Templates/Forms

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.  Please use the following documents specific to your project:

Assent Template

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.

Assent Form example used for minors age 7-12 years

Consent Templates

Participant Informed Consent  – to be used with normal-healthy adult participants age 19 years (State of Nebraska) or older

UNL Student Informed Consent – 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 – to be used when the target population does not have the legal authority to consent for themselves including minors or decisionally-impaired adults.

Parent-Legal Guardian Notification – to be used in educational settings, 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.

Exempt Research Guidance and Templates

Exempt Research Guidance (and Templates) – to be used when conducting research that qualifies for an Exempt category of review.  This document describes the categories of review, provides guidance on processes and procedures that provide maximum flexibility and efficiency when conducting exempt research while complying with UNL policies and procedures.  This document contains recruitment and consent templates that can be used for development of an IRB application and after approval.

Report New Information, Unanticipated Problems, Non-compliance, Serious Adverse Events, etc.

Incident Report Form – to be used when situations arise in an active and approved project that must be reported to the IRB.  Incidents that require reporting must be reported within 48 hours of awareness and should be submitted to your IRB Coordinator.

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.  Language found in this form should not be revised as this is the standard requirements regulated by the Health Insurance Portability and Accountability Act.

Translation Certification

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.