Application Process 

CITI Training

Before beginning any project involving human subject’s research, all individuals on the research team (faculty, staff, and students) must complete a training certification program. UVU is contracted with CITI (Collaborative IRB Training Initiative) for customized training in the protection of human subjects in research. Your training will automatically be updated into the UVU IRB system after you have completed the program.

Register for CITI Training for Human Subjects Research at UVU

  1. Go to citiprogram.org
    Click the Register button in the top right corner.
  2. Type “Utah Valley University” in to the Select your organization affiliation section and then follow steps to register.
    You will create your own user name and password. This is not single sign-on so do NOT select “log in through my institution”.
  3. When you get to the Select Curriculum step (step 7) you will:
    1. Select either Faculty/Staff Researchers or Student Researchers under Human Subjects Research based on your current status at UVU.
    2. Select the Responsible Conduct of Research field most applicable to your line of research. For educational research this will typically be the Social and Behavior Responsible Conduct of Research Course.
    3. You are not required to take the CITI US Export Control Regulations Course or Conflicts of Interest course, although some individuals find the conflict of interest course beneficial.
  4. Click “complete registration”.
    Your CITI training course will now be available for you to begin. The course saves progress throughout so all modules do not need to be completed at one time.

Faculty/Staff Researchers Training Modules

There are seven required modules that all faculty/staff researchers will need to complete to earn this SBR IRB training certification. These seven modules should take approximately 2 to 3 hours to complete:

  • Belmont Report and CITA Course Introduction
  • History and Ethical Principles (SBR)
  • Defining Research with Human Subjects (SBR)
  • The Regulations and The Social and Behavioral Sciences (SBR)
  • Assessing Risk in Social and Behavioral Sciences (SBR)
  • Informed Consent (SBR)
  • Privacy and Confidentiality (SBR)

Researchers who do research with certain populations must also complete the applicable modules before submitting any related IRB protocols/packets. Faculty or staff members who work with students on research projects may also want to complete the Students in Research module (see Optional Modules) so they are familiar with the module their students will be required to complete. Optional modules include:

  • Research with Prisoners
  • Research with Children
  • Research in Public Elementary and Secondary Schools
  • International Research
  • Internet Research
  • Students in Research

TO BEGIN: access the CITI training program.

Student Researchers Training Modules

All students who will be doing human subjects research at UVU are required to complete the "Student Researcher" certification on the CITI website. It should take you approximately one hour to complete. This will provide you with important information for you to become a professional and ethical researcher. There are two required modules:

  • Belmont Report and CITI Course Introduction
  • Students in Research (SBR)

TO BEGIN: access the CITI training program.

Campus Administrators Training Modules

Campus Administrators are often researchers, or are in position where they must approve IRB packets submitted by their own faculty and staff. To ethically and thoroughly review these IRB submissions, administrators must understand ethical issues and challenges of human subjects' research and the applicable federal regulations. There are seven required modules that administrators will need to complete to earn this SBR IRB training certification. These seven modules should take approximately 2 to 3 hours to complete:

  • Belmont Report and CITA Course Introduction
  • History and Ethical Principles (SBR)
  • Defining Research with Human Subjects (SBR)
  • The Regulations and The Social and Behavioral Sciences (SBR)
  • Assessing Risk in Social and Behavioral Sciences (SBR)
  • Informed Consent (SBR)
  • Privacy and Confidentiality (SBR)

TO BEGIN: access the CITI training program.

IRB Members/Staff Training Modules

Faculty and staff serving on the UVU IRB must receive additional training to gain the depth and breadth needed to competently and professionally serve on the UVU IRB and review IRB submissions. In addition to the seven modules required of faculty/staff, IRB members must complete all 13 of the primary modules. IRB members may be reviewing IRB packets that deal with special populations or circumstances, it is imperative that they are knowledgeable about the IRB requirements of doing so. The complete training should take between 4-6 hours. The 13 modules include the following:

  • Belmont Report and CITA Course Introduction
  • History and Ethical Principles (SBR)
  • Defining Research with Human Subjects (SBR)
  • The Regulations and The Social and Behavioral Sciences (SBR)
  • Assessing Risk in Social and Behavioral Sciences (SBR)
  • Informed Consent (SBR)
  • Privacy and Confidentiality (SBR)
  • Research with Prisoners
  • Research with Children
  • Research in Public Elementary and Secondary Schools
  • International Research
  • Internet Research
  • The IRB Member Module

TO BEGIN: access the CITI training program.

