IRB Submission & Review Types Questions/Answers
Questions
How do I find out general information about the UK IRB and human research?
Where should I start to determine what type of IRB review will be required?
How do I request IRB approval for changes while conducting the research?
Does ORI provide educational resources for researchers?
What information or resources are available for conducting survey research?
Answers
How do I find out general information about the UK IRB and human research?
The IRB FAQs answer common questions regarding review operations, Medical vs. Nonmedical IRB, informed consent, terminology, etc. Categories include General IRB, Need for IRB Review, Informed Consent, and Continuing/Annual Administrative Review.
A printable FAQ handout provides answer to select questions for researchers or faculty new to the UK IRB process.
Where should I start to determine what type of IRB review will be required?
ORI has a Getting Started webpage [HTML] for individuals new to human subject research. The ORI IRB Review Types webpage [HTML] provides resources for determining which type of review a protocol will require.
Exempt and Expedited review is designed for minimal risk research. However, each category has conditions and limitations. Research that cannot meet the criteria for exempt or expedited review must be submitted for full review by a convened board.
In addition to checking the ORI guidance, researchers are encouraged to contact ORI for consultation and a preliminary interpretation of the most appropriate application type. Ultimately the IRB will choose the type of review based on the full application relative to the regulatory and ethical framework.
|
Review Type |
Risk/Initial Review Categories |
Initial Review by: |
Guidance |
|---|---|---|---|
|
Exempt |
Minimal Risk/6 Categories |
 1 IRB member (consultant if necessary) |
UK ORI New Common Rule Exemption Categories Tool [PDF] |
|
Expedited |
Minimal Risk/7 Categories |
 1 IRB member (consultant if necessary) |
Issues to be Addressed when conducting Expedited Review [PDF] |
|
Convened |
Greater than Minimal Risk or doesn't fit in above categories |
|
Research Risk Assessment Guidance [PDF] |
How do I request IRB approval for changes while conducting the research?
Modification Requests (MR) – submit a MR for any change to a protocol from what was previously approved. This includes proposed changes to the current IRB approved protocol or changes which impact an individual subject, but does not change the overall protocol (i.e., Exception or Deviation)
- Exception - one-time enrollment of a research subject in a protocol that fails to meet current IRB approved
- Deviation - one-time departure from the current IRB approved protocol once a subject has been enrolled
*Changes may not be initiated without IRB review and approval,
except where necessary to eliminate immediate hazard.
- Continuing Review (CR) or Annual Administrative Review (AAR)– changes may also be requested as part of the annual or continuing review submission.
Does ORI provide educational resources for researchers?
Yes, In addition to resource websites such as Getting Started and the IRB Survival Handbook, the ORI Education Team has built an Education Resource [HTML] library of topic-specific videos, recordings, and interactive tools. These resources aim to provide clear and accurate content, in a brief and engaging format.
What information or resources are available for conducting survey research?
The ORI Survey Website [HTML] includes survey guidance and tools developed to meet the diverse needs of survey researchers. It includes identifiable and anonymous consent templates, resources for advertising, survey platforms, fraud prevention, and regulations applicable to school-based surveys.
