Human Research Question & Answer Guide

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


Conflict of Interest (COI)

What is UK's policy on Conflict of Interest (COI)? Answer
How is researcher COI managed? 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
What are the IRB's expectations regarding oversight and delegation for medical intervention studies and clinical trials? Answer
What is your process for task delegation? Answer


Data & Safety Monitoring

Which studies require a Data and Safety Monitoring Plan (DSMP) at UK? Answer
What Data and Safety Monitoring Information are you required to report to the IRB? Answer


Recruitment & Study Population

Describe some key points for ethical and respectful recruitment methods. Answer
What additional provisions do you employ for protection of vulnerable populations, groups vulnerable to undue influence, or populations with cultural considerations? Answer


Informed Consent Process & Documentation

Describe your informed consent process? Answer
What is the difference between Informed Consent and the process of obtaining Assent and Parental Permission? Answer
What is Informed Consent Key Information? Answer
Does the Key Information need to be a full page of the entire consent is not much longer than a page? Answer
Under what conditions can informed consent be altered or waived for minimal risk research? Answer
Under what circumstances can documentation of informed consent be waived? Answer


Complaints, Concerns, Suggestions, Questions, Requests for Information

Who do you contact with a complaint, concern, or suggestions? Answer
What provisions do you have in place for receiving and handling a subject complaint or request for information? Answer
Who may a subject call outside of the study personnel, about their rights and welfare? Answer


Food and Drug Administration (FDA) Regulated Research

What is the difference between Single Subject Emergency Use and Planned Emergency Research? Answer


Community Engaged Research (CER)/Community Based Participatory Research (CBPR)

What resources are available to investigators conducting Community Engaged Research (CER) or Community Based Participatory Research (CBPR)? Answer
What are considerations for IRB review of CBPR? Answer


Outreach & Education for the Public and Potential Research Participants

Who provides outreach to educate the public and potential participants about human subject research? Answer


Feasibility & Resources

How do you assess and ensure availability of resources required to conduct research in a way that will protect the rights and welfare of participants? Answer