Human Research Question & Answer Guide
| What rules or guidelines are you expected to follow? |
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| What ethical standards or guides do you follow? |
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| 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? |
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| 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? |
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| Does UK research have an emergency preparedness and response plan? |
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| Could a Human Subject not have a heartbeat? |
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| When does secondary research with specimens or data require IRB review? |
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| What is the process for when determining whether an activity is under the purview of the IRB? |
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| How do I find out general information about the UK IRB and human research? |
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| Where should I start to determine what type of IRB review will be required? |
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| How do I request IRB approval for changes while conducting the research? |
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| Does ORI provide educational resources for researchers? |
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| What information or resources are available for conducting survey research? |
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| In addition to researchers, who is involved in conducting scientific review of human research at UK? |
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| What is the minimum IRB requirement for maintenance of research records? |
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| What additional information privacy regulations apply to select protocols? |
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| What is the difference between protecting the privacy interests of participants and maintaining the confidentiality of data? |
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| How do IRB regulations define minimal risk? |
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| How does the IRB assess the risk-benefit ration of the research? |
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| How might investigators minimize risks in research? |
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| What is UK's policy on Conflict of Interest (COI)? |
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| How is researcher COI managed? |
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| What are examples of events/issues that you report to the IRB? |
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| What unanticipated problems or adverse events are investigators required to promptly report to the IRB? |
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| What Responsibilities and Qualifications are required for research investigators? |
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| What are the IRB's expectations regarding oversight and delegation for medical intervention studies and clinical trials? |
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| What is your process for task delegation? |
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| Which studies require a Data and Safety Monitoring Plan (DSMP) at UK? |
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| What Data and Safety Monitoring Information are you required to report to the IRB? |
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| Describe some key points for ethical and respectful recruitment methods. |
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| What additional provisions do you employ for protection of vulnerable populations, groups vulnerable to undue influence, or populations with cultural considerations? |
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| Describe your informed consent process? |
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| What is the difference between Informed Consent and the process of obtaining Assent and Parental Permission? |
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| What is Informed Consent Key Information? |
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| Does the Key Information need to be a full page of the entire consent is not much longer than a page? |
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| Under what conditions can informed consent be altered or waived for minimal risk research? |
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| Under what circumstances can documentation of informed consent be waived? |
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| Who do you contact with a complaint, concern, or suggestions? |
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| What provisions do you have in place for receiving and handling a subject complaint or request for information? |
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| Who may a subject call outside of the study personnel, about their rights and welfare? |
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| What is the difference between Single Subject Emergency Use and Planned Emergency Research? |
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| What resources are available for investigators conducting FDA-regulated research? |
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| What resources are available to investigators conducting Community Engaged Research (CER) or Community Based Participatory Research (CBPR)? |
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| What are considerations for IRB review of CBPR? |
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| Who provides outreach to educate the public and potential participants about human subject research? |
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| 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? |
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