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.

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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

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B
C
Cancer Research
Children (Including Wards of the State)
Concerns or Suggestions:  IRB/ORI Administrative Process; Investigator Appeals; Subject Concerns
Confidentiality
       See Privacy and Confidentiality
Conflict of Interest / Significant Financial Interest
       IRB Member Conflict of Interest
       Investigator Conflict of Interest
Consent
       See Informed Consent/Assent
Continuation Review

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D
Data and Safety Monitoring
Deception Research
Department Chair Responsibilities
Decisionally Challenged/Impaired
Deviations
       See Exceptions
       See also Protocol Violations
Devices 
Drugs 

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E
Education 
       Researchers / Research Staff
       IRB Member Education/Training
Emancipated Individuals
Emergency Use of FDA Regulated Products
Exceptions
       See also Protocol Violations
Exemption Certification
Expedited Review

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F
Fetus Research
       See Pregnant Women, Fetuses, & Neonates
Finder’s Fees
Full Review (Initial)

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G
Genetic Research
Genetics & Repositories
       See Specimen Collection, Genetics, & Repositories

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H
HIPAA in Research
HIV/AIDS Research
Humanitarian Use Devices (HUDs)
       See Devices

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I
Illegal Drug Research
       See Alcohol and Illegal Drug Research
Illiterate English Speaking Subjects
       See also Off-site Research
Informed Consent/Assent
       Waiver of Informed Consent/Assent Process and Documentation
International & Non-English Speaking Subjects
       See also Off-site Research
Internet / Web Sites
Investigator/Research Staff Responsibilities
       See Principal Investigator (PI) Responsibilities
IRB Purview:  What Needs IRB Review
IRB Review and Approval:  Criteria for Approval and Specific Findings

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J  K

L
Legally Authorized Representatives (Children or Decisionally Impaired/Challenged)

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M
Modification of an Approved IRB Protocol

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N
Neonate Research
       See Pregnant Women, Fetuses, & Neonates
Noncompliance
       Reporting Noncompliance to IRB
       IRB Handling Allegations of Noncompliance

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O
Off-Site Research

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P
Principal Investigator (PI) Responsibilities
       See also Recordkeeping (PI)
Placebos
Pregnant Women, Fetuses, & Neonates
Prisoners
Privacy and Confidentiality
Protocol Violation Review

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Q
Quality Improvement

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R
Radiation Safety
Recordkeeping
       Principal Investigators (PIs)
       Institutional Review Board (IRB)
Recruitment of Subjects (Including Advertisements)
Regulations
Reporting Requirements
       IRB
        PI
       See also Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB for related forms
Repositories
       See Specimen Collection, Genetics, & Repositories
Research Staff Responsibilities
       See Principal Investigator (PI) Responsibilities
       See also Education (Researchers / Research Staff)
Risk Assessment

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S
Specimen Collection, Genetics, & Repositories
Students as Subjects
Study Closure

T
U
Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB

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V
Vaccine Trials
Veterans Affairs:  Human Subject Research

W 
Waivers
       See Waiver of Informed Consent/Assent Process and Documentation
       See HIPAA in Research (Waiver of Authorization)

X  Y  Z

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---

Topic Index

 

Alcohol or Illegal Drug Research

Protocol Specific Training (PST):

• OHRP:  IRB Guidebook Chapter V, Section I [PDF] [T1.0000]
• NIAAA:  Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation [PDF] [T2.0000]
• NACDA Guidelines for Administration of Drugs to Human Subjects [PDF] [T3.0000]

Cancer Research

• Markey Cancer Center/IRB/ORI Coordination SOP [PDF] [C6.0400]
• NCI CIRB SOP (NIH Pediatrics Cooperative Group Trials) [PDF] [C3.0400]
• IRB Application “Form G” (information for NIH-sponsored Cooperative Group Clinical Trial) [F1.0450]
• IRB Application Guidelines and materials to submit for Markey Cancer Center (MCC) Protocol Review Committee (PRC) (“Form GG”) [F1.2400]

