Documentation to Submit with Your IRB Application

The below forms are submitted to the NC State IRB Office with your IRB protocol or amendment application. Most of the forms are required where relevant, while a few are optional forms to be used at the researcher’s discretion. More information and reference links to further information are linked below; all applications, however, that propose to do research with human subjects during COVID-19 should review the Research in the time of COVID-19 document and review the COVID-19 forms below. Consent, parental permission, and minor assent templates can be found on the For Researchers portal.

Researchers should use these forms when submitting research during the COVID-19 pandemic. These forms are also found in the appendix of the COVID-19 guidance. You must follow COVID-19 guidance issued by the NC State IRB office found here. This guidance is regularly updated so make sure you are using the most updated version of the guidance. The forms will likely not change but if they do change, the guidance will let you know.

This form is used for Expedited studies that collect sensitive or complex data and for all Full Board studies regardless of the sensitivity of the data. This form should be completed with your departmental IT person. This form will help you plan out your research design around data management and security. Please find additional guidance for data management and security here.

This form is only used for studies that are supported by the DoD. This form is to be completed by someone unaffiliated with the study that has expertise in the scientific method(s) employed by the study. The completed scientific merit review form must be submitted with the IRB application. The IRB cannot approve the study without this review. The IRB office does not facilitate the scientific merit review for you. Please find guidance regarding DoD research here.

This is an optional form that researchers can submit to the IRB, it is not required. It is used to facilitate discussion and commitment from research team members regarding ethical practices and issues of compliance. Most researchers use this with student researchers.

This form is used when researchers want to access academic records, including researcher’s own course records, for research purposes. This form is to be completed by the researcher’s supervisor or department head and it gives permission for the researcher to access any of their own academic records without participant consent. This form is usually used to access past course records. Please find out more information regarding researcher FERPA requirements here.

This is an optional letter that researchers can complete and have the IRB office sign. This is sometimes used by researchers when submitting funding applications. This is not a required for your IRB application. If a funding application is with NSF, they will expect an official .118 determination letter instead of this letter of intent. To find out more information regarding a .118 determination letter, please find guidance here.

This form is submitted to the IRB when an NC State researcher wants to access HIPAA covered data from one of NC State University’s HIPAA covered entities. This letter template is used very rarely. The completed letter is submitted with an IRB application. Please find guidance regarding researcher’s HIPAA obligations here.

This form is used by researchers who are requesting the use of HIPAA covered data from participants directly. This is a template that the PIs should use to both gain permission to use the records and provide participants an option to revoke permission for record use. The form is used in conjunction with the NC State IRB consent form or parental permission form. Please find guidance regarding researcher’s HIPAA obligations here.

This form must be submitted with the IRB application for approval. It is a request for an NC State researcher who wants to “waive” participants’ authorization to access their HIPAA covered data for research purposes. This is very rarely used and rarely approved by NC State’s IRB. Please find guidance regarding researcher’s HIPAA obligation here.

This form is to be completed when a researcher wants to test the safety and efficacy of a commercially available or homegrown medical device. This form must be submitted with the IRB application for each device being tested for safety and efficacy. Please find more information about the use of medical devices in research here.

This letter template is to be used by students when submitting to the IRB requesting priority review of their IRB protocol. This form is only used in conjunction with the “Priority Review Process” special program. Please find out more information regarding the priority review process here.

This letter is a required part of the reliance agreement process for collaborative research endeavors. This form can also be used to make any necessary COI attestations for individual protocols during the normal IRB review process. This letter either affirms no COI is present or it details issues of COI. The IRB may discuss this form with our colleagues managing the NC State COI process. This form DOES NOT replace any COI obligations detailed here.

This form is the mechanism through which researchers request a reliance agreement, individual investigator agreement, or IRB acceptance of exemption determination. This form is to be completed by the researcher and uploaded into the IRB application system for the NC State IRB review and processing. This form details the expectations and roles regarding the reliance agreement. Please find more information regarding the reliance agreement process here.

This form is a part of the reliance agreement request process. This form is to be submitted to the NC State IRB office when the NC State IRB is serving as the IRB of record (reviewing IRB) and another IRB will be relying on the NC State IRB review and approval of a protocol. This form is to be completed by the collaborating PIs and conjunction with their IRB. Please find more information regarding the reliance agreement process here.

This form serves as an application to create a repository of human subjects’ data or biospecimens at NC State University. The form is to be completed and submitted with a repository data/specimen access plan with the researcher’s IRB application. This form should only be used if the researcher is applying for a repository at NC State University. This form is rarely used. If you have questions about a possible repository, please contact irb-director@ncsu.edu for more information.

This form is used to describe the researcher’s management of the proposed repository regarding data or specimens. This form should be completed with the researcher’s departmental IT person or in conjunction with EHS requirements for biospecimens. Once completed, it must submitted with the IRB application for a repository. This form should only be used if the researcher is applying for a repository at NC State University. This form is rarely used. If you have questions about a possible repository, please contact irb-director@ncsu.edu for more information.

This form is optional and can be used when the researcher is implementing the research method of photovoice. This form is to be completed between the researcher and the participant. It details expectations regarding ethical issues and compliance when completing photovoice. Though optional, the IRB suggests it’s use when employing photovoice. Please find guidance regarding photovoice here.

Researchers complete and upload this form to their IRB application that they submit to the NC State IRB office when study materials must be written in a language other than English. Please also see the guidance regarding the use of this form here.