Office of Research Compliance

IRB Forms

Study Applications - We are happy to announce that....

The InfoEd software will be use to submit IRB applications for review and approval.

The submission of IRB applications, continuing reviews, modification/amendments, and study closures, will use the InfoEd software for all submissions and the supporting documents.

Investigators wishing to submit documents for IRB review and approval must have a profile in the InfoEd software.

*Requirement: MUSM Medical School Students:

Please contact: Columbus: Emily McMackin, PhD, Macon: Gretchen Bentz, PhD, or Savannah: Raghavan Chinnadurai for IRB application submission process.

Steps to access IRB application:

  1. Please see the instruction manual for creating a profile in InfoEd - Creating an IRB profile.(PDF)
  2. Once the SPIN profile is created it will be necessary to access the electronic IRB application through infoed.mercer.edu. SPIN will not provide access to the InfoEd IRB application.
  3. An email will be sent with username and a request to reset password will be sent. DO NOT RESET PASSWORD
  4. Log into infoed.mercer.edu by using the username and the reset password received for access to the IRB application. Do not log into SPIN for access to the IRB application.
  5. Reset passwords will be sent Monday thru Friday from 8:30am until 5:00PM.

You are now ready to use the Consolidated IRB application and submit for IRB review.

Information:

Please make sure to add the department head and college dean to the application for the document to follow the correct route for IRB review.

If not, the application will not move forward for IRB review.

Please add these individuals under the personnel section of the application and the dropbox for the roles should be selected.

The route for personnel review:

Faculty Investigator>>>Chair>>>Dean>>>Office of Research Compliance

Student Investigator>>>Faculty Advisor>>>Chair>>>Dean>>> Office of Research Compliance

Please – save the application  if you plan to enter data and leave to return at a later time to complete the application.

For last step: Click first - Click here to validate mandatory fields  and then Click 2nd - save.

If you are unable to submit the application a dock will pop up indicating what should be corrected.

Clicking an item on the dock will take you back to the section of the application needing attention.

Upload documents:

The upload popup occurs when the user selects their file and provides a file name. 

To do a multiple upload, the user will need to click the “Add” button on the eForm for that table.  That will give them a new row, and they’ll add a Description, and click on the up arrow icon to upload that document:

Re-Enter to Complete a new Application or a new Modification/Amendment

  1. Log into the site by using your username and password.
  2. Please click on the tab that reads: Show a list of All my records to complete an IRB application or modification/amendment left incomplete or to make changes.
  3. Then click on the record number.
  4. Please unclick the check mark next to the[Click here to validate mandatory fields] area to add or change data within the application or modification/amendment.
  5. Once the IRB application is complete please click first - Click here to validate mandatory fields  and then click 2nd - save to route the application forward for review.

IRB Forms

IRB Affiliated Faculty Minimal Risk Application

IRB Mercer Student and Resident Minimal Risk Application

IRB Non-Affiliated Faculty Minimal Risk Application

IRB Non-Mercer Student Minimal Risk Application

IRB Mercer Clinical Trial Application

IRB Exempt Study Application

Amendments and Modifications

IRB Affiliated Faculty Minimal Risk Modification Application

IRB Mercer Student and Resident Minimal Risk Modification Application

IRB Non-Affiliated Faculty Minimal Risk Modification Application

IRB Non-Mercer Student Minimal Risk Modification Application

IRB Clinical Trial Modification Application

Continuing Review Applications

IRB Affiliated Faculty Minimal Risk Continuing Review Application

IRB Mercer Student and Resident Minimal Risk Continuing Review Application

IRB Non-Affiliated Faculty Minimal Risk Continuing Review Application

IRB Non-Mercer Student Minimal Risk Continuing Review Application

IRB Clinical Trial Continuing Review Application

Informational Items

Please submit informational items for IRB review using a Clinical Trial Modification Application.

IRB FDA 1572

IRB Statement for Payments to Human Subject Participants

HIPAA Authorization Waiver

Request for Waiver or Alteration of HIPAA Authorization (Microsoft Word)

Permissions and Requests

IRB Research Request for Use of Student Records (Microsoft Word)

IRB School Research Request (Microsoft Word)

Event Reports

IRB Adverse Event Behavioral Form

IRB On-Site Adverse Event Report Form

IRB Protocol Deviation/Violation Form

SAE Report Log

Study Closure

Please close the study once the work is completed.

Log into InfoEd and choose Final/Closure Report to close the study.

If your study involved one or more online surveys created through SurveyMonkey or Qualtrics services, please remember to email ORC_Online_Survey@Mercer.edu and request the closure of any surveys associated with your application.

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