Children (Including Wards of the State)

• IRB Application “Form W” (Children in Research) [WORD] [F1.1750]
• IRB Application Instructions for “Form W” [F1.1775]
• IRB Application Instructions for “Form D” [Medical F1.0225; Nonmedical F2.0250]
• Informed Consent SOP [PDF] [C3.0050]
• Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
• UK IRB Policy on Children in Research DRAFT [PDF] [D23.0000]
• Guidance for Enrolling K-12 Students as Research Subjects [PDF] [D79.0000]

Protocol Specific Training (PST):

• UK IRB Policy on Children in Research [PDF] [D22.0000]
• U.S. Dept. of Education/No Child Left Behind Guidance [PDF] [D60.0000]
• Summary of Children Regulations (Subpart D) [PDF] [D61.0000]
• Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] [D31.0000]

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Concerns or Suggestions:  IRB/ORI Administrative Process;

  Investigator Appeals; Subject Concerns                               

• ORI/IRB Administrative Procedures [D69.0000]
• Investigator Concerns About IRB Decisions [D69.0050]
• Subject Concerns or Suggestions [D69.0100]
• Subject Concerns/Complaints SOP [PDF] [C2.0500]
• Noncompliance SOP [PDF] [C2.0550]

Conflict of Interest / Significant Financial Interest

• Conflict of Interest in Human Research Studies: OHRP Guidance [PDF] [D73.0000]
• IRB Member Conflict of Interest

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

• Investigator Conflict of Interest

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

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Continuation Review

• Sample CR Report Form [PDF] [F14.0000]
• Continuation Review SOP [PDF] [C2.0250]
• Submission of Continuation Review Reports [PDF] [D40.0000]
• OHRP Guidance on Continuing Review [PDF] [T5.0000]
• Continuing Review After Study Approval (FDA Info Sheets 2000) [PDF] [T6.0000]
• IRB Continuation Review: Primary Reviewer Checklist [PDF] [F28.0000]

Data and Safety Monitoring

• Resources on Data and Safety Monitoring [D24.0000]
• Data and Safety Monitoring Plan SOP [PDF] [C3.0350]

Protocol Specific Training (PST):

• Resources on Data and Safety Monitoring [D24.0000]

Deception Research

Protocol Specific Training (PST):

• Planning Ethically Responsible Research:  A Guide for Students and Internal Review Board/Sieber [HTML] [T8.0000] Click on the HTML link for details on where to find deception research information.

Department Chair Responsibilities

• What Does the Department Chairperson's Assurance Statement on the IRB application mean? [PDF] [D17.0000]
• EVPR Memo:  Department Chairperson’s Assurance Statement on Institutional Review Board Applications [PDF] [D16.0000]
• IRB Application Form Z (Signature Assurance Sheet) [WORD] [F1.2000]
• IRB Application Guidance for Form Z [F1.2050]

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Decisionally Challenged/Impaired

• Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
• Informed Consent SOP [PDF] [C3.0050]
• IRB Application “Form T” (Research Involving the Decisionally Impaired) [WORD] [F1.1450]
  
• IRB Application Instructions for “Form T” [F1.1500]

Protocol Specific Training (PST):

• OHRP:  IRB Guidebook, Chapter VI, Section D [PDF] [T9.0000]
• University of Kentucky Decisionally Challenged/Impaired Subjects Policy [PDF] [D62.0000]

Devices 

• Medical Devices SOP [PDF] [C3.0150]
• IRB Application Form P (Use of Investigational New Device) [WORD] [F1.1100]
• IRB Application Instructions for “Form P” [F1.1150]
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [PDF] [D45.0000]
• IRB Policy for Compassionate/Emergency Use of a Humanitarian Use Device (HUD) [PDF] [D21.0000]
• Use of Investigational Drug/Device for Treatment Purposes, University of Kentucky Medical IRB Requirements [PDF] [D34.0000]
• Emergency Use Checklist [WORD] [F8.0000]

Protocol Specific Training (PST):

