IRB Survival Handbook

• Administrative Regulation 7:4 (formerly III-4.0-6) Human Research Subject Protection and Institutional Review Boards [HTML]
• Administrative Regulation 7:1 (formerly II-4.0-2) Research Misconduct [HTML]
• Administrative Regulation 7:2 (formerly II-4.0-4) Research Conflict of Interest and Financial Disclosure Policy [HTML]
• Administrative Regulation 7:9 Institutional Conflicts of Interest Involving Research [HTML]
• Administrative Regulation 10:1 Use of Technology Resources [HTML]

• NIAAA:  Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation [T2.0000] [HTML]
• NACDA Guidelines for Administration of Drugs to Human Subjects [T3.0000] [PDF]
• NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents [T29.0000] [PDF]

• UK Advance Research Recommendations https://advance.uky.edu/research-recommendations
• UK Center for Applied Artificial Intelligence  https://caai.ai.uky.edu/
• UK College of Medicine Artificial Intelligence in Medicine (AIM) Alliance https://medicine.uky.edu/sites/research/aim
• AI Bill of Rights https://www.whitehouse.gov/ostp/ai-bill-of-rights/
• Considerations for IRB Review of Research Involving Artificial Intelligence- Secretary’s Advisory Committee on Human Research Protections (SACHRP)  https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.html
• Artificial Intelligence (AI) Types and Use in Biomedical Research, National Institutes of Health (NIH) https://www.nibib.nih.gov/science-education/science-topics/artificial-intelligence-ai
• FDA Digital Health Policy Navigator to determine if AI/ML Software/Algorithm is subject to FDA Oversight and Regulatory Requirements https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator
• CITI Webinar Artificial Intelligence (AI) and Human Subject Protection. See the instructions for accessing the webinar from the Optional Course menu on CITI.

• UK Research Biospecimen Bank Guidance [D129.0000] [PDF]
• UK Research Registry Guidance [D130.0000] [PDF]
• Sample Repository/Registry/Bank Consent [F1.0170] [WORD]
• 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]
• 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]

• Markey Cancer Center/IRB/ORI Coordination SOP [C6.0400] [PDF]
• NCI CIRB SOP (NIH Pediatrics Cooperative Group Trials) [C3.0400] [PDF]
• IRB Application "Form G" (Department of Health and Human Services (DHHS)-approved protocols) [F1.0450] [HTML]

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

• IRB Application “Form W” (Children in Research) [F1.1750] [PDF]
• IRB Application Instructions for Vulnerable Populations - Children [F1.1775] [HTML]
• IRB Application Instructions for Assent (Informed Consent/Assent Process) [Medical F1.0225; Nonmedical F2.0250] [HTML]
• Informed Consent SOP [C3.0050] [PDF]
• Protection of Vulnerable Subjects SOP [C3.0100] [PDF]
• Guidance for Enrolling K-12 Students as Research Subjects [D79.0000] [PDF]
• UK ORI Parent Permission Sample  [PDF]
• OHRP Special Protections for Children as Research Subjects [HTML]
• OHRP FAQs on Research with Children [HTML]
• UK IRB Policy on Children in Research [D22.0000] [PDF] 
• U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [D60.0000] [PDF]
• Summary of Children Regulations (Subpart D) [D61.0000] [PDF]
• Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000] [PDF]
• UK ORI Children's Online Privacy Protection Act (COPPA) Guidance [PDF]

• What you need to know for conducting clinical trials [HTML]
• Research Participants [HTML]
• Definition of clinical research vs. clinical trial [HTML]
• OSPA Clinical Trial Agreements Information Site [HTML]
• OSPA ClinicalTrials.gov Guidance and General Information [HTML]
• Non-Indemnification Policy/Risk Management Committee (RMC) [HTML]
• Center for Clinical and Translational Sciences (CCTS) [HTML]

• Community-Engaged and Community-Based Participatory Research Frequently Asked Questions [D115.0000] [PDF]
• NIH Community-Based Participatory Research (CBPR) Program [HTML]
• UK Cares Community Engaged Research Training [HTML]
• K-12 Teacher & Support Staff Human Subject Protection (HSP) Training [Launch Course]

• Contact ORI [HTML]
• Subject Concerns/Complaints SOP [C2.0500] [PDF]
• Noncompliance SOP [C2.0550] [PDF]

