Application Sections

Who needs to be listed?

In this section all project personnel must be listed. This includes anyone who will interact with human subjects or will have access to data with personally-identifiable information.

There are limited exceptions for personnel who meet the guidelines for non-engaged personnel (see the Federal engagement guidelines for more detail). A common example would be a professional transcriptionist. If you are not sure if personnel should be listed, contact ORS for assistance.

Non-Loyola Research Personnel

There are separate areas in this section for Loyola personnel, and Non-Loyola personnel, but all personnel must be listed.

CITI

To be added, a researcher must have up-to-date CITI training and an active CAP account. Completing the CITI training for the first time will automatically create a CAP account. For outside researchers who may already have a CITI account elsewhere, they will need to affiliate their CITI account with LUC. See the page on CITI for more information.

CITI training must renewed every three years. Personnel with expired CITI training will not be approved.

Faculty Sponsors

For students (and some staff) a faculty sponsor is required. Faculty Sponsors must also have completed CITI training. See here for more information

Roles and Responsibilities of Personnel

For each member of the research team, aside from the PI and Faculty Sponsor, a detailed description of the personnel’s role in the project is required. This description should explain in what capacity this person will interact with human subjects or access data (e.g., recruiting participants, administering surveys, data entry).

Types of Funding

In this section of the application you will select what types of funding you have. Some selections will require you to provide more information.

External Funding

For external funding you need to list the associated PTAP number. If there is more than one source of funding, all PTAP numbers must be listed.

Degree Requirement

For student research that is a degree requirement (Masters Thesis, or Dissertation) the committee needs to have approved the proposal prior to IRB review. See the section on steps to complete before you apply for more information.

Where will the research be conducted?

In this section you will list each site where research will take place. For some projects that might be very specific, and for others more broad.

Online spaces may also be more specific (e.g. mTurk) or general depending on the research.

Has permission been granted?

For each non-LUC location please state if permission has been granted in writing. If yes, the signed permissions should be included in the attachments section of the application. If the signed permissions will be added later as an amendment, please note that.

Should this project be reviewed by another IRB?

If members of another institution will have access to individually identifiable information about the human subjects, then the project may need to be reviewed by the other institution’s IRB. You may need to check with the other institution to see if review is necessary. Additionally, some research sites may have their own IRB or ethics review requirements. See Outside IRB or Ethics Review for more information.

If the project is funded, your grant proposal should be uploaded in the Attachments section. In that case, you should respond 'Yes' to the question about attaching a proposal that details the research. If you've attached a dissertation proposal or other such documents, you should also select 'Yes.'

What to include in your Summary

This is the section where you get to summarize your research and have the best chance to provide a clear overview of your research project for your reviewers. The more detail you provide, the better your IRB reviewer will be able to assess the risks and benefits of the project.

Additionally, if there is some detail of the research procedure that does not easily fit into the other sections, but you feel is important for the IRB to know, this is where you can include that information.

Participant Groups

Having discussed your research procedures, now you can discuss all the participant groups and explain which procedures apply to which groups. (You will also have the chance to discuss your participant groups in more detail in the Recruitment section of the application.)

Some projects may only have one set of procedures or one set of participants which will make responding to this question very straightforward. For other projects, this is a good chance to clarify the specifics of the study design.

In this section you will discuss the risks and benefits of your project. In some ways, this is the most important section of the IRB application as evaluating risks and benefits is the heart of the IRB process. See the section on Risks and Benefits for a more in-depth discussion of Risks and Benefits and how they are mitigated and evaluated.

Minimal Risk or Greater than Minimal?

The federal regulations state that “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Visit our Risks and Benefits page for more information.

If a project presents more than minimal risk it will need to be reviewed through the convened review process.

Risks

In this section you should be open about all the potential risks of your project and how you will attempt to mitigate them. It is important to be balanced - be clear about the risks presented, but do not overstate risks either.