• Medical Devices [FDA Info Sheets] [PDF] [T10.0000]
• IRB Summary 21 CFR Parts 20 and 814 Subpart H -- Medical Devices:  Humanitarian Use Devices [PDF] [D54.0000]
• CDRH Humanitarian Device Exemptions (HDE) Regulation [PDF] [T11.0000]
• FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [PDF] [T12.0000]

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Drugs 

• IRB Application “Form O” (Use of Investigational New Drug) [WORD] [F1.0900]
• IRB Application Instructions for “Form O” [F1.0950]
• IRB Application “Form O-1” (Use of Approved Drug(s) for Unapproved Use) [WORD] [F1.1000]
• IRB Application Instructions for “Form O-1” [F1.1050]
• IRB Application “Form P” (Use of Investigational New Device) [WORD] [F1.1100]
• IRB Application Instructions for “Form P” [F1.1150]
• Summary of FDA Regulations on Exemption from IND Requirements [PDF] [D46.0000]
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [PDF] [D44.0000]
• Use of Investigational Drug/Device for Treatment Purposes, University of Kentucky Medical IRB Requirements [PDF] [D34.0000]
• Investigational Drug Service/IRB Coordination SOP [PDF] [C6.0350]
• Treatment IND SOP [PDF] [C3.0300]
• Emergency Use SOP [PDF] [C3.0250]
• Emergency Use Checklist [WORD] [F8.0000]

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Education 

• UK Human Research Education Options [PDF] [D48.0000]
• Researchers / Research Staff

~	University of Kentucky Mandatory Research Education Requirements [PDF] [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]
~	EVPR Memo: Mandatory Education Requirement for Investigators and Study Personnel Involved in Human Subjects Research [PDF] [D14.0000]
~	What Constitutes Study Personnel on a Protocol Involving Human Subjects? [PDF] [D28.0000]
~	Renewal of Certification for Human Subject Protections Training [PDF] [D29.0000]

• IRB Member Education/Training

~	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]

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Emancipated Individuals

• Informed Consent SOP [PDF] [C3.0050]
• UK IRB Policy on Children in Research DRAFT [PDF] [D23.0000]
• UK IRB Policy on Children in Research [PDF] [D22.0000]

Emergency Use of FDA Regulated Products

• Emergency Use SOP [PDF] [C3.0250]
• Emergency Use Checklist [WORD] [F8.0000]
• IRB Policy for Compassionate/Emergency Use of a Humanitarian Use Device (HUD) [PDF] [D21.0000]
• Treatment IND SOP [PDF] [C3.0300]

Exceptions

• Modification, Deviations, and Exceptions-IRB Review of Changes SOP [PDF] [C2.0300]
  • See also Protocol Violations

Exemption Certification

• Exemption Certification Request (application) [WORD] [F4.0000]
• Exempt Review SOP [PDF] [C2.0200]
• Issues to be Addressed When Conducting Exempt Review [PDF] [D37.0000]
• Exemption Certificate Signature Page [PDF] [F21.0000]

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Expedited Review

• Medical IRB Expedited Review Application [F1.0000 & F3.0050]
• Nonmedical IRB Expedited Review Application [F2.0000 & F3.0050]
• Expedited Initial Review SOP [PDF] [C2.0150]
• Issues to Address when Conducting Expedited Reviews [PDF] [D39.0000]
• OHRP Guidance on the Use of Expedited Review Procedures [PDF] [T13.0000]
• Guidance on Expedited Review of Minor Changes in Previously Approved Research [PDF] [D38.0000]
• Criteria for IRB Approval: Reviewer Checklist [PDF] [F26.0000]
• Expedited Reviewer Signature Page [PDF] [F20.0000]

Finder’s Fees

• Finder’s Fees - University of Kentucky Medical IRB Policy [PDF] [D25.0000]

Full Review (Initial)

• Medical IRB Full Review Application [F1.0000]
• Nonmedical IRB Full Review Application [F2.0000]
• Initial Full Review SOP [PDF] [C2.0100]
• Criteria for IRB Approval: Reviewer Checklist [PDF] [F26.0000]

