A Process Guide to Avoiding Common Pitfalls when Submitting an IRB Application

• Be sure to include the CITI certification date (the date the researcher was certified, not when the certification expires). The IRB administrator checks this date against the list Iona receives from CITI.
• Be sure all co-principal investigators are included with all of their relevant information (CITI certification date, email, etc.).
• If the application includes research assistants, their names and CITI certification dates have to be included in the application.
• A researcher is working with another organization if the organization is involved in the research through such things as providing space, access to subjects, personnel, etc. for the study. If you are working with another organization, you will need to provide one of two things from that organization: 1) A copy of the organization's IRB approval, or 2) a letter from that organization indicating that the organization is giving permission for the researchers to conduct the study with the organization.
• While the IRB will ultimately decide whether an application will be reviewed as exempt, expedited or full review, the applicant should indicate what type of review the applicant believes is appropriate. Here is a guide to each of the review types.
• Full Board Review: A proposed study has to be reviewed by the full IRB if there is substantial risk to the human subjects. A full board review will also likely be appropriate if the subjects will include any protected group of individuals who may not have full ability to provide informed consent, such as minors (17 years old or younger), prisoners, institutionalized people, or anyone else who may not have the ability to give free and informed consent to participation.
• Expedited Review: A proposed study can receive an expedited review by the IRB (that is, not every member of the board will review the application) if the proposal does not pose more than minimal risk to human subjects, and the subjects will not be members of any of the groups described above as necessitating full board review.
• Exempt: The applicant believes that the study being conducted does not qualify as research under federal law or is otherwise exempt from IRB approval under federal law. It is important to note that if the IRB grants exempt status, the study will not be deemed to be approved by the Iona IRB; instead, the IRB will have found that the study is exempt under federal law from IRB review for the reason(s) stated.

A.  Project Description

• Please provide a scholarly rationale for the work. The IRB does not assess the strength of the research approach, but when evaluating risk/benefit it is important to demonstrate the scholarly value of the project.

B.  Start and Completion Date

• The start date CANNOT be before IRB approval, and it MUST be completed within 365 days of approval. If the investigator plans for their study to last for longer than 365 days from the date of approval, they should apply for an extension at the end of the approval period of their initial application, which may only be done twice for a maximum of one year each. Approval may not be extended beyond three years of the original approval date. At the end of the second extension period, the investigator must submit a full application for continuing review if they would like to continue collecting data.

C.  Use of the Research

• If there will be any public dissemination of the data collected, it should be described here.
  This may include (but is not limited to):
  • Publication of a book, journal article, or thesis (including student Honors and masters theses)
  • Oral presentation in a public forum, including speaking and poster presentations at conferences, Iona Scholars Day, and Honors Thesis Day

• It is perfectly acceptable to indicate that your proposed study has no direct benefits to participants.
• If applicable to your study, it may be possible that participants may benefit from learning more about the research process on a broader level.
• Study outcomes, potential contributions to the field at large, or any other implications of the research study findings are not direct benefits to research participants.
• If doing an intervention study, the intervention may have direct benefits to participants (indicate those here). If the study includes a control group who does not receive the intervention, you must offer the intervention to all participants at the conclusion of the study or their participation.

A.  Describe the Risks

• All studies have at least a minimal risk. Do NOT state that your proposed study has no risk. Remember--the goal is not to demonstrate that your study is risk-free. Rather, the goal here is to explain the potential risks involved, however minimal, and the steps that will be taken to minimize these risks.
• Some common (minimal) risks include:
  • risk to privacy if participants are sharing personal information about themselves.
  • risk of experiencing discomfort when being asked about feelings, attitudes, life experiences, etc., or when completing a task that may be perceived as difficult
  • risk of experiencing discomfort when being presented with a particular topic (e.g., reading material, viewing images, watching a video, etc.) that may trigger unpleasant feelings
  • risk of coercion, particularly if the PI is also the participant’s instructor
  • risks associated with everyday Internet use (if administering an online study)
• Privacy applies to the research participant and their right to have control over their personal information. Confidentiality (which is an extension of privacy) applies to the data being collected, and the assurance that the information will not be shared with unauthorized persons.
• NOTE: All of the risks listed in this section will need to be indicated in the consent form as well. Risk to privacy and steps taken to mitigate this risk will also be addressed in Section VII of this application.

