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Human Research Educational Materials, Regulations and Policy Guidance
by Topic

To jump to a topic, click on your choice in the menu below:


A - F

G - W


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]

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Advertising (see also Recruitment)

        • PI Guide to Identification and Recruitment of Human Subjects for Research [PDF]
        • Research Advertising [PDF]
        • 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]

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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 FWA00005295.

        • Terms of Assurance [HTML]
        • UK's sample IRB Authorization Agreement [PDF]
        • 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] (Also, see IRB Application "Form Z" [HTML])

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

Biological Specimens (see also Coded Private Information)

        • OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [HTML]

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]

Certificate of Confidentiality

        • Certificate of Confidentiality Summary Sheet [PDF]
        • Privacy vs. Confidentiality - What's the Difference? [PDF]

Children in Research

  • UK IRB Policy on Children in Research [PDF]
  • U.S. Dept. of Education/No Child Left Behind [PDF]
  • Family Educational Rights and Privacy Act (FERPA) Guidance [PDF]
  • U.S. Dept. of Education Subpart D (34 CFR 97) [HTML]
  • Guidance for Enrolling K-12 Students as Research Subjects [PDF]
  • Special Protections for Children as Research Subjects (OHRP) [HTML]
    • FAQs on Research with Children [HTML]

Clinical Trials (see also Research Participants [HTML])

  • Guidance on IRB Review of Clinical Trial Websites [PDF]
  • OSPA Clinical Trial Agreements Information Site [HTML]
  • Center for Clinical and Translational Sciences (CCTS) [HTML]
  • Registration of Clinical Trials - NIH Guidance [HTML]
  • Non-Indemnification Policy/Risk Management Committee (RMC) [HTML]

Closure of Studies

  • Two circumstances when IRB approved active protocols may be closed by the PI and/or the IRB [PDF]
  • Study Closure Standard Operating Procedures (see SOP 4d) [HTML]

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Coded Private Information (see also Biological Specimens)

  • OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [HTML]

Common Rule (see also Federal Regulations)

  • Department of Health and Human Services (HHS) [HTML]
  • 45 CFR 46 ("The Common Rule" - Human Subject Protections) [PDF]
  • Comparison of FDA and HHS Human Subject Protection Regulations (by FDA) [HTML]

Compliance (see also Noncompliance and Regulatory Reminders)

  • OHRP Compliance Oversight Activities: Determinations of Noncompliance - 2/4/09 [PDF]

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Confidentiality

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

Conflict of Interest

  • Conflict of Interest/Financial Disclosure Policy (OSPA) [HTML]

Consent (see Informed Consent)

Criteria for IRB Approval

  • Guidance to Criteria for IRB Approval [PDF]

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Data and Safety Monitoring

  • Resources on Data and Safety Monitoring [HTML]

Decision Charts - OHRP Human Subject Regulations Decision Charts [HTML]

 

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Education Options [PDF] Revised 3/23/12

This document provides a summary of the University of Kentucky’s and Veterans Affairs Medical Center’s human subject protection educational initiatives.

Emergency Research

  • Use of Investigational Drug/Device for Treatment Purposes: UK Medical IRB Requirements [PDF] UNDER REVISION-Come back soon for Update!

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Engagement in Research (see also Off-site Research)

  • OHRP's web site for "Guidance on Engagement of Institutions in Human Subjects Research" [HTML]

Ethical Principles [HTML]

  • Belmont Report [HTML]
  • Declaration of Helsinki [HTML]
  • Nuremberg Code: Directives for Human Experimentation [HTML]

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Federal Regulations

Recent Changes at the Federal Level Impacting IRBs [PDF]

Online Regulations Governing Human Subjects Research:

  • Department of Health and Human Services (HHS) [HTML]

     45 CFR 46 ("The Common Rule" - Human Subject Protections) [PDF]

  • 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)

    38 CFR 16 [HTML]

For additional information regarding federal regulations and 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

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

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

Finder’s Fees (see also IRB (UK) Policies)

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

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Genetic Research

  • Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF]
  • Summary and Guidance regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [PDF]

HIV/AIDS (see also AIDS)

  • Protection of Human Subjects in Research Involving HIV Testing [PDF-under revision]
  • Reporting Requirements for Diseases and Conditions in Kentucky [PDF]

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Human Research Accreditation Training (see Case Studies)

Impaired Consent Capacity

  • University of Kentucky Impaired Consent Capacity Policy [PDF]
  • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF]
  • Advice to Legally Authorized Representatives of Adult Participants in Nonmedical Research [PDF]
  • Assessing Consent Capacity in Clinical Research: New Directions [PDF]
  • Study Overview: Example A for Impaired Consent Capacity [PDF]
  • Study Overview: Example B for Impaired Consent Capacity [PDF]

