Application Help

You will be asked to provide the full title of the study and an abbreviated study title. The abbreviated title is useful for investigators who have multiple studies about similar topics. You must fill in both areas, then press "Save and Continue to Next Section." This button is your best friend.

2.1: List the department of the Principal Investigator (PI). Be sure the radio button in the “Is Primary” is checked for the PI. The primary department is where the scientific review should take place if the study is required to complete one.

Add the departments of the co-investigators.

The checkboxes are used if you want to remove information.

Press "Save and Continue to Next Section."

3.1 PRINCIPAL INVESTIGATOR: Click on the "Add User" button. Only one eligible faculty can be added to this subsection. The PI must demonstrate qualifications to oversee the study by completing their iRIS profile and uploading their CV in the system. The Principal Investigator on any IRB-approved human research assumes primary responsibility for the ethical conduct of the research and for meeting all IRB requirements.

3.2 RESEARCH TEAM: All research team members must complete CITI training. Any individual who is involved in designing, conducting, or reporting human subjects research activities is considered research personnel. Such involvement can include:

• Obtaining information about living individuals by interviewing or interacting with them for research purposes;
• Obtaining identifiable private information about living individuals for research purposes;
• Obtaining the voluntary informed consent of individuals to be subjects in research;
• And studying, interpreting, or analyzing identifiable private information or data for research purposes.

Each research team member is responsible for ongoing requirements in the conduct of approved research that include, in summary:

• Obtaining and documenting informed consent of subjects or subjects' legally authorized representatives prior to the subjects' participation in the research.
• Obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document.
• Ensuring that progress reports and requests for continuing review and approval are submitted to the IRB.
• Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB.
• Keeping study records as required by the HHS regulations for at least three years after completion of the study (other sponsor or federal oversight may extend this requirement).

External Investigators: To add non-BYU investigators, please click here.

3.3 STUDY CONTACT: This subsection is self-explanatory.

Press "Save and Continue to Next Section."

4.2: Determination of Review Needed - Check one

If you know IRB review is required, select the first option and press "Save and Continue to Next Section" and you will advance to section 5.0.

If you are unsure if your study requires IRB review, select the appropriate option and the application will take you through regulatory definitions to determine if you need to submit an application. The more boxes you select, the more likely your study requires IRB review and you should continue with the rest of the application.

4.5: If you are still unsure if your project requires IRB review or you do not think the project is research or involves human subjects, click on the second option.

4.6: If you would like to consult with the IRB, select “yes” and press "Save and Continue to Next Section." You will be taken to the INITIAL REVIEW SUBMISSION PACKET, section 1.0. press "Save and Continue to Next Section."

Section 2.0 Lay Summary: In section 2.1 provide the details of the project, a justification for why you think this may or may not require an IRB review.

Include the following information:

• Source of the data
• The audience of the data
• If you are exclusively using secondary data, will the data de-identified before you receive it?
• Whether you believe the study fits the regulatory definition of research and human subjects.
• The intended scope and result of the project.

5.2: Please ensure that the department of the PI is listed here.

5.3 Who has performed Scientific Review of the research?

• Refer to the "?" for exceptions to Scientific Review.
• For more information about scientific review, please click here.
  
  • Please note that the scientific review is separate from the IRB. Oversight is managed by the college associate dean of research.

5.6 Describe any additional expertise regarding qualifications of the investigators(s).

If investigators have a particular expertise specific to the study, please describe it in this section. Examples of specific expertise to include in this section are experience/training to:

• Draw blood
• Extract biopsies
• Use the MRI facility
• Conduct therapeutic interventions
• Collect and handle data on sensitive topics
• Conduct focus groups
• Conduct interviews
• Using sensitive identifiable secondary data
• Interact with children in research
• Conduct research in another country and/or with marginalized populations

International Studies: Description of the research team’s knowledge of or experience in the host country.

6.2 Is this research being funded by one or more external sources?

Please be sure to include the R0 account number assigned by RAO for funded projects.

The IRB must account for all externally funded studies and provide information to sponsors when it is requested.

The IRB will ask you how you plan to conduct the study if you indicate that there is no funding for the study.

