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A

Administrative Regulations (UK)

Alcohol or Illegal Drug Research

B

Banks, Repositories, Registries, Specimen/Tissue, Genetic/Genomic Data Sharing

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C

Cancer Research

Children (including Wards of the State/Emancipated Individuals) (Vulnerable Subjects)

Research Involving Children - Comprehensive webpage that provides additional tools and information on research involving children.

Clinical Trials

Community-Engaged/Participatory Research

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

Confidentiality/Privacy/Data Security

Conflict of Interest/Significant Financial Interest

Continuation Review/Annual Administrative Review

Continuation Review (CR)/Annual Administrative Review (AAR) [HTML] - Comprehensive webpage that provides additional tools and information on developing a Continuation Review application and the Continuation Review process.

Select Forms/Guidance:

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D

Data and Safety Monitoring

Deception Research

Debriefing and Permission to Use Data Form [F1.0365]

Recommended Readings:

  • Seiber, Joan E. Planning Ethically Responsible Research: A Guide for Students and Internal Review Board. Vol. 31, SAGE Publications, 1992, pp. 64-74.
  • Sieber, Joan E, and Martin Tolich. Planning Ethically Responsible Research. 2nd ed., SAGE, 2013.
  • Sieber, Joan E. “Deception in Social Research I: Kinds of Deception and the Wrongs They May Involve.” IRB: Ethics and Human Research, vol. 4, no. 9, Nov. 1982, pp. 1–5.
  • Sieber, Joan E. “Deception in Social Research II: Evaluating the Potential for Harm or Wrong.” IRB: Ethics and Human Research, vol. 5, no. 1, Jan. 1983, pp. i-3.

Department Chair Responsibilities

Devices (Medical Devices including Mobile Medical Devices/Software)

Digital Technology and Internet Research

Suggested Reading (not adopted by UK IRB):

Diversity, Inclusion, and Equity

Drugs/Dietary Supplements

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E

Economically or Educationally Disadvantaged Persons (Vulnerable Subjects)

Research Involving Economically or Educationally Disadvantaged Persons Guidance [D139.0000] (PDF)

Education (Researchers/Research Staff/IRB Members)

Emergency Use and Expanded Access of FDA Regulated Products

Ethics

Exempt Review

IRB Review Types - Comprehensive webpage that provides additional tools and information 

Expedited Review

IRB Review Types - Comprehensive webpage that provides additional tools and information 

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F

Faculty Advisor Responsibilities

Faculty Advisor's Assurance Statement:

"This is to certify that I have reviewed this research protocol and that I attest to the scientific merit of this study; to the qualifications of the investigator(s) to conduct the project; that facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided as appropriate.

**If the Principal Investigator is completing this project to meet the requirements of a University of Kentucky academic program, in addition to Department Authorization, the student's faculty advisor should sign the Assurance Statement. The student's faculty advisor is accepting a supervisory role in guiding the student in conducting regulatory compliant research and therefore must be certified in human research protection training throughout the life of the protocol."

Take just a few minutes to check out the ORI video training "Faculty Advisor Responsibilities" including ORI tools to help your students succeed with human subject research.

FDA-Regulated Research

FDA-Regulated Research

Federal Agency Specific Requirements (DoD, DoJ, EPA, etc.)

Federalwide Assurance (FWA) (#00005295)

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.

Federal Regulations

Full Review (Initial)

IRB Review Types - Comprehensive webpage that provides additional tools and information 

Future Use, Sharing, Record Reviews and Secondary Research (includes NIH Data Sharing Policy Fact Sheet)

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I

Impaired Consent Capacity (inc. Legally Authorized Representatives) (Vulnerable Subjects)

Research Involving Adults with Impaired Consent Capacity - Comprehensive webpage that provides additional tools and information on research involving adults with impaired consent capacity.

Informed Consent/Assent

Informed Consent/Assent - Comprehensive webpage that provides additional tools and information on developing Informed Consent and the Informed Consent Process. 

International & Non-English Speaking Subjects

Investigator/Research Staff Responsibilities

Researchers - Comprehensive webpage that provides additional tools and information for Researchers and research support staff.

Select Forms/Guidance:

Investigators Who Are Also Considered Sponsors

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M

Modification Requests

Modification Requests - Comprehensive webpage that provides additional tools and information on developing a Modification Request.

