AAHRPP Questions of the Week

Reference Guide [PDF]


UK Human Research Protection Program

What rules or guidelines are you expected to follow? Answer
What ethical standards or guides do you follow? Answer
If you propose research be conducted at an international location, what do you inform the IRB regarding applicable local regulations, ethics review requirements, or cultural norms? Answer
How does UK ensure the rights and welfare of participants are protected when the investigator is operating at a non-UK facility, is conducting collaborative research, or when oversight is shared with or deferred to another organization or IRB? Answer


What Needs Institutional Review Board (IRB) Review?

Could a Human Subject not have a hear beat? Answer
When does secondary research with specimens or data require IRB review? Answer
What is the process for when determining whether an activity is under the purview of the IRB? Answer


IRB Submission & Review Types

How do I find out general information about the UK IRB and human research? Answer
Where should I start to determine what type of IRB review will be required? Answer
How do I request IRB approval for changes while conducting the research? Answer


Scientific Design & Minimizing Risk

In addition to researchers, who is involved in conducting scientific review of human research at UK? Answer
What is the minimum IRB requirement for maintenance of research records? Answer
What additional information privacy regulations apply to select protocols? Answer
What is the difference between protecting the privacy interests of participants and maintaining the confidentiality of data? Answer
How do IRB regulations define minimal risk? Answer
How does the IRB assess the risk-benefit ration of the research? Answer
How might investigators minimize risks in research? Answer


Monitoring & Reporting Requirements

What are examples of events/issues that you report to the IRB? Answer
What unanticipated problems or adverse events are investigators required to promptly report to the IRB? Answer


Qualifications, Training, and Oversight

What Responsibilities and Qualifications are required for research investigators? Answer