7.2 Please identify the methods of data collection (check all that apply)

Carefully review this section and include all intended methods you will use to collect data.

Check “Internet” for online procedures such as surveys, interviews using software such as Zoom, and studies about social media.

Physical Activities: is movement carried out by the body using muscles that require energy? An example, an investigator asks subjects to wear a pedometer to measure their steps in a typical day without deviating from their normal activities.

Exercise Intervention: a form of physical activity that consists of structured, planned, repetitive movements to improve and/or to maintain physical fitness. An example is when subjects are asked to swim freestyle for one mile to measure the rotation of their shoulder muscles.

Ethnographic Studies: check ‘Other’ and write “Field observation” in the pop-up text box to explain the study.

This permits you to take notes related to each interview, including about the location and non-verbal communication. If social media is a source of data, in Section 7.3 explain the nature of the social media being used and how it will be used. For example, collecting data based on participating as a researcher in an online forum, that is, being a virtual participant observer, is different from collecting data via an ‘Online Survey’.

7.3 Write a complete description of all procedures involving human subjects in the proposed research.

Label each subsection and answer each subsection completely in order. Failure to organize this section may result in a delay of the review.

• 7.3.4 & 7.3.5 These subsections are critical to the IRB’s assessment of your study; please follow the directions and provide all interactions between investigators and research subjects. Be sure to specify, if you are conducting more than minimal risk studies, physically rigorous or invasive studies, highly sensitive studies, who will be collecting the data, and how it will be done. Describe the environment where the study will be done and how research personnel will assist in study procedures.

For ethnographic studies, describe in detail where, when, and how the study will be conducted and who or what are the subjects of study. Detail whether the location is a public setting and what type of data will be observed.

Failure to provide details about the study procedures will delay the review.

• 7.3.6 If the study does not have multiple arms, please write N/A.
• 7.3.8 Studies using devices, apparatuses, or tools should provide an image and how they will be used in the research. If it is a multi-phase study, create a timeline or a table of events or charts to support information you previously provided in section 7.
• 7.3.9 If you are using existing data, provide the following information:
  
  • Description of data
  • Source of data and how you will obtain access
  • Why the data was originally gathered
  • The size of the dataset
  • Any identifying information in the dataset

7.4 Provide details about the data collection instruments you will be using and the rationale for the inclusion of each.

Discuss the particulars of the research instruments, questionnaires, interview guides, and other evaluation instruments in detail. Provide a justification for each of the instruments you plan to use.

For a novel or newly developed instrument, please include how and by whom it was created and the reason for its inclusion.

Please make sure the language in the study instruments is appropriate for the population and that the questions are appropriate for the research question.

For Qualitative Studies, if you are doing a qualitative interview-based and/or focus group study, indicate that you will use an ‘Interview Guide.’

Please do NOT include the actual questions in this section as you will upload the entire set of instruments in the initial submission packet after you complete the application. Only list by name the instruments you will use.

7.5 Describe your statistical or qualitative analysis plan. How will you know if you research hypothesis or research focus is supported or not?

Please provide the statistical methods accepted in your discipline used to analyze the data.

7.6 Will any of the research activities occur at locations outside of BYU?

For online studies please state if it is an international and/or domestic distribution of the study.

Data security regulations are growing globally and it will be important for you to specify which countries, provinces, or states where you will conduct the study. You will need to review the regulations of the locations where you plan to recruit subjects and write into your protocol how you plan to comply with each regulation. Please consult with the college/department general counsel representative if you need additional help.

For Ethnographic Studies: To state in advance all the sites where ethnographic research will be conducted may be difficult. The description for ethnographic research might be a specific location plus the phrase “and other sites that emerge as appropriate in the course of the research will be added by modification for IRB review.” Please be mindful that depending on the country, you may need to provide information about how you plan to comply with local and national data security laws.

7.7 Will deception or incomplete disclosure be used in the research design?

Deception/incomplete disclosure are typically only acceptable in studies with no more than minimal risk. Please detail why this study is minimal risk.

