Institutional Review Board FAQ
What type of research requires review by the IRB?
Any research activity involving human subjects or data of human subjects conducted on the premises of Roseman University, or conducted by Roseman University investigators, needs to be in compliance with the policies and guidelines set forth in the Roseman University IRB Standard Operating Procedures (SOP).
What qualifies as research?
The federal regulations define research as “a systematic investigation designed to develop or contribute to generalizable knowledge.” Quality assurance, quality improvement projects or program evaluations may not fall under the Institutional Review Board jurisdiction. Any feedback or clarification requests must be submitted in writing to firstname.lastname@example.org.
What is a human subject?
The federal regulations define human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information.”
What is a research protocol?
A research protocol is a detailed plan outlining the proposed research.
Who may submit a research protocol for IRB review?
A Principal Investigator (PI) assumes primary responsibility of the proposed research investigation. Roseman students may be involved as a co-investigator or research support under the supervision of a faculty member as the PI.
Are forms or templates required for research protocol submissions to the Institutional Review Board?
Yes. Standardized forms for IRB submissions and templates for consent can be accessed through the IRBNet Forms and Templates button. Please download and save the appropriate PDF forms to your local drive before completing the forms.
What type of human subjects protection training is required?
Roseman Investigators – Effective January 1, 2018, the Roseman University IRB will only accept the Human Subjects Research course by Collaborative Institutional Training Initiative (CITI). To register and complete the CITI training click on the image below.
For written instructions on creating account, click here. Be sure to use your Roseman email.
External investigators may complete NIH or CITI (if available through their home institution.)
How do I show I completed a CITI course completion certificate or report?
Roseman Investigators – link your CITI account to your IRBNet account using your CITI Member ID (the 5 to 8-digit number shown at the top of the page when you log in to your CITI account). Please refer to “3 – Linking CITI account to IRBNet account” found under Forms and Templates in IRBNet for further information.
External investigators – upload their training credentials as a separate document in the submission package.
Who needs to create an IRBNet account?
All Roseman University research investigators, including students and residents, must create an IRBNet account to 1) link their CITI training certificates and 2) access and monitor their individual research project review progress. External investigators do not have to create an account.
How do I create IRBNet account?
To create an IRBNet account, click on the image below.
Look for New User Registration in the upper right hand corner and follow the prompts. Once the registration process is completed, you will receive an activation email request to your email account. Be sure to use your Roseman University email account.
How do I submit a research protocol to the Roseman University IRB?
Log into IRBNet and click on “Create new project.” Standardized forms for IRB submissions and templates for consent can be accessed through the IRBNet “Forms and Templates” (left hand button column) button. Please download and save the appropriate PDF forms to your local drive before completing the forms.
Download and review the following training materials which include screenshots.
- Submitting your first project with IRBNet
- Managing IRBNet after the initial project submission
- Linking CITI account to IRBNet Account
How do I know I submitted correctly?
The project status in IRB will change from “Work in Progress” to “Pending Review” AND the IRB will reply by email to the submission notice confirming submission.
What happens after a research protocol is submitted?
The submission is reviewed for completeness and internal consistency. Based on that administrative review, the investigator may be asked to make corrections, provide clarification, or submit additional documents. The next step is review based on the level of IRB review (see below).
What are the different levels of IRB review?
There are three levels of IRB review:
- Exempt determination
- Expedited Review
- Full Review – any protocol that does not meet the criteria for exempt determination or expedited review.
The PI may not determine the level of review The IRB will determine the level of review.
How long does the IRB review and approval process take?
The review and approval time will vary significantly based on the level of review and other factors such as turn-around time by the PI in response to the administrative review, Board review, and complexity of the project among others. It is important that the PI plans accordingly.
How often does the IRB Full Committee meet?
Full IRB meetings are held quarterly or as needed.
Can I start the research after submitting the protocol to the IRB for review?
Under no circumstances may a research investigation be started before the IRB decision on approval or exemption is received. Lack of communication from the IRB may not be misinterpreted as an approval. To check protocol review status, login to your IRBNet account.