Human Subject Use Forms

• IRB Application Packet, MS Word
• Request for IRB Exemption (Administrative Review), MS Word
• Sample Informed Consent Form, MS Word
• Informed Consent Checklist, MS Word
• IRB Modification/Addendum Form, MS Word
• IRB Continuing Review Form, MS Word
• IRB Letter of Intent Form, MS Word (the Letter of Intent is described more fully below)
• Unanticipated Problem or Adverse Event Reporting Form, MS Word

Where do I send my application?

Application packets should be sent to Debra Paxton's attention preferably by e-mail to debra_paxton@ncsu.edu or by campus mail at Campus Box 7514.

Who should I contact with questions?

Direct your questions to Debra Paxton, IRB Administrator preferably by e-mail at debra_paxton@ncsu.edu or by phone at 515-4514.

How long does the review process take?

Depending on the type of review (NC State has adopted three types of review, Administrative, Expedited and Full-Board depending on risk to subjects, composition of subject population and other factors) the review and approval process can take between 1 and 6 weeks. Thorough preparation and planning on your part, as well as engagement of the IRB office early in the application process will ensure an efficient process.

Can I begin my study without IRB approval?

The short answer is NO! However, NC State will allow for the acceptance of a sponsored agreement and the establishment of an account number understanding th at this may be necessary to begin the initial development of a human subject protocol necessary to submit for review and approval by the IRB. Understand, under no uncertain terms is an investigator or members of the investigative team allowed to commenc e with human subject research, including recruitment or initial advertisement, without the express permission and authorization granted by the IRB.

How can I take Human Subject Ethics Training?

Collaborative Institutional Training Initiative (CITI) is a free, comprehensive ethics training program for researchers conducting research with human subjects.

Can I submit a proposal without IRB approval?

Yes, provided the sponsor allows it. The IRB office has adopted a process that allows for proposals involving human subject research that does not yet contain an approval from the IRB to be submitted under a Just In Time (JIT) process. This process involves the submission of a simple and very brief form called a Letter of Intent to be submitted to the College Research Office and forwarded to SPARCS when routing a proposal for approval. This process does not relieve the investigator from the responsibility to secure IRB approval prior to commencing any human subject re search, including recruiting of subjects or initial advertisement.