Select Forms/Guidance:

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N

Noncompliance

  • OHRP Compliance Oversight Determinations - 2/4/09 [D96.0000] [HTML]
  • FDA Compliance & Enforcement [HTML]
  • Reporting Noncompliance to IRB
    • Subject Concerns/Complaints SOP [C2.0500] [PDF]
    • Submitting Concerns, Suggestions, or Questions for Improving the Human Research Protections Process [H1.1200] [HTML]
  • IRB Handling Allegations of Noncompliance
    • Noncompliance SOP [C2.0550] [PDF]
    • Termination or Suspension of Research by the IRB SOP [C2.0600] [PDF]
    • Serious or Continuing Noncompliance or Unanticipated Problems Involving Risks: IRB Reporting to Federal Agencies [D27.0000] [PDF]

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O

Off-Site Research

Off-Site Research: Letter of Support, Local Context, & Additional Requirements [HTML]

Other Human Research Protection Sites

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

Other Human Research Review Committees

Other Human Research Review Committees [HTML] - Comprehensive webpage that provides additional links to other Human Research review committees at UK.

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P

Pregnant Women, Fetuses, & Neonates (Vulnerable Subjects)

Research Involving Pregnant Women, Fetuses, and/or Neonates [HTML] - Comprehensive webpage that provides additional tools and information on research involving pregnant women, fetuses, and/or neonates.

  • Protection of Vulnerable Subjects SOP [C3.0100] [PDF]
  • IRB Application “Form U” (Research Involving Pregnant Women, Fetuses, &/or Neonates) [F1.1550] [PDF]
  • IRB Application Instructions for Vulnerable Populations - Pregnant Women, Fetuses, Neonates [F1.1600] [HTML]
  • Summary of Pregnant Women, Fetuses, & Neonates Regulations 45 CFR 46 Subpart B [D64.0000] [PDF]

Prisoners (Vulnerable Subjects)

  • Research Involving Prisoners [F1.1700] [HTML] - Comprehensive webpage that provides additional tools and information on research involving prisoners.
  • Protection of Vulnerable Subjects SOP [C3.0100] [PDF]
  • IRB Application (Research Involving Prisoners "Form V") [F1.1650] [PDF]
  • Prisoner Representative Reviewer Signature Form [F23.0000] [PDF]
  • OHRP Prisoner Frequently Asked Questions [HTML]
  • KY Department of Corrections (DoC) Policies and Procedures: Research, Surveys, and Data Requests [PDF]
  • Summary of Prisoners Regulations 45 CFR 46 Subpart C [T63.0000] [PDF]
  • OHRP Guidance on the Involvement of Prisoners in Research – 5/23/03 [T22.0000] [HTML]
  • Research Involving Prisoners Flow Chart [T23.0000] [PDF]
  • 45 CFR Part 46 Waiver of the Applicability of Certain HHS Provisions for HHS Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects [T24.0000] [HTML]

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Q

Quality Improvement Program

Quality Improvement Program for Human Research Protections [HTML] - Comprehensive webpage that provides additional tools and information on Quality Improvement.

Select Forms/Guidance:

  • Quality Improvement Program Directed On-Site Review SOP [C5.0050] [PDF]
  • Quality Improvement Program Principal Investigator Self-Assessment Review SOP [C5.0150] [PDF]
  • Online PI Self-Assessment Form [HTML]
  • Quality Improvement Program Administrative Assessment Review SOP [C5.0200] [PDF]
  • Consent/Assent Form Checklist (Essential Elements of Informed Consent) [O1.0000] [PDF]
  • Basics for Easy-to-Read Informed Consent Documents [O11.0000] [PDF]

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R

Radiation Safety

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

Recordkeeping

Two circumstances when IRB-approved active protocols may be closed by the PI and/or the IRB [D76.0000] [PDF]

Principal Investigators (PIs)

  • Study Closure SOP [C4.0200] [PDF]
  • A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [D9.0000] [PDF]

Institutional Review Board (IRB)

  • Minutes of IRB Meetings SOP [C4.0050] [PDF]
  • IRB/ORI Record-Keeping SOP [C4.0250] [PDF]

Recruitment of Subjects/Advertising (Also see "Students as Subjects")

  • A Principal Investigator’s Guide to Identification and Recruitment of Human Subjects for Research [D7.0000] [PDF]
  • IRB Application Instructions - Advertisements (Proposed advertisement(s) of any type for recruiting subjects) [F1.0750] [HTML]
  • Guidance on IRB Review of Clinical Trial Websites [D26.0000] [PDF]
  • Research Recruitment and Advertising in Human Research [HTML, ~15 minutes]
  • E-9: Compensation to Research Subjects [HTML]
  • E-7.7: Payments to Foreign Nationals [PDF]
  • Finder's Fees - University of Kentucky Medical IRB Policy [D25.0000] [PDF]

Reportable Diseases/Conditions

  • Reporting Requirements for Diseases and Conditions in Kentucky [E2.0000] [PDF]
  • Protection of Human Subjects in Research Involving HIV Testing [D65.0000] [PDF]

Reporting Requirements (Unanticipated Problem/Safety Reporting, Deviation/Exception, Protocol Violation)