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Genetic Research

• IRB Application Guidelines and materials to submit for “Form EE” (Institutional Biosafety Committee (IBC)) [F1.2300]
• IBC/IRB/ORI Coordination SOP [PDF] [C6.0100]

Protocol Specific Training (PST):

• Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF] [D57.0000]
• Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories [PDF] [D58.0000]
• Human Genetic Research -- OHRP: IRB Guidelines, Chapter 5, Section H [PDF] [T14.0000]

HIPAA in Research

• HIPAA Educational Module Instructions [PDF] [D80.0000]
• HIPAA Instructions for all IRB Applications [WORD] [F1.0600]
• HIPAA Forms
• HIPAA Authorization Regulations [PDF] [D19.0000]
• HIPAA Guidance for Requesting and Completing the Waiver of Authorization [PDF] [D20.0000]
• EVPR Memo: To Investigators regarding HIPAA Regulations [PDF] [D15.0000]
• HIPAA in Research SOP [PDF] [C2.0450]

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HIV/AIDS Research

• Reporting Requirements for Diseases and Conditions in Kentucky [PDF] [E2.0000]

Protocol Specific Training (PST):

• OHRP:  IRB Guidebook, Chapter 5, Section F [PDF] [T15.0000]
• Protection of Human Subjects in Research Involving HIV Testing [PDF] [D65.0000]

Illiterate English Speaking Subjects

• See also Off-site Research

Protocol Specific Training (PST):

• FDA Info Sheets: Illiterate English-Speaking Subjects [PDF] [T16.0000]

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Informed Consent/Assent

• Informed Consent SOP [PDF] [C3.0050]
• IRB Application “Form C” (Informed Consent Template) [Medical [WORD] [F1.0150]; Nonmedical [WORD] [F2.0150]]
• IRB Application Instructions for Proposed Informed Consent Document (“Form C”) [Medical [F1.0175]; Nonmedical [F2.0175]]
• IRB Application “Form D” (Assent Form Template) [Medical [WORD] [F1.0200]; Nonmedical [WORD] [F2.0200]]
• IRB Application Instructions for “Form D” [Medical [F1.0225]; Nonmedical [F2.0250]]
• Consent/Assent Checklist - Quality Improvement Review [PDF] [O1.0000]
• “Basics for Easy-to-Read Informed Consent Documents” Checklist [PDF] [O11.0000]
• Waiver of Informed Consent/Assent Process and Documentation

~	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]
~	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]

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International & Non-English Speaking Subjects

• Informed Consent SOP [PDF] [C3.0050]
• IRB Application Instructions and information for “Form H” (recruitment of Non-English speaking subjects) [F1.0500]
• See also Off-site Research

Protocol Specific Training (PST):

• OHRP Compliance Activities:  Common Findings and Guidance – 2002 [PDF] [T25.0000]
• OHRP:  IRB Guidebook Chapter 6, Section K [PDF] [T17.0000]
• FDA Info Sheets:  Non-English Speaking Subjects [PDF] [T18.0000]
• Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols [PDF] [T26.0000]

Internet / Web Sites

• Guidance on IRB Review of Clinical Trial Websites [PDF] [D26.0000]

Protocol Specific Training (PST):

• Research on the Internet:  A Brief Guide for IRBs [PDF] [D55.0000]

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IRB Purview:  What Needs IRB Review

• When do activities involving human subjects need Institutional Review Board (IRB) review and approval? [PDF] [D1.0000]
• Determination of Research Activities That Need IRB Review SOP [PDF] [C1.0100]

