IRB: Forms and Templates

This document contains instructions and two consent form templates compliant with the current federal regulations for use with adults.

• These documents contain instructions and a template form compliant with the current federal regulations and NC State Standards. 
• The “Exemption Consent Template” is for minimal risk research eligible for exemption. 
• The “Informed Consent Non-Exempt Template” is used for all mid-level (e.g., Expedited) and Full Board studies. With modification, this template can be used to create “opt-out forms” for research information sheets when the study qualifies for  a waiver of consent.

These documents contain instructions, a parental permission form, and three minor assent templates (for ages 7-10, 11-13, and 14-17 years old) to be used with all NC State IRB-approved research with minors.

• The parental permission and minor assent templates are appropriate for obtaining parental permission and assent remotely and in person.
• The “Parental Permission Template can be modified to create “opt-out forms” for research information sheets when the study qualifies for  a waiver of consent.

Broad consent allows the researcher to keep a participant’s re-identifiable or identifiable information or biospecimens for future unspecified research if the participant (or parent/guardian and child, if researching minors) agrees.

• Unspecified research is where the participant is not informed of the nature of the research or the purpose of the research.
• Broad consent can never be required of participants and carries some additional researcher responsibilities.
• If a researcher sought Broad Consent from participants in an IRB-approved study, the researcher must track which participants did and did not say yes to Broad Consent. 
• When the researcher wants to use the identifiable/re-identifiable data for which Broad Consent was sought and obtained, they are required to apply for IRB approval through NC State. However, the use of this identifiable/re-identifiable data where Broad Consent was obtained may undergo Administrative review resulting in Exemption, where without Broad Consent, the use of the identifiable/re-identifiable data would require mid-level (Expedited) review and approval.
• There are two templates: one for adult participants and one for parents/guardians of a minor participant. The minor assent form templates have stock language discussing broad consent for minors aged 11 and up that a research team can use if appropriate, but it must be used in conjunction with seeking parent/guardian permission for broad consent.

A waiver of consent or parental permission may be requested from the IRB Office. This request is made through the IRB application. Waivers of consent are granted on rare occasions. If a researcher wants to use an “Opt Out” form for their study instead of an “Informed Consent” form, then the research must qualify for a “Waiver of Consent.”

Translations of study documents are required for Expedited and Full Board studies. Translations of study documents are not required for studies that are determined to be Exempt. Study-related information that is given to a subject or a subject’s legally authorized representative must be in a language understandable to the subject or representative. This translation verification form must be submitted with the IRB application before approval. 

This template is used when researchers want to access academic and course records, including the researcher’s own course records, for research purposes where consent/assent/parental permission will be prospectively obtained but where the researcher needs permission to do the research from a gatekeeper at that site.

This 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/parental permission was not or will not be obtained and a waiver of consent is sought.

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.

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 individual’s HIPAA 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.

This 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.

This form is used for Expedited and Full Board studies that collect highly or ultra-sensitive data, complex studies, or for other reasons determined by the IRB. This form can also be used for studies that wish to establish a small-scale research data repository for future research projects. This form should be completed with your departmental IT representative or by submitting a request to NC State’s Help Desk. This form will help you plan out your research design around data management and security. 

This form is submitted to the NC State IRB Office with your IRB protocol or amendment application for “in-person research” during the time of COVID-19. The researcher should edit the form to match their study design and submit it with their application.

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.

This form serves as an application to create a small-scale repository of human subjects’ data or biospecimens at NC State University. The form is to be completed and submitted with a data management and security 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 can be used when the researcher is implementing the research method of photovoice. This template is to be edited by the researcher and implemented with the participant completing photovoice activities. It details expectations regarding ethical issues and compliance when completing photovoice. Though optional, the IRB suggests its use when employing photovoice. 

This is a template that researchers can use to facilitate discussion and commitment from research team members regarding ethical practices and issues of compliance. Most researchers use this with student researchers. This is a good template to facilitate discussion once the IRB protocol has been reviewed with each research team member.

This is both a template and guidance. It is meant to serve as a guide for new researchers regarding how to set up their Qualtrics survey 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.

This template is a tracking spreadsheet that can be used to keep track of research team members, their affiliation and agreement statuses, and their training completion information. Though it is not required to use, it can aid PIs in tracking the life of a research team and communicating research team-member roles and training to the IRB.

This form is completed by an expert in the local context for international research. This form is to be submitted immediately prior to the IRB application’s final review and approval. It should not be completed 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. 

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. This email template can be used by researchers when requesting assistance from a local reviewer.

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. This review is completed by the expert immediately prior to the IRB 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. 

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. This email template can be used by researchers when requesting assistance from a participant context reviewer. 

This template is used for studies that are supported by the Department of Defense (DoD). This form can be completed by someone unaffiliated with the proposed 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. If the researcher prefers, a letter may be submitted to the IRB instead of this form, but the content should be similar in nature. The IRB cannot approve the study without this review. The IRB office does not facilitate the scientific merit review.

This is a template that researchers can use to submit with their IRB application regarding any conflicts of interest. This is usually used with cooperative research and on some occasions may be requested by the IRB. This template provides structure for principal investigators detailing their conflicts of interest. If there is a conflict of interest, this should also be addressed with the NC State COI Office. 

This form serves as the mechanism through which NC State 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 page. 

This form is used as 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 principal investigators and in conjunction with their IRB, as it provides necessary information about the collaborating PI and where the research is taking place. Please find more information regarding the reliance agreement process on the Cooperative Research page. 

This 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. Please find more information regarding Individual Investigator training requirements on the Cooperative Research page.

This form is used by NC State Biomedical Engineering (BME) researchers to submit IRB protocols. This form is used in conjunction with the IRB application and replaces some of the information in the application.