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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.

For a comprehensive overview of the University of Kentucky's accredited human research protection program, download the Comprehensive Plan:

Important!University of Kentucky Human Research Protection Program Comprehensive Plan [PDF, 22 pgs.]

 

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. Click Opens new web page for free Acrobat Reader software, needed for opening PDF links. PDF links on this page are set to open a new web page. Note: Following each item listed is an ID number in brackets for internal use only.

To do a search by key word just on this page, press CTRL-F and enter the word in the "Find" field that appears at the top of the browser window.

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)
Administrative Regulations (UK)
Adverse Event/Adverse Reaction
       See Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB
AIDS (see also HIV/AIDS)
Alcohol or Illegal Drug Research
Advertising (see also Recruitment)
Assent
       See Informed Consent/Assent
       See Children
Assurance Information (see also Federalwide Assurance)

B

Bioethics, Program for
Biological Specimens (see also Coded Private Information, or Specimen Collection, Genetics, & Repositories)


C
Cancer Research
Children in Research (Including Wards of the State)
Clinical Trials
Closure of Studies
       See Study Closure
Coded Private Information (see also Biological Specimens, or Specimen Collection, Genetics, & Repositories)
Common Rule
       See Federal Regulations
Compliance
       See Noncompliance
Comprehensive Plan (for UK Human Research Protections)
Community Engaged/Participatory Research
Concerns or Suggestions:  IRB/ORI Administrative Process; Investigator Appeals; Subject Concerns
Confidentiality/Certificate of Confidentiality (see also 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

Back to Top

D
Data and Safety Monitoring
Deception Research
Decisionally Challenged--> see Impaired Consent Capacity
Department Chair Responsibilities
Department of Defense
Deviations
       See Exceptions
       See also Protocol Violations
Devices 
Dietary Supplements (See Drugs)
Drugs 

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

Back to Top

F
Federal Agency Specific Requirements
Federal Regulations
Federalwide Assurance
Fetus Research
       See Pregnant Women, Fetuses, & Neonates
Finder’s Fees
Full Review (Initial)

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

H
HIPAA in Research
HIV/AIDS Research
Home Health Care (See separate page "Research Conducted in Subject's Home")
Humanitarian Use Devices (HUDs)
       See Devices
Human Research Training/Education
       See Education

Back to Top

I
Illegal Drug Research
       See Alcohol and Illegal Drug Research
Illiterate English Speaking Subjects
       See also Off-site Research
Impaired Consent Capacity
Informed Consent/Assent
       Waiver of Informed Consent/Assent Process and Documentation
International & Non-English Speaking Subjects
       See also Off-site Research
Internet Research
Investigator/Research Staff Responsibilities
IRB Purview:  What Needs IRB Review
IRB Resource Guide
       See Ethical Principles, or Regulations
IRB Review and Approval:  Criteria for Approval and Specific Findings

Back to Top

J  K

L
Legally Authorized Representatives (Children or Adults with Impaired Consent Capacity)

M
Modification of an Approved IRB Protocol

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

Back to Top

O
Off-Site Research
Other Human Research Protection Sites

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

Q
Quality Improvement

Back to Top

R
Radiation Safety
Recordkeeping
       Principal Investigators (PIs)
       Institutional Review Board (IRB)
Record Review
Recruitment of Subjects (see also Advertising)
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)
Return of Research Results or Incidential Findings
Risk Assessment

Back to Top

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

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

V
Vaccine Trials

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

X  Y  Z

Back to Top


Topic Index

Administrative Regulations (UK)

  • Administrative Regulation 7:4 (formerly III-4.0-6) Human Research Subject Protection and Institutional Review Boards [PDF]
  • Administrative Regulation 7:1 (formerly II-4.0-2) Research Misconduct [PDF]
  • Administrative Regulation 7:2 (formerly II-4.0-4) Research Conflict of Interest and Financial Disclosure Policy [PDF]
  • Administrative Regulation 7:9 Institutional Conflicts of Interest Involving Research [PDF]

 

Advertising(see also Recruitment)

  • PI Guide to Identification and Recruitment of Human Subjects for Research [PDF] [D7.0000]
  • Research Advertising [PDF] [D89.0000]
  • Compensation to Research Subjects (UK Office of the Treasurer Policy) [PDF]

 

AIDS (see also HIV/AIDS)

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

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]
  • NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents [PDF] [T29.0000]

 

Assurance Information(see also Federalwide Assurance)

Basic Assurance Requirement - Approved through the Office for Human Research Protections (OHRP):

An institution engaged in human subjects research (not otherwise exempt) that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects. The University of Kentucky holds an FWA under the number FWA 00005295.