• The deception/incomplete disclosure should have no adverse effects on welfare of the subjects. Please outline how all adverse effects are minimized.
• The IRB must determine that the value of the study is sufficient to warrant waiving some aspects of the requirement for full disclosure in the informed consent process.
• Please outline the scientific validity for using deception in this instance. For example, "There is no alternative to address the scientific question in a valid manner but to use deception/incomplete disclosure. Other effective, non-deceptive approaches are not feasible." Please detail why alternatives are not feasible. 
• Debriefing is done, when appropriate, and the deception/incomplete disclosure are explained to the participant before the end of participation in the research. Please detail if you are debriefing participants, and if not, why not.
• When appropriate, subjects could be informed prospectively of the use of deception/incomplete disclosure and consent to its use. The following suggested consent language provides an example of this: "In some research studies, the investigators cannot tell you exactly what the study is about before you participate in the study. We will describe the tasks in the study in a general way, but we can't explain the real purpose of the study until after you complete these tasks. When you are done, we will explain why we are doing this study, what we are looking at, and any other information you should know about this study. You will also be able to ask any questions you might have about the study's purpose and the tasks you did. Though we may not be able to explain the real purposes of the study until after you complete the tasks, there are no additional risks to those that have been described in this consent form."

8.2 Subject contact: Any contact or interactions with participants?

Interactions can be both direct, like face-to-face, or indirect, like the distribution of an online survey.

Click “No” if your study is LIMITED to the review of data that has already been collected.

8.3 How many subjects do you plan to enroll? Provide an explanation and justification for the number of subjects.

The justification to recruit research subjects serves two purposes: to evaluate that risks are limited to as few subjects as possible, and the number of subjects can reasonably yield significant results.

It is important to consider several factors to determine the number of subjects:

• Type of Research: Quantitative and qualitative research employ different methods to determine how many subjects to recruit. The IRB will review methods that are accepted within the disciplines.
  
  • For Qualitative studies, estimate how many interviews you are able to do in a session, the time commitment of the interaction, over the data collection period to provide a reasonable range.
  • For Ethnographic studies, provide your best estimation of the number of people with whom you will interact as a participant observer. Reasonable estimates would include the duration of the study, the time commitment, and the number of key informants you can talk to in a day.
• Level of Risk: The greater the risk of the study, the greater the scrutiny on the justification for the number of subjects recruited to the study.

The IRB understands that screening procedures and withdrawals from the study may decrease the number of subjects who complete the study. Be generous yet reasonable in estimating the number or range of subjects you will need to complete the study procedures.

You cannot go over the approved number of subjects until you submit a modification of the protocol to the IRB for review and approval. Enrolling more subjects than approved by the IRB introduces a concern if the investigators are exercising appropriate oversight of the protocol.

The size of the target population should be a reasonable range. For quantitative studies, perhaps a range of 200-300 would be reasonable, whereas, 200-1200 would be not be reasonable because the range is too broad.

**Please be sure to submit a complete response by providing an explanation and justification.

8.4 Recruitment

If you review records from hospitals, clinics, or schools, check the “records review.” You will need to answer section 8.6.

8.5 Describe the subjects in terms that are most pertinent to the project.

Describe the target population. If applicable, describe methods for sampling larger populations and randomization procedures if conducting experimental manipulations.

Describe the eligibility criteria subjects must meet to be in the study. Include a rationale for subject selection based on review of gender or ethnic categories particular to the research area being studied and a rationale/justification for any exclusions based on race or ethnicity. Justify the following restrictions if applicable: age, gender, ethnicity, race, and socioeconomic status. Include enrollment restrictions based on childbearing status, pregnancy, and other disparities that may impact on enrollment if they apply. The distribution of men and women should be equitable so they equally share the benefits and the burden of the research. Therefore, provide justification in terms of scientific contraindications for unequal distribution of one gender.

Describe criteria that would exclude an individual from the research study. Generally this would include age, gender, physical, or mental conditions. Please provide a justification for doing so. There may be other populations that would not be appropriate for the study, list them and explain why they should not be enrolled.

8.6 Describe the records you intend to review.

This section is self-explanatory.

9.2 Identify any vulnerable populations

This section is intended to elicit information regarding additional protections when specific populations are included in a research study. It is not intended to trigger an exclusion of these populations.

