IRB Consultant Intake Form


    Researchers who will engage in any form of interaction or contact with participants need to complete this application. Researchers using existing records as part of their study and will not engage in any form of interaction or contact with participants should complete the Records Based Research Application. If you are making revisions to your current IRB application, do not complete this form. The Doctoral CapstoneScreening Form is no longer in use, instead complete this IRBApplication.

    IRB Application data user entry

    Study Information


    Complete this application if you are collecting new data (either directly or indirectly) from participants. If you are also analyzing existing records, use this application. If you are analyzing existing data only (e.g. secondary or archival data), complete the Records Based
    Research Application. You will only have one application for your study in IRBManager. The Doctoral Capstone Screening Form is no longer in use. If you are looking for the screening form, instead use the correct application to submit to the IRB.
    Learners should use the collaborate feature to share this form with their mentors/faculty instructors. See posted guidance for how to use this function.

    You will only have one application in IRBManager, do not create copies:

    • If you have completed an application that was deferred or approved with conditions, do not start a new application. You need to make revisions to the application form you previously submitted.

    • If you have submitted an application to the IRB and you need to make changes, do not start a new application. Contact the IRB Office

      (contact@irb-consultants.com) and request that they return your application.


    This is version 3.0 of the IRB Application effective January 2024. This is the current version of the application.

    Version 3.0 of the IRB Application effective January 2024


    Note that this autogenerated information is based on the researcher’s registration with IRB Manager and cannot be changed on the application. If your learner ID or email address is incorrect, contact the IRB Office for assistance. Note that IRB Consultant does not collect information about specialization during registration for IRB Manager, therefore this section will always be blank.


    Note that this autogenerated information is based on the researcher’s registration with IRB Manager and cannot be changed on the application. If your learner ID or email address is incorrect, contact the IRB Office for assistance. Note that IRB Consultant does not collect information about specialization during registration for IRB Manager, therefore this section will always be blank.


    Note that this autogenerated information is based on the researcher’s registration with IRB Manager and cannot be changed on the application. If your learner ID or email address is incorrect, contact the IRB Office for assistance. Note that IRB Consultant does not collect information about specialization during registration for IRB Manager, therefore this section will always be blank.


    Note that this autogenerated information is based on the researcher’s registration with IRB Manager and cannot be changed on the application. If your learner ID or email address is incorrect, contact the IRB Office for assistance. Note that IRB Consultant does not collect information about specialization during registration for IRB Manager, therefore this section will always be blank.


    Enter your mentor/faculty instructor’s email address and then hit ‘Tab’. This should display the contact for your mentor. To give your mentor/faculty instructor access to your form, click the ‘Collaborators’ link at the top of the page. See this FAQ for guidance on how to use the collaborate feature.
    Note: You cannot enter your own email address/information here.You must enter in your mentor/faculty instructor’s email address to be compliant with University policies. If your mentor/faculty instructor’s email address is not recognized in the system, double-check with them that they are registered in IRBManager and which email account they are registered under.


    Enter the approved title of your doctoral project as it appears on your final approved doctoral project plan.


    Professional doctorate learners: Read the list carefully to ensure that you have chosen the correct school and program.
    PhD learners: choose from the list the appropriate school with ‘PhD’ after it.


    IMPORTANT:You must include a copy of the completed Research/Project Action Plan, Scientific Merit Review Form, Proposal, or SMART form. The required document will depend on your program. The email from the school/dissertation support stating that you have approval is not sufficient. If you fail to provide a copy of the completed, approved research plan/form, your application will be returned to you. This may delay the initial review of your IRB submission.
    Dissertation learners: You must include a copy of the finalized and approved Research/Project Action Plan, Scientific Merit Review Form, Proposal, or SMART Form. The required document needed will depend on your program.
    All other learners: You must include a copy of the finalized and approved Capstone Plan, Action Plan, Signature Assessment, or similar document. The required document needed will depend on your program.
    DNP learners: You must upload the finalized and approved Project Charter, Project Implemenation Plan, and Logic Model (if applicable).
    DBA learners: You must include a copy of the finalized and approved chapters 1-3.
    IMPORTANT: You must upload the actual full document(s) as above. The email from the school stating that you have approval is not necessary. If you fail to include a copy of the required document (see list above), you IRB form will be returned to you.