Project Development

Planning and preparation are the key to a successful IRB application. If you have never submitted an application to the Utah Valley University Institutional Review Board before, this page will outline how to begin planning for your human subject’s research. It is the PI’s responsibility to oversee and ensure proper completion of information to the IRB including the original submission and all revisions requested during IRB review.

  1. Develop your Research Plan

    All researchers will need to have a clear project design before they are ready to submit their application to the IRB. A complete research plan includes:

    • Literature Review. Provide a review of the literature that explains how your project fits in to what is currently known about your field of research. This should include a description of the gaps in the current knowledge and how your project will address those gaps. Outline the objectives of your research and if appropriate for the study state the hypothesis being tested. Information should be written so that individuals outside of you area of expertise can understand the basis for your research.
    • Study Design. Provide a clear description of the methods you will use to test your hypothesis/study objectives. A complete study design explains all procedures/activities that the study subjects will be asked to participate in. These activities must be clearly detailed regarding how and when they will be performed, including how much time will be expected from the participants. All randomization and control methods must be included.
    • Study Participant Selection and Recruitment. Define how you will select your study participants, including any specific inclusion or exclusion criteria such as age, gender, or other factors pertinent to the study. Keep in mind that certain research populations require additional considerations and protections because they may be vulnerable to coercion and undue influence. These populations include: prisoners, minors (under 18), and individuals with impaired decision-making ability. Only include these populations in your research design if it is necessary to your research question. If applicable, describe methods used to recruit participants such as email solicitations or flyers. All recruitment material will need to be attached to your application for review.
    • Data Analysis. State the methods to be used for analysis and interpretation of the data, including any statistical analyses to be completed. These methods should complement the design of the study itself.

  2. Consider the Risks to Research Participants

    A key role of the IRB is to assess the risks of the research to the participants. In order to approve research the IRB must find that:

    1. Risks to subjects are minimized by using procedures consistent with sound research design and which do not expose subjects to unnecessary risks.
    2. Risks to the subject are reasonable in relation to the anticipated benefits of the study.
    3. Risks are clearly and accurately described to potential subjects.

    The PI is responsible for identifying and describing risk to participants in their IRB application. They will also have to inform the participants of these risks including reasonably foreseeable discomforts, inconveniences, or harms in the informed consent documents.

    When assessing the risks to participation in a study, the investigator should consider:

    • Medical risks. Some research presents risk of physical injury to subjects. Investigators should describe any reasonably foreseeable risks or discomforts from participation in the study protocols such as discomforts due to placement of medical devices, physical harm associated with the study itself, and possible side-effects or ineffectiveness of a drug or treatment.
    • Psychological risks. Some research has the potential to cause changes in the thoughts and emotions of study participants. Investigators should describe any reasonably foreseeable risks or discomforts such as emotional distress/discomfort, feelings of stress or guilt, psychological trauma from remembering past experiences, embarrassment,
    • Social/legal/economic risks. Some research involves handling of sensitive information which could result in injury to subjects through breach of confidentiality resulting in embarrassment within a subjects business or social group, loss of employment, or criminal prosecution. Most notably are studies that collect information about drug/alcohol use, mental illness, sexual behavior, and illegal activities. Investigators should clearly detail precautions to ensure that the research does not cause these risks as described below.
    • Confidentiality/Privacy. Describe any risk to the loss of confidentiality of information about the participant and their risk of loss of privacy. This includes a description of the procedures used to maintain the confidentiality of study records/data and how their privacy will be protected. In some cases confidentiality or privacy will not be able to be maintained, for example in focus groups or group therapy, this should be clear in the application and description to the participant.
    • Vulnerable populations. Special considerations should be given to risks associated with vulnerable populations. Consider that the study may involve other populations vulnerable to coercion and undue influence besides those listed in federal guidelines. Other such populations could include students, socially/economically disadvantaged persons, faculty and staff of the University, undocumented immigrants, refugees etc. Risks specific to these populations should be addressed.