B.  Steps to Minimize Risks

• For each risk that was listed in Section A, you must now clearly explain the steps that will be taken to minimize the risk.
• Some common steps taken to minimize risks include:
  • Risk to privacy and maintaining confidentiality
    • Data and consent forms are not linked.
    • Personal identifying information used to track participants across multiple study administrations (i.e., repeated measures) are not linked with any data collected.
    • Participant rosters with personal identifying information should are stored separately from any data, password protected, accessible only by authorized study personnel, and destroyed upon completion of the study.
    • Data is collected in a private setting (in person) and/or through a secure online platform.
    • Wherever possible, personal identifying information is not collected.
    • De-identification of all data (e.g., assigning subject ID numbers).
    • Hard copy data is secured in locked location accessible to authorized research personnel only.
    • Electronic data access is password protected and accessible to authorized research personnel only.
  • Risk of experiencing discomfort
    • Participants are ensured that they may skip any item or withdraw from/discontinue the study at any time without penalty.
    • Participants are ensured that their performance on any measure administered does not indicate their level of intelligence, cognitive ability, and/or provide any diagnostic information.
    • All Iona participants will be referred to the Iona University Counseling Center at 914-633-2038 should they require any mental health services. Students can access help from the Counseling Center 24/7. If the participant is not an Iona University student, they will be referred to the 24-hour crisis hotline (800)-273-TALK (8255), crisistextline.org, or instructed to text “GO” to 741741 to get an immediate response from a trained counselor at the Crisis Text Line (all of which are also listed in the consent form and in the debriefing statement).
  • Risk of coercion (if the PI is also the instructor of the research participant)
    • A separate research personnel (listed on this application) is the designated contact person for all study-related correspondence with participants.
    • A separate research personnel administers the consent form, the study itself, and the debriefing.
    • Participants are ensured that their participation (or decision to not participate) will have no bearing on their grades in the PI’s course(s).
  • Risks associated with online studies
    • Use a data collection platform that meets Iona’s online research confidentiality/security requirements described in our online research guidelines.
    • Include documentation that the data collection platform meets the online research security requirements. For example, Qualtrics is a common platform.
    • Use settings that prevent the collection of IP addresses. These settings are not always the default. For example, Qualtrics describes anonymizing responses.
    • Ensure participants are informed of the privacy policies of any relevant online third parties (e.g., MTurk’s Privacy Notice) and of how any identifying information collected via those parties (e.g., MTurk Worker IDs) will be handled to minimize risks to privacy.
  • Indicate that all adverse events will be reported immediately to the faculty PI and supervisor to ensure that the situation is handled appropriately and that all IRB requirements have been met.
  • NOTE: All of the steps taken to mitigate risks listed in this section will need to be indicated in the consent form as well. Risk to privacy and steps taken to mitigate this risk will also be addressed in Section VII of this application.

A. Expected Number

• Is the number you’re providing realistic given the methods of recruitment you describe in D?
• Is the number appropriate for answering your research questions as you have posed them?

B.  Participant Characteristics

• Describe your expected participants.
• Explicitly address whether or not participants may fall into categories (a), (b), (c), or (d).

   C.  Pregnant Women

• This item is self-explanatory.

D. Recruitment

Be as specific as possible. Who will send the recruitment materials? Who will receive them? How will they receive them?

• The exact language to be used in recruiting (e.g., announcements, flyers, emails) must be included here or at the end of the application.
• If emails will be sent, include disclaimer language like the following: Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact ______ (phone number). Iona University allows researchers to use email to send its faculty, staff, and student information about research opportunities as part of its research mission. The content of this email message has been approved by the Iona University Institutional Review Board (IRB). IRBs are charged with protecting the rights and welfare of people who take part in research studies.”

E.  Expected Time Commitment

• Explicitly state how much time you expect participants to spend on each component of the study.
• E.g., “The total time commitment is estimated at 30 minutes: 10 minutes for the Informed Consent, 15 minutes to complete the survey, and 5 minutes for the debriefing.”

F. Compensation

• This item is self-explanatory.

A.  Deception

• If you are misleading the participants in any way about the purposes of the research, explain the deception and the necessity for it here.
• Deception by omission—when you are not lying but are intentionally leaving information out of your consent form—must also be explained here.

B.  Chronological Description

• This is the “meat” of your application. In order to determine the risk to your participants, the IRB needs to know exactly what their experience will be in your study.
• This section should read like a narrative. Put yourself in your participants’ shoes and explain their experience in the study, from the moment they are recruited to when they are given the debriefing.

C. Raw Data from Records

• This item is self-explanatory.

D.  Materials

• We need to see the exact materials that the participants will be interacting with. Be sure to describe the materials and include copies. The materials cannot be altered after the study is approved without an Addendum.
• It is also important that you describe the source of your materials, whether you created them or are borrowing them from another entity. You are responsible for attaining permission to use any borrowed materials.

A.  Informed Consent

• For research studies being conducted online, you must explain that the consent form will be integrated into the web-based study on the data collection platform being used.
  • Explain how consent will be given (e.g., selecting “I have read and understood the terms of participation outlined above, and freely consent to participate in this study. I certify that I am at least 18 years of age and am therefore able to freely consent to participate in this study.”)
  • Indicate that participants will not be able to proceed to the study without giving consent. (Be sure to select and enable these settings in the online platform).

