HRPP/IRB Forms and Templates
The list of forms are divided into two categories, IRB forms to manage the lifecycle of the research study, and HRPP forms, to aid researchers with collaborative research arrangements, single IRB requirements, Data Use (DUA)/Data Transfer (DTA) agreements and guidance with FDA regulated studies that are reviewed by the University of Utah IRB.
The forms contain instructions, guidance and examples to help you to create a compliant document.
Submissions in iRIS
|IRB Application||You can see the copy of the entire application for your reference, however, submissions are made through the online system iRIS.|
|Standard Consent Form||This form contains all required elements of consent for subjects 18+ years old, complete with a signature line|
|Standard Consent Form with Key Information||Same as the standard consent form but with additional requirements for consent forms longer than 3 pages.|
|Implied Consent Statement||For studies conducted entirely or in part via electronic methods, you may choose to include the consent information in the recruitment email or at the beginning of the online survey. Subjects will consent to the research by clicking "Agree" or "Continue" (or similar) if they wish to participate.|
|Focus Group Consent Form||Confidentiality in a focus group cannot be guaranteed. However, the researcher must be clear about what methods s/he will use to protect privacy and data security.|
|Verbal Consent Script||
Verbal consent means that the researcher delivers a verbal version of a consent form and subjects give their verbal consent in place of written consent to participate. Subjects should be given the opportunity to ask questions and provided with a copy of the information sheet.
The IRB will ask to see a consent script to evaluate the consent process.
Researchers must document in their research file when the consent discussion took place and if there were any issues.
Parental Permission/Assent Forms
|Parental Permission||Parents or legally authorized representatives are required to provide permission for minors to participate in research studies in most cases.|
|Parental Permission with Key Information||Permission from Parents or Legally Authorized Representative (LAR) if the form is longer than 3 pages.|
|Child Assent Ages 7-14||Child must be mature enough to understand what they are asked to do in a research study and actively show his/her willingness to participate. Mere failure to object should not be construed as assent.|
|Youth Assent Ages 15-17||Youth assent forms will include information similar to the adult consent form.|
Media Release Forms
|Adult Media Release Form||For studies collecting data through audio/video/photos, please use this form. This form can be incorporated into the standard consent and permission forms|
|Minor Media Release Form||Data collection from minors 7 to 17 years using audio/video/photos.|
Modifications, Renewals, Adverse Event Reports, Closure Forms
|To submit modifications to an approved study, reporting a problems/adverse event, renew an existing active study, or to close a research study are all found in iRIS.|
|Recruiting Ad Sample||Refer to this sample form for tips to create recruiting materials.|
|Research Site Approval Sample||This form provides draft language of when a researcher seeks permission to recruit research subjects at a site (schools, clinics, agency, etc.) or to conduct the research on site.|
|Reliance Agreement: BYU Defers to another IRB||Use this template for BYU IRB to defer another IRB to perform the review of non- exempt research.|
|Data Share Agreement: BYU Owns Data||A formal contract between entities to describe data that will be shared and the terms and conditions to share the data. This template is for data owned by BYU.|
|Scientific Review Checklist||Scientific review (SRC) is overseen by the college/department leadership, separate from the IRB. Under certain conditions, human research applications must be peer reviewed after the study is entered in iRIS but BEFORE it is submitted to the IRB. (provide link to scientific review page). Please contact your associate dean of research to contact the SRC representative.|