If you do not believe your project presents a risk to participants, do not say that there are no risks, instead say, “There are no foreseeable risks involved in participating in this research beyond those experienced in everyday life.”

Benefits

Explain the anticipated benefits to the participants and society.

Examples of direct personal benefits include receiving diagnostic tests and therapy. These are rare outside of the context of medical research. If participants will not benefit directly from participating in the study, say so ("There are no direct benefits to participants"). This should also be stated in the consent form.

Afterward, you can discuss potential or broader benefits such as contributions to scientific knowledge and technological advances.

Compensation, such as payment for participation, is not considered a benefit in IRB terms, and should not be discussed here.

Circumstances which may raise the level of risk

The next few questions will ask about specific aspects of the research design which could present additional risk to participants. If you respond 'Yes' to any of these questions, a textbox will appear, allowing you to explain the risks and the steps you will take to mitigate them. See below for the questions and the types of information the IRB is looking for in response. Also see our Risks and Benefits page for more information on different types of risk

In this section you will discuss recruitment, both who you will be recruiting and how you will be recruiting them. See the section on Recruitment and Participation for a more in-depth discussion on recruitment.

Here you will use the first text box to explain who you plan to recruit. Provide demographic detail, but (even if you already have specific people in mind) do not provide identifying information.

In the second text box, answer how you will recruit. Provide as much detail as possible here, and if other people will help with recruitment (such as posting flyers, or emailing lists) discuss how you will enlist their help as well. Any recruitment documents (flyers, email templates, oral scripts) discussed here, needs to be uploaded in the attachments section as well.

Next the application asks about including certain groups (pregnant women, human featuses, neonates, prisoners, or children). These groups are considered vulnerable populations and are afforded extra protections by the federal regulations. Later you will also be asked about the inclusion of people that do not speak, read, or write English, and cognitively impaired participants. You will also be asked to consider if the investigator has a dual role that could influence potential participants.

If you respond 'Yes' to any of these questions, an extra text box will appear, giving you space to explain why these groups are necessary for the research, and how you will minimize their risk. See the section on Recruitment and Participation for more information on vulnerable populations and other factors that require additional care in planning recruitment and research.

Total Number of Participants

Here you will give the total number of participants you expect for all the procedures discussed in the application. This number should match what you discuss in the other sections of the application.

If you amend the application to add additional phases of the project later, make sure to update this number to include the additional planned participants.

This number is the maximum number of participants you will be approved to include. If you go over this number without an approved amendment from the IRB, it is considered non-compliance and the IRB will require steps to remedy the issue.

Inclusion and Exclusion Criteria

The final text box allows for clarification on inclusion and exclusion criteria. This is particularly helpful for projects with multiple participation groups. Here you can clarify who will be included in each group, what (if any) factors will exclude potential participants, and the size of each group.

Often researchers will say there are no exclusion criteria for their study (everyone is invited to participate), but nearly all studies will have at least some exclusion criteria. Common examples include age (not being an adult) and language (not speaking the language of the research team).

When added up, the total number of participants in each group discussed here should match the number given above as the total number of participants.

In this section you will discuss your consent process(es). Depending on the study design your project may have one consent process or it may have multiple.

For example, if there are multiple parts of the study (such as a study with interviews, surveys, focus groups, and observations) and each part of the study is collected from different participant groups, then each consent process should be described. Or if some participants (but not all) may be included in additional procedures (such as interviewing a sub-sample of survey respondents), then multiple consent processes will take place and must be described.

Another situation where multiple consent processes will be needed, is an interview project where some interviews will take place online and some in-person. Those consent processes will probably be different and should both be described in detail.

Waivers of Consent and Waivers of Documented Consent

The first few questions on the page seek to establish if a full, documented consent process will take place. See our page on informed consent for more information on consent and documenting consent.

