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 of Health Sciences IRB Policy Manual.

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 requests or clarification requests must be submitted in writing to irb@roseman.edu.

What is a human subject?

The federal regulations define a human subject as “a living individual about whom an investigator (whether professional or student) conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

Who should submit a research protocol for IRB review?

The IRB recommends that the Principal Investigator (PI), who is a faculty member, draft and submit the protocol as the individual who will assume primary responsibility of the proposed research investigation.  Roseman students may be involved as part of the research team in a capacity determined by the PI.  All members of the research team are under the supervision of the faculty member, as the PI.

Who can be the PI on a protocol?

Roseman Faculty and staff are considered “Affiliates” in IRBManager and can be the PI on a protocol. Students, Residents, and Non-Affiliates (individuals who do not have an appointment at Roseman) cannot be the PI on a protocol.

Click here for an outline of the Initial Submission form to allow for students to help collaborate.

Are forms or templates required for research protocol submissions to the Institutional Review Board?

Yes. The standardized forms for IRB submission and templates for supporting documents are accessible in IRBManager. The forms in IRBManager are “smart” forms and do not need to be downloaded, they can be completed and submitted within the IRBManager system.

What type of human subjects protection training is required?

Roseman Investigators – Must complete the Human Subjects Research course by Collaborative Institutional Training Initiative (CITI). To register and complete the CITI training click on the image below.

For instructions on creating an account and selecting the correct courses, click here.

Be sure to use your Roseman email address to allow your CITI account to be linked to your IRBManager account.

External Investigators – investigators not affiliated with Roseman University must either demonstrate that they meet their institution’s human subject research training policies, by submitting the institutional policy and the training certificate, or take Roseman’s required CITI training.

Which CITI course should I take?

Roseman investigators must complete either Human Subjects Research – Biomedical and/or Human Subjects Research – Social & Behavioral CITI training.

Investigators involved in clinical trials, regardless of funding source, must take the appropriate Good Clinical Practice CITI training module. Investigators of protocols funded by the National Institutes of Health (NIH) or National Science Foundation (NSF) must also take the appropriate Responsible Conduct of Research CITI training module.

Click here, to view instructions on how to create an account and select the required IRB course(s).

Click here, to watch a video demonstrating how to create an account and select the required IRB course(s),

How do I show I completed a CITI course completion certificate or report?

Roseman Investigators – If your Roseman email address is associated with your CITI account, the CITI training should be automatically linked to your account. If your training is not, please contact the IRB Office.

External investigators – upload the institutional policy and the training credentials on the ‘Results and Additional Info’ page of the application.

Who needs to create an IRB Manager account?

All Roseman University Faculty Investigators, must create an IRBManager account to 1) Demonstrate completion of CITI Human Subject Research training, 2) Access, and monitor the research project review progress. External investigators and Roseman University students can be added as ‘contacts’ on protocols to demonstrate completion of the required CITI training.

How do I create IRBManager account?

If you had an account and protocols on IRBNet – email the IRB Office to have your login information sent to you. Registering via this method will allow for your protocols in IRBNet to be transitioned to your new account on IRBManager.

If you did not have an IRBNet account – click on the image below and select ‘Click here to register.’ which is located in the bottom left hand corner of the ‘Login’ box.

Be sure to use your Roseman University email address when signing up for an account in IRBManager. IRBManager only accepts @roseman.edu email addresses.

Click here, to view the Quick Start Sheet to get started with IRBManager.

Click here, to view a video that helps with getting started with IRBManager.

How do I submit a research protocol to the Roseman University IRB?

Log into IRBManager and click on “Start xForm” to start a new Initial Submission Application. To access forms for studies that are already approved, click on the study on the dashboard and then click “Start xForm.” Accessing xForms within the study will allow you to complete the Adverse Event Reporting Form, Closure Form, Continuing Review/Annual Check-In Form, and Modification Request Form.

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 receive a ‘Changes Requested’ email asking for corrections, clarifications, or 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:

  1. Exempt determination
  2. Expedited Review
  3. 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.

What do I do after receiving a Changes Requested email?

Click on the link in the email to be directed to your protocol in IRBManager. Address all requested revisions outlined in the email. IRBManager automatically tracks what changes you made, so there is no longer a need to complete a Revisions letter.

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.

For Exempt Review, expect the Administrative review to take up to 1 week. We will send either approval or a ‘Changes Requested’ email. The PI will then determine how quickly the process can go depending on how soon she/he addresses the changes requested. Reviewing the submitted revisions can take up to an additional week. Depending on the quality of the revisions, the PI can receive an additional ‘Changes Requested’ email, if more changes are needed, or it will be forwarded to the IRB Chair for final review and determination.

For Expedited Review, expect the Administrative review to take up to 1 week. If the protocol requires changes a ‘Changes Requested’ email will be sent. The PI will then determine how quickly the process can go depending on how soon she/he addresses the changes requested. When the administrative review is completed, the protocol will be sent to at least two IRB Members for review. We give IRB Reviewers 2 weeks to complete their review, as IRB Members are volunteers who donate their time. After the IRB Reviewers complete their review, the IRB Office may send out one final Changes Requested email based on the most recent review and recommendations. Once the requested revisions have been made, the protocol will then be sent to the IRB Chair for a final review which can take up to 1 week. If the chair does not require changes, a letter of approval will be sent.

How often does the IRB Full Committee meet?

Full IRB meetings are held monthly.

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. To check protocol review status, login to your IRBManager account.

My protocol has been approved, is there anything else I need to do?

Yes, if any incident of injury, adverse effects, or unanticipated problems experienced by subjects in research takes place, the incident must be reported to the IRB via the Adverse Event Reporting Form.

Also, if any modifications need to be made to the protocol, the PI must submit a Modifications Form on IRBManager. Login to IRBManager, select the study on the Dashboard and click “Start xForm” to be directed to the Modification Form.

Regardless of risk level, all protocols must undergo an Annual Check-In. Protocols that were determined more than minimal risk must undergo a Continuing Review. The PI will receive notifications regarding the required Annual Check-In 60, 30, and 1 day prior to expiration.

Are there any other reference materials that would help with building my IRB protocol?

Yes! Please visit the IRB Bulletin Page for lots of tips for a successful IRB submission. Also, we have videos that we are happy to send to investigators that walkthrough what we are looking for in IRB submissions. Email irb@roseman.edu to request access to the videos.

Still have questions?

Email irb@roseman.edu.