B.  Storage Location

• Hard copies of consent forms are typically stored in a locked cabinet within a locked room accessible only to authorized personnel.
• For research studies being conducted online, you must explain whether consent forms will be obtained electronically and securely, and whether hard copies of the forms will be printed (if so, how will these be secured?)

A.  Personally Identifying Information

• It is acceptable to collect personal identifying information if it is relevant to the research and if confidentiality is protected. Please make sure to include any personal identifying information here.

B.  Explanation for Collecting Personally Identifying Information

• Here, justify your need for any personal information described in part A.

C.  Personally Identifying Information From Other Than Participants

• Self-explanatory

D.  Steps to Secure Personally Identifying Information

• Any time that personal identifying information is collected, there is the risk of breach of confidentiality. Please describe all measures taken to prevent against accidental or malicious release of information. This should include physically securing files (in a locked drawer, on a locked computer), or if data are anonymized so that information cannot be linked to an individual.

  NOTE: This section may be redundant with IIIB (steps to mitigate risk), and that’s OK. You should address how you are protecting participant confidentiality in both sections.

• Overall note: A debriefing is needed after any data collection to provide to the subject information about the study and what steps the subject can take to follow up with the researcher, the college or anyone else who might be a necessary contact after the study (for example, a counseling hotline if there is a risk that the subject could become anxious from participation). The goal of a debriefing is to return the subject to the same place the subject was before participating in the study.

A.  Debriefing Procedure

• The applicant needs to fully describe from the subject's point of view how the subject will receive the debriefing. Section A is also the place to explain why a debriefing will not be provided if the study cannot provide a debriefing to participants.
• If the study employs deception -- that is, if the subject is given information that is not true to further the study -- the researcher has to explain the deception as part of the debriefing and restore the participant's trust. The applicant has to explain in section B in detail how this will be done. For example, if an experimental study shows participants a new article that is purported to be from the Associated Press, but the article has been constructed by the researcher, the debriefing would have to explain that fact and why it was done (e.g., to study how people react to certain content from a source considered to be objective and unbiased).

• See required elements and example of consent form here.
• Additional considerations for consent forms for online research (scroll down to Informed Consent section) can be found here.
• Consent forms should be written in lay language. The Iona IRB recommends that the consent form be written no higher than an 8th grade reading level wherever possible, but recognizes that some consent forms may include descriptions of technical details at a higher level. CHECK YOUR CONSENT FORM FOR TYPOS!
• Checklist: Essential elements of consent form
  • List all PIs and their contact information
  • Purpose of the study (a brief, general overview in 1-2 sentences). If using active or passive deception, participants should be informed whenever possible that there may be some withheld or incomplete information that will be disclosed at the conclusion of their participation. If it is not possible to add this language to the consent form, a justification should be provided to the IRB in Section VI.A of the application.
  • Inclusion criteria if any (e.g., must be at least 18 years old to participate)
  • Procedures, including time required
  • Potential risks and steps taken to minimize these risks
    • Importantly, all the risks and steps taken to mitigate these risks that were described in Section III of the IRB application MUST be included in the consent form using appropriate lay language.
  • Potential benefits (if any)
  • Confidentiality assurances
  • Voluntary participation and right to withdraw
  • Right to debriefing
  • Institutional contact (Dr. Tricia Mulligan, Interim Provost)
  • Signature or check-box authorization to consent (see IRB consent form example for authorization statement)

The debriefing statement should include, at the very least, the following pieces of information:

• Information on the principal investigator, including name, college, department, email, and phone.
• For student applications, information on the study's supervisor (faculty member), including name, college, department, email, and phone.
• A clear and concise description of the study, including the goal of the study. If there is any deception, it must be revealed and explained here.
• Instructions on how to take actions related to any risks of the study (for example, a mental health hotline for participants who become anxious from participation).
• Information on who a participant should contact about questions related to the study (the principal investigator and/or faculty supervisor) or if the participant is concerned about the way the participant has been treated (the provost is the contact point).

• Any materials that are generated as a mechanism to communicate information about your study to potential participants must be included in your IRB application. This is to help the IRB consider risks to potential participants such as coercion. Relevant marketing materials include (but are not limited to):
  • Flyers or other advertisements to recruit participants
  • Text of emails sent to potential participants
  • Scripts that will be read to attempt to recruit participants
  • Text of posts to social media

You are required to attach, or to provide a link to, any research materials to be used in this study, as described in Section VD (e.g., standardized surveys, questionnaires, interviews, photographs, audio or video recordings). If inclusion is not practical or possible, a clear rationale must be provided in Section VD.

In designing your instruments, please consider the risk of psychological harm associated with the use of biased language, making sure to use language that is inclusive of all your potential participants. This can sometimes be an issue when asking demographics questions related to gender or racial identity but may show up in other ways. Please consider when and for whom the instrument was designed and whether revisions can be made to be more inclusive of all your study participants.