IRB Review and Approval:  Criteria for Approval and Specific Findings

• UK Guidance to Criteria for Institutional Review Board (IRB) Approval [PDF] [D6.0000]
• Specific Findings Requiring IRB Documentation [PDF] [D5.0000]
• Consent/Assent Checklist - Quality Improvement Review [PDF] [O1.0000]
• Emergency Use Checklist [WORD] [F8.0000]
• Criteria for IRB Approval:  Reviewer Checklist [PDF] [F26.0000]
• VA Research: Reviewer Checklist [PDF] [F27.0000]
• IRB Continuation Review: Primary Reviewer Checklist [PDF] [F28.0000]
• HIPAA Authorization Checklist [PDF] [F24.0000]
• HIPAA Waiver of Authorization Checklist [PDF] [F25.0000]
• Consultant Signature Page [PDF] [F22.0000]
• Expedited Reviewer Signature Page [PDF] [F20.0000]
• Modification Reviewer Signature Page [PDF] [F29.0000]
• Prisoner Representative Reviewer Signature Form [PDF] [F23.0000]
• IRB Introduction [PDF] [D47.0000]
• Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4) [PDF] [D71.0000]

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Legally Authorized Representatives (Children or Decisionally Impaired/Challenged)

• Informed Consent SOP [PDF] [C3.0050]
• UK IRB Policy on Children in Research DRAFT [PDF] [D23.0000]
• UK IRB Policy on Children in Research [PDF] [D22.0000]
• University of Kentucky Decisionally Challenged/Impaired Subjects Policy [PDF] [D62.0000]
• IRB Application “Form T” (Research Involving the Decisionally Impaired) [WORD] [F1.1450]

Modification of an Approved IRB Protocol

• 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]
• Modification Reviewer Signature Page [PDF] [F29.0000]

Noncompliance

• OHRP Compliance Activities: Common Findings and Guidance (2005) [PDF] [D68.0000]
• Reporting Noncompliance to IRB

~	Subject Concerns/Complaints SOP [PDF] [C2.0500]
~	Submitting Concerns and Suggestions for Improving the Human Research Protections Process [D69.0000]

• IRB Handling Allegations of Noncompliance

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

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Off-Site Research

• ORI’s Off-site Research Guidance [PDF] [D10.0000]
• Off-Site Research SOP [PDF] [C1.0350]
• IRB Application “Form N” (Off-site Research) [WORD] [F1.0825]
• IRB Application Information for “Form N” [F1.0850]
• OHRP’s “Engagement of Institutions in Research Memo” [D70.0000]
• SAMPLE IRB Authorization Agreements [PDF] [D12.0000]

PI Responsibilities

• A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [PDF] [D9.0000]
• Investigator-Initiated Questions [PDF] [M3.0000]
• Sponsor-Investigator Clinical Trials with FDA Regulated Products [PDF] [M4.0000]

Placebos

Protocol Specific Training (PST):

• The Ethics of Placebo-Controlled Trials [PDF] [T21.0000]

Pregnant Women, Fetuses, & Neonates

• Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
• IRB Application “Form U” (Research Involving Pregnant Women, Fetuses, &/or Neonates) [WORD] [F1.1550]
• IRB Application Instructions for “Form U” [F1.1600]

Protocol Specific Training (PST):

• Summary of Pregnant Women, Fetuses, & Neonates Regulations 45 CFR 46 Subpart B [PDF] [T64.0000]

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Prisoners

• Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
• IRB Application “Form V” (Research Involving Prisoners) [WORD] [F1.1650]
• IRB Application Instructions for “Form V” [F1.1700]
• UK/ORI’s Summary Sheet on Certificate of Confidentiality [PDF] [D56.0000]
• Prisoner Representative Protocol Reviews [PDF] [D75.0000]
• Prisoner Representative Reviewer Signature Form [PDF] [F23.0000]

Protocol Specific Training (PST):

• Summary of Prisoners Regulations 45 CFR 46 Subpart C [PDF] [T63.0000]
• OHRP Guidance on the Involvement of Prisoners in Research – 5/23/03 [PDF] [T22.0000]
• Research Involving Prisoners Flow Chart [PDF] [T23.0000]
• 45 CFR Part 46 Waiver of the Applicability of Certain HHS Provisions for HHS Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects [PDF] [T24.0000]

