Getting Started

• 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:
  • Census Regional Analyst Edition
  • Kentucky Race/Ethnic Table
  • Kentucky Population Data
• 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
  • Research Involving Pregnant Women, Fetuses, and/or Neonates

See the relevant heading in the IRB Survival Handbook, 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

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.

• Off-site or Collaborative research
• Single IRB Reliance for select multi-site or collaborative research

Biosafety, Radiation Safety, Markey Cancer Center, etc.

FDA-Regulated Research

• Consent/assent templates are available in E-IRB and on the informed consent webpage
• The Informed Consent Development link includes lay term glossaries, resources to improve readability, Key Information examples and more
• See Sample Key Information for examples of information to present first in the document and process
• Attach consent/assent files – See the tutorial on how to attach for approval stamps and replace attachments
• Use the Informed Consent Requirement Checklist to ensure documents have all items required by federal regulations and local policies
• ORI Remote Informed Consent Guidance

Waiver of Consent vs Waiver of Consent Signatures

• Video tutorial on how to obtain signatures
• Faculty Advisor signature/responsibilities
• Department Chair signature/responsibilities (PDF)

• Respond to Requested Revisions video tutorial
• ABC's of E-IRB - Approved Status video tutorial

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.

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.