Principal Investigators (PIs)

  • University of Kentucky Investigator Quick Guide to IRB Reporting Requirements [D109.0000] [PDF]
  • Other Reviews [HTML] - Comprehensive webpage that provides additional tools and information on reporting Deviations/Exceptions, Protocol Violations, and Unanticipated Problems.
  • Modification - IRB Review of Changes SOP [C2.0300] [PDF]
  • Modification Requests: Modification of a Currently Approved Protocol [D67.0000] [HTML]
  • Protocol Violation Review SOP [C2.0400] [PDF]
  • Continuation Review SOP [C2.0250] [PDF]
  • Deviations and Exceptions - IRB Review of Changes [C2.0325] (3/15/19) [PDF]
  • Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [C2.0350] [PDF]
  • IRB Policy on Unanticipated Problem and Safety Reporting to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) [D2.0000] [PDF]
  • Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/NonPrompt Reporting [PDF]
  • See Unanticipated Problem/Safety Reporting under Other Reviews for related forms [HTML]
  • Reporting Requirements for Diseases and Conditions in Kentucky [E2.0000] [PDF]

 

Institutional Review Board (IRB)

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

Repositories, Registries, Specimen/Tissue Banks/Genetic/Genomic Data Sharing

  • UK Research Biospecimen Bank Guidance [D129.0000] [PDF]
  • UK Research Registry Guidance [D130.0000] [PDF]
  • Sample Repository/Registry/Bank Consent [F1.0170] [WORD]
  • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [D58.0000] [PDF]
  • Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [D101.0000] [PDF]
  • Guidance on the NIH Genome Data Sharing (GDS) Policy [D104.0000] [PDF]
  • OHRP Guidance on Research Involving Coded Private Information or Biological Specimens [T27.0000] [HTML]
  • NIH Decision Chart for Research Involving Private Information or Biological Specimens [T65.0000] [PDF]
  • IRB Application Guidelines and materials to submit for “Form EE” (Institutional Biosafety Committee (IBC)) [F1.2300] [HTML]
  • IBC/IRB/ORI Coordination SOP [C6.0100] [PDF]
  • Instructions for Informed Consent Documentation Relating to Genetic Information Nondiscrimination Act (GINA): Medical IRB [F1.0175] / Nonmedical IRB [F2.0175] [HTML]
  • DHHS - The Genetic Information Nondiscrimination Act of 2008 - Information for Researchers and Health Care Professionals [D106.0000] [PDF]
  • Human Genetic Research -- OHRP: IRB Guidelines, Chapter 5, Section H [T14.0000] [PDF]
  • OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [D74.0000] [PDF]
  • FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [T12.0000] [PDF]
  • FDA Blood & Blood Products [HTML]
  • UK Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research” [D117.0000] [PDF]
  • 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 [D118.0000] [PDF]
  • Single-Subject Consent to Receive or Refuse Result or Incidental Finding - Sample Consent [D119.0000] [PDF]
  • The MRCT Center of Brigham and Women's Hospital and Harvard: Return of Individual Results [HTML]
  • National Academies of Science, Engineering & Medicine Consensus Study Report: Returning Individual Research Results to Participants [HTML]

Risk Assessment

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

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S

Students as Subjects (Vulnerable Subjects)

  • Protection of Vulnerable Subjects SOP [C3.0100] [PDF]
  • Guidance for Enrolling University Students as Research Subjects [D4.0000] [PDF]
  • Considerations for the IRB when reviewing protocols from College of Education Early Childhood, Special Education and Counselor Education program [PDF]
  • K-12 Teacher & Support Staff HSP Training Course [HTML Interactive Video]
  • IRB Application Information for “Form II” (Medical Center and/or College of Medicine residents or fellows as research subjects) [F1.2500] [HTML]
  • Guidance for Enrolling K-12 Students as Research Subjects [D79.0000] [PDF]
  • Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000] [PDF]
  • U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [D60.0000] [PDF]

Study Closure

  • Study Closure SOP [C4.0200] [PDF]
  • Two circumstances when IRB-approved active protocols may be closed by the PI and/or the IRB [D76.0000] [PDF]

Study Personnel

  • What Constitutes Study Personnel on a Protocol Involving Human Subjects? [D28.0000] [PDF]
  • Adding Non-UK Study Personnel [D163.0000] [PDF]

Single IRB Reliance

Single IRB Reliance [HTML] - Comprehensive webpage that provides additional tools and information on Single IRB Reliance.

Suicidality and Research Ethics

Suicide Ideation or Behavior Among Research Participants [PDF]

Survey Research

Survey Research [HTML] - Comprehensive webpage that provides tools and information for researchers conducting survey research.

  • Informed Consent for Survey Research [HTML]

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