Checklist for Applicants

Institutional Review Board

Checklist for Applicants

Review this checklist before submitting your application. If you are missing any of the following you could have your application rejected as incomplete

  Are you using the most recent forms downloaded from the compliance website? http://compliance.kean.edu

  Have you filled out all of the sections of the form?

  Have you obtained all of the necessary signatures?

A. PROTOCOL DESCRIPTION

  Have you described the background and goals of the project and provided a literature review and research citations to support the purpose and rationale for study?

  Have you included all of the following information about the involvement of human subjects?

  Described in detail exactly who the subjects are who will be taking part in your study

  Listed how many subjects will be involved

  Described exactly what human subjects will be asked to do, including the frequency and duration

  Described in detail how the participants will be recruited and attached copies of recruitment flyers, letters, or script

  Described how long the research study will last

  Described where the research will be conducted

  If it will be conducted at another institution, have you provided a signed copy of the IRB approval or permission letter from that institution using the proper format?

  Have you clearly described the plans for obtaining informed consent, following the procedure for recruitment in order?

B.  RISKS AND BENEFITS

  Have you described the expected benefits of participating in this study?

  Have you listed all of the possible risks?

  Have you indicated for each that the level of this risk is high, moderate, or minimal?

  Have you described the procedures you have put in place to protect participants from each of these risks?

C.  CONFIDENTIALITY

  Have you described how confidentiality will be maintained?

  Have you described how and where the data will be kept throughout the duration of this project?

D. INFORMED CONSENT FORM

On your consent form have you conveyed all of the following pieces of information to subjects?

  Identifying who you are and where you are from and using the Kean seal on all forms

  Stating the purpose and goal of the study

  Telling respondents how long participation will take

  Describing the procedures involved

  Described any and all risks associated with participation

  Described any and all benefits associated with participation

  Stated whether or not there is any compensation associated with participation and, if there is compensation, described what it is

  Described to participants how records will be kept confidential

  Stated that participation is voluntary and that refusal to participate involves no penalty or loss of benefits

  Stated that participants can withdraw from the study at any time

  Provided the names and contact information for the primary researcher, their faculty sponsor, as well as the phone number and e-mail for the IRB

  Provided numbers for participants to contact incase study deals with issues of a personal or private nature

  Included affirmation statement that states subjects have read the form, understand its contents, and agree to participate in the study.

  Included area for the participant to sign the consent form

  If dealing with minors, have you included an assent form?

E.  DEBRIEFING FORM

Have you included a debriefing form that contains all the following?

  Statement thanking participants for their participation

  Revelation of the purpose of the study

  Revelation of any deception involved

  Information about compensation discussed

  Names, phone numbers and email addresses included for the principal investigator and their faculty advisor (if applicable)

  Email and phone for the IRB

  Contact information in case participation has caused them to feel uncomfortable in any way. This should take the form of a place or number participants can call for counseling.

F. DOCUMENT CHECKLIST

The following documents must be included with your application

  Copy of proof of successful completion of online IRB tutorial (NIH Certificate of Tutorial Completion) for all members of the research team

  Copy of Informed Consent form

  Copy of Assent form (if applicable)

  Copy of Debriefing form

  Copy of recruitment flyer, letter or script

  Copies of any and all survey instruments

  Copies of any and all stimuli that will be presented to participants

  Copy of approval letter from other institution authorizing researcher to collect data on its grounds

  If research is being conducted in conjunction with other school, proof of IRB approval from that institution

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