  3. Describe the Benefits of the Research

    The PI should describe the potential benefits(s) that may be gained through this research. These benefits should be supported with sufficient evidence for the IRB to reach the same conclusion. The IRB will use this description to determine whether the risks of the research are reasonable in relation to the anticipated benefits. There are two main categories of benefits that may occur during a research study.

    • Direct benefits. These are expected benefits that the study participant gains from being part of the study itself. These can take the form of education, therapy, information, empowerment, and direct treatment such as a medical exam or experimental drug/clinical intervention.
    • Indirect benefits. This describes the importance of the research to society as a whole or to future individuals such as students in next year’s class or future patients with the same disease. This is especially important for the PI to describe if there are no direct benefits to the study participants.

    It is important to note that being compensated for research (e.g. money, gift card, extra credit in a course) is NOT considered a benefit for participating in the study.

Assemble the Application

Complete the Protocol Description Form found here. This form is required to be uploaded to your online application,

Collect all Research Tools/Documentation

In order to assess the risks for study participants the IRB must review all material that participants will be exposed to. After the research plan is designed, applicants should generate all study materials required for recruitment and completion of the study itself. These include items such as:

  • email text for recruitment emails
  • recruitment flyers
  • finalized survey or interview questions
  • links to videos participants will be asked to watch
  • descriptions of modules/tasks/education participants will be asked to complete
  • informed consent or assent documents

If you are completing your research at an outside institution not affiliated with Utah Valley University please obtain documentation from them stating that they give permission for you to complete a research study at their location. This documentation must be included as part of a complete application for IRB review.

Informed consent is a basic ethical obligation and legal requirement for researchers working with human subjects. It is required to ensure study participants understand the research before they volunteer. This includes knowing what they will be asked to do as part of the study and appreciating the risks involved in participation.

An informed consent document is required to provide study participants with the information they need to decide whether or not to volunteer for a research study. The Utah Valley University IRB is moving away from offering consent document templates in order to allow for more flexibility in providing participants directed information related to each study. Consent documents must contain all the basic elements outlined in the Department of Health & Human Services (HHS) regulations (45 CFR part 46), and for some studies HHS regulations require additional elements to be included.

Basic Elements of Informed Consent

The basic elements required to be in all consent documents include:

  1. A short, focused summary paragraph as an introduction to the consent document. This is a new requirement based on the 2018 revised Common Rule. A summary paragraph example, and a description of the other most relevant 2018 Common Rule changes, can be found here. The summary paragraph should include:
    1. A statement that the project is research and is voluntary.
    2. A summary of the research including purpose and duration
    3. A highlight of the risks and benefits of the study.
  2. A description of the procedures to be followed (what the participant will be asked to do) and the duration of the participants involvement.
  3. A description of any reasonably foreseeable risks or discomforts.
  4. A description of any benefits to the participant or to others.
  5. A description of how confidentiality of records will be maintained.
  6. Information on who to contact with questions about the research (PI contact information) or research participants rights (IRB contact information)
  7. Statements that participation is voluntary, refusal to participate will result in no penalties or loss of benefits, and that the participant can change their mind and withdraw from the study at any time.

The UVU IRB provides a checklist of requirements to assist investigators in preparing their consent documents. You may download that checklist here.

The University of Utah’s IRB provides an excellent resource for researchers interested in learning more about each of the consent requirements here.

