HRPP/IRB Forms and Templates

The list of forms are divided into two categories:

IRB Forms - to aid investigators 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 investigators 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.

IRB Forms

Submissions in iRIS

The following forms are PDF copies for your reference only. Smart forms are in iRIS and will logic according to your responses

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.
Modification Request Form	This is a copy of the modification request form for your reference. Please note that modification requests are filled out and submitted through the online system iRIS.
Continuing Review Form	This is a copy of the continuing review form for your reference. Please note that these requests are filled out and submitted through the online system iRIS.
Adverse Event Form	This is a copy of the adverse event form for your reference. Please note that this form is filled out and submitted through the online system iRIS.
IRB Closure Form	This is a copy of the IRB closure form for your reference. Please note that this form is 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.

Consent Forms

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.
GDPR Informed Consent Addendum	GDPR: For studies collecting personal data of people located in the European Economic (EEA), Europe.

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.

Sample Forms

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.

HRPP Forms

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 Agreements

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.

Other

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.