The first question is "Will documented consent be obtained from all subjects?" If the answer is 'Yes' then you are already done with this section of the page. If you will be altering the consent process, or if your documentation procedures do not meet the legal standards for documentation, then you should select 'No' which will lead you to the next question.

Exempt research does not have the same consent requirements and waivers do not apply. Even if you answer 'No' to "Will documented consent be obtained from all subjects?" you should answer 'No' to the waiver questions before moving onto the other sections of this page. For expedited and convened reviews, see below.

Are you requesting a waiver of consent?

For most studies the answer to this will be 'No,' but see our page on informed consent for situations where this may apply. If you respond 'Yes,' you will need to show in the following text boxes that your study meets each of the regulatory requirements for granting a waiver of consent.

Are you requesting a waiver of documented consent?

Requesting a waiver of documentation of consent is more common, particularly with the rise in online research. There are two conditions in which the waiver of documentation of consent can be granted. See our page on informed consent for more details, but if your study is minimal risk, Condition Two is likely the correct choice. You will be asked to discuss why the waiver is appropriate for your study.

Describe the process involved in obtaining informed consent from participants

This is the main section where you will describe your consent process or processes. You should provide the IRB with as much detail as possible. How, when, where, and by whom participants will be provided with informed consent forms or information about the research should be specified. It should be clear if consent processes will be in-person or online, and how different consent processes apply to different participant groups. If there are multiple people on the research team, it should be clear which of them will be gathering consent. All consent documents discussed here should also be uploaded in the attachments section.

Language Barriers and Translation

Here you will describe if there are any anticipated language barriers (such as illiteracy, low-reading comprehension, or not speaking English fluently). If so, you should describe in detail the accommodations you will make, or translation plans. See the Translation section for more information.

Deception

If your study includes deception this is where you will describe in detail how they will be deceived and, then, how they will be debriefed. The debriefing is considered part of the informed consent process. For some studies, the IRB may ask that participants be given the chance to withdraw their data once the deception is revealed. Debriefing documents should be included in the attachments section.

In this section you will discuss your privacy and confidentiality plans. See the section on Privacy and Confidentiality for more information.

Masking Data

The first few questions ask whether people and organizations will be masked in your study. You have the chance to provide an explanation. For some studies it will make sense to mask participants and organizations, and for some that may reduce the value of the data. When participants and organizations are not masked that can raise the risks of the study (such as loss of confidentiality), and data security plans may need to be more stringent.

List each type of data

Here you will describe each type of data you will collect (surveys, interviews, observations, records, etc.) and what types of identifiers are included with each. If different types of data will be correlated, you will need to describe what sorts of identifiers will allow for the correlations.

You will also want to describe your plans for de-identifying data. You should describe if, when, and how you will deidentify the data - What identifiers need to be removed? Will any remain?

In some cases identifiers such as names and contact information need to be kept for compensation purposes, or participants have agreed to let their information be stored so they can be contacted for future studies. In those cases, contact information should be collected and kept separately from the study data. You should describe your data storage plans for both the study data and for the contact information.

Data Storage

Here is where you will discuss the data storage plans. In the past, this was often a 'locked cabinet' but as more and more data is stored digitally, it is important to keep on top of up-to-date security practices and include them in your research plans. If you need resources, it may be beneficial to reach out to LUC ITS.

In this section you will also talk about who has access to the data. This can include your research team, but when thinking about digital data, it is also important to think about the privacy policies of different websites or software companies.

Audio and Video Recordings

Audio and Video Recordings are considered identifiable information, which means that extra care must be taken when storing these types of data. The final section allows you to detail how the data will be stored.

For some studies, it may not be necessary to retain the audio video recordings once transcribed. If only transcripts are retained (and any identifying references are removed), this data can be considered de-identified. The final section of this page gives you the chance to discuss the transcription process.

If an outside transcription service (whether digital or human) is used, the IRB will need to know that they have a confidentiality policy in place. If an individual is hired who does not work for a company with a policy in place, the researcher may be asked to draft their own confidentiality policy which should be uploaded in the attachments section.

