Roeseman

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 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.”

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 – 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 written instructions on creating an account, click here. Be sure to use your Roseman email.

External investigators – may complete NIH or CITI (if available through their home institution.)

Which CITI course should I take?

Roseman investigators must complete either Human Subjects Research – Biomedical and/or Human Subjects Research – Social & Behavioral CITI training. Depending on the research, some investigators may be required to complete both of the above mentioned training modules.

Records-Based Research, Genetic Research, Research with Pregnant Women, Fetuses, and Neonates, FDA Regulated Research, and HIPAA Research requires Human Subjects Research – Biomedical.

Public Elementary and Secondary School Research, International Research, or Internet-Based Research, requires Human Subjects Research – Social & Behavioral.

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 account and training 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 “Application Form for New Project Submission” as well as any other the appropriate PDF forms to your local drive before completing the forms.

Download and review the following training materials which include screenshots.

  1. Submitting Your First Project with IRBNet
  2. Managing IRBNet After the Initial Project Submission
  3. Linking CITI Account to IRBNet Account
  4. Linking CITI Training to Package (Begin with Part B)

How do I know I submitted correctly?

The project status in IRB will change from “Work in Progress” to “Pending Review.”

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 an Information Required Letter 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 an Information Required or Modifications Required letter?

Address all requested revisions in the Information Required and/or Modifications Required letter. Create a revisions letter that contains point-by-point responses to all comments in the Information Required and/or Modifications Required letter.

Create a “New Package” and upload all revised documents and the 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.

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.

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 in a “New Package” on IRBNet. The Modifications Form can be found under “Forms and Templates.”

Still have questions?

Click the button below to schedule an appointment with the IRB Administrator.

Please note, the IRB Administrator is unable to help draft content, as it is a conflict of interest. However, she can help with:

  • IRBNet Navigation and Forms
  • CITI Training Requirements
  • IRB Submission Pipeline