    See our FAQs for guidance on how to retrieve and save the CITI completion report. You must upload the completion report that includes the list of all modules completed, the certificate of completion is not sufficient.
    IRB Consultants requires all learners keep their CITI training current throughout the dissertation process. Note that CITI expires after three years so, if your CITI training has expired or will expire while you are collecting data or interacting with participants, you must retake CITI and upload the current completion report here. See Campus for further information on research ethics education and CITI.

    Conflict of Interest


    The IRB is responsible for ensuring that conflicts of interest in research do not affect the rights and welfare of human participants. A conflict of interest exists when the researcher, research supervisors and/or research assistants have personal, professional, or financial relationships that could compromise the integrity of the research. Dual roles with participants are a common type of conflict of interest in research.


    Researchers should address potential conflicts of interest whether or not they anticipate their decisions will be impacted by a financial,
    professional, or personal interest. A conflict of interest can impact or bias research at any point in the design, execution, analysis, or interpretation of data. A conflict of interest can exist if there may be an external perception of bias or influence. Potential conflicts of
    interest should be addressed even when the researcher believes there is a low likelihood of occurrence or limited circumstances that would constitute a conflict.


    The IRB has an obligation to assess conflicts of interest and can do so at any point during the research. All members of the research team are obligated to provide full disclosure of all potential conflicts of interest, including, but not limited to: financial relationships and the financial interests they create, personal relationships, professional relationships, political relationships, or other relationships or pre-
    existing roles that involve contact with potential future participants.
    While some dual roles and conflicts cannot be eliminated entirely, it is the ethical responsibility of all members of the research team to establish a plan to mitigate conflicts of interest such that potential harms to human participants; their data; or their documents are
    minimized.

    Selection


    Indicate if any of the following apply to your research. Choose all that apply


    The IRB, and federal regulations require that all potential conflicts of interest (COI) are disclosed by the researcher. Failure to disclose a potential conflict of interest is unethical, and if a potential conflict is discovered later during the doctoral process, there are potential sanctions.


    Note that you must disclose the potential conflict of interest even if you and/or your doctoral committee believe that it does not constitute an actual COI. It is unethical and in violation of IRB Consultants policies to fail to report a potential COI.


    In the previous question, you indicated that you do not have a potential conflict of interest. Verify that you do not have a potential COI by answering yes to this question.


    Note that you must notify the IRB immediately if a potential conflict of interest arises. Click on the ‘previous’ button at the bottom of this page to return to the potential conflict of interest questions if you are unsure if you have a potential conflict of interest.

    Yes

    Participants and Sample


    If your study does not specifically target any of these populations, you should select “None of the above.” It is important to understand the definitions of these groups before making your selection. A minor refers to any individual who is not considered a legal adult in the state or country where they reside; therefore, you must verify the age of majority applicable to your research location. Medically vulnerable individuals include those diagnosed with a medical or mental illness, as well as those experiencing acute symptoms. The category of prisoners applies if your study involves incarcerated or institutionalized individuals. For non-native English speakers, you should select “yes” if participants are not proficient in English and require translation services, and “no” if they are fluent. You should choose veterans if your study involves individuals who have served in the military. Additionally, if you plan to recruit University faculty, staff, or learners, you must refer to the University Site Permission guidelines available on Campus/i Guide. It is important to note that requests to use IRB Consultants as a research site are not reviewed by the IRB Office; instead, they undergo a separate review process managed by the Compliance Specialist.


    This number should represent the total number of participants you plan to recruit in order to achieve data saturation. It must be entered as a whole number only. If you are considering a range of participants, you should report the higher end of that range to ensure adequate representation and completeness of data.


