What is a Human Subject? Q & A
This session will give a brief background on human subject research and will identify what is considered a human subject and when you may need to take extra steps.
October 18, 2023
Why Consent is Important: Obtaining & Documenting Informed Consent
This session will explain the critical importance of obtaining consent and how to document consent properly.
October 26, 2023
Human Subjects Protection Virtual Conference
November 2-3, 12-4 pm ET
Join us November 2-3 for our annual human research protections conference, entitled "Human Research Protections: Unstoppable". This year's event will address issues of critical importance to human research protections, including:
Click here to register!
All subsequent pages on this site contain information to assist you in the process of obtaining IRB approval and managing your project post-IRB approval.
Please familiarize yourself with this information before initiating the IRB process and be sure to visit the Frequently Asked Questions page.
We look forward to working with you!
Northern Kentucky University
Institutional Review Board
405 University Center
Highland Heights, KY 41099
Phone: (859) 572-5168
Common types of research reviewed by the IRB:
Suk-Hee Kim, Ph.D., C.O.I., M.S.W., B.A.
The School of Social Work, College of Health and Human Services
Andrea Lambert South, Ph.D.
Department of Communication Studies
Gary Newell, Ph.D.
Department of Computer Science
Jason Merrick, MSW
Voting Member for prisoner/ex-offender
Karen O'Connell, PhD, RN, CEN, NEA-BC
College of Health and Human Services, School of Nursing
Shauna Reilly, Ph.D.
Department of Political Science, Criminal Justice and Organizational Leadership
Anita R. Southwick, MPA, MS-ELOC, CCRP
Research, Grants, and Contracts
Kalif Vaughn, Ph.D.
Department of Psychological Science
Erin Watters, BA, CCRP
Unaffiliated Member, Cincinnati Children's Hospital
Lynne Zajac, Ph.D., RN
Department of Advanced Nursing Studies
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.
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:
Click here to locate a Mentor IRB checklist to help prepare for IRB submission.
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.
The Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research. It is approved by the Office for Human Research Protections (OHRP) for all human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS). The FWA is also approved by OHRP for federalwide use, which means that other U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects (also know as the Common Rule) may rely upon the FWA for the research they conduct or support.
NKU FWA #00009011