IRB FAQs

What is the definition of research?

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Department of Health and Human Services (DHHS) regulations 45 CFR 46.102 (d)

To be considered a “systematic investigation”, a research project must meet all of the following:

1. Attempt to answer research questions (in some research, this would be a hypothesis).
2. Is methodologically driven, that is, it collects data or information in an organized and consistent way.
3. The data or information is analyzed in some way, be it quantitative or qualitative data.
4. Conclusions are drawn from the results.

“Generalizable knowledge” is scholarly work that is intended to be shared, published, presented to colleagues and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge.

In contrast, internal activities specific to Kean University or work performed for an outside entity which cannot be generalized to any other outside entity are not “research” because they do not contribute to “generalized knowledge”.

What is IRB?

IRB is an acronym for  Institutional Review Board. The Kean University IRB is a body of peer researchers and observers charged with reviewing research involving human subjects to protect the rights and welfare of the people who participate in the research.The role of the IRB is to assure compliance with the Code of Federal Regulations, Title 45 (Public Welfare), Part 46 (Protection of Human Subjects).

The IRB evaluates:

1. Assurances that the privacy and rights of participating subjects are fully protected. 
2. Adequacy of the protocols used and their relevance to required desired outcomes;
3. Ways to reduce or prevent these risks;
4. The level of anticipated risks to the subjects that may result from participation in the project;

How do I determine if I need IRB approval for my research?

If there are “human subjects” involved in the activity and the proposed activity is “research” as defined by 45 CFR 46, then IRB approval is required.

What do I submit and where do I send my materials?

You submit your application along with required supplemental documents through Cayuse Human Ethics. 

How long do I have to keep the records after the completion of the research?

Regulatory documents should be maintained for all studies, regardless of sponsor/funding source, or whether the research is funded. As per Federal Regulations, the HHS protection of human subjects regulations require both institutions and Principal Investigators to retain research-related records. As per Kean IRB policy research records must be maintained a minimum of five years after the research is completed and the study closed with the IRB. Records may need to be kept longer if other requirements apply.

Who reviews proposals sent to the IRB?

Members of the IRB represent the schools/college of Kean University, administration, staff, and the external community, consistent with the regulations of the Federal government. The majority of IRB members are Kean faculty.

How often does the IRB meet?

The IRB meets 12 times a year. There is at least one meeting every month from September through June. The IRB does not meet in July and August.

Examples of research that does not contribute to generalizable knowledge and IS NOT subject to IRB review:

1. Classroom projects in a research methods class or laboratory class where the findings will only be reported to the class and/or instructor. (The instructor is responsible for the ethical conduct of this study)
2. Evaluation of a classroom curriculum (evaluations are gathered from students and analyzed solely for internal review to improve the curriculum)
3. In-house program evaluations and accreditation studies
4. Work for a private or public entity that generates a report to the same entity where the data is unique and specific, not generalizable
5. Journalistic interviews

I am a student doing research for a class assignment. How do I determine if my class project requires approval from the IRB? 

Class assignments are typically initiated and completed within a single term. These assignments require students to interact with individuals or collect data about individuals to teach research methodology and help students understand concepts. Usually, they are not intended to create new knowledge or to be disseminated through scholarly publication. Thus, class projects do not meet the federal regulatory definition of “research”, and they do not require IRB approval. However, if your project involves data collection about sexual activity, use of alcohol or illegal drugs, or involvement of illegal activities, and/or if your project includes vulnerable individuals such as minors, pregnant women, prisoners, or cognitively impaired individuals, then your instructor should determine the potential for harm and consult with the IRB.

I am a student doing a class project, honors project, thesis, and/or an independent study project involving human subjects and requiring IRB approval. What is the role of my faculty adviser in the IRB approval process?

All student research requiring IRB approval must be sponsored by a faculty adviser. The faculty adviser serves as the Principal Investigator (PI) and is responsible for reviewing and endorsing the IRB application and co-signs the application indicating as such. The signature of the faculty adviser indicates that they have read the application

1. To make sure the application is properly categorized with regard to application type (exempt, expedited, or full review).
2. To make sure that the application is complete.
3. To ensure that the student realizes the potential for harm and all possible steps are taken to eliminate risks to the individuals involved
4. To make sure that the application is grammatically correct and is comprehensible.

What are the different types of IRB review and how do I know which type of application to submit?

There are three levels of IRB review: exempt, expedited, and full review. Applicants should request the level of review they feel is appropriate for their project. 

Some research involving human subjects may be declared to be exempt from review by the IRB. However, researchers are still expected to abide by informed consent requirements and all documents shared with the human subjects must state that the research is exempt from IRB review according to Kean University’s policy. Some research activities involving human subjects that are expected to pose no more than minimal risk will fit into one or more of eight categories and reviewed by the IRB through an expedited review process. When the research does not fit within an exemption or an expedited review category, it must be reviewed and approved through full review by a convened IRB. 

What is the deadline for application submission to the IRB?

New Exempt and Expedited applications are accepted on a rolling basis.  New Full board applications are due the first Wednesday of each month for consideration at that month's IRB panel meeting.

After I have submitted my application to the IRB, may I begin my research while I am waiting for approval?

No! Any research involving the participation of human subjects must not be conducted until the IRB committee has reviewed the research protocol and (a) determined that the study is exempt from further review or (b) given approval of the research study.

Once I submit my application, will I be notified as to whether it will be reviewed by the committee meeting for that month? 

The status of your application can be tracked on the dashboard within Cayuse Human Ethics.

If I have questions with regard to IRB policy and procedures, whom should I contact?

Contact the IRB staff at irb@kean.edu.

What happens if I need to make changes to my research?

If you make any changes to the basic research design, instruments, etc., you will need to file a change form with the IRB. If you wish to collect data after the one-year expiration date, you will need to file an IRB renewal request. Any deviation from the approved research protocol must be reviewed prior to the implementation of those changes.