IRB: Forms and Templates

The file contains instructions and several consent form templates for different types of exemption-eligible research compliant with the current federal regulations and NC State University standards. Download the file to be able to edit the applicable template for your protocol. NOTE: Due to the 2023 Parents Bill of Rights law, the parental opt-out form is not allowed if research will be conducted in a K-12 public school in North Carolina.

Exemption Consent Templates

The exemption consent templates are for minimal-risk research eligible for exemption.

Non-Exempt Consent Template

The informed consent non-exempt template is used for all mid-level (e.g., expedited) and convened 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.

Each file contains instructions and one or more templates to be used with all NC State University IRB-approved research with minors. The parental permission and minor assent templates are appropriate for obtaining parental permission and assent remotely and in person. Download the file to be able to edit the relevant template(s) for your protocol.

Parental Permission Template

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. NOTE: Opt-out forms are not allowable for K-12 research in North Carolina public schools under the 2023 Parents Bill of Rights law.

The minor assent templates file includes three templates for ages 7-10 years old, 11-13 years old, and 14-17 years old.

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 University. However, the use of this identifiable/re-identifiable data where broad consent was obtained may undergo administrative review resulting in exemption whereas, without broad consent, the use of the identifiable/re-identifiable data would require mid-level (expedited) review and approval.
• There are two broad consent templates in the document linked below: 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.
• Download the file to be able to edit the appropriate template for your protocol.

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.” NOTE: Waivers of parental permission are not allowable for K-12 research in North Carolina public schools under the 2023 Parents Bill of Rights law.

Translations of study documents are required for expedited and convened 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. 

Some organizations that release FERPA data to researchers require a “data use agreement.” In that agreement, the organization releasing the records will either require a certain level of IRB review/approval or the researcher to handle the data at a certain data protection classification. The researcher must articulate these classifications and requirements in the IRB application. Two major organizations that release educational data subject to FERPA are NCDPI and NCERDC. Each of these organizations has special requirements that researchers should be prepared to address in the IRB application.

NCDPI Data

NCDPI requires all data they release to researchers, be treated as data that NC State University would classify as “red” data.  Even if NC State’s IRB would not require this level of data security based on the dataset itself, we must comply with NCDPI’s terms. So, any IRB submission using data from NCDPI, must have an accompanying  NC State IRB data access and security plan where the data are treated as “red” data. The IRB review/approval level will depend on the funding, data categories and elements, and other procedures in the study. 

NCERDC Data

NCERDC data requires IRB review and approval at the expedited level (mid-level review/approval) before data is released. Even if NC State’s IRB would not require this level of review based on the dataset itself, we must comply with NCERDC terms. So, the NC State IRB will review any study using NCDERC data at a minimum review level of expedited. When submitting for IRB approval, you will need to state that NCERDC requires expedited review (at minimum), request a “waiver of consent,” justify that seeking consent for the use of this data is impractical, and submit an NC State IRB data access and security plan where the data are treated as “red” data. That plan should comply with NCERDC expectations around data security.

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. The signed letter does not need to be uploaded to the IRB application unless the NC State University IRB asks the researcher to do this.

This letter template should be signed and submitted to the IRB with a protocol application when an NC State University researcher wants to access HIPAA-covered data from one of the University’s HIPAA-covered entities regardless of whether participant consent is sought or not. This letter template is rarely used.

This form is used by researchers 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 participant’s authorization to access their HIPAA-covered data for research purposes. This is very rarely used and rarely approved by NC State’s IRB.

A data use agreement (DUA), which may also be called a data sharing agreement, data transfer and use agreement, or another similar title, is a legally binding agreement between a data provider and a data recipient that requires a signature or other acknowledgment to facilitate the transfer of data between the parties. Please refer to the Research Administration and Compliance “Data Use Agreements” guidance. 

For all studies that access or collect highly or ultra-sensitive data or for other reasons determined by the IRB, a Data Access and Security Plan is required. This plan is made in conjunction with the researchers, their local IT, the IRB, and NC State’s “Security and Compliance.” To request a Data Access and Security plan for an IRB protocol, please submit the request via the “Service Now Portal” and a representative from NC State’s “Security and Compliance” will contact you to get started.

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 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 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 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. PIs do not need to upload this spreadsheet to the IRB application.

This form is used by NC State Biomedical Engineering (BME) researchers and uploaded as part of their protocol submission to the IRB office. This form is used in conjunction with the IRB application and replaces some of the information in the application. 

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 unit standard 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 unit standard 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 supported by the Department of Defense (DoD). This form can be completed by someone unaffiliated with the proposed study who 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 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 a 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 University COI office. 

This form serves as the mechanism through which NC State University 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 University 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. You can find more information regarding Individual Investigator training requirements on the Cooperative Research page.

Please do not complete this form without reviewing the NC State University IRB’s NC State University researchers’ use of a private IRB unit standard and ensuring that your project meets the eligibility criteria to use a private IRB.

NIH prioritizes the responsible management and sharing of scientific data derived from human participants. All studies approved by the NC State University IRB on or after January 25, 2023, that are supported by the NIH must undergo annual renewal of the protocol’s approval. As part of the renewal process, the PI should complete and submit a renewal request supplement form for NIH-supported studies with the IRB application’s renewal request.

When all study procedures are completed and no data are being analyzed for the study, the researcher should close the study with the IRB office. This entails completing the study closure request form and submitting it through the eIRB system.