  • Terms of Assurance [HTML]
  • UK's sample IRB Authorization Agreement [PDF] [D12.0000]
  • UK's Assurance Information through OHRP web site [HTML] (search "U of Kentucky")
  • OHRP-Approved UK IRB registration [PDF]
  • What Does the Department Chairperson's Assurance Statement on the IRB application mean? [PDF] [D17.0000] (Also, see IRB Application "Form Z" [HTML])

 

Bioethics, Program for UK Healthcare web page for the Program for Bioethics [HTML]

Back to Top

Biological Specimens (see also Coded Private Information and/or Specimen/Tissue Collection, Genetics, & Repositories)

  • UK Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [PDF] [D117.0000]
  • OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [HTML]

 

Cancer Research

 

Children in Research (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]
  • Guidance for Enrolling K-12 Students as Research Subjects [PDF] [D79.0000]
  • U.S. Dept. of Education Subpart D (34 CFR 97) [HTML]
  • Special Protections for Children as Research Subjects (OHRP) [HTML]
    • FAQs on Research with Children [HTML]
Protocol Specific Training (PST):
  • UK IRB Policy on Children in Research [PDF] [D22.0000]
  • U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [PDF] [D60.0000]
  • Summary of Children Regulations (Subpart D) [Under Revision] [D61.0000]
  • Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] [D31.0000]

Back to Top

Clinical Trials (see also Research Participants [HTML])

  • ORI FAQ's: Definition of clinical research vs. clinical trial [HTML]
  • Guidance on IRB Review of Clinical Trial Websites [PDF] [D26.0000]
  • OSPA Clinical Trial Agreements Information Site [HTML]
  • Non-Indemnification Policy/Risk Management Committee (RMC) [HTML]
  • Investigational New Drug (IND) Development Toolkit (University of Washington) [HTML]
  • Center for Clinical and Translational Sciences (CCTS) [HTML]
    • CCTS Industry Sponsored Clinical Trial Initiation Checklist – comprehensive list of potential processes, procedures, or services related to initiating an industry sponsored clinical trial at the University of Kentucky [link coming soon]
    • CCTS Investigator-Initiated Clinical Trial Initiation Checklist – comprehensive list of potential processes, procedures, or services related to initiating an investigator-initiated clinical trial at the University of Kentucky  [link coming soon]
  • Registration of Clinical Trials - NIH Guidance [HTML]
    • NIH: Interactive Flowchart - Identifying an "Applicable Clinical Trial" [HTML]
    • NIH: Interactive Flowchart - Identifying the "Responsible Party" [HTML]
    • NIH: At-a-glance - FDA Amendments Act Requirements [HTML]
    • NIH: How to register? [HTML]
    • CCTS site for Clinicaltrials.gov registration [HTML]

 

Coded Private Information(see also Biological Specimens)

  • UK Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [PDF] [D117.0000]
  • OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [HTML]

 

Comprehensive Plan

  • University of Kentucky Human Research Protection Program Comprehensive Plan [PDF, 21 pgs.]

 

Community Engaged/Participatory Research

  • Community-Engaged and Community-Based Participatory Research Frequently Asked Questions [PDF] [D115.0000]
  • Training:
    ~
    CIRTification: Community Involvement in Research Training [HTML]
    ~

    FHI 360 Research Ethics Training Curriculum for Community Representatives (RETC-CR) [HTML]

    ~

    FHI 360 Research Ethics Training Curriculum (RETC) [HTML]

    ~
    Johns Hopkins University Human Subjects Research Ethics Field Training Guide [PDF]

    Back to Top

Concerns, Suggestions, or Questions:  IRB/ORI Administrative Process;

  Investigator Appeals; Subject Concerns

 

Confidentiality/Certificate of Confidentiality (see also Privacy and Confidentiality)

  • Privacy vs. Confidentiality - What's the Difference? [PDF] [D32.0000]
  • Certificate of Confidentiality Summary Sheet [PDF] [D56.0000]
  • UK Confidentiality and Data Security Guidelines for Electronic Data [PDF] [D105.0000]

 

Conflict of Interest / Significant Financial Interest

  • Conflict of Interest in Human Research Studies: OHRP Guidance [OHRP document-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
    ~
    UK Administrative Regulation (AR) 7:2 Financial Conflicts of Interest in Research [PDF]
    ~

