Although many activities conducted by faculty, students, and staff may be labeled as research, the IRB reviews only those projects meeting all three criteria established by Federal regulations:
1) The project involves obtaining data from a living human subject through intervention or interaction with the individual, or identifiable private information, AND
2) The project is an intentional and systematic investigation using the prevailing methodologies in the discipline, including research development, testing, and evaluation, AND
3) The ultimate aim of the project is to generate generalizable results expected to contribute to the development of knowledge in the discipline. (The concept of generalizability is usually applied to quantitative research, but applies to qualitative research as well because of the expectation to contribute to knowledge.) "Contribute" may mean publication but can also mean dissemination in another venue, such as a conference, poster session, etc.
Source: Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Part 46, Protection of Human Subjects (hereafter, 45 CFR 46).
IRB reviewers try to reply to the Principal Investigator (PI) or send an approval within two weeks or ten classroom/school days. This is not a guarantee, especially around holidays, spring break and during the summer. However, it is rare if a PI doesn’t receive some type of communication from the IRB reviewers within this time frame unless the protocol requires a Full Board review. This will take more time since it requires the entire IRB committee to meet and discuss.
If you receive comments about your IRB application from the IRB reviewers before an approval, please be aware that there will be time between your reply to the reviewers and an approval or additional comments as well. Do not assume you will receive an approval in two weeks.
Additional communications may be required prior to an approval.
Studies approved as Exempt do not expire.
Studies approved as Expedited will typically not expire. The IRB has the ability to require a continuing review and determine how frequently the continuing review will be required.
Studies approved as Full Board expire every year. The PI must follow IRB procedures for submitting a continuing review at least 30 days prior to the annual expiration date. The procedure for submitting a continuation can be found here.
CITI Training is a web-based educational site utilized by the NKU IRB to meet federally mandated requirements that anyone involved in research be trained prior to initiating research. CITI has several training components including those for general human subject research, research with minors or school children, and research within the healthcare system. You can find information on how to get started on CITI via the NKU CITI training website.
NKU requires all researchers to take, and pass with an 80% or higher score for each module, the following courses in CITI:
History and Ethical Principles, Assessing Risk in Social and Behavoral Sciences, Informed Consent, and Privacy and Confidentiality.
Researchers funded by either National Science Foundation (NSF) or Public Health Service (PHS) grants are required to take and pass a Financial Conflict of Interest (FCOI) module (Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (COI-Basic)) with an 80% or higher score.
Students/trainees that are funded by either National Science Foundation (NSF) or select National Institutes of Health (NIH) grants are required to:
Take and pass the Responsible Conduct of Research (RCR) course with an 80% or higher score for each individual module.
Please note that CITI will tell you that you are passing with 80% but you will not pass unless you have an 80% or higher on each individual module.
Mentor IRB will prompt researchers with questions relevant to the study type. The only uploaded documents into the system should be supplemental documents that may include:
Recruiting announcements (classroom, bulletin boards, emails)
Data collection tools
Surveys, questionnaires, sample questions
Description of software or online testing applications
Permission to conduct research on organization letterhead with signature (if applicable)
Click here to locate a Mentor IRB checklist to help prepare for IRB submission.
All amendments must be submitted through Mentor IRB prior to implementation. Any previously approved document that is being revised (i.e. consent form, recruitment materials, etc.) must be submitted in a track changes version and a clean version with changes accepted.
Instructions for how to submit a study amendment for studies approved before 07/01/2017 can be found here.
Instructions for how to submit a study amendment for studies approved after 07/01/2017 can be found here.
You are required to use the NKU Informed Consent, Assent, and Parental Permission templates and to use a NKU IRB stamped informed consent/assent form for your study. Mentor IRB will automatically stamp the informed consent documents electronically with an approval date and an expiration date.
Please visit the NKU IRB Informed Consent web page for additional tools related to informed consent.
Per NIH, “A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive health-related research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.” For more information, please visit the NIH CoC Kiosk.