When filling out this section you should be as specific as possible. How much will each participant receive? Will the amount be paid at one time or over different phases of the study? How will it be paid (cash, gift card, electronic transfer, etc.)? When will participants be paid? Will they be paid if they do not complete the full study?

The IRB will need all of these details to ensure that participants are being paid fairly and that the amount is not coercive. Payment is an incentive to participate, but the amount cannot be so large that it impedes a potential participants ability to weigh the risks and benefits of their participation. There is no strict number that is considered too much or too little, as people in different circumstances will be affected by different amounts. Instead, you must carefully consider what payment is appropriate for your participants.

Payment Methods

Payment may take the form of compensation (a set amount for participation), reimbursement (re-funding participants for certain costs incurred such as travel, meals, childcare, etc.), or tokens of appreciation (small tangible gifts such a coffee mug or candy).

When compensating participants there are various forms of payment: cash, gift cards both physical and electronic, check, electronic cash transfer. It is important to make sure that the method of payment is appropriate for your participant group. For example, a check will not be appropriate if most of your study population does not have a bank account. A gift card to a specific location is only useful if it is a place that participants shop.

Additionally, the method of payment should not put participants at risk. Risks are specific to the setting and participants. In some places carrying cash could be a risk. For other participants it might be a risk if their participation was discovered (such as domestic violence studies) so a check or electronic transfer that could be traced might be inappropriate.

Timing of Payment and Pro-rating Payments

It is also important that the timing of the payment does not become coercive. For long-term studies payment should be distributed in phases. For participants who want to withdraw from the study, this gives them the opportunity to do so freely.

For short term studies it may be appropriate to simply pay at the end of the study, but if there are multiple parts of the study, the IRB may also ask that these studies be pro-rated. In some cases researchers may want to pay for certain levels of completion. In those situations, the exact standards that will be used to judge completion rates must be clear in both the IRB application and consent information.

Communicating Payment Information

Payment information can be mentioned in recruitment documents, but must not be a focus of the description.

During the consent process, payment procedures must be described in detail. This includes the amount, the method of payment, and the timing of payment. If payment will be pro-rated then the timing and amount of each payment must be made clear (for more complex studies a table may help organize the study timeline).

If participants need to take certain steps for payment (such as collecting a code from the end of an online survey), or if there are any limits on payment (gift cards that must be used in a certain time frame) this must be described in the consent information.

Paying Participants

The researcher must ensure that all payments are made as described in the consent information. It is also the responsibility of the researcher to ensure that their payment methods follow University financial policies.

Payment in the form of a Raffle, Lottery or Drawing

When payment will take place in the form of entry into a raffle (also called a lottery or drawing), then both the application and the consent information needs to include:

• The amount and total number of payments to be awarded
• The odds of winning (calculate by reporting the ratio of payouts to number of participants who will be compensated)
• The approximate timing of the drawing
• How participants who are awarded will be notified.

This section is where you will upload any documents related to the study or application.

The IRB needs to see everything that participants will see, so this includes:

• Consent materials: Verbal scripts, Forms, Contact information
• Assent materials: Scripts, Forms, Contact information
• Recruitment materials: verbal scripts, email or social media templates, mailing materials, flyers, advertisements
  • All recruitment materials must include the time commitment for participants
• Study Instruments: Surveys, Experimental material, Interview or Focus Group guides, Writing prompts, Instructions for participants, etc.

Other materials may also be needed. These include:

• Grant applications or research proposals
• Confidentiality agreements for transcriptionists or other workers
• Letters of permission from research sites
• IRB approvals from other institutions
• Certificates of Confidentiality
• Committee approvals for graduate work

Only the most recent version of a document should be attached. For example, if you amend the application to update a consent form, you should delete the outdated version, leaving only the version that will be used going forward.