    Explain the specific inclusion criteria individuals will need to meet in order to qualify for participation in your study. If you have multiple populations, clearly describe the criteria for each. Inclusion criteria will vary depending on the nature of your study, but some factors for inclusion criteria are: age, gender, race, ethnicity, education level, type of education, socio-economic status, experience of certain phenomena or life events, presence or absence of certain mental health conditions or medical conditions, etc. It is important that your sample has the attributes necessary for you to answer your research questions.


    Exclusion criteria are used to determine whether individuals who meet the inclusion criteria have additional characteristics that would exclude them from participation in your study.
    For example, if a researcher is intending to study the affect of daily social media usage on feelings of sadness in 18–25 year old women, an exclusion criterion may be to exclude individuals who have a diagnosis of depression. An additional exclusion criterion for this study may be to exclude individuals who use social media for work-related purposes only.
    NOTE: Exclusion criteria should not be the opposite of inclusion criteria. Exclusion criteria would be characteristics that would prevent an individual from being eligible to be in the study even if they meet the inclusion criteria.


    The screening process is how you will confirm that a potential participant is eligible (meets the criteria) to be in your project. You must describe the process that will be used to confirm the eligibility of potential participants.


    Upload a list of the screening questions, script, and/or sequential protocol you will follow to determine eligibility. The reviewer should see exactly what you plan to say.
    Screening questions should align to the eligibility criteria. The phrasing of the screening questions is important, particularly with vulnerable populations and sensitive topics.

    Recruitment and Consent Procedures

    Indicate which recruitment methods you will use to solicit potential participants


    Choose all of the recruitment methods that you will use, and refer to the guidance below: If you intend to hold informational sessions, present to a group, or have a booth at an event, then choose “In person recruitment.” If you intend to have participants inform other potential participants about the study, choose “snowball sampling” (note that snowball sampling must be approved by the school in your approved doctoral plan and that the IRB does not always approve snowball sampling if it is not appropriate for the population/topic). If individuals who are not participants will assist or recruit potential participants by sending emails, holding information sessions, handing out flyers, etc., choose “Individuals/organizations other than the researcher shall be recruiting participants.” Do not choose this option for snowball sampling, and do not choose this option if you are hiring a company such as SurveyMonkey to recruit on your behalf. If you will create a website and/or a social media page or group for recruitment, choose “Creating a website/social media page.” If you intend to use SurveyMonkey’s Audience Feature or a similar service, choose “Hiring a 3rd party company.”


    Note: If you change your recruitment strategy between school approval of the approved doctoral plan and the submission of your IRB application, please discuss the impact of the change(s) with your mentor. Your school or program may require an update to the approved doctoral plan or a new merit review (changes in sampling technique may lead to a misalignment between the sample and the research questions). It is the responsibility of the researcher to ensure that any changes are properly vetted through the mentor and any other necessary school-based reviewers.

    Indicate which recruitment methods you will use to solicit potential participants.

    No answer provided.


    You must use the appropriate template that can be found on Campus under Informed Consent Forms. You may need multiple consent forms if you have multiple data collection strategies or are collecting different types of data. For example, if some participants will complete the survey online and others will use paper copies, then you will have slightly different consent forms. If you are collecting data via interviews with some participants and via focus groups with other participants, for example, you should have a consent form for each type of data collection. Instructions for using these templates: You must read the full instructions document (Consent and Assent Template Instructions) located at the link above. If you are conducting research with minors, you will need assent templates and parental consent forms for the study. Even if you conduct a QI/PI or an AIP with a group of participants who *must* participate in a process change, training, etc., consent remains valuable. In some circumstances where COI is present, the study should remain voluntary, and this is evident throughout the consent process. In all circumstances, participants must have the right to decline to have their data used in a doctoral project. Use of a consent form will make these conditions clearer to participants, and it is respectful to inform them of any risks to their employment, reputation, or data security. Please complete your consent form with these concepts in mind.