    Investigator Conflict of Interest/OSPA/IRB Coordination SOP [PDF] [C6.0650]

    ~
    Office of Sponsored Projects Administration (OSPA) Resources on Financial Conflict of Interest [HTML]
    ~

    Instructions for OSPA's Online Financial Disclosure [PDF]

    ~

    OSPA's Disclosure of Financial Interest Survey Sample [PDF]

    Back to Top

Continuation Review

  • Sample CR Report Form [PDF] [F14.0000]
  • Continuation Review SOP [PDF] [C2.0250]
  • Time-Saving Tips for Continuation Review of an IRB Approved Study [PDF] [D40.0000]
  • OHRP Guidance on Continuing Review of Research [PDF] [T5.0000]
  • IRB Continuing Review After Clinical Investigational Approval (FDA Info Sheets 2000) [PDF] [T6.0000]
  • IRB Continuation Review: Primary Reviewer Checklist [PDF] [F28.0000]

 

Data and Safety Monitoring

Protocol Specific Training (PST):

 

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.

Back to Top

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]

 

Department of Defense

  • Summary of Requirements for Department of Defense Supported Human Research [PDF] [D107.0000]
  • Department of Defense Supported Research: Checklist [PDF] [D108.0000]

 

Devices 

  • Medical Device Clinical Investigations , Compassionate Use, and Treatment IDE SOP [PDF] [C3.0150]
  • IRB Application Form P (Use of Any Device Being Tested in Research ) [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]
  • Summary of FDA Regulations on Investigational Device Exemptions (IDE) and Exemption from IDE Requirements [PDF] [D97.0000]
  • FDA Flow Charts for Regulations Applying to Investigational Devices (IDE) [D127.0000] [PDF]
  • FDA Emergency and Early/Expanded Access Program for Drugs and Devices [PDF] [D34.0000]
  • Device Development (Coordinator 101) [PDF] [D81.0000]
  • Emergency Use Checklist [WORD] [F8.0000]
  • University of Kentucky Sponsor-Investigator Mandatory Training [PDF] [D82.0000]
  • FDA Device Advice Early/Expanded Access (Four mechanisms where FDA may make an unapproved device available for use) [HTML]
  • Food and Drug Administration (FDA) Resources [PDF] [D116.0000]
  • Humanitarian Use Device SOP [PDF] [C3.0200]
  • Humanitarian Use Device (HUD) Training FAQ [HTML]
  • Great Expectations: a stepwise process for determining need for an IND or IDE (3/10/14 presentation) [PDF]

Protocol Specific Training (PST):

  • IRB Review of Medical Device Research [PDF] [D110.0000]
  • Medical Devices [FDA Info Sheets] [PDF] [T10.0000]
  • IRB Summary - Humanitarian Use Devices [21 CFR Parts 20 and 814 Subpart H] [PDF] [D54.0000]
  • FDA's Guidance for HDE Holders, IRBs, Investigators - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers [HTML] [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]
  • FDA's Guidance on "Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices" [PDF] [T31.0000]

Back to Top

Dietary Supplements (See Drugs

Drugs 

  • IRB Application “Form O” (Use of Any Drug Being Tested in Research ) [WORD] [F1.0900]
  • IRB Application Instructions for “Form O” [F1.0950]
  • IRB Application “Form P” (Use of Any Device Being Tested in Research ) [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]
  • FDA Flow Charts for Regulations Applying to Investigational New Drugs (INDs) [D127.0000] [PDF]
  • FDA Emergency and Early/Expanded Access Program for Drugs and Devices [PDF] [D34.0000]
  • ORI Dietary Supplement Study FAQ [PDF] [D122.0000]
  • Investigational Drug Service/IRB Coordination SOP [PDF] [C6.0350]
  • Expanded Access Online Training from the American Society of Clinical Oncology [HTML]
  • Expanded Access Program (EAP) for Drugs SOP [PDF] [C3.0300]
  • Emergency Use SOP [PDF] [C3.0250]
  • Emergency Use Checklist [WORD] [F8.0000]
  • University of Kentucky Sponsor-Investigator Mandatory Training [PDF] [D82.0000]
  • Introduction to Investigational Drugs for non-research personnel [PDF] [D67.0000]
  • Food and Drug Administration (FDA) Resources [PDF] [D116.0000]
  • Drug Enforcement Administration (DEA) Office of Diversion Control presentation [PDF]
  • Great Expectations: a stepwise process for determining need for an IND or IDE (3/10/14 presentation) [PDF]

