IRB Survival Handbook
A
UK Administrative Regulations (AR)
University of Kentucky Administrative Regulations (AR) and policies that apply to human research
- AR 7:4 (formerly III-4.0-6) Human Research Subject Protection and Institutional Review Boards
- AR 7:2 Financial Conflicts of Interest in Research
- AR 7:9 Institutional Conflicts of Interest Involving Research
- AR 10:1 Policy Governing Access To and Use of University Information Technology Resources
- UK Policy - Due Process (formerly AR 7:1): Research Misconduct (Effective Date: 10/27/25)
Alcohol or Substance Abuse Research
Resources for Alcohol or Substance Abuse Research
- NIAAA: Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation
- NACDA Guidelines for Administration of Drugs to Human Subjects
- NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents
- College of Problems on Drug Dependence Human Research (CPDD)
Artificial Intelligence/Machine Learning Human Research
Artificial Intelligence/Machine Learning Human Research: Resources for investigators using or developing AI models in human research.
B
Biobanks
Specimen/Tissue/Data Registries: Comprehensive webpage that provides tools and information on Biospecimens, Biobanks, Data Registries, Genetic Research, GINA, Genomic Data Sharing, and Secondary Research.
C
Cancer Research
Resources for Cancer Research
- Markey Cancer Center/IRB/ORI Coordination SOP [C6.0400]
- NCI CIRB SOP (NIH Pediatrics Cooperative Group Trials) [C3.0400]
Children (including Wards of the State/Emancipated Individuals) (Vulnerable Subjects)
Research Involving Children: A comprehensive webpage that provides tools and information on Research Involving Children, Enrolling K-12 Students as Subjects, Parent Permission, Assent, Exemptions, Federally Mandated Categories, and Additional Regulatory Protections.
Clinical Trials
Clinical Trials: A comprehensive webpage that provides information on Clinical Research vs. Clinical Trials, What You Need to Know for Conducting Clinical Trials, UK ClinicalTrials.gov, Clinical Trial Consent Forms, and Clinical Trial Resources & Training
Community-Engaged/Participatory Research
Community-Engaged and Community-Based Participatory Research Frequently Asked Questions [D115.0000]: A comprehensive webpage that provides information on Community-Based Participatory Research.
Concerns, Suggestions, or Questions: IRB/ORI Administrative Process; Investigator Appeals; Subject Concerns
Resources for concerns, suggestions, and questions about IRB/ORI Administrative Processes; Investigator Appeals; Subject Concerns.
Confidentiality & Privacy
Confidentiality/Privacy in Research: A comprehensive webpage that provides information on Confidentiality, Certificates of Confidentiality, and Privacy in Research.
See also: Data Security
Conflict of Interest/Significant Financial Interest
Human Subjects Conflicts Resources: A comprehensive webpage that provides resources on Conflict of Interest and Financial Disclosure for IRB Members and Investigators.
Continuation Review/Annual Administrative Review
Continuation Review (CR)/Annual Administrative Review (AAR): A comprehensive webpage that provides additional tools and information on developing a Continuation Review application and the Continuation Review process.
D
Data and Safety Monitoring
Resources for Data and Safety Monitoring: A comprehensive webpage that provides resources on data and safety monitoring.
Data Security
Data Security: A comprehensive webpage that provides data security information on Electronic Data, Honest Brokers, UK Information Technology Services Policies & Procedures, UK General Data Protection Regulations, HIPAA, Family Education Rights and Privacy Act (FERPA), Digital Data, and the Children Online Privacy Protection Act (COPPA).
Deception Research
Debriefing and Permission to Use Data Form [F1.0365]
Department Chair Responsibilities
Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.
Devices (Medical Devices, including Mobile Medical Devices/Software)
FDA-Regulated Research: A comprehensive webpage that provides tools and information on Medical Devices, Mobile Medical Devices/Software; Digital Health Policy; Compassionate Use, Humanitarian Use Device (HUD), Investigators Who Are Considered Sponsors, Investigational Device Exemptions (IDE), Nonsignificant Risk Device (NSR), and Food and Drug Administration (FDA) Resources.
Digital Technology and Internet Research
Digital Technology and Internet Research: A comprehensive webpage that provides information on digital technology and internet research.
Drugs/Dietary Supplements
FDA-Regulated Research: A comprehensive webpage that provides tools and information on Medical Devices, Mobile Medical Devices/Software; Digital Health Policy; Compassionate Use, Humanitarian Use Device (HUD), Investigators Who Are Considered Sponsors, Investigational Device Exemptions (IDE), Nonsignificant Risk Device (NSR), and Food and Drug Administration (FDA) Resources.