    Study Procedures


    IMPORTANT INFORMATION: Choose all that apply. Failure to indicate a data collection strategy will result in delays to obtaining IRB approval.
    For example: if you are implementing an intervention, you must choose “Implementing an intervention.” If you will be collecting data via in-person interviews, internet surveys, and focus groups, you must indicate all three on the application.
    Notes on choosing the right study procedures: The “Observations” item refers to specific observations of coded behaviors required to answer a primary research question, or specific observations of coded behaviors that occur naturally in public settings without researcher intervention.
    Note: do not choose this option for watching interviewees and body language as they are interviewed. This should be chosen only if behaviors will be quantitatively coded and analyzed to answer a research question. The IRB will review your approved doctoral plan to ensure that the study procedures in the application are aligned. Failure to align the approved plan and the IRB application will result in delays in your review, as the IRB needs to have accurate documentation of the intended procedures and documents.
    NOTE: If there are discrepancies between the approved doctoral plan and the IRB Application, only those procedures in the IRB Application are approved. Note that VoIP refers to internet phone services such as Zoom, Webex, or Skype. If you intend to observe online chat rooms, forums, or discussions, choose “Online observations.” For “analysis of existing records,” this applies ONLY to records that were created for another purpose or study. These records must exist before the research begins. This item does not refer to records (e.g., email or mailing lists) that will be used for recruitment only; if that is the case, do not choose this item. It also does not apply to records that will be created and analyzed during the study.


    Few doctoral studies will need to conduct a pilot study. You should only plan on conducting a pilot study if your committee and/or school requires it. Note that pilot studies require IRB approval before implementation, as pilot studies collect data from participants. You may not conduct the pilot study until after you have received IRB approval for the entirety of the study. If changes are required to your study procedures based on the pilot study findings, you must submit those changes via the IRB Modification Form and wait to receive IRB approval before you implement them.
    Expert reviews of interview questions/field tests do not collect data from participants and therefore may be completed before IRB approval.
    For further information consult the IRB’s Campus page: Guidance on field tests, pilot studies, and test runs.
    If your study does not require an expert review or pilot study, choose “none of the above,” though note that the IRB may require an expert if deemed necessary to ensure the appropriateness of the data collection tool.


    Exclusion criteria are used to determine whether individuals who meet the inclusion criteria have additional characteristics that would exclude them from participation in your study.
    For example, if a researcher is intending to study the affect of daily social media usage on feelings of sadness in 18–25 year old women, an exclusion criterion may be to exclude individuals who have a diagnosis of depression. An additional exclusion criterion for this study may be to exclude individuals who use social media for work-related purposes only.
    NOTE: Exclusion criteria should not be the opposite of inclusion criteria. Exclusion criteria would be characteristics that would prevent an individual from being eligible to be in the study even if they meet the inclusion criteria.


    Explain possible risks and discomforts. Consider the following potential areas: privacy/anonymity/confidentiality, economic or financial, employment, social or reputational, emotional or stressful, physical or medical, interpersonal, data security, etc. For further guidance on risks, click this link for information on Campus.


    Per University’s Third Party Guidance, “Research Assistants may not collect raw data or conduct interviews in place of the University doctoral learner.” Click here for further information on IRB Consultants’ guidance for use of third party assistance. Note that this question only applies to use of a third party to assist with data collection and not use of a third party to assist with recruitment, data analysis, or editing.


    This may include statisticians or other researchers that will assist with analyzing or verifying your data. If you decide after IRB approval to employ a qualified individual to assist with data analysis and will be sending them identifiable data, you must notify the IRB and obtain approval prior to use. All use of third-party consultants in the final write-up (dissertation, capstone project, etc.) must comply with University’s requirements on third-party services. Consult Campus for further information. Be certain to consult with your mentor/faculty instructor to ensure that your program allows the use of a statistician or other consultant to assist with data analysis. Note: You are responsible for conducting your data analysis. A statistician or other research assistant can only assist in the manner described in the third-party services document. A consultant cannot be the primary individual to choose, perform, or interpret the data analyses. You are responsible for writing the results of the analyses; a consultant cannot write portions of the doctoral manuscript for you. Most importantly, you must have a complete understanding of the analyses that were run, why they were run, and what they mean. Remember: it is your doctoral work. Your consultants must sign a confidentiality agreement prior to assisting in your study. If they do not have a confidentiality agreement, you may use the one provided by University found on Campus. You are not required to have this agreement signed in order to obtain IRB approval, but you must have it signed prior to providing anyone with study data. Provide a copy to the IRB once it is signed, and wait for confirmation from the IRB before any data are transferred to a third-party consultant.