Protocol Specific Training (PST):

  • FDA Guidance for Clinical Investigators, Sponsors, and IRBs – Determining Whether Human Research Studies Can Be Conducted Without an IND [FDA-PDF] [T30.0000]
  • IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer 2004 [PDF]

Back to Top

Education 

  • UK Human Research Education Options [PDF] [D48.0000] This document provides a summary of the University of Kentucky's human subject protection educational initiatives.
  • Human Research Related Educational Video or Broadcast Recordings (list of resources) [PDF] [D103.0000]
  • Office for Human Research Protections (OHRP) Human Subject Regulations Decision Charts [HTML]
  • Researchers / Research Staff
  • ~
    Frequently Asked Questions (FAQ's) on Human Subject Protection (HSP) and Other Mandatory Training for Study Personnel on IRB Research Protocols [HTML] - Includes information and instructions for completing IRB education including mandatory HSP training, 3 year refresher HSP training, FDA Sponsor-Investigator training, as well as other available courses such as the CITI HIPAA course, CITI Good Clinical Practice (GCP) course, and the Humanitarian Use Device (HUD) course.
    ~
    What Constitutes Study Personnel on a Protocol Involving Human Subjects? [PDF] [D28.0000]
    ~
    University of Kentucky Sponsor-Investigator Mandatory Training Description [PDF] [D82.0000]
    ~
    Principal Investigator Q & A Guide [PDF] [D121.0000]
    ~
    ORI002 Protecting Personal Health Information in Research - Understanding the HIPAA Privacy Rule: an optional course available on UK's Blackboard Course Website. Instructions for accessing Blackboard course on HIPAA in Research [PDF] [D80.0000]
    ~
    Other Required Research-Education [HTML] - provides links to trainings offered or mandated based on protocol-specific, sponsor, institutional, or funding agency requirements.

  • IRB Member Education/Training
  • ~
    IRB Members/ORI Staff Training SOP [PDF] [C1.0250]
    ~
    IRB New Member Orientation Module [PDF, 128KB, 14 pgs.] [D41.0000]
    ~
    Individual Orientation for New IRB Members Outline [PDF] [D53.0000]
    ~
    Vice Chair/CR Primary Reviewer Reference Guide [PDF] [D77.0000]
  • Case Studies & Quizzes (for Human Research Accreditation Training)
    • #1 Case Study: Quality Improvement versus Research [PDF]
    • #2 Case Study: Changing Study Procedures [PDF]
    • #3 Case Study: Obtaining Informed Consent vs. Documenting Informed Consent [PDF]
    • #4 Case Study: Privacy vs. Confidentiality [PDF]
    • #5 Case Study: IRB Approval Lapses [PDF]
    • #6 Case Study: Human Participation in Research: Blood in the Lab [PDF]
    • #7 Case Study: Conflict of Interest [PDF]
    • #8 Case Study: Vulnerable Populations [PDF]
    • #9 Quick Quiz - topics: record retention; federalwide assurance; vulnerable populations; mandatory human research protections training [PDF]
    • #10 Quick Quiz - topics: minimal risk; PI assurance; subject concerns or suggestions; waiver of documentation of informed consent [PDF]

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Electronic Data

  • UK Confidentiality and Data Security Guidelines for Electronic Data [PDF] [D105.0000]
  • UK Healthcare Electronic Communication Policy [PDF]
  • UK Information Technology Policies [HTML]
  • UK Administrative Regulation 10:4 - Social Media Use Policies and Guidelines [PDF]
  • IRB Considerations for Social Network Analysis Research [PDF]

 

Emancipated Individuals

  • Informed Consent SOP [PDF] [C3.0050]
  • 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]
  • Expanded Access Program (EAP) for Drugs SOP [PDF] [C3.0300]
  • FDA Emergency and Early/Expanded Access Program for Drugs and Devices [PDF] [D34.0000]
  • Food and Drug Administration (FDA) Resources [PDF] [D116.0000]

 

Ethical Principles

  • Belmont Report [HTML]
  • Declaration of Helsinki [HTML]
  • Nuremberg Code: Directives for Human Experimentation [HTML]
  • IRB Resource Guide [HTML]
    The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.

