APPLICATION REQUESTING CHANGE REVIEW OF A RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS
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All applicants must submit the following items:
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This application
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Consent form(s) if applicable
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CITI Human Subjects Training Certificate
If applicable, these items must also be submitted with the application for it to be considered complete:
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Advisor (found here) and Co-Pi form (found here)
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Assent form (for participants under 18)
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An additional Consent form for participants being photographed or recorded via digital media
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Site permission (if applicant is conducting research anywhere other than Kean University)
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Copies of all survey instruments, interview questions, recruitment letters, emails, advertisements
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Permission to use measures created by a different researcher
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Complete answers to all questions must be provided and all necessary documentation submitted.
Incomplete applications will be returned without review.
General Information
Provide the Following Information
Describe in detail proposed changes to the following sections:
Briefly describe the context and goals of your research project. Summarize the background, nature, rationale and significance of the proposed study. In outline form, clearly state the objectives of the research, major hypothesis and research design. Provide three to five references. Please be advised that the IRB is composed of individuals from many disciplines and thus the description of your research should be written in terms readily comprehensible by non-experts.
Describe the involvement of the human subjects in this project. Selection of subjects must be equitable and, in the case of protected populations such as children, prisoners, pregnant woman etc. should address their special needs. Clearly state the following: Who are the subjects? What will they be doing? How many subjects will be involved in the project? What is the relationship (if any) between the researcher and the subjects?
Specify how subjects will be recruited (e.g. advertisements, announcements in class, e-mail, internet, etc.). NOTE: Be aware of privacy provisions when designing recruitment activities. The text of any advertisement, letter, flier, oral script or brochure used to solicit potential subjects must be attached.
Provide a description of the procedures to be followed. Include copies of questionnaires and/or interview protocol, or a sufficiently detailed description of measures to allow the IRB to under the nature of human subjects participation. Indicate the duration of anticipated research as applicable from the viewpoint of the participant (the length of each session and the number of sessions).
Describe the setting (e.g., a classroom) and the location (e.g., name of school) where the research will be conducted. (NOTE: If research is to be conducted at another institution or facility (e.g. a school, community center, place of business, etc.) a signed copy of the permission letter from that institution authorizing the researcher to collect data on its grounds must be attached).
State in detail your plans for obtaining each subject's informed consent to participate in this project Describe how this information will be conveyed to subjects. BE SPECIFIC! Outline the steps chronologically (attach copy of informed consent form). NOTE: At least 2 copies of the forms should be handed out to participants, with one for them to sign, date and hand back and one for them to keep for their records. If research involves minors, explain in detail the assent process. Attach copy of verbal assent script or written assent form. Submit an additional ICF, in case of participants being photographed or recorded via digital medium.
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Explain benefits of participating in the study for participants. If none, state this. Then explain the benefits of the study in general and to the public. List all possible or expected benefits.
There are 3 parts to this section. Please make sure you answer all 3 parts. All research carries some degree of risk, even if minimal (the risk of everyday life). You must identify all possible risks to subjects. Address how much risk the research introduces into the existing situation.
8a). Describe all the possible risks (physical, psychological, sociological, legal, financial, or other) that can result from participation in this project.
8b). Indicate whether or not the risk(s) you described is considered "high, moderate, or minimal”.
8c). Describe in detail the procedures you have designed to minimize each of the identified risks
These are separate issues. You must address both. Privacy applies to the person (e.g., how potential participants are identified and contacted; who is present during the research activities; how public is the setting; is the researcher accessing the minimum amount of information necessary). Confidentiality applies to the data (e.g., identifiable data; access to data; under what circumstances data may be shared) Describe in detail how privacy will be protected and confidentiality will be maintained.
Specify how you will keep your data secure, and maintain confidentiality during and after the research. Be specific and describe how data will be stored throughout the duration of the project and upon its completion. PLEASE NOTE THAT ALL CONSENT FORMS AND DATA MUST BE KEPT UNDER LOCK AND KEY FOR 5 YEARS.
Describe how you will ultimately dispose of your data after you have completed your research (e.g. shredding, deleting digital files). PLEASE NOTE THAT ALL RESEARCH RECORDS MUST BE MAINTAINED FOR AT LEAST FIVE YEARS AFTER THE COMPLETION OF THE RESEARCH.
Are you using any scales or instruments you did not create yourself? If so, list the names of those scales and provide a copy of the permission to use the instrument. If it is in the public domain, please indicate below. If you purchased the scale, provide proof of purchase.
If applicable, provide the following: 1) a description of the debriefing procedures to be used in cases where deception has occurred: 2) a statement describing what actions you will take should the research reveal the possibility of a medical or other potentially troubling condition.
Please address all other changes below as requested in your provisional letter by listing each change individually. This includes changes you have made to your supporting documents.
Example:
- Modifying consent forms - ICF Debrief Section
- Modifying number/age groups of participants - Section 2
- Modifying survey methods - Section 12, etc.
Attachment
Please upload a single PDF File
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Click here for a guide on how to combine PDF files.
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If applicable, include as an attachment to this form copies of all revised survey instruments/permission letters,
revised consent, assent, and debriefing forms and training certificates for new individuals who were not
identified on your original application.
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* Only attach files if they have been changed for a provision. You do not need to re-attach a file you included on your initial submission if it did not change. (Except signatures. Documents must be signed on each submission).
* Combine all the documents into a single PDF file in this specific order: ​
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Advisor Signature Page (if needed). Click Here to download.
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Extra Co-PIs Signature Page (if needed) Click Here to download.
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CITI Training Certificates
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Consent and Debrief Forms (Assent and video/audio included)
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Site Permission
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Copies of all measures, survey instruments, interview questions, recruitment letters or emails, advertisements
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Permission to use measures created by a different researcher.
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All other documents.
The undersigned accept(s) responsibility for the study, including adherence to DHHS regulations, New
Jersey law, and Kean University policies relative to the protection of the rights and welfare of
subjects/participants in this study. In the case of student applications, the Faculty Advisor and the student
share responsibility for adherence.
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By signing this form, I certify that I am familiar with Kean University policies and federal and state
regulations regarding the protection of human subjects in research. I will not begin this study until I
receive a written notice of approval, without provisions, from the IRB. I will conduct this study following the
approved protocol. I will report any adverse events or emergent problems to the IRB; will obtain IRB
approval before implementing any modifications of protocol; and, will request continuing review and
approval for any activities beyond the study end date.
Direct questions about the IRB application and review process and schedule to irb@kean.edu or visit the
IRB website at https://www.kean.edu/offices/research-and-sponsored-programs/irb-research-
compliance