    If you are intending to use these services but have not yet obtained the service, still select the service(s) here. Choose all that apply. You may mark more than one answer. If you are not currently intending to use third-party assistance but choose to use a service (aside from an editor) at a later date, this must be submitted as a modification request and approved by the IRB prior to using the service. You must wait for approval of that modification before using the service. Failure to receive IRB approval before using a third-party service may result in a non-compliance investigation and/or determination that the data cannot be used and must be destroyed.

    Data Security and Retention


    Common types of sensitive data include items such as:
    Social security number
    Credit Card Numbers
    Debit Card Numbers
    Bank Account Numbers
    National identification numbers
    Passwords
    Tax Information
    Veteran and disability status
    Earnings History
    Credit Records
    Financial History
    Income
    Photos and other comparable
    images
    Current Employer
    Educational History
    Gender, ethnicity, and race
    Political opinions, religious beliefs,
    or philosophical beliefs
    Health and medical conditions,
    including past medical history
    (includes mental and physical health)
    Biological samples (e.g. blood,
    urine)
    Trade union membership
    Biometric data (e.g. fingerprint)
    Sex life
    Sexual Orientation
    Any other unique identifying
    number, code, or characteristic (e.g.
    student ID number)
    Detail what sensitive data will be collected and provide rationale for collection.
    Gender, ethnicity, and race
    Explain why sensitive data are needed to answer research questions. Do not collect sensitive data for general descriptive
    purposes.


    Information on protection of participant confidentiality and data encryption can be found under the IRB resources in Campus
    NOTE: learners may only use information and data that have been approved by the IRB. Any additional data given to you by an individual or site (such as your research site or survey hosting service) cannot be used for data analysis unless 1) participants provided consent to use the data in your research, and 2) you must submit a modification request to the IRB before using the data. If approved, and if participants have consented, you can use the data. Otherwise, the data should be destroyed.
    If qualitative data are collected via interview, what recording device will be used? How will tapes/files be named? Do not audio record the consent process, do not ask participants to state their names on the recording, do not place first or last names on the tapes/files, and (if applicable) ask participants not to name others during their interviews. These precautions will increase confidentiality.
    If quantitative data are collected via survey, what procedures will be used to maximize privacy and confidentiality as these data are collected? Note: if data are collected online and are intended to be anonymous, then the survey platform must be set in a manner that does not collect IP addresses. If data are collected in person and in a group setting, participants should be seated in a manner that allows privacy when completing the survey, and privacy envelopes should be used as surveys are passed back to the researcher. Etc.


    Information on protection of participant confidentiality and data encryption can be found under the IRB resources in Campus:
    Consider use of a physical lock box, encryption of data, or similar means of securing data from the place of interview/survey collection to a home office or computer. Laptop computers and removable drives with data must be secured during transport.


    Information on protection of participant confidentiality and data encryption can be found under the IRB resources in Campus:
    Remember that all forms of data must be maintained for seven years. Access to data should be limited to the researcher and should not be readily available to others (e.g., not kept on a family computer).
    1. Describe how you will secure any paper forms (e.g., consent forms, surveys) in locked cabinets or similar locked containers. Describe how any computer or removable drive with data will be secured.
    2. Explain how you will maintain personal identifiers separately from your data.
    NOTE: Make a back-up copy of all audio files, transcripts, original data, surveys, etc. The back-up copies of all data should be secured as well as the originals.


    For more information on data destruction and protection see Data Security and Destruction on Campus.