 

Exceptions

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

 

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] form [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] form [F20.0000]

 

Federal Agency Specific Requirements

  • Summary of Requirements for Department of Defense Supported Human Research [PDF] [D107.0000]
  • Department of Defense Supported Research: Checklist [PDF] [D108.0000]
  • Summary of Department of Education (DoED) Requirements [PDF] [D111.0000]
  • Summary of Department of Energy (DoE) Requirements [PDF] [D112.0000]
  • Investigator Checklist for Verification of Compliance with the Department of Energy (DOE) Requirements for the Protection of Personally Identifiable Information (PII) or Protected Health Information (PHI) [PDF] [WORD] [RTF] [F35.0000]
  • Summary of Environmental Protection Agency (EPA) Requirements [PDF] [D114.0000]
  • Environmental Protection Agency (EPA) Research: IRB Reviewer Checklist [PDF] [F33.0000]
  • Summary of Department of Justice (DoJ), National Institute of Justice (NIJ), and Bureau of Prisons (BoP) Requirements [PDF] [D113.0000]
  • Department of Justice (DOJ), National Institute of Justice (NIJ), and Bureau of Prisons Supported Research: IRB Reviewer Checklist [PDF] [F34.0000]
  • Federal Agency “Specific” Requirements IRB/ORI Coordination SOP [PDF] [C6.0900]

 

Federal Regulations (see also Regulations)

  • Recent Changes at the Federal Level Impacting IRBs [PDF] [D86.0000]
  • Food and Drug Administration (FDA) Resources [PDF] [D116.0000]
  • Comparison of FDA and HHS Human Subject Protection Regulations (by FDA) [HTML]

    Online Regulations Governing Human Subjects Research:

    • Department of Health and Human Services (HHS) [HTML]
      • 45 CFR 46 ("The Common Rule" - Human Subject Protections) [HTML]
      • Office for Human Research Protections (OHRP) Human Subject Regulations Decision Charts [HTML]
      • NIH Guidances:
        • Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
          Notice Number: NOT-OD-12-129 [HTML]
        • Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards):
          Notice Number: NOT-OD-12-130 [HTML]
    • Food and Drug Administration (FDA) [HTML]
      • 21 CFR 50 (Protection of Human Subjects) [HTML]
      • 21 CFR 56 (Institutional Review Boards) [HTML]
      • 21 CFR 312 (Investigational New Drugs) [HTML]
      • 21 CFR 812 (Investigational Device Exemptions) [HTML]
      • Comparison of FDA and HHS Human Subject Protection Regulations (by FDA) [HTML]
    • Veterans Affairs (VA)

For additional information regarding federal regulations and University of Kentucky policies governing the use of human subjects in research, contact:

Ada Sue Selwitz, Director
859-257-2861

Noé Tirado-Muñiz, Associate Director
nti224@email.uky.edu, 859-257-8295

 

Federalwide Assurance (FWA) (#00005295) (see also Assurance Information)

  • Terms of Assurance [HTML]
  • UK's sample IRB Authorization Agreement [PDF] [D12.0000]
  • UK's Assurance Information through OHRP web site [HTML] (search "U of Kentucky")
  • OHRP-Approved UK IRB registration [PDF]

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Full Review (Initial)

 

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]
  • Instructions for Informed Consent Documentation Relating to Genetic Information Nondiscrimination Act (GINA): Medical IRB [F1.0175] / Nonmedical IRB [F2.0175]
  • DHHS - The Genetic Information Nondiscrimination Act of 2008 - Information for Researchers and Health Care Professionals [PDF] [D106.0000]

Protocol Specific Training (PST):

  • Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF] [D57.0000]
  • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [PDF] [D58.0000]
  • Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [PDF] [D101.0000]
  • Guidance on the NIH Genome Data Sharing (GDS) Policy [PDF] [D104.0000]
  • 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

Protocol Specific Training (PST):

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

 

Impaired Consent Capacity

  • Protection of Vulnerable Subjects SOP [PDF] [C3.0100]
  • Informed Consent SOP [PDF] [C3.0050]
  • IRB Application “Form T” (Research Involving Adults with Impaired Consent Capacity) [Web-Based Tool to determine research risk level and likelihood of consent impairment] [F1.1450]
  • IRB Application Instructions for “Form T” [F1.1500]
  • Assessing Consent Capacity in Clinical Research: New Directions [PDF] [D95.0000]
  • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF] [D87.0000]
  • Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [PDF] [D88.0000]
  • Study Overview: Example A for Impaired Consent Capacity [PDF] [D98.0000]
  • Study Overview: Example B for Impaired Consent Capacity [PDF] [D99.0000]
Protocol Specific Training (PST):
  • OHRP:  IRB Guidebook, Chapter VI, Section D [PDF] [T9.0000]
  • University of Kentucky Adults with Impaired Consent Capacity Policy [PDF] [D62.0000]