General Information and Tips for Preparing Your Consent Document

The consent document should clearly describe the research as it is presented in the IRB application. When writing your informed consent you should:

  1. Use the second (you) or third (he/she) person to present the study details.
  2. Write in plain language at a level appropriate to the subject population. You should avoid technical jargon and complex terms, and keep the writing to an 8th grade reading level.
  3. Ensure that the consent document is written in the participant’s native language if they have limited proficiency in English.
  4. Ensure that the possibility of coercion and undue influence is minimized.
  5. Avoid exculpatory language that waives, or appears to waive, any legal rights the subject may have, or releases the investigator/institution from liability due to negligence.

Waiver of Consent or Documentation of Consent

Under the HHS Common Rule, the IRB may approve an informed consent process that:

  • Waives the requirement to document informed consent (i.e. to obtain a signature on the consent document), or
  • Waives or alters some or all of the elements of informed consent.

A waiver of documentation of informed consent means that the participants are provided with the required consent information, but the PI is not required to obtain the participant’s signature on the consent document. In order to approve a waiver of documentation of informed consent the IRB must determine that:

  • The signature would be the only record linking the subject to the research and the main risk of the study is breach of confidentiality; OR
  • The research is no more than minimal risk and involves no procedures where written consent is normally required outside a research context (ex. surveys/interviews that are completed online or by telephone); OR
  • The participants are members of a cultural group in which signing forms is not normal/acceptable practice.

Waivers or alterations of informed consent elements can be requested for projects that are no more than minimal risk and involve the secondary analysis of data or projects involving deception. In order to approve a waiver or alteration of elements of consent the IRB must determine that:

  • The research is no more than minimal risk.
  • The research could not be practically completed without the waiver/alteration.
  • The waiver/alteration would not adversely affect the rights of the participants.
  • The research could not be carried out using deidentified data, if the research includes identifiable private information.

You must indicate in your Axiom Mentor application if you are requesting a waiver of documentation or a waiver/alteration of consent elements. You will be required to provide additional information justifying the request.

Assent Documents for Research Involving Children (participants under 18 years of age) or Decisionally Impaired Individuals

Permission from one or more parents (for minors) or the legally authorized representative (for decisionally impaired individualsⱡ) is required through the informed consent process when those not able to provide consent are to be involved with research. However, while children/decisionally impaired individuals are not legally able to provide informed consent, they may possess the ability to assent or dissent from participation. Children/individuals should be asked if they are willing to participate in a research study if they are capable of understanding what is being asked of them. To determine whether a child/individual is capable of assenting the PI (and the IRB) should take into account the ages, maturity, and psychological state of the participants. Assent documents should:

  • Be written at the reading level appropriate for the age/understanding level of the subjects.
  • Offer an explanation of the study, possible risks, and benefits using language the participants can understand.
  • Clearly explain that the subjects do not have to be part of the study if they don’t want to be.
  • Provide a signature line or record that verbal assent was obtained. A simple failure to object should not be taken for assent.

ⱡPlease note that as a general rule, all adults, regardless of diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgement. Assent is only required from persons formally adjudged to be decisionally impaired to consent. Federal guidelines do not provide standardized methods for determining capacity to consent. If working with subjects with cognitive or psychiatric disorders, the investigator should have a plan for assessing subjects’ ability to understand the nature of the research and information relevant to their participation; and to express a reasoned choice to volunteer or decline. The capacity to understand these concepts allows for an adult to consent to their participation without need for a legally authorized representative.

Please contact the IBR Office at [email protected] or schedule an appointment with the IRB Administrator (Appointments - sence (uvu.edu)) if you have questions about the consent process.

