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SWAG视频Carolinas Campus

Submission Process

All research projects that involve human subjects must have approval from the Institutional Review Board (IRB). Examples of research are surveys, interviews, observations of activities or behaviors, exercise tests, blood or other tissue collections, psychological or medical measurements or intervention and sensory responses. In addition, any research involving responses from people or access to records about people must be reviewed. Research studies involving human subjects are reviewed in one of three ways: exempt review, expedited review and full board review.

The SWAG视频Institutional Review Board now accepts electronic protocol submissions via IRBNet鈥檚 electronic protocol management system. IRBNet is a web-based system that allows researchers (both SWAG视频affiliated and non-SWAG视频affiliated) to submit IRB applications online, track the progress of submitted applications and save IRB protocol-related documents online. You may access IRBNet from virtually any computer using a web browser by visiting聽.

The process for applying for IRB approval begins with creating an IRBNet User ID and password.聽

  • Training guide for new IRBNet users (PPT)
  • When establishing your user profile you will need to select your institution/organization as Edward Via College of Osteopathic Medicine-Blacksburg, VA. While SWAG视频has multiple campuses, there is a single IRB which is managed from the Virginia Campus. Faculty and staff from other campuses should select that which is listed above.
  • Training guide for new submissions (PDF)聽The new submission walks researchers and study coordinators through the five-step new project submission process.聽 Please contact聽irb@vcom.edu聽for institutional log in information.聽

The Principal Investigator is charged with assuring that all necessary documents are uploaded electronically into the system and should sign off on the package prior to package submission to the IRB. The IRB Administrator will work closely with the principal investigator to ensure the appropriate forms are completed, and will assist with the preparation of other items that may be needed. IRB forms can be found on the SWAG视频IRB website under聽IRB Forms, as well as in the Forms and Templates Library of IRBNet.

Step 1: Design the Application

Users will need to log into IRBNet using the user name and password created. For new applications, users will select 鈥淐reate a New Project鈥 and follow the prompts.

During this step, researchers will upload all documents required for the application (e.g. IRB Application, Consent Forms or Waiver Request, Recruitment Materials, Data Collection Instruments, etc).聽Please note there have been updates to the previously used forms.聽All forms utilized by the SWAG视频IRB can be found on the IRB Webpage under聽IRB Forms, as well as in the Forms and Templates Library of IRBNet.聽

  • The new IRB application form has been revised to include all information previously submitted in the Research Protocol Document, as well as Forms A, B or C. Researchers are now required to submit only one document titled IRB Application, along with consent forms and supporting documents.

Step 2: Share this Package

Once a researcher has completed designing their package, the package will need to be shared with any team member who will be working as an investigator or collaborator on the study. The list of project team members in IRBNet should match that which is reported in th response to question 1.5 of the IRB application.聽You will only be able to share a package with individuals who have registered for an account in IRBNet.聽

  • Co-Author = Co-Investigator

You may provide individuals with FULL, WRITE or READ access

  • FULL Access聽- Users that are granted FULL access can perform all functions without restriction. This includes editing the project documents, sharing the project with other users, submitting document packages for review [Modification Requests, Continuing Review Requests, Close Out Requests] and deleting packages. Only Project Owners with day-to-day responsibility for this project should be granted FULL access. Users with FULL access will receive automatic email copies of all project notifications and alerts that are sent to the project owners.
  • WRITE Access聽- Users that are granted WRITE access can view and edit project documents, collaborate with other users and add their signature, but may not grant access to other users, submit packages for review or perform any other administrative functions.
  • READ Access聽- Users that are granted READ access can view project documentation, collaborate with other users and add their signature, but may not edit project documents or perform any other administrative functions.

For additional information on granting access to individuals, please contact the IRB Administrator.

Step 3: Sign this Package

The electronic signature becomes a permanent part of your electronic audit trail. Before a package can be submitted to the SWAG视频IRB Review, the package must be signed by the聽Principal Investigator聽as acknowledgement that he/she has reviewed the package for accuracy and completeness, and is accepting the responsibility for primary oversight of the project. Once the package has been e-signed by the PI, any individual with FULL access may proceed to Step 4.

Step 4: Submit this Package

After the package design is complete (all required documents have been uploaded) and the package is signed by the Principal Investigator, you may submit your project鈥檚 package to the SWAG视频IRB for review. When submitting your package, please be sure the default board highlighted for submission is Edward Via College of Osteopathic Medicine. Once the package has been submitted, the SWAG视频IRB will be notified of your submission and given access to view your electronic documents. The SWAG视频IRB will also be permitted to electronically record their review decision, which will be saved as a permanent part of your project record. You will automatically be notified when the review decision is electronically recorded.

  • Once a package has been submitted for review, the package will be locked from editing. To unlock a package prior to a review determination, please contact the IRB Administrator.

Step 5: Post-Submission Actions

Revising an approved protocol

Any change to an approved protocol must be reviewed and approved by the IRB prior to the implementation of changes (recruitment procedures, personnel changes, inclusion/exclusion criteria, data elements collected, etc).聽To revise an approved [existing] protocol, log into IRBNet and go to 鈥淢y Projects鈥. Find and open the protocol requiring revisions. You will want to select 鈥淐reate a New Package鈥. This will allow you to prepare new or modified documents (such as Modification Requests-Form G, Continuing Review/Close out Reports-Form D, Adverse Event Reports-Form E) by creating a new document 鈥減ackage鈥 on an existing project.

You will then be taken to the Designer page where you will be able to upload [Attach a New Document] any documents that need to be revised.

  • The SWAG视频IRB asks that ALL revised documents be submitted with track changes or changes highlighted to assist with the review process

After uploading the revised documents, please sign and submit the package to the Edward Via College of Osteopathic Medicine IRB for review. As with new submissions, you will automatically be notified when the review decision is electronically recorded.