When some or all of the participants are likely to be vulnerable to coercion or undue influence such as children, prisoners, pregnant women, mentally disabled persons, economically or educationally disadvantaged persons, employees of companies, schools, or organizations, or students of the investigator, additional safeguards will need to be included in the study to protect the rights and welfare of these subjects.

For each vulnerable population you choose, the IRB is required to ask additional questions regarding the protection of these groups.

• Pregnant woman/fetus should only be checked if the study focuses on this group. If they are incidental to the study, do not check this group.
• Other options may include the recruitment of employees by their supervisors, etc.

10.3 Type of compensation and the maximum value

Explain the types of payments to subjects including justification for the amounts. Be specific about the nature of each type of payment making a distinction between compensation for participating in the research versus reimbursements for expenses.

For study related compensation, state the form the compensation will take such as cash, gift certificate, extra credit, etc. Compensation is not a benefit to participating in the research and should not be stated as such.

Ethnographic Studies: Discuss any forms of reciprocity.

International Studies: If your study includes compensation of subjects in foreign countries, it is important that you document what you know about the country and the local norms and acceptable forms of compensation. Include the following information—

• Value both in US and local currency
• Local household income information (e.g. how much an average household earns in a month or a year in US and local currency)
• Whether the compensation could pose undue influence on the subject’s decision to participate

10.4 Procedures to distribute compensation

Explain when and how subjects will be compensated. Be specific for studies taking place over a long time where compensation is disbursed periodically.

International Studies: If there are culturally appropriate ways to distribute compensation, please describe them here.

11.2 What are the benefits?

The most common mistake researchers make in this section is not answering both bullets: direct benefits and general importance of knowledge. Please also note that compensation is not considered a benefit.

Direct Benefits: The benefit comes as a direct result of the subject’s participation in the research. The benefit should be fairly immediate and the expectation of the benefit should be well-founded scientifically. Typically social/behavioral/educational research does not provide direct benefits. It is okay to state, “There are no direct benefits to subjects (key informants) in this study.”

Indirect Benefits: The benefit may be incidental to the subject’s participation. Some examples of indirect benefits are: contributing to knowledge, sharing ones experiences to benefit others, potentially affecting a condition, culture, point of view, and feeling useful. Many social behavioral research studies provide indirect benefits to human subjects.

It is okay if the study does not provide any direct benefits, however, it MUST contribute to knowledge in your field, literature, system, network, etc. For example, talking about issues might be beneficial for some subjects or data may help to improve services in the future.

12.2 Limited to analysis of existing information?

• Mark this answer YES only if your study is limited to reviewing data/biospecimens that have already been collected.
• If there is interaction in any way, direct or indirect, please answer NO. Section 12.3 will pop up for you to identify risks of the study.

12.3 List known risks

All research with human subjects involves some risk, however minimal. Therefore do not say there is no risk. If the risk is minimal say so and identify the nature of the minimal risk(s).

Describe any potential risks that subjects may encounter by participating in your research project. Such risks may include but are not limited to psychological stress, loss of privacy or confidentiality, social risks, legal risks, economic risks, or physical harm.

Some risks of harm are foreseeable and others unforeseeable. For example, a foreseeable risk may include psychological distress during and after a study of suicide ideation that involves subjects who are suicidal. Risk level can also be dependent on the participants such as when a psychological test that is routine and poses no more than minimal risk may be considered more than minimal risk if taken by a person who suffers from a mental illness, severe anxiety, or depression. If applicable, comment specifically on risks of imposing an intervention on someone who may have an existing psychological condition or disorder.

Other foreseeable risks may include risks associated with a possible loss of confidentiality. Investigators should be sensitive to the vulnerabilities of the population under study and how a breach of confidentiality may impact a subject’s standing with the community, employer, spouse, school, etc.

For studies where the subject needs to undergo a blood draw, MRI, DEXA scan, or other medical tests, the risks associated with those tests should be fully described.

For observational studies, consider whether the observation could include sensitive information. Consider the impact of the presence of an investigator. Detail whether individuals will be identifiable based on the data collected.

