IRB Application Tips

What is the purpose of your research?

Provide a brief literature review and research citations to support the study’s purpose and rationale. Only include information that is critical to the present study and avoid reusing an entire literature review from a thesis or grant proposal. Instead, the purpose section should be concise and tailored to the IRB application and should conclude with clearly stated objectives. It should demonstrate that the proposed procedures are methodologically sound and capable of answering the questions they are intended to answer. If it is not clear from the purpose statement, the PI should also briefly explain why they believe the chosen level of review is appropriate.

What subject/participants will be involved in your research?

Clarify how many participants will be involved in the study and how the sample size will be determined. Researchers are responsible for enrolling only the number of subjects that were specified and approved in the protocol.

Equitable Selection

Clarify how the subjects will be selected. Subject selection must be equitable, or the PI must describe the rationale for the invitation of specific subjects.

Research in the Classroom

For research being conducted in K-12 schools, PIs should clearly describe in what capacity they are employed at the school and whether they will be recruiting from among the students, parents or staff with whom they already deal with in the course of their regular work duties. When possible, consider collecting data from a classroom other than your own.  When this is not possible, justify the need to collect data from your students, and describe the safeguards that will be used to ensure that students and parents do not feel unduly influenced to participate.  When describing action research, provide documentation to support the research procedures used in the classroom so that reviewers from other fields can sufficiently understand the rationale behind your methodology and safeguards.

Review the Kean University IRB guidelines and suggestions for additional safeguards for Research in the K-12 Classroom. Review the checklist for consent/assent forms and include all the required language (e.g., participation is voluntary, refusal to participate involves no penalty or loss of educational benefits, deciding to participate will not affect grades, etc.). Be consistent between the protocol description and the language use on the informed consent, assent, and debriefing forms.  When possible, copy and paste material from the application to the forms to ensure consistency between the description of the research procedures and the forms.  Verify that the reading level of the forms is appropriate for the intended audience.

Research in the Workplace

Review the Kean University IRB guidelines for Research in the Workplace. Clearly describe in the protocol and consistently state on all informed consent and debriefing forms the safeguards the PI will use to minimize coercion and undue influence.  

Recruiting:

Explain the recruitment process in detail including the methods that will be used, timing, location, and roles of all individuals involved. Provide a copy of all recruitment materials including any letters, emails, fliers, interview scripts, etc. Research with minors should use the following recruitment procedure in this order: After IRB approval, a flier is sent home or emailed to parents; if parents are interested, they contact the PI to learn about the study. If they agree to allow their child to participate, they sign parental consent and receive a copy of the consent form for their records. After parental consent is obtained, the students are informed about the study. If they agree to participate, they sign the assent form and receive a copy for their records. PIs working with young children should detail how they will obtain assent using age-appropriate methods supported by literature relevant to their population. 

Duration:

Clarify the time or other commitment required of the participants including number of sessions, duration of each session, and total duration including any follow-up activities.

Location:

Specify where the research activities will take place. When possible, choose a research location that is a neutral site rather than a private a home.  If this is not possible given the purposes of the study, the PIs must provide justification for using the chosen site.

Obtaining Consent:

Describe informed consent process.  Explain how potential participants will be told about the study and given the opportunity to ask questions.  Describe how they will be given the opportunity to sign the informed consent form physically or electronically and how they will be able to receive a physical or digital copy of the consent form for their records if they desire one. Explain what will occur if participants do not give consent (e.g., they will be thanked for their interest and will receive a debriefing form or be taken to a screen with an electronic debriefing form if completing their survey online).

Benefits:

Describe the benefits to the subject or to others that may reasonably be expected from the research. When the subjects are not expected to reap any direct benefits from the study, inform the subject that they will not personally receive any benefits; then, describe how the study will benefit the larger community, our understanding of science, etc. 

Risks:

Risk is exposure to harm, including physical, psychological, emotional, professional, social, financial, legal, or other types of harm.  Note that this includes survey or focus group question topics that are potentially sensitive and could trigger emotional distress. IRB applications must identify all possible risks that can result from participation in the study.  If no risks are anticipated beyond the risks encountered in normal, daily life, the application and the documents shared with the subject must state that the risks are minimal.

Procedures to Protect from Risks 

Specific strategies for minimizing or preventing the risks and protecting the welfare of the subjects must be explicitly described. This may include reminding participants that they can quit at any time without penalty, referring them to appropriate agencies for counseling, and providing contact information if they have questions about the study.  Note that the Kean Counseling Center only assists Kean students. Research subjects outside of the Kean community who need counseling should be directed to a free, community-based counseling center or hotline. If such services are provided at the subjects’ workplace, these services may be investigated and offered to subjects on the informed consent and debriefing forms.

Privacy:

Studies with human subjects must maintain confidentiality. Clearly outline the steps that will be taken to ensure that there are no links between the identity of the subjects and the results of the work. The PIs should describe their plans to do this if they are administering an anonymous survey.  If a platform such as Teams will be used to conduct live sessions, the PIs should explain the security features and steps that will be used to maintain privacy and protect participants.

Data Storage:

Paper Files

If data collection will involve paper files, include the location of the locking file cabinets that will store the data. Include a statement that access will be provided to the IRB, if requested.

Electronic Files

If electronic files will be used, describe the safeguards that will be taken to protect the data, such as password protection of computers, cloud storage websites, and databases where files are maintained. If data will be downloaded and stored, include the location of the computer or devices that will hold the files. Include a statement that access will be provided to the IRB, if requested. Describe how the data will be destroyed after 5 years (e.g., electronic files deleted, paper files shredded, etc.).

Measures:

Online Surveys

Verify that your survey addresses all the online survey guidelines found on the Kean University IRB website including the level of risk, collection of personally identifiable information, assurance that informed consent is obtained and participants are debriefed, and exclusion of forced responses (or the rationale for using them).

Survey/Measure/Forms Review

Submit the finalized survey or the interview or focus group questions you plan to use with your application. If significant modifications to the questions are made, the PI must submit a modification via Cayuse so that the IRB can review the updated questions.

Site permission

Before any research activities can begin, the IRB requires site permission documentation from an appropriate authority at each school, district, worksite or other external facility. While the IRB will grant approval to an application without this documentation, a Modification must be submitted via Cayuse to verify permissions are in place before the project may start. Use the templates available at the Kean IRB’s website OR provide a signed approval letter on school/district/company letterhead that includes:

• Person or entity providing permission, including title, contact information and confirmation of appropriate authority to provide permission

• Title of the study

• Description of the project and activities to be conducted at the site

Surveys

Provide a printout of the online survey or provide a link to the online survey. 

Include permission to use measures and copyrighted material, or indicate that they are in the public domain.

Informed Consent, Assent, and Debriefing Forms

When possible, copy and paste material from the application to these forms to ensure they are consistent with the protocol description. When writing the debriefing form, use past tense to summarize what participants did, and if the participants are students, do not include a thank you statement on the consent/assent forms. Use Kean University contact information on the forms, such as Kean email addresses and office phone numbers. If audio or video recording will occur as part of data collection (e.g., during an interview or focus group), a separate consent form for recording must be attached. (Please see this template)  

For additional updates and access to IRB applications, forms and additional information, please visit the IRB’s webpage.