Informed consent is an adult participant’s agreement to be in a research study or for their identifiable private data to be used for research purposes.

To prepare your consent form(s) for initial IRB review, follow these steps:

1. Download the correct template: Choose the template that best fits the specific type of study you want to conduct.
2. Customize the text: Edit the template in Microsoft Word so it accurately describes your study’s specific details, procedures, and contacts. Use simple language that is easy for an average person to understand. Check the readability of the consent form and remove all template instructions, prompts, comments, and red text. Proofread the form for spelling and grammar.
3. Upload a clean file: Submit your finished form to the IRB as a clean, editable Word document. Avoid uploading PDFs or locked files as the IRB needs to be able to review the document and track suggested changes directly in the text.

Informed consent is an adult participant’s agreement to be in a research study or for their identifiable private data to be used for research purposes.

To prepare your consent form(s) for initial IRB review, follow these steps:

1. Download the correct template: Choose the template that best fits the specific type of study you want to conduct.
2. Customize the text: Edit the template in Microsoft Word so it accurately describes your study’s specific details, procedures, and contacts. Use simple language that is easy for an average person to understand. Include pictures if participants will be wearing or using a device. Check the readability of the consent form and remove all template instructions, prompts, comments, and red text. Proofread the form for spelling and grammar.
3. Upload a clean file: Submit your finished form to the IRB as a clean, editable Word document. Avoid uploading PDFs or locked files as the IRB needs to be able to review the document and track suggested changes directly in the text.

Parent permission is a parent or legal guardian’s formal agreement allowing their child to participate in a research study. It acts as the legal equivalent of informed consent since minors cannot legally consent for themselves.

Even when parent permission is obtained, the NC State University IRB requires minor assent for children aged 7 and older unless there is a scientific justification or participant protection reason for not doing so.

To prepare your permission form(s) for IRB review, follow these steps:

1. Download the correct template: Choose the template that best fits the specific type of study you want to conduct.
2. Customize the text: Edit the template in Microsoft Word so it accurately describes your study’s specific details, procedures, and contacts. Use simple language that is easy for an average person to understand. Check the readability of the permission form and remove all instructions, red text, comments and prompts. Proofread the form for spelling and grammar.
3. Upload a clean file: Submit your finished form to the IRB as a clean, editable Word document. Avoid uploading PDFs or locked files as the IRB needs to be able to review the document and track suggested changes directly in the text.

Parent permission is a parent or legal guardian’s formal agreement allowing their child to participate in a research study. It acts as the legal equivalent of informed consent since minors cannot legally consent for themselves.

Even when parent permission is obtained, the NC State University IRB requires minor assent for children aged 7 and older unless there is a scientific justification or participant protection reason for not doing so.

To prepare your permission form(s) for IRB review, follow these steps:

1. Download the correct template: Choose the template that best fits the specific type of study you want to conduct.
2. Customize the text: Edit the template in Microsoft Word so it accurately describes your study’s specific details, procedures, and contacts. Use simple language that is easy for an average person to understand. Include pictures if participants will be wearing or using a device. Check the readability of the permission form and remove all instructions, red text, comments and prompts. Proofread the form for spelling and grammar.
3. Upload a clean file: Submit your finished form to the IRB as a clean, editable Word document. Avoid uploading PDFs or locked files as the IRB needs to be able to review the document and track suggested changes directly in the text.

Minor assent is when a child agrees to take part in a research study. Because children are not old enough to give legal “consent,” they give assent instead. This happens after the parent or guardian gives permission for the minor to be in the study and the study is explained to the child so they understand what will happen and decide whether they want to join the study.

Minor assent is separate from parent permission. A parent’s “yes” cannot override a child’s “no.” Researchers cannot force a child to participate if they refuse or show reluctance.

Researchers must tailor the assent form to the youngest reading level within a target age bracket so all can easily read and understand it. Studies spanning a wide age range (e.g., ages 8–16) require multiple assent forms to match the different developmental stages of the participants.

