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 provided in the documents below; all applications, however, that propose to research with human subjects during COVID-19 should review the Research in the time of COVID-19 guidance and upload a completed COVID-19 additional procedures packet to their application using the template document. Consent, parental permission, and minor assent templates along with the broad consent addendum can be found on the For Researchers portal.

Please note that all research protocols, including exemptions, must submit proofs of all required human subjects research training for all NC State University members of the research team and any individual investigators to be reviewed. Please read the NC State University Training Requirements for Completing Research with Human Subjects document to learn what training will be required for your protocol and the CITI Set-Up Tutorial to register for the CITI training at no charge using your NC State credentials. Without access to CITI training, individual investigators will need to follow the training and documentation process outlined for individual investigators.

Researchers should use the COVID-19 Additional Procedures Packet  Template when submitting research during the COVID-19 pandemic.  You will need to edit the file to reflect your particular research proposal and processes before uploading the file as a clean, edited Word document to your IRB application’s supporting documentation section. There should be no IRB instructions, prompt verbiage, or red text in the document you submit to the IRB. All in-person research must follow the COVID-19 guidance issued by the NC State IRB office found in the Research in the Time of COVID-19 guidance.

The data access and security plan form is used for Expedited studies that collect sensitive or complex data such as whole genome/exome sequencing or personal trauma histories, all Full Board studies regardless of the sensitivity of the data, and for studies that wish to establish a research data repository for future research projects. 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 on the For Researchers portal’s data management section.

The scientific merit review form is only used for studies that are supported by the Department of Defense (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 in the NC State IRB DoD-affiliated research policy statement.

The ethics agreement form 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.

The gatekeeper access to site template is used when researchers want to access academic and course records, including the researcher’s own course records, for research purposes where the consent/assent of the participants (and, if appropriate, parental permission) has been/will be obtained but where you need permission to do the research from a gatekeeper at that site. Please find out more information regarding researcher FERPA requirements in the NC State IRB FERPA policy statement.

The department head or supervisor records access template is used when researchers want to access academic and course records, including the researcher’s own course records, for research purposes where the consent/assent of the participants (and, where appropriate, parental permission) was/will not be obtained. Please find out more information regarding researcher FERPA requirements in the NC State IRB FERPA policy statement.

The internal PI requesting access to NC State University held HIPAA records 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 in the NC State IRB HIPAA policy statement.

The participant authorization and revocation 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 the researcher’s HIPAA obligations in the NC State IRB HIPPA policy statement.

The request to waive participant authorization from the IRB form must be submitted with the IRB application for approval for any NC State researcher who wants to waive a 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 in the NC State IRB HIPPA policy statement.

The individual investigator training completion and affirmation form is a required part of the reliance agreement process for collaborative research endeavors at NC State University where an individual investigator agreement is sought and the individual investigator(s) do not have access to the CITI training platform. The completed and fully signed form should be submitted to the NC State IRB office through upload as a supporting document to the IRB application that will be reviewed with all other application materials during the normal IRB review process. The form will be accepted at the NC State IRB’s discretion based on the content of the completed form.  For more information about the individual investigator training, please consult the Cooperative Research subsection of the For Researchers portal

When reviewing research in international settings, the IRB may require a local context review to be done by an expert who is not a member of the research team and who doesn’t otherwise have a conflict of interest, whether that conflict is financial, relational, or structural. The local context review form is completed by the expert immediately prior to your eIRB application’s final review and approval; it should not be done with the initial drafts of the application. While the IRB office will indicate when a local context review is necessary and appropriate to do, the researcher, not the IRB office, is responsible for facilitating the local context review per the NC State IRB Policy Statement on Local Context and Participant Context Reviews. The researcher must upload the completed, signed, and locked local context review form to their IRB application’s supporting documentation section of their eIRB application for the NC State IRB office to review. Use the local context review form in conjunction with the local context review directions and email templates file and the NC State IRB Policy Statement on Local Context and Participant Context Reviews.

When reviewing research in international settings, the IRB may require a local context review to be done by an expert who is not a member of the research team and who doesn’t otherwise have a conflict of interest, whether that conflict is financial, relational, or structural. The local context review directions and email templates are used immediately prior to your eIRB application’s final review and approval; they should not be used with the initial drafts of the application. While the IRB office will indicate when a local context review is necessary and appropriate to do, the researcher, not the IRB office, is responsible for facilitating the local context review per the NC State IRB Policy Statement on Local Context and Participant Context Reviews. Use the local context review directions and email templates file with the local context review form and the NC State IRB Policy Statement on Local Context and Participant Context Reviews.

When reviewing research involving people considered contextually vulnerable, the IRB may require a participant context review to be done by an expert who is not a member of the research team and who doesn’t otherwise have a conflict of interest, whether that conflict is financial, relational, or structural. The participant context review form is completed by the expert immediately prior to your eIRB application’s final review and approval; it should not be done with the initial drafts of the application. While the IRB office will indicate when a participant context review is necessary and appropriate to do, the researcher, not the IRB office, is responsible for facilitating the participant context review per the NC State IRB Policy Statement on Local Context and Participant Context Reviews. The researcher must upload the completed, signed, and locked participant context review form to their IRB application’s supporting documentation section of their eIRB application for the NC State IRB office to review. Use the participant context review form in conjunction with the participant context review directions and email templates file and the NC State IRB Policy Statement on Local Context and Participant Context Reviews.

