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IRB Training, Submission Procedures, Deadlines and Application Forms

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Human Subjects Research Links

Required Training – Human Subjects Research

All investigators, key personnel, and faculty advisors are required to complete human subjects research training at least once every three years and provide a copy of training documentation to the Institutional Review Board (IRB) with all applications submitted for review.

EKU provides a subscription to the Collaborative Institutional Training Initiative (CITI) online training system, and the Basic Course for Human Subjects Research is used to satisfy training requirements. Click here to access the CITI Training Guide for instructions on registering and using the CITI training system. When registering, the responses to Items 1 and 2 under Step 7 in the instructions are critical to registering for the correct course.

At the end of the training, a completion report and certificate will be issued. Completion documentation must be attached to the application at the time of submission for the principal investigator and all other key personnel. If the Principal Investigator is a student, the faculty advisor must also complete the training and attach completion documentation.

Individuals must first complete the Basic Course; the Refresher Course is used only for recertification (every three years) of individuals who have previously completed the Basic Course and provided a completion report to the IRB. If a Refresher Course certificate is submitted to the IRB, documentation of a previous completion of the Basic Course must also be included.

The initial training typically takes 2-3 hours to complete, depending on each individual’s familiarity with human subjects research regulations. Once an account is set up, individuals may complete the course modules in as many sessions as needed by simply logging in and resuming work on the course. IRB proposals are not reviewed until all required training documentation has been submitted.

IRB Exempt Research

Projects that qualify for exemption under the federal regulations are reviewed by the IRB through a limited review process. If the IRB determines that the project is eligible for exemption and that the research protocol includes appropriate protections for the human subjects, the project is exempt further review for three years as long as there are no changes to the research protocol.

Research activities are exempt when the project involves not greater than minimal risk and when the only involvement of human subjects falls within one or more of the categories of exemption. Research involving greater than minimal risk or involving any activities that fall outside these categories must be reviewed by the IRB through expedited or full review procedures. In addition, studies that involve prisoners as subjects (other than incidentally without the investigator’s knowledge) require full review.

Categories of Exemption, effective January 21, 2019:
Category 1: Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate safeguards to protect the privacy and confidentiality of the subjects.

IMPORTANT: Subpart D: Additional Protections for Children Involved as Subjects in Research restricts Exemption 2 in the following ways: (1) For research involving children, exemption 2 (i) and 2 (ii) above may be applied only to research involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed; (2) Exemption 2 may not be applied to survey procedures or interview procedures involving children as subjects; and (3) Exemption 2 (iii) above may not be applied to research involving children.

Category 3: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate safeguards to protect the privacy and confidentiality of the subjects.

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

IMPORTANT: Note that this exemption applies only to adult subjects and cannot be applied to research involving children.

Category 4: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Category 6: Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

IRB Expedited Review

Research activities may be reviewed by expedited review procedures when they involve no greater than minimal risk and when the only involvement of human subjects falls within one or more of the expedited review categories listed below.  Research involving greater than minimal risk or involving any activities that fall outside these categories must be reviewed by the IRB through full review procedures.  In addition, studies that involve prisoners as subjects (other than incidentally without the investigator’s knowledge) require full review. 

Expedited Review Categories:
Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) below is met: (a) Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.); or Research on medical devices for which (i) an investigational device exemption application is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.  Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)  Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

IRB Full Review Research

When a study presents greater than minimal risk to its subjects, includes any activities that fall outside the Federally-defined categories for exemption and expedited review, or involves prisoners as subjects, full review is required. Full reviews must be conducted by the full IRB committee at a convened meeting with a quorum of voting members and at least one non-scientist voting member present. In addition, if the study involves prisoners, a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity must also be present and have voting rights for the review of the study.

IRB Reporting Forms

Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. Form R: Protocol Revision Request is to be used to request approval to implement changes to a previously approved protocol. Such changes may include:

  • Revisions to the study’s research procedures
  • Extension of a study’s end date
  • Revisions to recruitment materials and/or procedures
  • Revisions to consent, assent, and/or parent/guardian permission form(s) and/or procedures
  • Revisions to data collection instrument(s)
  • Revisions to the number of subjects to be recruited
  • Revisions to study personnel
  • Other revisions

Research protocols that have been approved by the IRB are approved only for the period indicated on the approval notification. If used to request approval to extend the study beyond the approved expiration date, this form must be submitted at least two weeks in advance of the project’s expiration date and may be used to request an extension of a study up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the initial approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms and submission process.

Please note: Form R must be downloaded, completed, and submitted online through InfoReady ReviewTM.The final report must be filed with the IRB within 30 days of the project’s expiration date.

Research protocols that were initially approved by the IRB through either expedited or full review procedures prior to January 21, 2019 are subject to annual review by the IRB if the project extends for more than one year. Studies that were initially approved through expedited review procedures on or after January 21, 2019 may not be subject to continuing annual review, and investigators should review their approval notification for continuing review requirements. All studies approved through full review, regardless of the initial approval date, are subject to annual continuing review.

A completed Form C: Continuing Review must be submitted to the IRB prior at least two weeks prior to the anniversary date of the protocol’s approval for each year the study is active, up to a maximum of three years from the study’s initial approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms.

To request approval to extend the project beyond the approved study period, Form R: Protocol Revision is required and may be used to satisfy the annual continuing review requirement.

Please note: Form C must be downloaded, completed, and submitted online through InfoReady ReviewTM. The final report must be filed with the IRB within 30 days of the project’s expiration date.