Informed Consent

  • Waiver of Requirement for Informed Consent (DHHS) [PDF]
  • Waiver of Requirement for Documentation of Informed Consent (DHHS) [PDF]
  • Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF]
  • Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories [PDF]
  • Instructions for Informed Consent Documentation Relating to Genetic Information Nondiscrimination Act (GINA): Medical IRB [HTML] and Nonmedical IRB [HTML]
  • Lay Terms [PDF]
  • OHRP Frequently Asked Questions on Informed Consent [HTML]
  • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF]
  • Advice to Legally Authorized Representatives of Adult Participants in Nonmedical Research [PDF]
  • Would you ever need to re-consent a research participant? [PDF]

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International Research

  • Office for Human Research Protections (OHRP)

    International Issues [HTML]

    International Compilation of Human Subject Protections [HTML]

    International Compilation of Human Subject Research Protections [PDF] - This is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. 

  • 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]

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Investigational New Drugs/Devices (see also IRB (UK) Policies)

  • Summary FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [PDF]
  • Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [PDF]
  • Summary of FDA Regulations on Investigational Device Exemptions (IDE) and Exemption from IDE Requirements [PDF]
  • Summary of FDA Regulations on Exemption from IND Requirements [PDF]

Investigator Responsibilities

  • PI Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [PDF]
  • University of Kentucky Sponsor-Investigator Mandatory Training [PDF]
  • OHRP Investigator Responsibility Frequently Asked Questions [HTML]
  • FDA Guidance for Industry: Investigator Responsibilities [PDF]

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IRB Reporting to Federal Agencies

  • Serious or Continuing Noncompliance or Unanticipated Problems Involving Risks: IRB Reporting to Federal Agencies [PDF]

IRB Resource Guide [PDF, 3MB, 344 pgs., Revised January 2011]

The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.

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IRB Survival Handbook (A to Z) [HTML]

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

 

IRB (UK) Policies (see also Finder’s Fees)

  • Use of Investigational Drug/Device for Treatment Purposes: UK Medical IRB Requirements [PDF] UNDER REVISION-Come back soon for Update!
  • Finder’s Fees - University of Kentucky Medical IRB Policy [PDF]

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Listserv Archives

7/28/08 UPDATE: The Listserv Archives have been replaced with electronic dissemination of the IRB Review Newsletter posted on the "What's New?" web page. To view listserv messages disseminated from June 2008 and earlier, please click here: [HTML]

Noncompliance (see also IRB Reporting to Federal Agencies)

  • OHRP Compliance Oversight Determinations - 2/4/09 [HTML]

Off-site Research

  • ORI's Off-site Research Guidance [PDF]
  • OHRP's "Engagement of Institutions in Research" Guidance [HTML]
  • SAMPLE IRB Authorization Agreement [PDF]
  • SAMPLE Individual Investigator Agreement [PDF]
  • Johns Hopkins University Human Subjects Research Ethics Field Training Guide [PDF]

Online Training

  • CITI [HTML]
    • CITI Instructions [PDF]
  • Dunn & Chadwick [HTML]
    • Dunn & Chadwick Instructions [PDF]
  • IRB New Member Orientation Module [PDF, 128KB, 14 pgs.]
  • HIPAA Educational Module Instructions [PDF]
  • Human Research Related Educational Video or Broadcast Recordings (list of resources) [PDF]

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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]

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Privacy

  • Privacy vs. Confidentiality - What's the Difference? [PDF]
  • Family Educational Rights and Privacy Act (FERPA) Guidance [PDF]

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Recruitment (see also Advertising)

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

Regulatory Reminders

  • Expedited Review [PDF]
  • Health Insurance Portability and Accountability Act (HIPAA) [PDF]
  • Humanitarian Use Devices (HUD) [PDF]
  • Non-Prompt Reporting of External Adverse Events/Problems [PDF]
  • Risks to Research Subjects [PDF]

Risk Assessment

  • University of Kentucky Research Risk Assessment Guidance [PDF]

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Specific Findings Requiring IRB Documentation [under revision]

Students as Subjects

  • Guidance for Enrolling University Students as Subjects [PDF]
  • Guidance for Enrolling K-12 Students as Research Subjects [PDF]

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Study Personnel

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

Tissue/Specimen Repositories

  • Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories [PDF]

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Waiver of Informed Consent Requirements
  • Waiver of Requirement for Informed Consent (DHHS) [PDF]
  • Waiver of Requirement for Documentation of Informed Consent (DHHS) [PDF]

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