HRPP/IRB Forms and Templates
The list of forms are divided into two categories:
- IRB Forms - to aid researchers in filling out the necessary forms required for IRB applications submitted on iRIS and managing the lifecycle of their research studies.
- 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||This is a copy of the entire application for your reference. Please note that applications are filled out and submitted through the online system iRIS.|
|Standard Operating Procedures||This a copy of the BYU IRB's standard operating procedures and policies.|
|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||This form is the same as the standard consent form but with additional requirements for consent forms longer than 3 pages.|
|Implied Consent Statement||This form is for studies conducted entirely or in part via electronic methods. For these studies 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||This form is for focus group consent. 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||This script template is for verbal consent. 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 should be 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||This is form is for parental permission. Parents or legally authorized representatives (LAR) are required to provide permission for minors to participate in research studies in most cases by signing a permission form.|
|Parental Permission with Key Information||This form is for permission from parents or legally authorized representatives (LAR) when the form is longer than 3 pages.|
|Child Assent Ages 7-14||This form is for child assent. 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||This form is for youth assent. Youth assent forms will include information similar to the adult consent form.|
Media Release Forms
|Adult Media Release Form||This form is for studies collecting data through audio/video/photos. This form can be incorporated into the standard consent and permission forms|
|Minor Media Release Form||This form is for 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, report a problem/adverse event, renew an existing active study, or to close a research study go to 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.|
Memo of Understanding Templates
|BYU IRB MOU||This form is required when the PI for a study is not a tenure-track faculty member. Use this form for studies in which the BYU IRB is the IRB of record.|
|MOU for Another Institution's IRB||This form is required when the PI for a study is not a tenure-track faculty member. Use this form when the IRB review for a study is being completed by another institution's IRB.|
|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||This template is a formal contract between entities to describe data that will be shared and the terms and conditions to share the data. It is for data owned by BYU.|
|Scientific Review Checklist||This form is for the scientific review (SRC) process which is overseen by the college/department leadership and is 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. More information about this process can be found here. Please reach out to your Associate Dean of Research to contact the SRC Representative.|