Templates or Forms should be used when there is a standard set of materials or information that needs to be conveyed to your research participant(s) and, if applicable, those who are authorized to provide consent on their behalf. Templates provided by the UNL Human Research Protection Program (HRPP) can be useful tools when developing your IRB application materials. Templates with information applicable to consent, recruitment, confidentiality, etc. are available.
Note: Our templates have been updated to reflect 2018 new regulatory requirements per the changes to the Common Rule (45 CFR 46). The templates will look different and convey information in a slightly different manner than previous templates. For the most part, the information is still very similar to what was provided previously. However, these changes have been made in order to help us meet the new requirements, promote a consent process through conversation with the participant and also be in alignment with peer institutions as we anticipate further collaboration.
While not required, this information sheet should be used in order to assist in communicating with potential in-person human research participants.
Assent Form– to be used when a minor or decisionally-impaired adult participates in research, does not provide consent on their own accord, or a waiver of parental/legal guardian consent was approved by the IRB.
Social-Behavioral Adult Participant Informed Consent (Updated 05/03/2020)– to be used with normal-healthy adult participants age 19 years (State of Nebraska) or older.
Biomedical Adult Participant Informed Consent (Updated 05/03/2020)– to be used with normal-healthy adult participants age 19 years (State of Nebraska) or older.
UNL Student Informed Consent (Updated 05/03/2020)– to be used with normal healthy UNL students – restrictions apply to the use of this form specific to the corresponding project.
Parent-Legal Guardian Informed Consent with Parent Notification Form (Updated 05/03/2020)– to be used when the target population does not have the legal authority to consent for themselves including minors or decisionally-impaired adults.
The end of the document also includes a Parent Notification Form. This is to be used in combination with the informed consent in educational settings when the project has been approved by the site including the use of notification only AND the project is not subject to the Protection of Pupil Rights Amendment.
Web, Email and/or Cover Letter Based Informed Consent (Updated 05/03/2020)- to be used when consent will be sent to participants via email or letter and not completed in-person or via written signature.
Certificate of Confidentiality Template Language – to be used when a project has been issued a Certificate of Confidentiality by the National Institutes of Health or any other Federal agency. A certificate can be issued either as part of the projects award terms or through a separate CoC application process. To learn more about CoCs please visit our Guidance Topics (A-Z) page.
Genetic Information Nondiscrimination Act (GINA) Template Language – to be used for non-exempt genetic research involving human subjects conducted or supported by Health and Human Services (HHS). GINA defines a genetic test as an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes. To learn more about GINA, please visit the Office of Human Research Protection’s (OHRP’s) webpage. For more information on this topic, please visit our Guidance Topics (A-Z) page.
ICH-GCP Consent Form Template Language – In addition to required elements of informed consent described in UNL HRPP policy #9.001 Required Elements of Informed Consent, the following language must be included in a consent form if the project is subject to UNL IRB policy #3.019 International Conference on Harmonization – Good Clinical Practice (ICH-GCP) E6R2 Compliance.
ClinicalTrials.gov (CT.gov) Template Language – to be used in all projects requiring CT.gov registration. To learn more about CT.gov registration requirements please visit our Guidance Topics (A-Z) page.
EU GDPR Consent Form Template Language – to be used when a project includes the collection, storage or processing of personal data involving a country in the European Economic Area (EEA). To learn more about the European Union General Data Protection Regulation (EU GDPR) please visit our Guidance Topics (A-Z) page.
Mandatory Reporting Consent & Assent Form Template Language – to be used when a project involves children and mandatory reporting may be an appropriate consideration, as well as disclosure of when and why investigators may need to break confidentiality. Template language is available for in-state, out-of-state, adult, and parent/guardian consents, as well as assent forms.
Risk of Harm to Self or Others Consent Form Template Language – to be used when a project involves procedures and/or questions that may result in an investigator having information within the study data from a participant regarding harm to self or others.
