IRB Survival Handbook

IRB Survival Handbook
for Human Research Protections

Contents of the IRB Survival Handbook focus primarily on UK policies and procedures for human research review, and the IRB application process.

A to Z Index

Click on the letter of the alphabet in the menu below to jump to the topic starting with the same letter. Once you have found your topic, click on the blue text of your choice - the link will take you to a list of web links and/or documents that apply to that topic.

Downloadable documents are denoted by the type of document in brackets (e.g., "[PDF]") and open in a new window; all other links open applicable web pages in the same window. Note: Following each item listed is an ID number in brackets for internal use only.

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A
Acute Care Waiver (see Waiver of Informed Consent/Assent Process and Documentation)
Adverse Event/Adverse Reaction
       See Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB
Alcohol or Illegal Drug Research
Assent
       See Informed Consent/Assent
       See Children

~	IRB Member and Consultant Conflict of Interest SOP [PDF] [C1.0200]
~	IRB Member Conflict of Interest Statement [PDF] [F17.0000]

~	Investigator Conflict of Interest/OSPA/IRB Coordination SOP [PDF] [C6.0650]
~	IRB Application “Form X” (Research Financial Interest Disclosure Statement (RFIDS) for externally-funded research [PDF] [F1.1800]
~	IRB Application Instructions for “Form X” [F1.1850]
~	IRB Application “Form Y” (Research Financial Interest Disclosure Statement (RFIDS) for non-externally-funded research) [WORD] [F1.1900]
~	IRB Application Instructions for “Form Y” [F1.1950]

~	University of Kentucky Mandatory Research Education Requirements [HTML] [D33.0000]
~	Education Requirement for Investigators and Study Personnel Involved with Human Subjects Research [PDF] [D13.0000]
~	CITI Course Instructions [PDF] [D42.0000]
~	Dunn & Chadwick Instructions [PDF] [D43.0000]
~	What Constitutes Study Personnel on a Protocol Involving Human Subjects? [PDF] [D28.0000]
~	Renewal of Certification for Human Subject Protections Training [PDF] [D29.0000]
~	University of Kentucky Sponsor-Investigator Mandatory Training [PDF] [D82.0000]

~	IRB Members/ORI Staff Training SOP [PDF] [C1.0250]
~	UK IRB Member Orientation Module [PDF] [D41.0000]
~	Individual Orientation for New IRB Members Outline [PDF] [D53.0000]
~	Vice Chair/CR Primary Reviewer Reference Guide [PDF] [D77.0000]

~	Informed Consent SOP [PDF] [C3.0050]
~	IRB Application “Form E” (Request for Waiver of Informed Consent Process) [WORD] [F1.0250]
~	IRB Application Instructions for “Form E” [F1.0300]
~	IRB Application “Form F” (Request for Waiver of Documentation of Informed Consent Process) [WORD] [F1.0350]
	~ Cover Letter Template (for survey/questionnaire research) [WORD] [F1.0355]
~	IRB Application Instructions for “Form F” [F1.0400]
	*Protocol Specific Training (PST):*
~	Waiver of Informed Consent (excerpt from IRB Overview) [PDF] [T19.0000]
~	Waiver of Documentation of Informed Consent (excerpt from IRB Overview) [PDF] [T20.0000]
~	Acute Care Waiver (excerpt from IRB Overview) [PDF] [T28.0000]

~	Subject Concerns/Complaints SOP [PDF] [C2.0500]
~	Submitting Concerns, Suggestions or Questions for Improving the Human Research Protections Process [H1.1200]

~	Noncompliance SOP [PDF] [C2.0550]
~	Termination or Suspension of Research by the IRB SOP [PDF] [C2.0600]

~	Study Closure SOP [PDF] [C4.0200]
~	A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [PDF] [D9.0000]
~	Two circumstances when IRB approved active protocols may be closed by the PI and/or the IRB [PDF] [D76.0000]

~	Minutes of IRB Meetings SOP [PDF] [C4.0050]
~	IRB/ORI Record Keeping SOP [PDF] [C4.0250]
~	Two circumstances when IRB approved active protocols may be closed by the PI and/or the IRB [PDF] [D76.0000]

~	Mandated Reporting to External Agencies SOP [PDF] [C4.0150]
~	Serious or Continuing Noncompliance or Unanticipated Problems Involving Risks: IRB Reporting to Federal Agencies [PDF] [D27.0000]
~	Termination or Suspension of Research by the IRB SOP [PDF] [C2.0600]

~	Modification of a Currently Approved Protocol [D67.0000]
~	Modification Request Form [WORD] [F5.0000]
~	Modification, Deviations, and Exceptions-IRB Review of Changes SOP [PDF] [C2.0300]
~	Protocol Violation Review SOP [PDF] [C2.0400]
~	Protocol Violation Reporting Form [WORD] [F7.0000]
~	Continuation Review SOP [PDF] [C2.0250]
~	Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [PDF] [C2.0350]
~	Policy on Prompt Reporting for Unanticipated Problems, Serious or Life-Threatening Events, and Anticipated or Unanticipated Related Deaths to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) [PDF] [D2.0000]
~	See also Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB for related forms
~	Reporting Requirements for Diseases and Conditions in Kentucky [PDF] [E2.0000]

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IRB Survival Handbook for Human Research Protections

IRB Survival Handbook
for Human Research Protections