Privacy and Confidentiality

• Privacy vs. Confidentiality: What's the Difference? [PDF] [D32.0000]
• Protection of Human Subjects in Research Involving HIV Testing [PDF] [D65.0000]
• Reporting Requirements for Diseases and Conditions in Kentucky [PDF] [E2.0000]
  • See also HIPAA in Research

Protocol Specific Training (PST): 

• UK/ORI’s Summary Sheet on Certificate of Confidentiality [PDF] [D56.0000]
• Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] [D31.0000]

Protocol Violation Review

• Protocol Violation Review SOP [PDF] [C2.0400]
• Protocol Violation Reporting Form [WORD] [F7.0000]

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Quality Improvement

• University of Kentucky Quality Improvement Program for Human Research Protections (Description) [D18.0000]
• Quality Improvement Program Directed On-Site Review SOP [PDF] [C5.0050]
• Quality Improvement Program Routine On-site Review SOP [PDF] [C5.0100]
• Quality Improvement Program Principal Investigator Self-Assessment Review SOP [PDF] [C5.0150]
• Online PI Self-Assessment Form [https://www.research.uky.edu/cfdocs/ORI/IRB_QA/]
• Quality Improvement Program Administrative Assessment Review SOP [PDF] [C5.0200]

Radiation Safety

• Radiation Safety Officer (RSO) Coordination SOP [PDF] [C6.0500]      
• IRB Application “Form Q” (Use of Radioactive Materials (Radiation Safety Form)) [WORD] [F1.1200]
• IRB Application Information and instructions for “Form Q” [F1.1250]

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Recordkeeping

• Principal Investigators (PIs)

~	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]

• Institutional Review Board (IRB)
  

  ~	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]

Recruitment of Subjects (Including Advertisements)

• A Principal Investigator’s Guide to Identification and Recruitment of Human Subjects for Research [PDF] [D7.0000]
• IRB Application Information for “Form L” (Proposed advertisement(s) of any type for recruiting subjects) [F1.0750]

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Regulations

• Overview of Basic IRB Regulations [PDF] [D30.0000]

Reporting Requirements

• IRB

~	Federally 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]

• PI

~	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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Risk Assessment

• University of Kentucky Research Risk Assessment Guidance [PDF] [D8.0000]

Specimen Collection, Genetics, & Repositories

• OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [PDF] [D74.0000]
• FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [PDF] [T12.0000]
• Tissue Banking Post HIPAA:  Requirements of 45 CFR part 46 (Julie Kaneshiro) [PDF] [D72.0000]

Protocol Specific Training (PST):

• Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF] [D57.0000]
• Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories [PDF] [D58.0000]
• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 22.7KB] [T27.0000]

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Students as Subjects

• Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
• Guidance for Enrolling University Students as Research Subjects [PDF] [D4.0000]
• IRB Application Information for “Form II” (involvement of Medical Center students and/or College of Medicine students as research subjects) [F1.2500]
• Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] [D31.0000]
• U.S. Dept. of Education/No Child Left Behind Guidance [PDF] [D60.0000]
• Guidance for Enrolling K-12 Students as Research Subjects [PDF] [D79.0000]

Study Closure

• Study Closure SOP [PDF] [C4.0200]

Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB

• 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]
• Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [PDF] [C2.0350]
• UK’s Internal Prompt Reporting Form [WORD] [F9.0000]
• UK’s External Prompt Reporting Form [WORD] [F10.0000]
• UK’s Letter for Sponsors [PDF] [D3.0000]
• UK’s Non-Prompt Reporting Form [WORD] [F11.0000]

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Vaccine Trials

Protocol Specific Training (PST):

• OHRP: IRB Guidebook, Chapter 5, Section C [PDF] [T4.0000]

Veterans Affairs:  Human Subject Research

• VA Research: Reviewer Checklist [PDF] [F27.0000]
• VAMC/IRB/ORI Coordination SOP [PDF] [C6.0300]
• IRB Application “Form R” (VA Form 10-1223 for research using Veterans Affairs (VA) subjects, facilities, or resources) [WORD] [F1.1300]
• IRB Application Information on Veteran Affairs Research and the UK IRB (“Form R”) [F1.1350]

 

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