Exempt Certification Form (Revised 07/06/06):
Federal regulations specify six categories of human subjects research that are exempt from continuing review by the IRB. Exempt research is reviewed by the IRB Chair, a designated IRB member, or another specified designee. Investigators must complete an Exemption Certification Form and submit it to the IRB for review. There are no submission deadlines for studies that qualify for exemption. These are processed and reviewed as received. For more information about the Exempt review, visit our Exempt Categories Help Page.

Expedited and Full Application (Revised 07/06/06):
Expedited and Full Committee Review research is submitted for approval on the same application.  Expedited is described as less than minimal risk and is eligible for review in several appropriate categories outlined by the Federal Code of Regulations.  These are contained within the application.  A template for writing the Informed Consent document and or requesting a waiver to informed consent is separate from the application but on the website.

Continuing Review (Revised 1/4/08)
By federal guidelines, the IRB is required to conduct substantive review of all Expedited and Full Committee Review protocols at intervals not less than once a year. The Principal Investigator will receive notification of the need for Continuing Review approximately 6-8 weeks prior to the date of expiration of approval. The Continuing Review must be submitted and approved prior to the date of expiration. Studies for which the Principal Investigator does not submit the needed Continuing Review prior to expiration of approval will be terminated by the IRB. A new protocol will need to be submitted and approved for any studies which are terminated.

Amendment Request
The amendment request form is used whenever the Principal Investigator makes any change to an already approved protocol. This form must be submitted prior to instituting the change. These changes may include a change in a survey tool, the addition or deletion of a research site, a change in personnel, a change in methodology, or a change in the Principal Investigator. The amendment request is processed in a manner similar to the review category of the original protocol. The Principal Investigator is notified in writing of the decision of the IRB.

Adverse Event / Unanticipated Problem
The adverse event / unanticipated problem reporting form is used whenever there is an unexpected occurrence that involves a research participant. This form is also used for deviations from an approved research protocol. The adverse event / unanticipated problem reporting form is completed and signed by the Principal Investigator and submitted to the Institutional Review Board (IRB). The IRB reviews the form and assigns a member of the IRB to review the event and contacts the Principal Investigator for any needed clarification. The IRB member then presents an oral report at the next convened committee meeting at which time a decision is made by the IRB as to any needed actions. The Principal Investigator is notified in writing of the Committee's decision.

Final Summary Report
Upon completion of a project, the Final Summary Report - Permanent Closure of Research Study must be completed and submitted to the IRB Administrator as soon as possible.

Health Sciences South Carolina (HSSC) IRB Request for Cooperative Review, CU Version (Revised 02/23/08): After initial approval by one HSSC institution, this document should be submitted (with all protocol materials) to the IRB(s) at the collaborating HSSC institution(s) for determination of whether the review will be accepted by the(se) IRB(s).

Health Sciences South Carolina (HSSC) IRB Request for Cooperative Review of Continuing Reviews, Amendments / Revisions and Reportable Events, CU Version (Revised 02/23/08): After approval of any continuing reviews, amendments, revisions, or reportable events by one HSSC institution, this document should be submitted (with all approved materials) to the IRB(s) at the collaborating HSSC institution(s) for determination of whether the review will be accepted by the(se) IRB(s).

Initial Reviewer Form (Revised 11/14/07)

Reviewer Form for Research Involving Children (Revised 09/11/06)

Reviewer Form for Research Involving Cognitively Impaired Participants (Revised 03/09/07)

Reviewer Form for Research Involving Prisoners (Revised 09/11/06)

Reviewer Form for Amendment Request (Revised 09/11/06)

Reviewer Form for Continuing Review (Revised 09/11/06)