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.

Informed Consent

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 8^th 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 individuals^ⱡ) 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.