For all non-exempt studies, a final report must be filed with the IRB within 30 days of the project’s expiration date. A final report must be filed with the IRB within 30 days of a study’s completion expiration date, unless the study was approved for exemption. Final reports must be submitted through your InfoReady Review account following the instructions below:

  • Log in to your InfoReady Review account using your EKU credentials (email address and password).
  • Click the Applications link from the top menu bar.
  • Select the title of your initial application.
  • Click the Progress Report button for your application from the far right column.
  • Complete the information fields and attach a copy of the results obtained in the study (i.e., summary, article, paper, abstract from a resulting publication or presentation, etc.).
  • Click the Finalize button to submit your report. This button is located just above the attachment fields.

IRB Submission Deadlines for Full Review Applications

Applications for exemption and expedited review are reviewed on a rolling basis. However, investigators are advised that the IRB members are faculty who are away from the University during the summer, between semesters, and other times when the University is closed. There will be a delay in the review of applications during these times. In addition, the review of student applications is dependent upon the approval of faculty advisors and committee members and can be delayed if these individuals are not available to review applications in a timely manner.

Research protocols submitted for full review must be received by the deadlines below to be reviewed at that month’s review meeting. Applications submitted after the deadline will be scheduled for review at the next meeting. Investigators are encouraged to attend the meetings to answer questions or address concerns raised by IRB committee members. Investigators should expect a delay in approval if they are not able to attend the review meeting.

Full Review Meeting Schedule

Submission DeadlineMeeting Date & TimeMeeting Location
March 14, 2025March 31, 2025 at 1 pmZoom

IRB Submission Procedures and Application Forms

All investigators, key personnel, and faculty advisors are required to complete human subjects research training at least once every three years and provide a copy of training documentation to the IRB with all applications submitted for review. EKU provides a subscription to the Collaborative Institutional Training Initiative (CITI) online training system, and the Basic Course for Human Subjects Research is used to satisfy training requirements. Click here for detailed instructions on registering and using the CITI training system. At the end of the training, a completion certificate and report will be issued. Documentation must be attached to the application at the time of submission for the principal investigator, key personnel, and faculty advisors.

Please note: When adding courses in CITI, Questions 1 and 2 are critical in ensuring that you are completing the correct course. You must select one of the two investigator groups in Question 1 to register for the Basic Course. In Question 2, please choose “I have not completed the Basic Course.” Please choose “no” or “not at this time” for the Responsible Conduct of Research, Conflicts of Interest, Laboratory Animal Welfare, and Biosafety items. These courses are not required for IRB purposes. Please be sure the course you complete is called Biomedical Research – Basic/Refresher or Social & Behavioral Research – Basic/Refresher and that the Stage is Basic. The only exception to this is if you completed the Basic Course three years ago and need to complete the Refresher course, which will show as “Due Now” in your course menu. If your current training is a Refresher course, you must also attach documentation of your past completion of the Basic Course.

Once you have completed training and learned about how to protect human subjects in research, your next step is to classify your study into one of three Federally-defined categories. The level of review required for a study depends on the specific activities to be undertaken in the study. For the exemption and expedited levels of review, the study must present no greater than minimal risk to the subjects, and all activities must fall within specific categories of research activities. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

For more information about classifying your study, please visit the links below to view details about each level of review.

When your application materials are ready for submission, please follow the steps below to submit online.

  • All applications for IRB review must be submitted online by the principal investigator.
  • After completing the application form and all required attachments, access the online submission system. Choose the appropriate review level from the list of available opportunities and click the Apply button on the right. If needed, you can filter the category column by Institutional Review Board (Human Subjects Research).
  • If you are a current EKU employee or student, click the option to log in as an EKU user. Your user name is your EKU email address, and your password is the same as what you use to log in to EKU’s network.
  • Complete the basic information in the online application and upload the application form and all required attachments in their original file formats (i.e., Microsoft Word documents). Please do not convert files to PDFs. PDFs are allowable for signed documents, CITI training documentation, and other files that were provided to you in PDF format. If you copy and paste text into the application’s form fields, please format your text to Tahoma font in size 10 prior to copying.
  • Upon receipt of a new online application, the IRB administrator will review the submission for completeness and return incomplete applications for updates prior to processing.
  • Once an application is accepted by the IRB administrator, it will be assigned to the faculty advisor (if the principal investigator is a student) and then to the department chair for approvals prior to being reviewed by the IRB.
  • If the IRB reviewers have questions or request updates to the application materials, the principal investigator will be notified by email and asked to resubmit application materials by email.
  • Once the IRB has approved the application, the principal investigator will be notified by email.

There is no deadline for the submission of limited review or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive feedback from an IRB reviewer or notification of approval in approximately two weeks from the time department chair approves the submission. Approval times will be extended during the summer months, winter break, and other times when faculty are away from campus.

Applications submitted for full review must be submitted by the published deadlines. Applications submitted after the deadline for an upcoming meeting will be scheduled for review at the following meeting. Investigators will be notified when an application is scheduled for review and invited to attend the meeting. Attendance at the full review meeting provides the opportunity to answer questions from the IRB members during the review process. If the investigator is unable to attend the meeting, a list of questions and concerns will be prepared after the meeting and sent to the investigator by email. If there are outstanding concerns, the committee will not be able to vote on the application, and investigators should expect a delay in the approval process until the next scheduled meeting.

If the faculty advisors, department chair, or IRB reviewers have questions or request updates to the application materials, the principal investigator will be notified by email and asked to resubmit updated application documents by email. Once the IRB has approved the application, the principal investigator will be notified by email.

All IRB communication is sent to official EKU email accounts. It is the responsibility of the investigators to check email regularly during the review process and respond to inquiries promptly. Delayed responses will always result in a delay in the approval process.