All IRB applications should be submitted through the electronic submission system called IRBNet. IRBNet is a web-based system that allows researchers to create, modify and submit their IRB forms and documents electronically.

 

Some of the benefits of the system include:

  • Maintenance of the IRB study file in electronic form accessible by the investigator or IRB office at any time as long as Internet access is available
  • Allows the research team to share files and collaborate on the preparation of forms and documents
  • All signatures are electronic and can be completed from each person’s computer
  • Instant submission.  Once all files are included in the package and the required electronic signatures are obtained, that package is submitted by clicking the submit button
  • All notifications from the IRB Office (approvals, modifications required, expiration notices, etc.) are communicated electronically within the system

 

Instructions for Using IRBNet
Written instructions for using IRBNet can be downloaded.  The IRB Office also provides individual or group IRBNet training upon request.

  1. Instructions for creating an account in IRBNet:  These instructions describe how to access IRBNet and how to create a user ID and password can be downloaded here.
  2. Instructions for creating a new study in IRBNet describe how to create a new study in IRBNet and can be downloaded here.
  3. Instructions for submitting a continuing renewal in IRBNet describe how to create a new package within the study file so that a continuing review application and associated materials can be uploaded and can be downloaded here.
  4. Instructions for submitting a modification or amendment in IRBNet describe how to create a new package within the study file so that an amendment or modification application and associated materials can be uploaded and can be downloaded here.

 

Signatures
All signatures are electronic and require the person to click the “Sign this package” button in IRBNet.  The Principal Investigator must sign the application.  If the PI wishes to designate another person to sign on their behalf, the designee can click on the “designee signer mode.”  An electronic signature from a designee still requires that the PI has read the documents in the package in their entirety and agrees they are ready for submission.

 

To get the required signatures in IRBNet, the study must be shared with the individual whose signature is required.  For example, a research coordinator that prepares the forms and documents and assembles the package must share the study with the PI.  The PI can then review the documents and once they are approved, the PI should click on the signature button.  To share the study, click on the share this project button and then select the person’s name and the level of access to give them.  The person must be a registered IRBNet user.

 

Studies that will utilize any core within the CRC must have the signature of the PCIR Director, or designee.  Each protocol must also be shared with the CRC via the CRC website.  It must include an electronic application for the PCIR Director’s signature.

 

Students must have their thesis chair signature before submission.

 

Training:
CITI training must be completed before the application can be reviewed.

 

Collaborative Research Projects:
MSM has reciprocity agreements with Children’s Healthcare of Atlanta (CHOA), Emory University (pending) and Georgia Tech (pending), for IRB oversight of collaborative projects.  The IRB Office at each investigator’s institution should be consulted before submitting an application.  The IRB Offices will discuss the proposal to determine which IRB will be the IRB of record for the study and direct the investigators for how to proceed with their submission.

 

IRB of Record:
MSM has signed authorization agreements with the American Cancer Society and the Interdenominational Theological Center (ITC) to serve as their IRB of record.

 

Documents to include in Submission Packages:
All applications are unique and require different sets of materials.  Examples of items that might be included in the different types of submission packages are listed below.

 

  • New Study Application
    • Initial IRB Application Form
    • Consent Form
    • Protocol
    • Advertisements/Recruiting materials
    • Data collection forms

 

  • Continuing Renewal Application
    • Continuing Review IRB Application Form
    • Consent Form (current version in use)
    • Applicable amendment/modification materials

 

  • Amendment/Modification Application
    • Amendment/Modification IRB Application Form
    • Modified Consent Form with changes highlighted or marked
    • Modified Protocol with changes highlighted or marked
    • Advertisements
    • Data collection forms

 

  • Adverse or Unexpected Event
    • Unanticipated Problem AE On-Site Report Form

 

  • MPH Student Submissions
    • Initial IRB Application Form
    • Prospectus
    • Letters of support for conducting research at non-MSM sites
    • Data collection forms

 

Submission Times
Applications may be submitted at anytime.  Those studies to be reviewed by the full Board usually need to be submitted 4-6 weeks before the meeting date.  This allows time for the initial screening of the application in the IRB Office, a pre-review by a Board member, initial corrections by the investigator, a thorough review by a Board member primary reviewer, additional corrections by the investigator, and review by all Board members for deliberation at a convened meeting.

 

The time between submission of the application and study approval varies with the complexity of the project, the clarity and thoroughness of the application form as well as the clarity and reading level of the consent form.  An application is not sent for full board review until the reviewer and IRB Office agree that any major deficiencies have been corrected.

 

The IRB meets on the 2nd (Social & Behavioral) and 3rd (BioMedical) Wednesday each month.