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Submitting Institutional Review Board Applications

It is the responsibility of the researcher to be familiar with the IRB Charter and to submit applications for review as indicated. The application process is determined by the level of IRB review indicated. Levels of review include exempt, expedited, and full review (see Appendix B). Application to the IRB must be made prior to soliciting subject participation or data collection.

Informed consent is an essential part of ethical human subjects research. The requirement to obtain the informed consent of individuals before involving them in research is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. “Respect for persons” requires that individuals are treated as autonomous agents, the rights and welfare of persons with diminished autonomy are appropriately protected, and potential research participants are given the opportunity to choose what shall or shall not happen to them.

Informed consent is an ongoing process. Even in the absence of new information or changes to research procedures, periodic review or confirmation of a participant’s consent is often desirable, e.g., in studies that take place over a long period of time, particularly complex studies, or longitudinal studies involving progressive disorders or aging populations. Participants must be in a position to freely decide whether to withdraw or to continue participating in the research.

All applications must contain a copy of the informed consent document intended to be used. The IRB will provide informed consent guidelines (see Appendix B). Institutional Review Boards and investigators are responsible for ensuring that research subjects provide informed consent prior to participating in research, unless the requirement for informed consent is waived or altered by the IRB.

Questions and forms can be directed to IRB@spcc.edu.


Safeguards for Minors Involved in Studies

All minors involved in a study will be required to submit a parental informed consent form before they can participate in a study. In the event of an online study, any student who is a minor will be required to have a hard copy parental informed consent form filled out and returned before they are given access to the study website. Each minor should be given an individual code to allow them access to the website, in order to prevent other minors from participating without proper consent.


The IRB will review each application based on a developed rubric. The SPCC IRB will determine that all required elements have been met requirements have been met:

Decisions Available

Exempt Review:

  1. Approval: The activity may start as soon as approval for exempt status is received if all other relevant SPCC requirements have been met.
  2. Approval Pending with Required Modifications: Approval of a protocol will be granted by the IRB representative after the addition or removal of contingencies identified by the IRB Chair.
  3. Referral to Full Board: The IRB Chair may elect to send the protocol to the full board for review.

Expedited Research:

  1. Approval: The activity may start as soon as approval is received if all other relevant SPCC requirements have been met.
  2. Approval Pending with Required Modifications: Approval of a protocol will be granted by the IRB representative after the addition or removal of contingencies identified by the IRB Chair.
  3. Deferred: The protocol requires extensive modifications and must be re-submitted to the IRB reviewer for reconsideration.
  4. Referral to Full Board: There are sufficient questions that the IRB chair believes it necessary to refer the application for full IRB review.

Full IRB Review:

  1. Approval: The activity may start as soon as approval is received if all other relevant SPCC requirements have been met.
  2. Approval Pending with Required Modifications: Approval of a protocol will be granted by the IRB Chair after addition or removal of contingencies that are identified by the IRB during its convened meeting. Return to the full Board is not required.
  3. Deferred: The protocol requires extensive modifications and must be re-submitted to the IRB for reconsideration after modifications are made.
  4. Denied: The activity may not be conducted as proposed. The researcher will be provided with written documentation of the reasons for the IRB’s decision. A new application may be submitted for consideration after being revised to address the reasons for denial.