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.
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– to be used with normal-healthy adult participants age 19 years (State of Nebraska) or older.
Biomedical Adult 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 with Parent Notification Form– 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.
Broad Informed Consent– to be used in lieu of informed consent only with respect to the storage, maintenance, and secondary research use of private information and identifiable biospecimens.
Web, Email and/or Cover Letter Based Informed Consent- to be used when consent will be sent to participants via email or letter and not completed in-person or via written signature.
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.
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.
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.