Participants who have limited English proficiency may be enrolled in your research provided that you have the resources to communicate effectively during the recruitment process, while obtaining consent, and for the duration of the study. The short form consent is typically used when the potential participant does not speak English and there is not enough time to translate the English version of the approved consent document into a language the potential participant understands.
Use of the short form process and forms below MUST be approved prior to implementation through submission of the Short Form Request Form. Please review HRPP policy #9.008 titled Use of the Short Form Consent Document to learn about the process of approval.
Private Health Information (PHI) Authorization Template
PHI Authorization Form– to be used when the research project will require the research participant to provide permission to access private or protected health information from a covered entity and you do not readily have access to the covered entity’s own PHI Authorization form. Minimal information is required to be added since most of the language found in this form should not be revised. The template provides language that meets the standard requirements regulated by the Health Insurance Portability and Accountability Act.
Advertisements / Fliers
While researchers are not required to use the templates for advertisements or fliers, the UNL IRB offers the following examples for use:
These templates are to be used when contacting participants for recruitment, reminders or follow-up notifications whether via phone, email or letter.
Investigator Checklist for IRB Protocol Submission
PI Checklist for IRB Protocol Submission – to be used by investigators when filling out IRB protocols to assist with ensuring that important details are addressed, requirements are met, and appropriate supporting documents are created and uploaded before submitting to the IRB for review. Note: There is no requirement to use or attach this document when submitting an IRB protocol, it is simply an available resource.
ICH-GCP Documents for Policy Compliance
The following documents and links to external websites will assist the UNL Principal Investigator to submit the necessary materials for new project form submission when a project is subject to International Council for Hamonization – Good Clinical Practice (ICH-GCP) guidelines.
NUgrant New Project Form Instructions and Template – Investigators should be sure to review this document for additional information and clear instructions regarding if information should be provided within the the appropriate NIH Clinical Trial Protocol document or NUgrant New Project Form (and how to respond within the form).
NIH BSSR Protocol Word Template – This research protocol template could be used for Behavioral and Social Science Research (BSSR) Involving Humans
NIH IND/IDE Protocol Word Template – This research protocol template could be used for Biomedical Research involving humans
Report New Information, Unanticipated Problems, Non-compliance, Serious Adverse Events, etc.
The Reportable New Information Form (RNIF) can be found via NUgrant. For situations that arise in an active and approved project that must be reported to the IRB, please login to your specific project in NUgrant and click on “add a new form;” the RNIF is available as a form to be selected for completion. Incidents that require reporting must be reported within 48 hours of awareness. A detailed listing of what is required for reporting on the RNIF is also described in NUgrant where you select the form. If you have questions about the RNIF or a situation that may need to be reported, please do not hesitate to call or email your IRB Coordinator.
Protocol Deviation Tracking Log
Protocol Deviation Tracking Log – investigators should use this template to record all protocol deviations (administrative, minor and major) that occur. This tracking log should track a comprehensive list of all protocol deviations that occur during an approved/active project. This form should be submitted when reporting minor or administrative protocol deviations in a non-exempt project at the time of continuing review or annual update.
Serious Adverse Event (SAE)/Adverse Event (AE) Tracking Logs
Serious Adverse Event (SAE)/Adverse Event (AE) Tracking Logs – PIs, project personnel, and staff should use these templates to record all serious adverse events and/or adverse events that occur. One or both of the tracking logs can be utilized for an entire study, or for individual participant records.
Transcriptionist Confidentiality Agreement Form
Transcriptionist Confidentiality Agreement Form – to be used for projects where the person performing the transcription for a research study is not a member of the project personnel and not part of a company/entity that transcribes research as a commercial service. To learn more about when a transcription confidentiality agreement is needed, please reference section III.B.1 of the Office of Human Research Protection’s (OHRP’s) guidance.
Translation Certification Guidance and Form – to be used when any documents related to an IRB approval or determination must be translated from either English to a particular language or vice versa.