12.4 How will you minimize risks listed in the previous question?

Please be sure to address each risk you list in section 12.3 and how you will minimize each risk. Researchers often make the mistake of addressing only some of the risks.

For physical interventions, biopsies, blood draws, and rigorous exercise, please explain safety precautions, sanitation procedures, and treatment of wounds, bruising, and injury. Please provide detailed information. The IRB will send back the application to rewrite this section if you do not thoroughly address mitigation for higher risk studies.

12.5 Medical or Psychological Services

If your study includes physical interventions biopsies, blood draws, suicidal ideations, and/or sensitive topics that include trigger questions, you should answer YES to this question.

12.6 Provisions for Resources

If a study covers a sensitive topic, for example, mental health issues, substance use, or alternative lifestyles that create personal dissonance, include contact information for local mental health providers to every research subject at the end of the first interview. This normalizes the presentation of this information and also relieves the investigator of the task of judging who might need such information. Even if the investigator is a mental health clinician, that is not the role s/he is enacting during a research interview. It is not recommended to leave it up to the research subject to ask for information about health professionals, as the person might not feel comfortable asking or the need might arise later.

13.2 Interventions with more than minimal risk

Mark YES for studies that include risks to subjects that are more than a normal person would experience in everyday life. For example, rigorous exercise interventions for non-athletes, sensitive topics that people don’t typically talk about every day to strangers, biopsies, DEXA scans, invasive studies with vulnerable populations, or longitudinal studies when the interventions include sensitive topics that could negatively affect the research subjects’ reputation, employability, health and well-being, etc.

The PI is responsible for ensuring that an appropriate plan is in place at the time of IRB submission and for ensuring that the safety-monitoring plan is implemented over the life of the protocol.

Key areas that should be included in the plan are:

• An explanation of the plan to monitor study progress and safety.
• A description of who will perform the monitoring reviews and at what frequency.
• The type of data and events (i.e., efficacy data, adverse events, and unanticipated problems involving risk to participants or others) that are to be captured under the monitoring plan.
• Procedures for communicating the outcome of reviews by the monitoring entity to the IRB, the study sponsor, and/or other appropriate entities.

As appropriate, also include the following:

• A plan for conducting and reporting interim analysis.
• Clearly defined stopping rules.
• Clearly defined rules for withdrawing participants from study intervention(s).

For more guidance please visit: https://www.nimh.nih.gov/funding/clinical-research/data-and-safety-monitoring-plan-writing-guidance.shtml

14.1 Select all that apply

There are three options to choose from to describe how you plan to obtain consent.

• Obtaining informed consent: This means that you will use the standard consent, which includes 8 required elements of consent, and obtain documentation of consent, meaning that the research subjects will sign the form. This format is the expectation of all research.
• Waiver or alteration of informed consent: Waiver of one or more elements of consent is permitted provided that the research is no more than minimal risk and meets specific criteria. Alteration of consent is appropriate if one or more of the 8 required elements is not relevant to the research activity.
• Waiver of documentation of informed consent: this is a request whereby a signed consent document is not required. Examples include online, verbal, and implied consent. Consent will still be obtained from participants, but they will not be required to sign the consent form. There are only three circumstances when the IRB may waive the requirement to obtain a signed consent form:
  
  1. The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she wants documentation).
  2. The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no-risk surveys or interviews).
  3. The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects. 

Ethnographic studies many times involve a waiver of informed consent. If the existence of a signed consent form itself poses risk to a research subject, a waiver of written informed consent should be requested. For example, if tested positive for a condition is an eligibility requirement for study participation, the existence of an informed consent form might increase a research subject’s level of risk.

14.2 Consent Process

Summarize how informed consent will be obtained, including how, when, where, and by whom it will be obtained.

