Do this when entering text for your proposal, but leave track changes on when you are addressing stipulations, so the HPRB can tell what was changed.
Also, when cutting and pasting material from a word processing program (e.g., Word), use: Control-Shift-V (for PCs) or Command-Shift-V (for Macs). This pastes without the formatting and makes fewer strange things happen when you try to edit.
Still having trouble? Please feel free to reach out by email at firstname.lastname@example.org.
CITI (ONLINE ETHICS TRAINING) QUESTIONS
Please follow these instructions carefully, so you do not take unnecessary courses.
Our online HPRB proposal submission system, Mentor, receives completion data from CITI. When you create a new proposal, Mentor will indicate whether you are currently certified.
It depends on the proposal type. All proposals go first to the Unit Designate in your school or division. Once completed, Unit Designate reviews go to the HPRB chair.
Approximate review timelines (during Fall and Spring, excluding J-term and holidays; expect longer review times in summer).
Please keep in mind that review times may be longer during busy periods of the year.
Review times do not take into account time for responding to stipulations.
You will receive an approval letter from the HPRB chair. You cannot begin your project until you have received this letter.
It is common to receive a request for stipulations before your project is approved. If you receive notice that the HPRB is requesting stipulations, you must respond to these stipulations and await final approval from the HPRB chair before beginning any work with human participants.
If revisions are requested within proposal sections, you should make changes by:
- Editing responses to the questions directly using the Edit Answer button.
- Responding in Reader Comments (e.g., to provide further information or provide a rationale for not making the requested changes)
After editing each question, you should click the Submit Revisions for Review box at the bottom of each question. This will make the Revisions Required text go away and be replaced by Revisions Submitted.
If revisions are requested to study documents, you should make necessary changes by:
- Editing study documents and uploading revised versions on main protocol page
- Adding missing documents on the main protocol page
When all materials are complete, click the Submit Revisions for Review box at top left of main protocol page. This notifies the HPRB chair that materials are ready for review.
Get into your proposal on Mentor. At the bottom of the main proposal page, there is a tab for Amendments.
Click on Create New Amendment. There are some instructions to read. Then click Create New Amendment and you will see a brief questionnaire.
If any study documents are affected by your proposed changes, revised versions should be uploaded. Click on the little document icon and you will see an option to upload documents.
Minor changes can be approved by the HPRB chair. Major changes may need additional review from the Unit Designate in your school/division or the full board.
You may not use revised procedures or documents until they are approved by the HPRB.
Your approval is valid for one year. The expiration date is included in your HPRB approval letter. It can also be found under the Annual Review tab at the bottom of the main protocol page for your project (in Mentor).
Mentor will send a reminder that your expiration date is coming up.
If you want to terminate your study before that date, click on the Annual Review tab at the bottom of the main protocol page in Mentor. Click on the Complete & Submit button.