Getting Started
Step 0: If you aren’t sure if your research activity requires IRB Review, check these resources:
- What needs IRB Review Video [HTML]
- What needs IRB Review Guide [PDF]
- Research vs. Quality Improvement [HTML Interactive Tool]
Additional information is available on the "What Needs IRB Review" webpage. [HTML]
If you’re still not sure or you need an official determination, complete the ORI Not Human Research (NHR) Form. [HTML]
Step 1: Complete your Human Subject Protection (HSP) training [HTML] and other applicable training required by UK (e.g., annual Responsible Conduct in Research (RCR) training).
Ensure all study personnel on the IRB application have current HSP training. You can submit the IRB application before training is completed, however completion is a condition of IRB approval. You can view training status in the columns labeled “HSP” and “HSP Date” in the Study Personnel section of your IRB application.
Study personnel without current HSP training may be removed until they complete the training, at which time you may submit a modification request (MR) [HTML] to add them back to the study personnel list.
Resources
- Human Subject Protection (HSP) Frequently Asked Questions (FAQs) [HTML]
- UK CITI Access [HTML]
- "Study Personnel – UK and Non-UK – Adding and Removing" E-IRB video tutorial [HTML]
- Adding Non-UK Study Personnel [D163.0000] [PDF]
- Responsible Conduct of Research & Scholarly Activity (RCR) [HTML]
- Sponsor/Investigator training (GCP) FAQs [HTML]
Step 2: Open the New Researcher Frequently Asked Questions (FAQs) interactive tool [HTML] as you begin the process. The FAQs provide fundamental information such as which review type and whether you should submit to the medical or nonmedical IRB. If you’re new to the UK Institutional Review Board (IRB) process, watch ORI’s brief IRB overview video. [HTML]
Useful Links to Bookmark as you complete your IRB application
- Research Terms Dictionary [HTML Interactive Tool]
- Acronyms list [PDF]
- IRB FAQs [HTML]
Step 3: Determine the applicable IRB review type. [HTML]
Exempt Review
Categories of minimal risk research reviewed by one IRB member
- Exemption Category Table Tool [PDF]
- Exempt Review Decision [HTML Interactive Tool]
- Exemption Decision Charts [PDF]
Expedited Review
Broad categories of minimal risk research reviewed by one IRB member and consultants if needed
- Issues to be addressed [PDF];
Full Convened IRB Review
Research that is greater than minimal risk or doesn’t fit in exempt or expedited categories.
Step 4: Complete the IRB submission in E-IRB. [HTML]
Before starting your application, watch the brief IRB Submission Tips video. [HTML] New investigators, student researchers, or studies with complex protocols or vulnerable populations are invited to request a consult with ORI staff for guidance. [REDCap Form]
Use the applicable checklist to help you navigate the application:
E-IRB System Resources
- ABC’s of E-IRB Video Tutorial Series
- Create Application Video Tutorials
- Attachment Management Video Tutorials
- Change Principal Investigator (PI) Video Tutorial
- E-IRB FAQs [HTML Interactive Tool]
- IRB Review Types webpage [HTML]
Step 5: Identify protocol-specific requirements to address in the application, including:
Subject Population
- Determine who the study population includes. This includes interaction, intervention with people or their private identifiable information or material.
- Estimate the demographics of the subject population. Consider using these tools:
- Consider safeguards for vulnerable populations, including:
- Economically or Educationally Disadvantaged [PDF]
- Impaired Consent Capacity Policy [PDF]
- UK IRB Policy on Children in Research [PDF]
- Guidance for Enrolling University Students as Research Subjects [PDF]
- Guidance for Enrolling K-12 Students as Research Subjects [PDF]
- Student Record Research - Family Educational Rights and Privacy Act (FERPA) [PDF]
- Student Survey Research - U.S. Department of Education/Protection of Pupil Rights Amendment (PPRA) [PDF]
- Research Involving Prisoners [HTML]
- Research Involving Pregnant Women, Fetuses, and/or Neonates [HTML]
Research-Specific Requirements
See the relevant heading in the IRB Survival Handbook [HTML], if any of the following requirements or issues apply to your study:
- Certificate of Confidentiality
- Clinical Trials
- Conflicts of Interest
- Data Security
- Deception
- Digital Technology and Internet Research
- Data & Safety Monitoring
- Disclose and manage Conflict of Interest
- Deception Research
- Future Use and Secondary Research
- Funding Agency Requirements
- Genetic or Genomic Data (Repositories, Tissue Banks, Registries)
- HIPAA in Research
- International Research
- Recruitment
- Suicidality in Research
- Survey Research
Research-Site-Specific or IRB Reliance (Multi-Site, Collaborative)
If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, IRB Reliance or other off-site permission issues may need to be addressed. (This may include national multi-center trials as well local studies involving sites/personnel external to UK.)
Contact IRBReliance@uky.edu early in the planning process so we can help you determine the type of coverage that is appropriate for your project.
Other Human Research Review Committees
Biosafety, Radiation Safety, Markey Cancer Center, etc. [HTML]
Step 6: Determine informed consent needs and check at least one of the items in the Informed Consent Section of the application.
Obtaining Informed Consent/Assent
- Consent/assent templates are available in E-IRB and on the informed consent webpage [HTML]
- The Informed Consent Development link includes lay term glossaries, resources to improve readability, Key Information examples and more [HTML]
- See Sample Key Information for examples of information to present first in the document and process [HTML]
- Attach consent/assent files – See the tutorial on how to attach for approval stamps and replace attachments [HTML]
- Use the Informed Consent Requirement Checklist to ensure documents have all items required by federal regulations and local policies [PDF]
- ORI Remote Informed Consent Guidance [PDF]
Waiving Informed Consent/Assent or Signatures
- Waiver of Consent vs Waiver of Consent Signatures [HTML]
Step 7: Obtain required signatures, then complete the submission section to submit your application to the Office of Research Integrity.