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Informed Consent/Assent

  • Templates/Samples
    • IRB Application “Form C” (Informed Consent Template) [Medical [WORD] [F1.0150]; Nonmedical [WORD] [F2.0150]]
    • Informed Consent/HIPAA Combined Template [Medical & Nonmedical [WORD] [F1.0160]]
    • Sample Consent to Participate in a Research Repository or Individual Study Banking Material for Future Use [WORD] [F1.0170]
    • IRB Application “Form D” (Assent Form Template) [Medical [WORD] [F1.0200]; Nonmedical [WORD] [F2.0200]]
    • Single-Subject Consent to Receive or Refuse Result or Incidental Finding - Sample Consent [PDF] [D119.0000]
    • Cover Letter Template (for survey/questionnaire research) [WORD] [F1.0355]
  • Instructions
    • IRB Application Instructions for Proposed Informed Consent Document (“Form C”) [Medical [F1.0175]; Nonmedical [F2.0175]]
    • Instructions for Informed Consent Documentation Relating to Genetic Information Nondiscrimination Act (GINA): Medical IRB [HTML] and Nonmedical IRB [HTML]
    • Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF] [D57.0000]
    • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [PDF] [D58.0000]
    • IRB Application Instructions for “Form D” [Medical [F1.0225]; Nonmedical [F2.0250]]
  • Guidance/Policies
    • Informed Consent SOP [PDF] [C3.0050]
    • Documentation of Informed Consent [PDF] [D94.0000]
    • Consent/Assent Checklist - Quality Improvement Review [PDF] [O1.0000]
    • “Basics for Easy-to-Read Informed Consent Documents” Checklist [PDF] [O11.0000]
    • Lay Terms Glossary [PDF] [D78.0000]
    • Health Literacy and Guidance for Improving Readability of Informed Consent Forms - by Program for Readability in Science & Medicine (PRISM) – [HTML]
    • OHRP Frequently Asked Questions on Informed Consent [HTML]
    • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF] [D87.0000]
    • Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [PDF] [D88.0000]
    • Would you ever need to re-consent a research participant? [PDF] [D100.0000]
    • FDA Communicating Risks and Benefits: Evidence-Based User's Guide [HTML]
    • ORI Outline of FDA Guidance for Industry: Use of Electronic Informed Consent in Clinical Investigations [PDF] [D120.0000]
  • 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]
    • 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]
  • Informed Consent Process Educational Series
    • Issue 1, 8/27/12: Did You Know? [PDF]
    • Issue 2, 9/14/12: Keys to an Effective Informed Consent/Assent Process [PDF]
    • Issue 3, 9/25/12: Informed Consent Vs. Documentation of Informed Consent -- What's the Difference? [PDF]
    • Issue 4, 10/8/12: Informed Consent/Assent for Research Involving Vulnerable Populations [PDF]
    • Issue 5, 10/18/12: Non-English Speaking Subjects or Subjects from a Foreign Culture [PDF]
    • Issue 6, 11/14/12: To Re-Consent or Not to Re-Consent, That is the Question... [PDF]

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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

  • Office for Human Research Protections (OHRP)
    • International Issues [HTML]
    • International Compilation of Human Research Standards [HTML] - Visit this web site for a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations.
    • ClinRegs – Clinical research regulations from around the globe. Hosted by the NIH National Institute of Allergy and Infectious Diseases [HTML]
  • Food and Drug Administration (FDA) [HTML]
    • FDA INFORMATION SHEETS - Guidance for Institutional Review Boards and Clinical Investigators 1998 Update: Non-English Speaking Subjects [HTML]

  • Council for International Organizations of Medical Sciences (CIOMS) [HTML]
    • International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) [HTML]

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 Research

Suggested reading (e.g., not adopted by UK IRB):

  • Ethical Decision-Making and Internet Research: Version 2.0 (Recommendations from the Association of Internet Researchers (AOIR) Ethics Working Committee) [PDF]
  • Online Survey Guidelines (from Colorado State University) [PDF]
  • Research in a Virtual World (from Colorado State University) [PDF]
  • Researching Public Sites/Communities, e.g., blogs, forums (from Colorado State University) [PDF]
  • Internet Research Ethics (from Stanford University) [HTML]
  • Social Networking and Ethics (from Stanford University) [HTML]
  • Secretary's Advisory Committee on Human Research Protection (SACHRP) Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations [PDF]