• Informed consent is an ongoing process that takes place between the investigator/study staff and study participants.  In most cases, this process is initiated with written informed consent at the start of the study. However, it also takes place as an ongoing dialogue between the investigator/research personnel and subjects during the entire duration of their participation.
• Describe any steps taken to minimize the possibility of coercion or undue influence.
• If children or adolescents are enrolled, describe how the consent process includes parental permission and subject assent.
• Will all adult subjects be competent to give informed consent? If not, respond to the following:
  
  • What is the likely degree of impairment? How will competency be assessed (e.g., informal assessment by the investigator, mini-mental status exam, formal psychiatric evaluation)?  Note: The methods of assessment of competence should be based on the population to be studied and the likelihood of cognitive or decisional impairment in that population.
  • Will subject assent be obtained? If no, provide justification. Note: Respect for persons requires that assent (or at least lack of active dissent) be obtained in most cases.

14.3 Who will provide consent, parental permission and/or assent?

This question is asking researchers who will consent to the study. Will the research subject him/herself provide consent? Will the legal authorized representative? Or the parent? This question is not asking who from the research personnel will obtain consent.

14.4 Minimizing possibility of coercion or undue influence.

Please specifically address issues such as explaining the voluntary nature of participation, any alternatives to participating, the ability to withdraw at any time, and the fact that the decision whether or not to participate will have no impact on the availability of care/services or benefits to which the subjects are allowed.

If students of the PI or co-PI are recruited for the study, a third-party who is unaffiliated with the study and not in a position of authority, is asked to recruit prospective subjects and to obtain consent.

In this same classroom recruiting scenario, data analysis will happen after final grades are submitted for the term/semester.

This information will help the IRB as it considers the appropriateness of the proposed informed consent process.

14.6 What language will be used to obtain consent?

• Describe the language used by those obtaining consent.
• Describe the language understood by the prospective participant or the legally authorized representative.

14.7 Protocol-specific Instruments

• It may be more effective to deliver the consent using other instruments other than a written document. Depending on the culture, age, education level, political climate of the target population, and the complexity of the study design, the consent process may utilize a video presentation, diagrams, photos, etc.

14.8 How long will participants have between the time they are told about the protocol and the time they must decide whether to enroll?

• Describe any waiting period between informing the prospective participant and obtaining the consent.

14.9-14.11 Waivers, alterations of consent and waiver of documentation of consent.

If in section 14.1 you checked the second and/or third options, you will select YES and then you will be asked to check the reasons why you are asking for the waiver/alteration in this section.

15.3 Provisions used to maintain confidentiality

MORE INFORMATION COMING SOON

How will you store the data?

Describe how the confidentiality of subject will be maintained. Describe if and how the data will be de-identified. Explain how the data will be kept confidential throughout the course of the research identifying those persons in possession of and/or who will have access to the data. Explain where and how the data will be stored and protected during the active research process.

Important issues here include password protection for computer files; the secure storage of external hard drives, if used; cloud storage (indicate nature of encryption while being uploaded, stored, downloaded); separate storage for materials with names and personal identifiers (e.g. signed Informed Consent Forms and contact information).

Focus Groups: Detail whether pseudonyms, nametags, or nicknames will be used. Be aware that confidentiality may not be protected for focus groups as participants may talk about the discussion outside of the focus group.

Interviews: Interviewees should not be named (unless their permission has been explicitly sought, and this should only be done where a name is essential for the pursuit of the research in question). Any recorded contribution, in written form, on tape etc., or in notes taken from the interview by the interviewer, should be used in accordance with the permission of the interviewee.

15.4 Disposition of data

• In the “Other” category explain what will happen to the data at the conclusion of the study: if the data will be destroyed, retained, and/or shared with other investigators for future research. If video and/or audiotapes were used in the data collection process, describe the disposition of the tapes and/or discs at the conclusion of the study.

For data that is retained or shared with other researchers, explain under what conditions personal identifiers will be used, if at all.

• The expectation of data destruction is another example of wording that reflects particular disciplinary views. In anthropology, for example, the expectation is that field notes, photographs, and other ethnographic materials will eventually be deposited in an archive, library, or museum. The important point here is that investigators should provide evidence of a plan for handling data that is mindful of the need to protect human subjects.

16.1 Information about study categorization.

This section is optional. The IRB will make a final decision about the category of review. However, if you would like to understand the likely categorization of your study, you can complete this section or mark NO and save and continue on.

16.2-16.5 will give you information about Exempt, Expedited, and Full-Board Reviews