Complete Application

HOW TO USE THE NEW “CAYUSE” SYSTEM 

 

The UVU IRB now uses a new third party system, Cayuse, for submission, review, and approval of IRB applications. Please click this Cayuse link to submit and renew all IRB proposals. Follow the steps below to submit your application for review: 

 

STARTING AN APPLICATION: 

  1. Log in using your SSO log-in information that you use to sign into your MyUVU account. 
  2. You will open to a screen with several rectangles that contain icons and labels. In the upper right-hand corner, there is a blue button with a “+” called “New Study.” Click on this button to begin your application. 
  3. If you do NOT see “Cayuse Human Ethics” in the top lefthand corner of your screen, you are in the wrong spot. You must click the “Products” dropdown menu in the upper lefthand corner of your screen and select “Human Ethics.” This will take you to a new page where you will be able to follow the steps below. 
  4. On the next screen, you’ll need to enter the title of your research study. Once you’ve entered your title, click the blue check mark to begin adding the required information to your submission. Up in the right-hand corner of the screen, you’ll see a new blue button that says “New Submission.” This is how you will begin compiling your required documents. Click “New Submission” to move forward and complete the following steps. 
  5. When you return to your application to continue work, you will also be able to open it for editing by clicking the small blue “initial” link found under “active submissions” on the main page of your protocol. (It is a small link, but it is one of the only blue hyperlinks on this screen.) 
  6. You will now be taken to a screen that shows a workflow of steps for your protocol. There will be a red flag above the word “Initial” that says your study is unsubmitted. Keep in mind that thetitle of your protocol is listed below, next to your IRB submission number. Your IRB submission number, or your “protocol ID number,” should look something like this: IRB - #### - ##. 
  7. On the far-right side of the page, you will see a section called “Required Tasks.” Click on the first hyperlink called “Assign PI” to be taken to the next screen. Make sure that you read the “Getting Started” information before proceeding.  
  8. In the bottom right corner, there are arrows that will help you navigate the pages in this screen. You must have read and agreed to the information on the “Getting Started” page in order to use the arrows and proceed. Click the forward button to continue. You will now see a list of items in blue along the left side of your screen. The “Getting Started” section has a checkmark. You will need to have a checkmark next to every section before you will be able to submit your protocol for review. Each checkmark will appear when every item in the section is completed. 
  9. Depending on the nature of your project and the information you input into cayuse, different sections may appear with additional information you will need to include.  
  10. As you move through the protocol sections, please make sure you periodically save your progress. You can do this by clicking the green “save” button in the upper righthand corner of your screen. This way, you can leave and come back to work on the protocol as you have time.  

 

FILLING OUT THE APPLICATION SECTIONS: 

PROJECT PERSONNEL  

  • For the Principal Investigator, you will click the FIND PEOPLE button and search for your name.  
  • Make sure you list yourself as the Primary Contact. If you are not listed as the primary contact, you will be locked out of the application. 
  • You may list other people as additional primary contacts if you choose to do so. However, be aware that anyone listed as a primary contact will have full access to view, edit, and alter the protocol application.  
  • The Faculty Sponsor is the faculty member with whom you are researching/for whose class you are completing this research. If you are a student researcher, you must have a faculty sponsor. 

BASIC INFORMATION 

  • If you are conducting research with people and/or at places other than UVU, you will need to answer questions about them on this page.  
  • External Sites: These would be clinics, other universities, schools, business, other organizations, etc.  
  • IRB Oversight Arrangements: You will need to be in contact with the other site(s) to determine whether they would prefer to be the Reviewing IRB or Relying IRB.  
  • Reviewing IRB: This means the site will use their IRB for research approval for your study. (for example, UVU would be the Reviewing IRB if another university wanted to defer to us). 
  • Relying IRB: This means the site will defer research decisions to the IRB of another site involved in the study. (For example, UVU would be the Relying IRB if another university wanted to function as the main IRB for the study). 
  • External Collaborators: This should ONLY be a yes if UVU is the Reviewing IRB.  
  • Relying on an External IRB: You will need to list the name of the IRB, the Point of Contact for that IRB (typically this is a member of the IRB with whom you have been communicating), the name of the site that will be leading your research, and the PI who is from that site.  
  • You will then upload your Consent/Assent forma, your study documents, and any documents you’ve received from the other site(s). 
  • Reliance Agreements: Please Keep in mind that a reliance agreement will almost always be necessary when working with another site university.  
  • Funding: If you are receiving any type of funding for your research, you MUST list the sponsor name.  