To prepare your minor assent forms for IRB review, follow these steps:

1. Download the correct templates: Select the assent template(s) that match the targeted age range of minor participants.
2. Customize the text: Edit the template(s) in Microsoft Word to accurately describes your study’s specific details, procedures, and contacts. Use simple, age-appropriate language. Remove all template instructions, red text, and prompts. Proofread for spelling, grammar, and readability.
3. Upload a clean file: Submit your finished form to the IRB as a clean, editable Word document. Avoid uploading PDFs or locked files as the IRB needs to be able to review the document and track suggested changes directly in the text.

Broad Consent allows participants (or their guardians) to let researchers store their identifiable data and biospecimens for future use. A participant/guardian cannot be required to give Broad Consent.

There are additional responsibilities for researchers if Broad Consent is sought and given.

• Researchers must track who gave Broad Consent and who did not.
• Researchers must remove a participant’s data if the participant or guardian changes their mind about Broad Consent – even if it’s years later.
• Researchers must apply for IRB approval before reusing the Broad Consent secondary data. While the data reuse will still require IRB approval, Broad Consent allows the new study to usually qualify for a faster IRB review leading to an exemption determination even if the research study that initially collected the data underwent a more stringent IRB review level.

When data is put into an AI tool, the AI company may store and use the data to train future models. Because this is an “unspecified future use” by a third party, a research team must have Broad Consent before putting participant data into an AI system. Even if a research team has Broad Consent, putting human data into AI tools creates major compliance challenges across several legal frameworks:

• 45 CFR 46 (Final Rule): Requires researchers to strictly track and safeguard participant data. Once participant data enters an external AI tool, researchers often lose the ability to control, track, or protect it.
• Children’s Online Privacy Protection Act (COPPA): Protects the online privacy of children under 13. Researchers cannot input a minor’s identifiable data into a third-party AI tool without explicit, verifiable, and prior parental permission.
• General Data Protection Regulation (GDPR) & Personal Information Protection Law (PIPL): These privacy laws grant individuals the “right to be forgotten” (the right to have their data deleted). Use of AI can conflict with these laws if it is nearly impossible to extract and delete a specific person’s data from an AI model once data has been inputted.
• EU Artificial Intelligence Act (EU AI Act): Mandates strict data governance and transparency processes, especially for AI tools that are deemed “high risk.” Scraping and feeding personal data into an AI tool without explicit, transparent participant consent is not permitted. The EU Act also prohibits AI use in specific ways that are legal and common in the United States.

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. Upload drafted forms to the IRB application’s supporting documentation section.

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. An executed DUA must be uploaded to the IRB application if one is needed for a research protocol.

For all studies that access or collect highly or ultra-sensitive data, require a NIH data sharing plan (NIH DMSP), data use agreement (DUA), material transfer agreement (MTA), or for other reasons determined by the IRB, a data and access security plan (DASP) is required. This plan is made in conjunction with the researchers, their local IT, the IRB, and NC State’s OIT Security and Compliance department (OIT S&C). To request a DASP for a human subjects research protocol, please submit the request via the “Service Now Portal” and a representative from NC State’s OIT S&C 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 and is in the process of being updated (planned release of updated form is Spring 2026). If you have questions about a possible repository, please contact irb-director@ncsu.edu for more information.

If research participants will use a commercially available but modified (either by members of the research team or non-research team individuals) or a purpose-built application or software only because of the research study, complete the information sheet located in Appendix D of the Applications and Software in Human Subjects Research guidance. Upload the information sheet to the supporting documentation section of your IRB application. This applies to all studies, including those eligible for exemption. This information sheet does not replace other applicable processes, such as code review, OIT ITPC review, or a data and access security plan (DASP).

