IRB: Forms and Templates
Due to the multiple regulatory requirements and applicable laws related to research with human subjects, the NC State University IRB office has compiled forms and templates to assist researchers in communicating their projects to the IRB office and to ease their efforts in designing communications with participants. Below are NC State University-provided templates and forms.
Informed consent, minor assent, and parental permission are required under the federal regulations governing research with human subjects unless a waiver of consent/parental permission is requested and granted. The requirements for informed consent are detailed in 45 CFR 46.116. Because these requirements are complex, the NC State IRB office has created editable templates for researchers to use. The templates provide instructions and fill-in-the-blank language that meet the regulatory requirements. You can view each consent template file, but in order to edit the file, you must download the file first. The informed consent process should be designed with your participants in mind and written at a 4th- to 6th-grade level.
Adult Consent 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.
Parental Permission and Minor Assent Templates
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.
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 Templates
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.
Requesting a Waiver of Consent or Parental Permission
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.”
Verification of Translation Form
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.
Communication with Participants
The NC State IRB has some optional templates that researchers can use when designing their study. These are templates for communicating with participants about activities occurring in the study. Researchers can take these templates, edit them to match their study procedures, and then submit the clean and edited documents to the IRB with their study application.
- Optional Interview/Focus Group/Lab Visit Scheduling
- Optional Interview/Focus Group/Lab Visit Confirmation and Reminder Emails
- Optional Member Checking Email
- MTurk HIT
- Confirmation and Reminder Emails
- Scheduling Activities through Qualtrics
For studies that involve accessing FERPA records for research purposes, there are some required letters that need to be submitted with the IRB application. This is because studies that involve FERPA records are beholden to the FERPA law and the regulations governing research with human subjects. Based on how, when, and who is accessing the records, studies involving FERPA data are reviewed at different levels. Please see the NC State IRB Unit Standard for FERPA for more information.
FERPA Records Access Letter
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.
For studies that involve accessing HIPAA records for research purposes, there are some required forms and letters that need to be submitted with the IRB application. This is because studies that involve HIPAA records are beholden to the HIPAA law and the regulations governing research with human subjects. Based on how, when, and who is accessing the records, studies involving HIPAA data are reviewed at different levels. Please see the NC State IRB Unit Standard for HIPAA for more information.
Internal PI Access Request for NC State-Held HIPAA Record
This form is submitted to the IRB when an NC State University researcher wants to access HIPAA-covered data from one of the University’s HIPAA-covered entities. This letter template is used very rarely. The completed letter is submitted with an IRB application.
HIPAA Participant Authorization and Revocation Form
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.
Request for a Waiver of Participant HIPAA Authorization 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.
Data Agreements and Plans
Data Use Agreements
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.
Data Access and Security Plan
This form is used for all studies that collect highly or ultra-sensitive data 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.
Application for Small-Scale Repository
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 firstname.lastname@example.org for more information.
Research Methods and Modes of Data Collection
In many cases, for different reasons, researchers must submit forms related to their modes of data collection or that provide additional information not captured in the IRB application. This includes information such as data management and security plans, details about devices used in research, additional procedures due to COVID-19, or ethical attestation forms for participants or research team members to complete.
Medical Devices Used in Research Form
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.
Ethics Agreement for Participants Implementing Photovoice
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.
Research Team Ethics Agreement
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.
Research Member Tracking
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.
Forms and Templates for Facilitating Additional Reviews and Secondary Processes
Some studies require additional reviews. Some of these reviews must happen before IRB approval is granted, and some of the reviews occur once IRB approval has been granted. These secondary reviews are related to the specific target population(s), study design, applicable laws, and sponsors.
Local Context Review Form and Template
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.
Participant Context Review Form and Template
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.
Scientific Merit Review Template
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 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.
Conflict of Interest (COI) Attestation Template
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 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.
Reliance Agreement Request Form
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.
Site Context for Reliance Agreements Form
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.
Individual Investigator Completion/Attestation Form
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.
BME Procedures Template
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.