    The site must be identified to the IRB. However, in the published dissertation or capstone paper the site must not be named. If there is a reason why the site must be named in the dissertation, contact the IRB Office before proceeding with your submission to the IRB. You will be required to provide the IRB with a rationale for why you wish to identify the site in your dissertation. Exceptions to this policy are rarely granted and only done so in instances where there is a strong rationale for why the site may not be identified and where potential risks to participants are minimized. In addition, the consent form will need to reflect the added risks to participants if the research site is published. Note that unless approved by the university, you may not name the site in your dissertation or capstone paper. You will be required to make revisions in later milestones if you submit a final manuscript in which the site is identified or easy to surmise. If your study does not have a site(s), answer no to this question. Provide rationale for why the research site will need to be identified in the published dissertation or capstone paper. No answer provided. Important information about site identification in the final doctoral manuscript: Your site must be de-identified. Exceptions are rarely granted. If an exception is granted, then participants must be notified in the consent form that the site will be named. Your site permission letter must explicitly state that identification is allowed (even if the site says its allowable, the IRB may not approve identifying the site).
    Note that exceptions are granted only in rare circumstances in which the site cannot be de-identified due to its unique nature. Your answer here must explain why de-identification is not possible. For guidance on participant and site anonymity, please check here: Participant and Site Anonymity Guidance.


    For example: all documents will be coded, you will use alpha-numeric codes for participants, you will collect anonymous data, you will collect data in a secure location, you will transport data in a locked container, you will separate identifiers immediately and maintain them separately, etc. You may not name or thank participants in your doctoral manuscript even with their permission.

    Data Security and Retention


    Note that permission letters to recruit from a site, access private information, conduct research activities at a site, and instrument permissions are not needed for your initial submission to the IRB. However, in order to obtain full IRB approval (which is necessary BEFORE beginning recruitment and data collection) you will have to provide all permission letters. See the IRB Site Permissions page on Campus for additional guidance.
    Site Permission Letters are needed for (including but not limited to):
    Permission to recruit participants from non-public spaces
    Permission to collect non-public information about an organization
    Permission to conduct study activities at an organization, school, medical clinic, business, non-public space, or some virtual spaces
    Permission to use non-publicly available records in your research
    Instrument Permissions:
    If you are using and/or modifying an existing instrument, you must have permission to use and/or modify the instrument from the original author.
    If you are using an instrument modified by another researcher, you must obtain permission to use the instrument from the researcher who modified the instrument and the original author of the instrument. For more information see Instrument Permissions on Campus.
    If you have created your own instruments, you do not need to provide instrument permissions.
    If the site requires you or University to sign a contract of any form (i.e., Memo of Understanding, Affiliation Agreement, Data Usage Agreement, Research Agreement), you must provide a copy of the agreement to the IRB. The IRB will review the contract as part of the application review. Additionally, if University is required to sign the agreement (and it has not already been through legal review), the IRB will coordinate the legal review of the contract. You should email a copy of the agreement to the IRB Office or upload a copy here. Consult Campus for further information on the contract review process. Note that learners, mentors, and chairs are not able to sign on behalf of University. As part of the contract review process, we will coordinate CU’s signing of the agreement. To add additional attachments, click the “add attachment” button and add more attachments until all letters have been uploaded.

    Additional Information

    Signature


    If you have not yet done so, review your application to ensure that your study procedures in the application match that of your approved doctoral plan. If the two documents are not in alignment, you will experience delays in obtaining IRB approval. Note that if there are discrepancies between the approved doctoral plan and the final, approved IRB application, only those procedures included in the IRB application are approved.
    If you have checked to ensure that your IRB application matches your approved doctoral plan form, choose yes.


    On the next page, you will be given three options:
    Save for later, Print, and Submit.
    If you are not yet done with this application, choose “Save for later.” This will exit you from the form and allow you to make changes and review your application. “Print” will display a printable version of the form. You may find it easier to review your answers in the print view. If you have completed your application and require no further changes, click “Submit.” Once you have submitted the form, you will not be able to make changes to the application until it is processed. Contact the IRB Office if you need to make changes after you have submitted the application.