STUDY DESIGN 

  • Study Background: You will need to explain in detail the background of what you intend to study. This is often referred to as a literature review.  
  • Hypothesis: List the hypothesis of your study. 
  • Objectives: these are what you hope your study will accomplish/answer. 
  • Study Design: Make sure this section is filled out in detail.  
  • Outcome Measures: This is how you will be measuring your data. What methods will you use to calculate/examine the information you gather from your study? 
  • Inclusion Criteria: What specific criteria must a research participant meet in order to be a part of your study? (ie age, year in school, etc.) 
  • Exclusion Criteria: What criteria would exclude a participant from your study? 

STUDY SELECTION 

  • Vulnerable Populations: Do not check ANY of these boxes unless you are purposefully studying one or more of these populations. Do not include any of them “just in case.” This section determines whether your study requires more intensive review. 
  • Excluded Vulnerable Populations: Only select “yes” if you intend to purposefully exclude any type of person/population from your study.  

STUDY PROCEDURES 

  • This section MUST be filled out in detail in order for your submission to move forward in the approval process.  
  • Identifiable Data/Specimens:  
  • Specimens: Any bodily fluid, hair, etc.  
  • Identifiable Data: Any data that would allow your subjects to be readily identified, such as audio/visual recordings, names, birth dates, etc.  

 

SUBMITTING YOUR APPLICATION: 

  1. When you are finished filling out the required information and you have check marks next to all of your blue panels on the left of your screen, review all of the completed sections and ensure that they are accurate and all necessary information is complete. When you are ready to submit your application for review from the IRB, navigate to the bottom of the blue menu on the lefthand side of your screen and click “COMPLETE SUBMISSION.” A pop-up box will ask you if you are sure you want to continue – if so, click “CONFIRM.”  
  2. After clicking “confirm,” you will be brought to a new page. The bar at the top of the page will show the progression of your application. In order to send your application to the IRB for review, you must certify it. To certify your application, click the blue button on the right side of the screen that says “certify.” Certify essentially just means “submit,” and by certifying your protocol, you are just submitting your protocol to the IRB for review. Click confirm after reading the pop-up message.  
  3. Do not click the button next to it that says “return” unless you want to make additional edits – “returning” the application means you are going back to the previous stages where you can edit and add information to your application. 

NEXT STEPS & REVISION REQUESTS: 

After submitting your application, you will be brought to a new page. The bar at the top of the page shows the progression of your application. After certifying your application, that status should say “under pre-review.” Pre-review is the stage where your protocol will be reviewed by the IRB coordinator before being sent for final review by board member(s).  

You will likely need to revise your protocol at certain points during the approval process – this is typical of the majority of protocols. You may receive revision requests during the pre-review phase by the IRB coordinator, and again during the review phase from board members. You will receive an automated email to notify you when you need to make revisions. The email will state that the submission has been “returned to investigators,” which means that the application has been sent back to you for changes and/or additional information. Instructions for how to address and respond to revision requests are below.  

 

RESPONDING TO REVISION REQUESTS 

You will receive an email when the person reviewing your submission has requested revisions from you. 

  1. After opening your submission again (open your submission to edit by clicking the blue “initial” link under “active submissions”), you will see the same blue menu on the left hand side as before, except now instead of check marks there will be comment bubbles that let you know what sections of your submission need revision. 
  2. When you scroll through the section that has a comment bubble, you will need to look very carefully for a small black comment bubble under one or more of the details of the study. These bubbles blend in quite well, so you will need to make sure you look carefully.  
  3. Click on “expand comments” to see the feedback that was left for you. You will be able to respond to the comments and/or alter your initial submission. 
  4. Click the drop-down section and change it from “unaddressed” to “addressed.” As soon as you do this on all of your comment bubbles, you will get a check mark in place of the bubble on the left-hand side of your screen in the blue menu. 
  5. Proceed with the same steps as above to send the submission back to the review stage. (*see “Submitting Your Application”)