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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) - 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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R

Radiation Safety

Recordkeeping

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

Principal Investigators (PIs)

Institutional Review Board (IRB)

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

Reportable Diseases/Conditions

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

Principal Investigators (PIs)

Institutional Review Board (IRB)

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

Return of Research Results or Incidental Research Findings

Risk Assessment

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

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