When reviewing research involving people considered contextually vulnerable, the IRB may require a participant context review to be done by an expert who is not a member of the research team and who doesn’t otherwise have a conflict of interest, whether that conflict is financial, relational, or structural. The participant context review directions and email templates are used immediately prior to your eIRB application’s final review and approval; they should not be used with the initial drafts of the application. While the IRB office will indicate when a participant context review is necessary and appropriate to do, the researcher, not the IRB office, is responsible for facilitating the participant context review per the NC State IRB Policy Statement on Local Context and Participant Context Reviews. Use the participant context review directions and email templates with the participant context review form and the NC State IRB Policy Statement on Local Context and Participant Context Reviews.

The PRP letter of intent 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 PRP program that was offered only during the 2020-2021 academic year. Please find out more information regarding the priority review process on the NC State IRB PRP program page.

The conflicts of interest (COI) attestation 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 by the Conflicts of Interest department at NC State University.

The reliance agreement request 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 on the cooperative research section of the For Researchers portal.

The site context 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 in conjunction with their IRB. Please find more information regarding the reliance agreement process on the cooperative research section of the For Researchers portal.

The application for a repository at NC State 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.

The medical devices 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 on the For Researchers portal.

The optional MTurk HIT template can be used to create your MTurk HIT for all levels of reviewed research.  Make sure that you edit the template to customize it to your research procedures and upload a clean, edited copy to your supporting documentation section of your IRB application.

The confirmation and reminder email templates are optional and can be used when a researcher wishes to confirm a scheduled interview date and time or remind a participant of a scheduled interview. With editing, these templates can be adapted for use with other virtual or in-person research activities where scheduling and reminding of participants would occur, such as lab visits and focus groups. If using the template, be sure to upload a clean, edited copy to your supporting documents.

The member checking email template is optional and can be used when a qualitative researcher wishes to engage their participants in member checking. If using the template, be sure to upload a clean, edited copy to your supporting documents and account for member checking in both your consent form and application’s discussion of procedures that participants will experience. If using the template, be sure to upload a clean, edited copy to your supporting documents.

The photovoice participant ethics agreement 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 its use when employing photovoice. Please find guidance regarding photovoice in the NC State IRB guidance on things to consider when conducting photovoice research.

The optional Qualtrics scheduling template is optional and can be implemented after consent is obtained on Qualtrics to begin the scheduling process with participants for interviews.  With editing, the template can be adapted for use with other virtual or in-person research activities where scheduling participants would occur, such as a focus group or lab visit. If using the template, be sure to upload a clean, edited copy to your supporting documents.

This optional Qualtrics set-up template is meant to serve as a guide for new researchers in how to set up their Qualtrics to include one or more of the following: screening, consent, broad consent, COVID-19 addendum and advance screening, research instrument, scheduling or in-person or virtual procedures, debriefing, and compensation information.

Researchers complete and upload the verification of translation 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 the form in the translation verification guidance.

The typical timeline for IRB review and approval of a complete and consistent protocol is:

  • 2 to 3 weeks for an exemption determination
  • 4 to 6 weeks for a study to be reviewed and approved via mid-level review also called “Expedited Review”
  • 4 to 6 weeks for studies requiring Full Board review and approval

Turnaround time for study review and approval is directly related to the following:

  • The quality of initial submission including consistency within the application and among supplemental documents. Most applications submitted are not complete.
  • The complexity of study design and vulnerability of participants, which may require that your study is subject to:
    • A local or participant context review
    • A code review for research with homegrown mobile applications
    • A scientific merit review (for Department of Defense (DoD) affiliated studies)
    • Additional regulatory requirements (HRPO review for DoD studies, Tribal IRB review for research targeting indigenous and First Nations people, Food and Drug Administration requirements for research with devices and/or drugs, GDPR law if including participants from the EEA, HIPAA or FERPA should your study be subject to those laws, etc.)
  • The workload volume of the IRB office and members of the Full Board, which fluctuates throughout the year, but is heaviest during the Fall and Spring semesters
  • The ability of the researcher to appropriately address IRB requested changes or clarifications in a timely manner

Studies that go through the IRB process smoothly and in accordance with the above-listed timeframes are studies where:

  • The researchers have undergone human subjects research training that is required by the NC State University IRB and their funder(s), the training is complete and valid,  and all training proofs are uploaded to the IRB application labeled with the protocol number, the last name of the person whose certificate of training it is, and a description of the training.
  • The researchers utilized the educational resources on the IRB website, including the instructions on completing the IRB application, guidance on various research methods, and guidance on researcher obligations that affect IRB review processes.
  • The researchers ensure that all appropriate documentation has been uploaded and accounted for, including the use of NC State IRB templates and forms.
  • The researchers had someone proofread the IRB application for clarity, jargon, and consistency prior to submission.

If a rushed review of a research protocol is needed because of unanticipated problems, please complete and submit the Rush Request Form. The IRB Director will determine within several business days whether or not your rush request will be granted. The rush request form should only be completed for faculty/staff protocols; students must submit normally and plan far in advance of when they want to start their research project.