Upon completion of the application, send the application to designated signees. Once they have signed, the PI will sign the application. After all signatures have been obtained, send the application to ORI.
Once your application has been submitted, you can find a view only version in your Submitted folder under your PI Dashboard.
Note: A student investigator (undergraduate, graduate, and postdoctoral students) must add a faculty advisor as study personnel to their protocol to meet the requirement of a University of Kentucky academic program. Additionally, faculty advisors must sign the Assurance Statement on the protocol to certify the scientific merit of the study, the qualifications of investigators, and the adequacy of the facility and resources needed to conduct the research.
Obtaining Required Signatures/Submit Application
- Video tutorial on how to obtain signatures [Signatures (Assurances) Section - How to Complete]
- Faculty Advisor signature/responsibilities [HTML]
- Department Chair signature/responsibilities [PDF]
How long does it take for a Full review study to be approved by the IRB?
Full reviews generally take longer to approve because the IRB must conduct the initial review (and sometimes subsequent reviews) at a convened meeting. A typical turnaround time for full review submissions includes:
- Protocol Submission: When an investigator submits a full review protocol, the E-IRB system schedules the application on the agenda for the next available IRB meeting. Medical IRBs meet every three weeks, and the Nonmedical IRB meets once a month. Protocols are scheduled “first-come, first-served” with a limited number of full reviews allocated per IRB meeting to ensure adequate time for discussion and deliberation.
- Initial IRB full review: IRB members receive the agenda for a convened meeting 7 working days in advance. Determinations for scheduled protocol reviews are made during the convened meeting.
- If the IRB committee requests revisions, ORI staff can take up to 3 working days to convey the IRB’s request. If the protocol is approved during the initial convened meeting, ORI staff may take up to 2 working days to communicate the determination.
- Additional IRB full review: If the IRB makes a ruling of minor revisions (directive or non-substantive changes), the IRB Chair is given the authority to approve the revisions through an expedited review procedure when they are submitted. In this instance, ORI staff can take up to 3 working days to screen revisions after the protocol has been resubmitted. The Chair reviewing the revisions can then take 10 working days to complete the review.
If the IRB requests major (substantive) clarification or revisions, the revisions cannot be approved through the expedited review procedure (i.e., only by the IRB Chair). An entire convened board will review the major revisions at the next available convened meeting. In this instance, the revisions should be submitted before the close of the meeting agenda.
Factors That Can Impact the Review and Approval Process
- Screening and reviewing timelines are working days and do not include weekends or holidays.
- The amount of time it takes an investigator to respond to a request for revisions from the IRB reviewer. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
- An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
- Limited ORI staff or high volumes of protocol application submissions.
How long does it take for an Expedited or an Exempt review study to be approved by the IRB?
Generally, IRB approval can take between 4-6 weeks. However, not all submissions will take that long, and some approvals may take longer. General turnaround for an exempt or an expedited approval includes:
- Initial Screening: Once a protocol application is submitted, ORI staff may take up to 3 working days to either contact the investigator for further information or send for IRB review. This is the same for Initial Reviews (IR), Modification Requests (MR), Annual Administrative Reviews (AAR), Continuation Reviews (CR), or Other Reviews (OR).
- Additional Screening: If a protocol application is returned to the investigator with screening comments from ORI staff or request for revisions from the IRB reviewer, ORI staff may take up to 3 working days for an additional screening after the protocol is resubmitted by the investigator.
- Initial IRB review: Once a protocol application has been assigned an IRB reviewer, the IRB reviewer is asked to complete their review for an IR, MR, AAR/CR, or an OR within 10 working days.
- Additional IRB review: If the IRB reviewer requests revisions be made to the protocol application, ORI staff may take up to 3 working days to communicate the IRB request for revisions to the investigator. When the investigator resubmits the revised protocol application, the IRB reviewer is asked to complete review of the revisions within 10 working days.
Factors That Can Impact the Review and Approval Process
- Screening and reviewing timelines are working days and do not include weekends or holidays.
- The amount of time it takes an investigator to respond to screening comments from ORI staff or request for revisions from the IRB. The longer the investigator needs or takes to resubmit the application, the longer the overall review and approval time.
- An IRB-requested consultant review of the application (e.g., due to subject population and/or non-English consent documents).
- Limited ORI staff or high volumes of protocol application submissions.
- IRB reviewers who volunteer their time can sometimes experience unforeseen circumstances that require reassigning the protocol to another reviewer.
What happens after IRB approval?
Conduct the Research
- Upon receipt of the IRB Approval letter, download "A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research" [PDF] and conduct your study in compliance to ethical and regulatory requirements.
- Download the one page quick guide for what you need to report to the IRB during the study, such as unanticipated problems or protocol violations [PDF]
- Obtaining IRB approval before modifying or deviating from your approved application [HTML]
- The IRB can only approve Expedited and Full review research for one year. ORI will remind you prior to the date approval expires, so that you can submit an annual report to prevent your approval from expiring. Download a sample Annual Administrative Review (AAR) for Expedited protocols or Continuing Review (CR) form for Full protocols, so you know the information to collect while conducting research. [HTML]
- Access the UK Electronic Research Notebook for data collection and retention [HTML]
