Protocol Templates and Forms
Table of Contents
IRB Forms
- OneAegis Submission Forms
- Consent Form Templates
- Parental Permission/Assent Form Templates
- Media Release Form Templates
Sample Recruiting/Site Approval Form Templates
HRPP Forms
- Memo of Understanding Templates
- Reliance Agreement
- Data Sharing Agreement
- External Investigator Form Template
- Individual Investigator Authorization
- Scientific Review Form Template
Protocol Templates & Forms
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 OneAegis 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 following forms are PDF copies for your reference only. Smart forms are in OneAegis and will logic according to your responses.
IRB Forms
OneAegis Submission Forms
The following forms are PDF copies for your reference only. Smart forms are in OneAegis and will logic according to your responses
| Viewable PDF | Description |
| This is a copy of the entire application for your reference. Please note that applications are filled out and submitted through the online system OneAegis. | |
| Modification Request Form | This form appears as an added section at the top of the standard application. Use it for all modification requests except changes to research personnel. Briefly describe the requested revisions in this section, then update all relevant parts of the application itself. Please provide complete and accurate information to help ensure a timely review and approval. |
| Personnel Modification Request Form | Use this form exclusively to add or remove research personnel. Please be sure that the individuals have completed CITI training before adding them to the study. |
| Continuing Review Form | Use this form to provide the required information for the ongoing oversight of an approved study. You must submit this form at least a month before the expiration date. |
| Adverse Event Form | Use this form to report any adverse events, unanticipated problems, or safety concerns that occur during the conduct of the study. Provide a clear description of the event, its impact on participants, and any actions taken in response. |
| IRB Closure Form | Use this form to formally close a study that has concluded all research activities, including data collection and participant follow-up. Provide a summary of study outcomes, confirm that no further participant involvement is required, and describe plans for data retention or destruction. |
Consent Form Templates
| Downloadable Microsoft Document | Viewable PDF | Description |
| Standard Consent Form | 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 | 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 | 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 | 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 | 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 Informed Consent Addendum | GDPR: For studies collecting personal data of people located in the European Economic (EEA), Europe. |
Parental Permission/Assent Form Templates
| Downloadable Microsoft Document | Viewable PDF | Description |
| Parental Permission | 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 | 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 | Child Assent Ages 7-14 | This form is for child assent. The 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 Ages 15-17 | This form is for youth assent. Youth assent forms will include information similar to the adult consent form. |
Media Release Form Templates
These templates are provided to assist investigators conducting research that involves audio recordings, video recordings, photographs, or other identifiable media collections. The forms are designed to help investigators clearly communicate how media will be collected, used, stored, shared, and protected during the study. Investigators should select the template that best aligns with their study population and incorporate the language into their consent, assent, or parental permission materials as appropriate.
| Downloadable Microsoft Document | Viewable PDF | Description |
| Adult Media Release Form | 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 | Minor Media Release Form | This form is for data collection from minors 7 to 17 years using audio/video/photo |
Sample Recruiting/Site Approval Form Templates
| Downloadable Microsoft Document | Viewable PDF | Descriptions |
| Recruiting Ad Sample | Recruiting Ad Sample | Refer to this sample form for tips to create recruiting materials. |
| Research Site Approval Sample | 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
| Downloadable Microsoft Document | Viewable PDF | Description |
| BYU IRB MOU | 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. |
Reliance Agreement
| Downloadable Microsoft Document | Viewable PDF | Description |
| Reliance Agreement: BYU Defers to another 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 Sharing Agreement
| Downloadable Microsoft Document | Viewable PDF | Description |
| Data Share Agreement: BYU Owns Data | 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. |
External Investigator Form Template
| Downloadable Microsoft Document | Viewable PDF | Description |
| External Investigator Form | External Investigator Form | This form is used when a researcher who is not affiliated with BYU will be engaged in BYU-approved human subjects research. This form documents the individual’s involvement, confirms that appropriate human subjects training has been completed, and clarifies institutional responsibilities for research oversight and compliance. |
Individual Investigator Authorization
| Downloadable Microsoft Document | Viewable PDF | Description |
| Individual Investigator Authorization | Individual Investigator Authorization | The Individual Investigator Form is used when an unaffiliated collaborator (someone not employed by or under the authority of BYU) will be engaged in BYU-approved human subjects research, and no institutional IRB relationship exists for that person. This form establishes a formal agreement between the individual and BYU’s IRB, extending BYU’s human research protection oversight to that investigator. |
Scientific Review Form Template
| Downloadable Microsoft Document | Viewable PDF | Description |
| Scientific Review Checklist | 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 OneAegis 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. |