E
Economically or Educationally Disadvantaged Persons (Vulnerable Subjects)
Economic or Education Disadvantaged Persons: A webpage with information on research involving economically or educationally disadvantaged individuals.
Education & Training
Training & Education: A comprehensive webpage that provides information on training and education for Researchers, Research Staff, IRB Members, and Non-UK Study Personnel.
Emergency Use and Expanded Access of FDA-Regulated Products
FDA Emergency Use/Expanded Access: A comprehensive webpage that provides information on Emergency Use and Expanded Access of FDA-regulated products.
Ethics
Ethics resources that pertain to human subject research:
- UK HealthCare Bioethics Program
- Belmont Report
- Declaration of Helsinki
- Nuremberg Code: Directives for Human Experimentation
- Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard Justice in Clinical Research [HTML], Toolkit [HTML], and Resources for IRBs/HRPPs to provide to Investigators/Research Teams [HTML]
Exempt Review
Exempt Review: A comprehensive webpage that provides tools and information on Exempt Review.
Expedited Review
Expedited Review: A comprehensive webpage that provides tools and information on Expedited Review.
F
Faculty Advisor Responsibilities
Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.
FDA-Regulated Research
FDA-Regulated Research: A comprehensive webpage that provides tools and information on Food and Drug Administration (FDA) research.
Federal Agency Specific Requirements
Select Federal Agency Requirements: A comprehensive webpage that provides information on Department of Defense (DoD) Supported Human Research, Department of Education (DoE) Requirements, Department of Energy (DoE) Requirements, Environmental Protection Agency (EPA) Requirements, Department of Justice (DoJ) Requirements, National Institute of Justice (NIJ), Bureau of Prisons (BoP).
Federalwide Assurance (FWA)
Single IRB Reliance: See Basic Assurance Requirements and Institutional Review Board (IRB) Authorization Agreement under “Sample Forms.”
Federal Regulations on Human Research
Federal Regulations on Human Research: A comprehensive webpage that provides information and tools on federal regulations impacting human subjects research.
Full Review (Initial)
IRB Review Types: A comprehensive webpage that provides additional tools and information on Initial Full Review.
Funding
See “Human Subjects” on NIH Office of Extramural Research (OCR).
Future Use
Secondary Research: A comprehensive webpage that provides information and tools for: Secondary Use Research, Coded Private Information, Records Review, and Data Management & Sharing.
G
Genetic Research & Genomic Data Sharing
Specimen/Tissue Banks/Data Registries: A comprehensive webpage that provides tools and information on Biospecimens, Biobanks, Data Registries, Genetic Research, GINA, Genomic Data Sharing, and Secondary Research.
H
HIPAA in Research
HIPAA in Research: Comprehensive webpage that provides additional tools and information on Covered Entities, HIPAA Identifiers, and Waiver of Authorization.
I
Impaired Consent Capacity (inc. Legally Authorized Representatives) (Vulnerable Subjects)
Impaired Consent Capacity Adults: A comprehensive webpage that provides additional tools and information on research involving adults with impaired consent capacity.
Informed Consent/Assent
Informed Consent/Assent: A comprehensive webpage that provides additional tools and information on developing Informed Consent, the Informed Consent Process, Assent, Impaired Consent Capacity, Short Form Process, Waiver or Alteration of Informed Consent, Remote Informed Consent, Electronic Informed Consent, Informed Consent for Survey Research, and Exception from Informed Consent (EFIC).
International & Non-English Speaking Subjects
Non-English, Foreign Culture: A comprehensive webpage that provides information on Non-English Speaking Subjects, Subjects from a Foreign Culture, Short Form Process, Document Translation, and the UK International Travel Policy.
Investigator/Research Staff Responsibilities
Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.
M
Modification Requests
Modification Requests: A comprehensive webpage that provides additional tools and information on developing a Modification Request.
N
Noncompliance
Noncompliance: A comprehensive webpage that provides information on human subjects research noncompliance.
Not Human Research (NHR)
Resources for determining what needs IRB review:
- What Needs IRB Review
- Research vs. Quality Improvement Interactive Tool
- Not Human Research (NHR) Form
O
Off-Site Research
Off-Site Research: A comprehensive webpage that provides information for Letters of Support, Local Context, & Additional Off-Site Requirements.
Other Human Research Review Committees
Other Human Research Review Committees: A comprehensive webpage that provides additional links to other Human Research review committees at UK.