Protocol Specific Training (PST):

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

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Investigator/Research Staff Responsibilities

  • A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [PDF] [D9.0000]
  • OHRP Investigator Responsibility Frequently Asked Questions [HTML]
  • FDA Guidance for Industry: Investigator Responsibilities [PDF]

    Investigators Who Are Also Considered Sponsors

    • Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [PDF] [D44.0000]
    • Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [PDF] [D45.0000]
    • University of Kentucky Sponsor-Investigator Mandatory Training [PDF] [D82.0000]

 

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]
  • Not Human Research (NHR) Determination Form [PDF] [F0.9999]
  • Guidance on IRB Review of Clinical Trial Websites [PDF] [D26.0000]

 

IRB Review and Approval:  Criteria for Approval and Specific Findings

  • Criteria for IRB Approval:  Reviewer Checklist [PDF] form [F26.0000]
  • UK Guidance to Criteria for Institutional Review Board (IRB) Approval [PDF] [D6.0000]
  • IRB Continuation Review: Primary Reviewer Checklist [PDF] form [F28.0000]
  • IRB Introduction [PDF] [D47.0000]
  • Consent/Assent Checklist - Quality Improvement Review [PDF] [O1.0000]
  • Emergency Use Checklist [WORD] [F8.0000]
  • Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4) [PDF] [D71.0000]
  • Exemption Certificate Signature Page [PDF] form [F21.0000]
  • Expedited Reviewer Signature Page [PDF] form [F20.0000]
  • Modification Reviewer Signature Page [PDF] form [F29.0000]
  • Prisoner Representative Reviewer Signature Form [PDF] form [F23.0000]
  • Consultant Signature Page [PDF] form [F22.0000]
  • HIPAA Authorization Checklist [PDF] form [F24.0000]
  • HIPAA Waiver of Authorization Checklist [PDFform [F25.0000]

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Legally Authorized Representatives (Children or Adults with Impaired Consent Capacity)

  • Informed Consent SOP [PDF] [C3.0050]
  • UK IRB Policy on Children in Research [PDF] [D22.0000]
  • University of Kentucky Adults with Impaired Consent Capacity Policy [PDF] [D62.0000]
  • IRB Application “Form T” (Research Involving Adults with Impaired Consent Capacity) [WORD] [F1.1450]
  • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF] [D87.0000]
  • Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [PDF] [D88.0000]

 

Modification of an Approved IRB Protocol

 

Noncompliance

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Off-Site Research

  • ORI’s Off-site Research Guidance [PDF] [D10.0000]
  • Off-Site Research SOP [PDF] [C1.0350]
  • Off-site Research - IRB Application Information [HTML] [F1.0850]
  • OHRP's "Guidance on Engagement of Institutions in Human Subjects Research" [HTML] [D70.0000]
  • SAMPLE IRB Authorization Agreement [PDF] [D12.0000]
  • SAMPLE Individual Investigator Agreement [PDF] [D83.0000]
  • IRB Reliance Request/Registration Form [WORD] [RTF]
  • Principal Investigator Responsibilities When Other Institutions Are Relying on the UK IRB [PDF]
  • Johns Hopkins University Human Subjects Research Ethics Field Training Guide [PDF]

 

Other Human Research Protections Sites

  • U.S. Department of Health and Human Services (DHHS) [HTML]
  • Office for Good Clinical Practice (previously the Office of Human Research Trials) [HTML]
  • Office for Human Research Protections (OHRP) [HTML]
  • DHHS Office of Research Integrity (ORI) [HTML]
  • U.S. Food and Drug Administration (FDA) [HTML]
    • Radioactive Drug Research Committee (RDRC) Program [HTML]
  • U.S. Department of Energy [HTML]
  • U.S. Department of Education [HTML]
  • National Archives and Records Administration Code of Federal Regulations [HTML]
  • National Institutes of Health (NIH) [HTML]
    • NIH Certificate of Confidentiality Information [HTML]
    • NIH Guidelines for Research Involving Recombinant DNA Molecules [HTML]
    • NIH Office of Extramural Research - FAQs [HTML]
  • Presidential Commission for the Study of Bioethical Issues [HTML]
  • International Conference on Harmonisation (ICH) Guidelines [HTML]
  • Public Responsibility in Medicine and Research (PRIM&R) [HTML]
  • PHS 398 Grant Application [HTML]

