Duke AHEAD membership requested information on the Institutional Review Board (IRB) submission process for health professions educators. After a Listening Session, the following Frequently Asked Questions list was developed below. This resource will be updated on an ongoing basis.
- What is the current process for submitting a declaration of exemption for an education-protocol application?
An education protocol application can be submitted as an exempt submission in iRIS for the IRB to determine if it meets exemption criteria. However, if the IRB says it is not exempt, then it must be submitted as a regular submission with a new protocol number. You can use content from the initial submission to support the resubmission.
- What are the new processes and procedures for submission? All submissions to the IRB for approval are submitted in iRIS.
- Read through this Getting Started webpage: https://irb.duhs.duke.edu/irb-review-process/getting-started.
- DUHS IRB applications are submitted using our online system, iRIS.
- You'll need to identify who would be considered Principal Investigator (PI) for this project. See this link and expand the question "What are the eligibility requirements for a principal investigator": https://irb.duhs.duke.edu/irb-review-process/getting-started
- Then, receive the required CITI training certification for conduct of research with human subjects. In CITI, you should affiliate with Duke Health in order to see the four required modules. Please ensure that your CITI account UserID uses your netID in this form netID@duke.edu:
- Biomedical Research with GCP - Basic/Refresher (Expires every three years from completion)
- Vulnerable Subjects - Research Involving Children
- Vulnerable Subjects - Research Involving Prisoners
- Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates
- See https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/docr-services-and-initiativesprojects/training-and-communications/citi-training
- All key personnel on this study must take the CITI training. To determine who is considered a key personnel, see: https://irb.duhs.duke.edu/irb-review-process/faqs/key-personnel
- If a key personnel has never logged on to iRIS before, they will need to do so one time for iRIS to connect to their NetID account. iRIS is the IRB online submission system: http://iris.duke.edu.
- If in the process of filling out your iRIS application you cannot locate the names of the key personnel, it means that person has never logged on to iRIS before; ask them to logon to iRIS.
- For technical instructions on how to navigate iRIS, see the following link which includes video training on LMS: https://medschool.duke.edu/research/research-support/research-support-o…
- How do I know if my submission may qualify as an exempt?
All exemption determinations must be made by the IRB.
https://irb.duhs.duke.edu/node/4091
https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
Chart 3 to 9
- How do I get the submission approved?
Once you submit in iRIS the IRB staff and reviewer work to get it approved. If it is approved and exempt, the study team receives an outcome letter and you can proceed. If it is a regular application, an outcome letter is sent, but there is an institutional approval that takes place and it must be received before proceeding. (Oncore)
- If we collect information from learners in any form should we do a submission and is it exempt or a regular submission?
If the program is a QI project and is working to improve processes at Duke it does not require submission to the IRB unless an authoritative determination is required. For example, if you want an official determination for a journal publication, etc. you can submit for IRB review and approval. The IRB has provided a checklist to help you determine if a project meets the criteria of a QI project (see link to policy).
However, if this initiative can turn to research through dissemination and spread, then a submission should be completed prior to the start of activities.
Additional Resource: https://medschool.duke.edu/research/research-support/research-support-offices/duke-office-clinical-research-docr/get-docr
- Are there examples of forms that should be used for application submissions and where can I access them?
Submissions to the IRB are confidential, however documents can be shared for informational knowledge through study teams and colleagues.
- How do we handle submission if Duke is primary research institution conducting the research, and an external institution is participating in the project?
The foundational process is not different than normal (exempt or regular). Include the roles of each institution. In the regular application, there is more details required, i.e. key personnel, what is information is being shared, data use agreements, reliance agreements and material transfer agreements. As a PI, be very clear about the roles of Duke versus the external institution. These details should also be included in an exempt application. If this is not clear, the IRB will request more detail.
- How do we handle non-exempt education projects?
When you start a new application in iRIS, you will be asked which application type you are submitting. Select Regular Study Application.
- Can we have a glossary of standardized educational language (FERPA, PERPA, education research, etc).
The important piece is what level of student involvement is required for the project.
https://campusirb.duke.edu/search/node/ferpa (Accessing Student Records, Scholarship for Teaching and Learning)
Summary of Protection of Pupils Rights Amendment (PPRA)
PPRA only applies to non-postsecondary institutions and on those that receive funding from US Dept of Ed. Also applies to any research funded by Dept of Ed.
Focus of PPRA is on the requirement for parental consent for collection of certain sensitive information.
Parental consent is required for studies involving surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:
- Political affiliations or beliefs of the student or the student’s parent
- Mental and psychological problems potentially embarrassing to the student or his or her family
- Sex behavior or attitudes
- Illegal, anti-social, self-incriminating and demeaning behavior
- Critical appraisals of other individuals with whom the student has close family relationships
- Legally recognized privileged and analogous relationships, such as those of lawyers, physicians and ministers
- Religious practices, affiliations, or beliefs of the student or student’s parent
- Income, other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under a program
IRB cannot waive informed consent or go against the way a school district applies PPRA
- If we have de-identified data, would that mean the submission is automatically exempt?
Several things would need to be considered: how was the data collected and did you interact with subjects to obtain data (which is related to human subjects). The entire activity would need to be submitted to the IRB, and they will make the determination. The study may be exempt or undergo expedited review, but the IRB will have ultimate determination.
Important to Note
All individuals listed on an IRB submission (even ones requesting an exemption determination) must have CITI training.