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 by the Roseman University IRB Standard Operating Procedures (SOP).
What qualifies as research?
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Quality assurance, quality improvement projects or program evaluations may not fall under the IRB jurisdiction. Any feedback or clarification requests must be submitted in writing to firstname.lastname@example.org
Where can I find the Roseman IRB Standard Operating Procedures (SOP)?
Review the IRB SOP thoroughly prior to submitting your research protocol for IRB review. The IRB SOP is available within your IRBNet account ‘Forms and Templates.’ You may also contact the IRB by email for a copy of the Roseman University IRB SOP.
Who needs to register for an IRBNet account?
All Roseman University investigators involved in human subject research can create an IRBNet account. Only electronic submissions of research protocols through IRBNet will be accepted for review by the Roseman University IRB.
How do I register for an account with IRBNet?
Follow the link above for IRBNet, click on New User Registration 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.
What is a research protocol?
A research protocol is a detailed plan outlining the proposed research.
How do I submit my research protocol to the Roseman University IRB?
Log into your IRBNet account, review the checklists for investigators and submit the application package. Make sure the IRB Pre-review checklist is completed and uploaded to the application package.
Are forms or templates available for research protocol submissions to the IRB?
Yes. Standardized forms for IRB submissions can be accessed through the IRBNet Forms and Templates. Please download and save the appropriate PDF forms to your local drive before completing the forms. All completed forms then need to be uploaded onto the IRBNet account as applicable to the specific research protocol.
What type of training is required along with the IRB protocol submission?
Currently, we are accepting both NIH certificate for Protecting Human Research Participants Training (https://phrp.nihtraining.com/users/login.php) as well as Human Subjects Research certificate by Collaborative Institutional Training Initiative (CITI). Please upload the relevant credentials in the IRBNet Track Training.
Note: Starting January 1, 2018, Roseman University IRB will only accept the Human Subjects Research certificate by Collaborative Institutional Training Initiative (CITI). Please click here to complete the CITI training.
Who is a Principal Investigator (PI)?
A PI is the Principal Investigator that assumes primary responsibility of the proposed research investigation. Roseman students may work under the guidance of a faculty member. Roseman students may be involved as a co-investigator or research support under the supervision of a faculty member as the PI.
Are co-investigators required to register with IRBNet?
Yes. All research investigators are encouraged to register with IRBNet to access and monitor their individual research project review progress.
What happens after a research protocol is submitted?
Based on the category of IRB review, a completed protocol may be deemed exempt from further IRB review or assigned to one or more reviewers. Notifications may be set up through the IRBNet account to review email alerts on any changes in status.
What are the different levels of IRB review?
There are three main categories of IRB review: Exempt, Expedited or Full Review. For more detail on the various IRB review types can be found in the IRB SOP. The PI may not assume a certain protocol to fall under Exempt category. IRB reserves the right to determine and place a proposed research in any of the three categories.
How long does the IRB processing take?
IRB processing may vary significantly based on review category and several other factors such as turn-around time from PI and reviewers, complexity of project among other. It is important that the PI plans accordingly.
How often does the IRB Full Committee meet?
Full IRB meetings are conducted quarterly or as needed.
Can I start the research after submitting the protocol to IRB for review?
Under no circumstances may a research investigation be initiated until IRB decision on approval or exemption is received. Lack of communication from IRB may not be misinterpreted as an approval. To check protocol review status, login to your IRBNet account.