 

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]
  • OHRP Prisoner Frequently Asked Questions [HTML]
  • Department of Corrections (DoC) Policies and Procedures: Research and Survey Projects [PDF]

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]
  • UK Confidentiality and Data Security Guidelines for Electronic Data [PDF] [D105.0000]

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 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]
  • Consent/Assent Form Checklist (Essential Elements of Informed Consent) [PDF] [O1.0000]
  • Basics for Easy-to-Read Informed Consent Documents [PDF] [O11.0000]

 

Radiation Safety

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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]

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Record Review

  • Retrospective and Prospective Record Review [PDF] [D126.0000]

Recruitment of Subjects (see also Advertising)

  • 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]
  • Guidance on IRB Review of Clinical Trial Websites [PDF] [D26.0000]
  • Research Advertising [PDF] [D89.0000]
  • Compensation to Research Subjects (UK Office of the Treasurer Policy) [PDF]
  • Finder’s Fees - University of Kentucky Medical IRB Policy [PDF] [D25.0000]

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Regulations (see also Federal Regulations)

  • Overview of Basic IRB Regulations [PDF] [D30.0000]
  • Recent Changes at the Federal Level Impacting IRBs [PDF] [D86.0000]
  • IRB Resource Guide [HTML]
    The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.
     

Reporting Requirements

  • IRB
  • ~
    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
      University of Kentucky Investigator Quick Guide to IRB Reporting Requirements [PDF] [D109.0000]
    ~ Reporting Requirements for Diseases and Conditions in Kentucky [PDF] [E2.0000]

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Return of Research Results or Incidental Research Findings

  • Frequently Asked Questions (FAQs) on the Return of Research Results or Incidental Research Findings [PDF] [D118.0000]
  • Single-Subject Consent to Receive or Refuse Result or Incidental Finding - Sample Consent [PDF] [D119.0000]
  • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [PDF] [D58.0000]

 

Risk Assessment

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

 

Specimen/Tissue Collection, Genetics, & Repositories (see also Biological Specimens, or Coded Private Information)

  • OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [OHRP document-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]
  • Regulations and Policies Related to the Research Use of Human Specimens & Data (Marianna Bledsoe) [PDF] [D102.0000]
  • UK Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [PDF] [D117.0000]
  • Sample Consent to Participate in a Research Repository or Individual Study Banking Material for Future Use [WORD] [F1.0170]
  • International Society for Stem Cell Research - Guidelines for the Clinical Translation of Stem Cells and [www.isscr.org] [TEMPLATE]
  • HIPAA and Research Repositories [HTML]
  • NIH Genomic Data Sharing (GDS) Policy [HTML]

Return of Research Results or Incidental Research Findings

  • Frequently Asked Questions (FAQs) on the Return of Research Results or Incidental Research Findings [PDF] [D118.0000]
  • Single-Subject Consent to Receive or Refuse Result or Incidental Finding [PDF] [D119.0000]

Protocol Specific Training (PST):

  • Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF] [D57.0000]
  • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [PDF] [D58.0000]
  • Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [PDF] [D101.0000]
  • Guidance on the NIH Genome Data Sharing (GDS) Policy [D104.0000] [PDF]
  • OHRP Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 22.7KB] [T27.0000]
  • NIH Decision Chart for Research Involving Private Information or Biological Specimens [PDF] [T65.0000]

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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]
  • Guidance for Enrolling K-12 Students as Research Subjects [PDF] [D79.0000]

Protocol Specific Training (PST):

  • Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] [D31.0000]
  • U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [PDF] [D60.0000]

 

Study Closure

  • Study Closure SOP [PDF] [C4.0200]
  • Two circumstances when IRB approved active protocols may be closed by the PI and/or the IRB [PDF]

 

Study Personnel

  • What Constitutes Study Personnel on a Protocol Involving Human Subjects? [PDF] [D28.0000]

 

Unanticipated/Anticipated Problem/Adverse Event Reporting to the IRB

  • IRB Policy on Unanticipated Problem and Safety Reporting 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] form[PDF] [F9.0000]
  • UK’s External Prompt Reporting Form [WORD] form[PDF] [F10.0000]
  • UK’s Non-Prompt Reporting Form [WORD] form[PDF] [F11.0000]
  • How to prepare your Unanticipated Problem/Adverse Events electronic submission: [PDF]

 

Vaccine Trials

Protocol Specific Training (PST):

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

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