If research participants will be asked to download or use any applications and/or software to their personal device (e.g., smart phone, laptop) for research purposes, draft an applications and software informed consent addendum using the template in Appendix C of the Applications and Software in Human Subjects Research guidance. Upload the consent addendum to the supporting documentation section of your IRB application. This applies to all studies, including those eligible for exemption. This informed consent addendum does not replace other applicable processes, such as code review, OIT ITPC review, or a data and access security plan (DASP).

The AI participant information sheet template for adults is designed to be a short reference for participants about how AI functions in the study, what data the AI has access to, what the AI does with participant data, and data protection measures. It is a supplement to, not a replacement for, informed consent processes and forms. Upload your edited participant information sheet for adults to the IRB application for review for all levels of studies, including exemptions.

The AI participant information sheet template for families with children is designed to be a short reference for guardians about how AI functions in the study, what data the AI has access to, what the AI does with that data, and the study’s data protection measures. It is a supplement to, not a replacement for, parent permission processes and forms. Upload your edited participant information sheet for families with children to the IRB application for review for all levels of studies, including exemptions.

The AI supplemental form is to be used for any study that will use modified or purpose-built artificial intelligence (AI) or generative artificial intelligence (GAI) with research participants or with their data. Upload the completed form to the eIRB application’s supporting documentation section for IRB review. The form may be requested by the IRB office for protocols that use AI or GAI that are commercially available and unmodified prior to use, but that is determined on a case-by-case basis.

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. A properly completed and uploaded participant procedures document for each participant pool in the study will allow BME researchers to skip answering selected IRB application questions because the information will be captured in the participant procedures document.

The code review instructions and form are for protocols that propose to use commercially available modified or purpose-built/homegrown software or applications in human subjects research. The code review must be completed by a subject matter expert who is not a member of the research team or otherwise has a conflict of interest and the review itself is required for studies reviewed at any level (including exemption) that propose research with a modified, purpose-built, or homegrown software or application. Upload the completed form to the supporting documentation section of the IRB application.

This form 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. Upload the completed form to the supporting documentation section of the application for the IRB to review.

This form is to be completed when a researcher will use a commercially available, modified, or purpose-built medical device or a combination of medical devices to test for safety and/or efficacy. This form must be submitted with the IRB application for each medical device used in the study.

This form is part of cooperative research processes at NC State University where an individual investigator agreement is sought, the individual investigator(s) does/do not have access to the CITI training platform, and the individual investigator(s) needs human subjects research training for the agreement to be executed. The alternative individual investigator training cannot be accepted for any research that is funded, more than minimal risk, a clinical trial, testing the safety/efficacy of a test article, involves invasive research procedures, or other context-dependent scenarios.

The completed and fully signed training form should be submitted to the NC State IRB office together with the IRB application materials. The signed 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 details on the Cooperative Research page.

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. The signed agreement does not need to be uploaded to IRB review.

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 principal investigators in tracking the life of a research team and communicating research team-member roles and training to the IRB. The spreadsheet should not be uploaded to the IRB application.

Please note: The spreadsheet lists a number of trainings – most are not required by the NC State IRB office. The spreadsheet must be edited by you to reflect the trainings that team members are required to take by the University and any project funders/sponsors/sites for the project that you are proposing for IRB review.

If any member of the research team will be using their personal (i.e., not managed by NC State) device to collect, store, or analyze research data, have them complete a device use attestation which can be found in Appendix B of the Applications and Software in Human Subjects Research guidance. The attestation does not need to be provided to the IRB unless the study requires a data and access security plan (DASP), an executed data use agreement (DUA), and material transfer agreement (MTA), and/or the IRB office or NCSU OIT has requested it be uploaded to your IRB 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 theNC 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 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 multi-site research protocol. This form is to be completed by the collaborating principal investigators and in conjunction with their IRB (i.e, the relying 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 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. 

Please do not complete this form without reviewing the NC State University IRB unit standard on researchers’ use of a private IRB and ensuring that the biomedical research 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 and submitting the study closure request, study closure form, and all protocol materials together through the online IRB application system.