IRB Forms

Submissions through InfoEd

• Provisional Application Information & Submission through InfoEd

  The Provisional Application is a temporary conditional approval that the IRB Office issues for funded projects processed through a CU grants office. Per institutional policy, expenditure/project accounts will not be established prior to the appropriate compliance review and clearance. 

  The temporary determination only allows the grant office to set up the funding account. This determination DOES NOT allow:

  • • any interaction or data collection with study participants , including recruiting of participants
    • access to identifiable data or biospecimens.

  The PI will have to submit a separate new Initial Application before any research activities with study participants may begin.

  The Provisional Application may be granted for the following situations:

  • • A CU-PI receives a notice of award from the sponsor and the sponsor is requesting an IRB letter and there is not an existing IRB record on file to cover the research activities proposed in the grant proposal.
    • A CU-PI is involved with a funded multi-institutional project and another institution’s IRB Office is the designated IRB of record for the study, but the IRB review is not finalized, and the CU-PI needs to set up a funding account from the subaward to pay for administrative expenses.
    • A CU-PI receives an award or subaward and needs additional time to develop the IRB protocol and data collection instruments but needs to set up a funding account to pay for administrative expenses.

  To submit the Provisional Application, follow the steps below:

  1. Log into InfoEd, and select “IRB” on the left navigation menu.
  2. The IRB eForms page will display, create a new “Provisional Application.”
  3. Enter the requested information and submit the request.
  4. Do not enter the names of other study team members on the Provisional Application, just the PI’s name and do not upload any training documents at this time.
  5. Select the InfoEd proposal record number assigned by the grants office for the records to be linked in InfoEd.

  If you have issues logging into InfoEd or with the IRB application, send an e-mail to the IRB Office or join one of the office hours sessions.

• Initial Applications Information & Submission through InfoEd

  Initial applications must be submitted through the online submission system, InfoEd. Refer to the InfoEd tutorials and quick guides for assistance with submitting your application.
  

  There are no submission deadlines for Exempt and Expedited level review applications. Submissions are processed as received. We recommend submitting your application at least 30-45 days before your anticipated start date. Exempt and Expedited applications are generally processed between 2-4 weeks.

  Submission timelines for Full Board review applications are available here: IRB Meeting Schedule (PDF). A consultation with the IRB Manager is required before submitting your Full Board application. Please send a meeting request to IRB@clemson.edu to schedule the consultation.

  What IRB supplemental documents are required for review?

  Some of the documents required are listed below but does not include an inclusive list. Please follow the instructions provided on the InfoEd applications.

  • Information that will be used for recruiting participants (advertising messages).
  • Data collection tools/instruments.
  • Informed consent documents (use IRB template).
  • Site support letters, if applicable.

  Need help with your application or have general questions, join one of the CU-IRB office hours session.

• Secondary Analysis Studies & Submission through InfoEd

  Requests for secondary analysis studies must be submitted through the online submission system, InfoEd. Refer to the InfoEd tutorials and quick guides for assistance with submitting your application.

  Requests for Data Use Agreements (DUA) or Material Transfer Agreements (MTA) must be submitted to the Office of Sponsored Programs (OSP).

  The OSP review may be conducted in parallel to the IRB Office’s review. The IRB Office review does not have to be completed for a PI to initiate the agreement request to OSP.

  The IRB Office will review the final draft of the agreement before finalizing the IRB review. OSP will contact the IRB Office when they have the final draft available for review.

  If you have issues logging into InfoEd or with the IRB application, send an e-mail to the IRB Office or join one of the office hours sessions.

• Multi-Institutional/Cooperative Research Projects - Selection within InfoEd

  Cooperative research are projects that involve investigators from multiple institutions. If Clemson researchers (employees or students) are “engaged” in a multiple institutional research project involving human subjects that project must be registered with the CU-IRB Office.

  An institution is “engaged in research” if it (or its employees, staff, or agents) has a key role in designing the research, conducting the research, analyzing and interpreting the results, or gaining informed consent from human subjects; may include some recruiting procedures. (Reference: 2022 SACHRP Recommendations: New Interpretation of the “Engaged in Research” Standard)​

  If the cooperative research was approved by another institution, Clemson researchers must register the study in InfoEd by submitting an Initial Application and selecting the study type “Multi-Institutional Study.”

  Additional related resources:

  • Refer to the section IRB Authorization Agreements (Reliance Agreement) for information on when a reliance agreement is required for the cooperative research.
  • September 26, 2024 presentation titled “CU-IRB Review Process for Cooperative Research Projects​ (Multi-Institutional Research)”
  • InfoEd tutorials and quick guides for assistance with submitting your application.

  If you have issues logging into InfoEd or with the IRB application, send an e-mail to the CU-IRB Office or join one of the office hour sessions.

• IRB Authorization Agreements (Reliance Agreement) Information & Submission through InfoEd

  Reliance Agreements are used by IRB offices for research projects that involve more than one institution. This process, known as the single IRB (sIRB) process, allows institutions to rely on one IRB’s review for the project to avoid duplication of effort.

  Clemson’s IRB Office (CU-IRB Office) is willing to enter into a Reliance Agreement with other institutions for studies reviewed at the Expedited or Full Board levels only.

  The IRB Office does not enter into Reliance Agreements for Exempt level studies. Exempt level studies must be reviewed at the local institution for each non-Clemson affiliated personnel.

  Requests to initiate a Reliance Agreement for the CU-IRB Office to rely on another IRB’s review must be submitted through the online submission system, InfoEd. Refer to the InfoEd tutorials and quick guides for assistance with submitting your application.

  After the CU-IRB Office receives the InfoEd application, IRB staff will contact the reviewing IRB to begin the sIRB process. 

  If you have issues logging into InfoEd or with the IRB application, send an e-mail to the IRB Office or join one of the office hours sessions.

• Amendment Requests

  Amendment requests must be submitted through InfoEd. Follow the step-by-step guide to submit the amendment.

  Please visit the IRB FAQ for information on when an amendment is required.

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