P
Pregnant Women, Fetuses, & Neonates (Vulnerable Subjects)
Research Involving Pregnant Women, Fetuses, and/or Neonates: A comprehensive webpage that provides additional tools and information on research involving pregnant women, fetuses, and/or neonates.
Prisoners (Vulnerable Subjects)
Research Involving Prisoners [F1.1700]: A comprehensive webpage that provides additional tools and information on research involving prisoners.
Privacy & Confidentiality
Confidentiality/Privacy in Research: A comprehensive webpage that provides information on Confidentiality, Certificates of Confidentiality, and Privacy in Research.
See also: Data Security
Q
Quality Improvement Program
Quality Assurance/Improvement Program for Human Subject Protection: A comprehensive webpage that provides Quality Assurance/Improvement tools and information on Wellness Check Visits, Directed On-Site Reviews, PI Self-Assessment Reviews, Administration Assessment Reviews, and Reporting Requirements.
Note: For information on when quality improvement activities require IRB review, see What Needs IRB Review.
R
Radiation Safety
Use of Radioactive Materials (Radiation Safety): A webpage providing resources for approval of the use of radioactive materials in human research.
Recordkeeping
Principal Investigators (PI) Guide for Human Research: A webpage that provides information on Records and Documentation.
See also: Study Closure
Records Review
Secondary Research: A comprehensive webpage that provides information and tools for: Secondary Use Research, Coded Private Information, Records Review, and Data Management & Sharing.
Recruitment of Subjects/Advertising (Also see "Students as Subjects")
Principal Investigators (PI) Guide for Recruitment: A comprehensive webpage that provides information and tools on Recruitment of Subjects, Advertisements, Compensation to Subjects, Payment to Foreign Nationals, and Finder’s Fees.
See also Students as Subjects
Reporting Requirements (Unanticipated Problem/Safety Reporting, Deviation/Exception, Protocol Violation)
Reporting Requirements: A comprehensive webpage that provides information on reporting requirements for Principal Investigators (PI), Institutional Review Boards (IRB), Diseases and Conditions in Kentucky, and HIV testing.
Repositories & Registries
Specimen/Tissue/Data Registries: Comprehensive webpage that provides tools and information on Biospecimens, Biobanks, Data Registries, Genetic Research, GINA, Genomic Data Sharing, and Secondary Research.
Return of Research Results or Incidental Research Findings
Return of Research Results: A comprehensive webpage that provides information on Return of Research Results, Incidental Research Findings, and Single-Subject Consent to Receive/Refuse.
Risk Assessment
Assessing Research Risk: A comprehensive webpage with information on Minimal Risk, Greater Than Minimal Risk, Identifying & Evaluating Risk, Minimizing Risk, Minor Increment Over Minimal Risk, and Risk/Benefit Ratio.
Roles & Responsibilities
Roles & Responsibilities: A comprehensive webpage that provides information on the roles and responsibilities for Investigators/Research Staff, Department Chairpersons, and Faculty Advisors.
S
Secondary Use Research
Secondary Research: A comprehensive webpage that provides information and tools for: Secondary Use Research, Coded Private Information, Records Review, and Data Management & Sharing.
Students as Subjects (Vulnerable Subjects)
Vulnerable Populations - Students: A comprehensive webpage that provides tools and information on Enrolling University Students, College of Education Early Childhood, Special Education, and Counselor Education Programs, K-12 Enrollment & HSP Training, Family Education Rights and Privacy (FERPA), and U.S. Department of Education Protection of Pupil Rights Amendment (PPRA).
Study Closure
Study Closure: A webpage that provides information on Study Closure Circumstances & Categories and Close vs. Expire.
Study Personnel
IRB Study Personnel: A comprehensive webpage with tools and information on HSP Training Requirements, Minors as Study Personnel, and Adding Non-UK Study Personnel.
Single IRB Reliance
Single IRB Reliance: A Comprehensive webpage that provides additional tools and information on Single IRB Reliance, UK Multisite Research, PI Assurance Statement, Relying Sites, Local Context, Communication Plans, Letters of Support (LOS), and Individual Investigator Agreements (IIA).
Suicidality and Research Ethics
Suicidality and Research Ethics: A comprehensive webpage that provides information on Fiduciary Duties, Risk Categorization, and Suicidality Study Types.
Survey Research
Survey Research: A comprehensive webpage that provides tools and information on Informed Consent for Survey Research, Survey Recruitment & Data Collection, Payment Considerations, Strategies for Preventing Online Survey Fraud, and Survey Platforms.