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:
- Attempt to answer research questions (in some research, this would be a hypothesis).
- Is methodologically driven, that is, it collects data or information in an organized and consistent way.
- The data or information is analyzed in some way, be it quantitative or qualitative data.
- 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:
- Assurances that the privacy and rights of participating subjects are fully protected.
- Adequacy of the protocols used and their relevance to required desired outcomes;
- Ways to reduce or prevent these risks;
- 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.
How do I start the process?
Under the submission information tab, you will find the different review categories. Please click on it to find more information on different types of IRB application review. Please print out the application and submit the paper copy to IRB office T-130 by the monthly deadline (posted on the website).
What do I submit and where do I send my materials?
You submit your application along with required supplemental documents to the IRB office located in T-130. Please review the application category and submit your consent form, assent form (if applicable), debriefing form, site permission letter of support from research sites and research instruments such as tests, surveys etc. (if applicable), NIH/CITI training certificates of PIs, CO-PIs and Faculty Advisors to the IRB office.
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:
- 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)
- Evaluation of a classroom curriculum (evaluations are gathered from students and analyzed solely for internal review to improve the curriculum)
- In-house program evaluations and accreditation studies
- Work for a private or public entity that generates a report to the same entity where the data is unique and specific, not generalizable
- 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 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
- To make sure the application is properly categorized with regard to application type (exempt, expedited, or full review).
- To make sure that the application is complete.
- To ensure that the student realizes the potential for harm and all possible steps are taken to eliminate risks to the individuals involved
- 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. The IRB Chair, in consultation with committee members, if necessary, will determine the correct level of review.
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.
Can I submit all my documents through email?
You must submit a paper copy of your application with all the appropriate signatures to Townsend Hall, room 130.
What is the deadline for application submission to the IRB?
Deadlines are posted on the compliance website. All applications must be complete and submitted two weeks before the monthly committee meeting as indicated on the compliance website.
After I have submitted my application to the IRB, may I begin my research while I am waiting for approval?
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?
We do not send automatic email responses confirming receipt of IRB Applications; however, upon preliminary review, if the application is incomplete we will notify the applicant via email.
If I have questions with regard to IRB policy and procedures, whom should I contact?
You should contact your faculty advisor. If necessary your faculty advisor may contact the IRB.
If my application is approved with provisions, what do I do next?
You should address each provision of the IRB committee by filling out the Provisional Form. This form can be found on the compliance website and must be submitted within two months from the date of your provisional approval.
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. You must use the change forms, available on the compliance website, to request a change of protocol review.
What happens if my research protocol is not approved by the IRB?
Principal Investigators may appeal an IRB decision. A principal investigator may appeal the decision by writing a letter to the IRB requesting reconsideration. At the discretion of the Chair, the principal investigator may make such an appeal in person or in writing to the IRB. An appeal of a disapproved research project must be reviewed at a full board meeting. The IRB retains final authority to approve the proposed research with human subjects.
Under what conditions may written informed consent not be necessary?
The investigator may obtain informed consent through the use of an oral consent script that includes information regarding the nature and duration, risks and benefits, alternatives, and cost to the subject. The subject will either verbally agree or not agree to participate in the study. This can only be done if (a) the only record linking the subject and the research would be the consent document and the potential risk would be the potential harm resulting from a breach of confidentiality, and (b) the research presents no more than minimal risk of harm to subjects.
If I am a Kean University student or faculty member doing research at another institution and IRB approval has been obtained from the other institution, do I also need approval from the Kean University IRB?
Yes, you must also receive approval from the Kean University IRB.
Is there anything else I should know?
All researchers submitting proposals and their faculty advisers must complete the NIH or CITI training and submit the certificate with the application. The NIH training website is found in the application packet. To go to the online training, click here. Please note that anyone named on a proposal form, including a thesis adviser, must submit the NIH certificate. Please retain a copy of your NIH certificate for future IRB submissions. NIH certificates must have a validity of 5 years. After 5 years, you must renew the certificate.
I am conducting a secondary analysis of existing data. Do I need to obtain approval from the IRB?
Yes. Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.
In order for the committee to evaluate research that includes secondary analysis, the researcher will need to provide:
- A complete protocol for the secondary study;
- The details of primary data collection (which may include the original protocol, consent, and approval, if research), or the source of publicly available data; and
- If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.
After these documents are submitted, the committee will be able to decide if the research is exempt, non-exempt, requires new consent, or does not need to be reviewed further.