Institutional Review Board (IRB)


Applicant Information

 

Checklist for Applicants

Before submitting your application take a minute to review this list.  If you are missing anyone of the following pieces of information you could have your application rejected. 

Roles and Responsibilities of Researchers

  1. Correctly complete IRB application (Provide any and all necessary documents for review to the IRB)
  2. Complete online tutorial offered by the National Institutes of Health (http://phrp.nihtraining.com/users/login.php) and obtain a Certificate of Tutorial Completion.
  3. Design and conduct ethical research
  4. Obtain IRB approval prior to initiation of research
  5. Comply with IRB requirements and federal regulations
  6. Implement research as approved and obtain prior approval for modifications
  7. Obtain informed consent from research participants and other required parties
  8. Document informed consent by providing subject with a copy and keeping copy for your own records
  9. Report adverse events and any non compliance immediately to IRB
  10. Retain records for five (5) years under lock and key

Common Reasons for Rejection and How to Avoid Them

  1. Poorly written documents.  Take a minute and carefully review your application prior to submission.  Make sure that the application is grammatically correct.  Application should not be difficult to read and/or understand.  Avoid using language that is obtuse or technical in nature. 
  1. Consent/Assent and Debriefing forms incorrectly filled out.
    • Make sure that appropriate consent, assent (if necessary), and debriefing formats are utilized. 
    • Not including appropriate contact information in the consent form. Must include the name, phone # and email of primary researcher and their faculty advisor as well as the email address and phone number for ORSP. 
    • Consent/Assent forms must not contain any deceptive language and must describe the research design in a language that is easy to understand. 
    • Consent/Assent forms need to be specific, laying everything out for the respondents.
    • Debriefing statement must be written in the past tense.
  1. If research is being conducted at outside institution such as school or other university.  IRB applicants must obtain approval from that institution and provide proof of this approval along with their application.
  • If planning to go into classrooms, the research must tell subjects on the consent form that their grade in class will not be affected by student participation in the study.  Researcher must clearly delineate the roles of student and subject. 
  1. Incorrectly confusing confidential with anonymous.  The two concepts are inherently different when it comes to research.  Whenever one is using a signed consent form, then research participation is not considered anonymous.  Participation can be kept confidential, but is not anonymous. 
  1. If a researcher is planning on using any validated scales or other copy written instruments, they must provide a copy of this scale/instrument along with the application.  They must also provide proof of permission to use the copy written instruments in the study. 
  1. The researcher needs to describe in their application every relevant piece of information about the subjects.  The applicant must be clear and detailed in describing how subjects will be recruited, where they will come from, the age range, what is required of them, any and all risks/benefits, etc. 
  • If working with minors (subjects under the age of 18), the researcher must demonstrate that all precautions have been taken.  This includes, but is not limited to, providing copies of the assent forms, parental consent forms, permission to go into classrooms (if research is being done in schools), any and all instruments, demonstrating that these documents are written in a language that is easy to understand.     
  • The applicant must clearly describe the recruitment process:  where will respondents come from, how they will be recruited, whether or not there is any incentive for participation (if so, what is it).
  • When using minors as subjects, do not refer to them as “subjects” on the parental consent forms. Refer to them as “participants”.
  • If working with a vulnerable population (i.e. minors, the elderly, etc.), all risks involved in participation must be described in detail
  • All research procedures must be described (including pre and post test procedures) in a clear manner.
  • Researcher must describe where research is to be conducted.
  1. Researchers must describe any and all provisions that will be undertaken to ensure privacy of the respondents.  If this does not match federal regulations, then the research will not be allowed to move forward until the applicant has clearly demonstrated this to the IRB. 
    • Researcher has to describe any and all possible risks.  The researcher must describe precautions that are made available to minimize the risk.
    • Any and all safety precautions that will be undertaken must be described in detail.
    • You must fully describe storage and disposal procedures.  Please note that signed informed consent forms and other forms of data (i.e. surveys) must be retained for at least 5 years by the researcher. 
    • Must describe process that minimizes feelings of coercion.  Respondents must not feel as if they were coerced or forced into taking part in the research. 
  1. If planning to apply for exempt status, need to fully and clearly describe why it is exempt and how it specifically fits into one of the exemption categories.

Classroom and Educational Primer

This document is for those researchers who are conducting research within classrooms where they are employed as a teacher or have a relationship with the participants.  

When conducting research with participants to whom the principal investigator is familiar with there is the risk of creating a coercive environment.  This may be unintentional on behalf of the researcher, but the risk still remains.  In order to minimize any intentional or unintentional coercion the IRB insists that following procedures should be utilized. 

Consent and assent forms have to address the following topics: 

  • Stress on the consent and assent form that this is an outside research study that is being conducted towards the fulfillment of a (Master’s or Bachelor’s) Degree at Kean University.
  • Highlight that this activity is not affiliated with any educational activity that they might have participated in previously.  This project is not endorsed nor is it affiliated with {INSTITUTION WHERE RESPONDENTS ATTEND SCHOOL}. 
  • Include language on the consent and debriefing forms that states participation is completely up to the parent and their child. 
  • At no time should participants feel that they have to participate.  They should only participate if they want or choose to. 
  • Participation will not impact any educational benefit that they are entitled to.  If at any time they feel uncomfortable or decide not to participant, they can withdraw from the study.  No one will be penalized if they choose to withdraw.
  • Participation in this research study will have no impact whatsoever on the child’s grades or standing in the class. If the parents decide not to participate they (or their child) will not receive any penalty.  Likewise, if they do participate they will not receive any extra reward or special favor.

All studies using this methodology should use the following procedures:

  • A fellow researcher on hand to administer the survey or data collection instruments. This person should not be affiliated with the school where the data collection is occurring.  The researcher/teacher should be out of the room at the time of data collection if possible. 
  • Full explanation on the debriefing of the experimental design as well as any and all manipulations used by the researcher
  • If at all possible, any and all aspects of the study should not interfere with normal educational practices
  • If any treatments are found to be effective, then these treatments should be administered to others
  • Language on the consent and assent thanking participants for their participation should be left off. 
  • At no time should participants feel that they should or have to participate.
  • Separate consent and assent should be obtained in situations where the research activity is also part of the normal educational lessons taught in the classroom.   At the most basic level, parents are consenting to have their child receive normal educational lessons that they are entitled to.  There should also be separate consent to have the child’s work/test scores/etc included as part of the study. Thus, parents may consent to have their child receive the instructional strategies described but may decide that they don’t want to have the test data included.