• Privacy vs. Confidentiality - What's the Difference? [D32.0000] [PDF]
• UK/ORI Certificate of Confidentiality Frequently Asked Questions (FAQs) [D56.0000] [PDF]
• Methods for De-identification for Honest Brokers [HTML]
• UK Confidentiality and Data Security Guidelines for Electronic Data [D105.0000] [PDF]
• UK Information Technology Services Information Security Policy & Procedures [HTML]
• UK General Data Protection Regulation (GDPR) Guidance [PDF]
• HIPAA in Human Research [HTML]
• Family Educational Rights and Privacy Act (FERPA) Guidance [D31.0000] [PDF]
• IRB Review and Digital Data Considerations [D131.0000] [PDF]
• Considerations for Protocol Design Concerning Digital Data [D132.0000] [PDF]
• UK ORI Children's Online Privacy Protection Act (COPPA) Guidance [PDF]

• DHHS Financial Conflict of Interest Guidance: Financial Relationships and Interests in Research Involving Human Subjects [D73.0000] [HTML]
• IRB Member Conflict of Interest:
  • IRB Member and Consultant Conflict of Interest SOP [C1.0200] [PDF]
  • IRB Member Conflict of Interest Statement [F17.0000] [PDF]
  • Consultant Conflict of Interest Statement and Confidentiality Agreement [PDF]
• Investigator Conflict of Interest
  • UK Administrative Regulations (AR) 7:2 Financial Conflicts of Interest in Research [PDF]
  • Investigator Conflict of Interest/OSPA/IRB Coordination SOP [C6.0650] [PDF]
  • Office of Sponsored Projects Administration (OSPA) Resources on Financial Conflict of Interest [HTML]

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:

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

• ORI Resources for Data and Safety Monitoring [D24.0000] [HTML]
• Data and Safety Monitoring Plan SOP [C3.0350] [PDF]

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

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.

• What Does the Department Chairperson's Assurance Statement on the IRB application mean? [D17.0000] [PDF]
• EVPR Memo:  Department Chairperson’s Assurance Statement on Institutional Review Board Applications [D16.0000] [PDF]
• IRB Application Form Z (Signature Assurance Sheet) [F1.2000] [PDF]
• IRB Application Guidance for Form Z [F1.2050] [HTML]

• IRB Application “Study Device Form” (Use of Any Device Being Tested in Research ) [F1.1100] [PDF]
• IRB Application Instructions for Study Device [F1.1150] [HTML]
• UK ORI Food and Drug Administration (FDA) Interactive Flow Chart: Medical Device Trials [HTML]
• FDA Digital Health Policy Navigator Tool for determining if a Mobile App or Software is an FDA-regulated medical device  [HTML]
• Medical Device Clinical Investigations , Compassionate Use, and Treatment IDE SOP [C3.0150] [PDF]
• Humanitarian Use Device SOP [C3.0200] [PDF]
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [D45.0000] [PDF]
• Summary of FDA Regulations on Investigational Device Exemptions (IDE) and Exemption from IDE Requirements [D97.0000] [PDF]
• Flow Charts for Applications of FDA IND and IDE Regulations [D127.0000] [PDF]
• Food and Drug Administration (FDA) Resources [D116.0000] [PDF]
• IRB Review of Medical Device Research [D110.0000] [PDF]
• IRB Summary - Humanitarian Use Devices [21 CFR Parts 20 and 814 Subpart H] [D54.0000] [PDF]

• Determining if FDA Regulations apply to Digital Technology [HTML]

• IRB Review and Digital Data Considerations [D131.0000] [PDF]
• Considerations for Protocol Design Concerning Digital Data [D132.0000] [PDF]
• UK ORI Interactive Tool for Determining if an Application or Software is an FDA-regulated Medical Device [HTML]

Suggested Reading (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]
• 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]
• Buchanan, E. A. (2011). Internet Research Ethics: Past, Present, and Future. In The Handbook of Internet Studies (eds M. Consalvo and C. Ess). (Available at the William T. Young Library)

• University of Kentucky (UK) Office of Research Integrity (ORI) Guidance: Gender Inclusive Language [PDF]
• University of Kentucky (UK) Office of Research Integrity (ORI) Video: Use of Gender-Inclusive Language [HTML Video]
• Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard: Achieving Diversity, Inclusion, and Equity in Clinical Research [HTML], Guidance Document [HTML], Toolkit [HTML], LGBTQIA+ Inclusion – Inclusive Language Checklist [HTML]
• SACHRP Recommendations for the Ethical Review and Inclusion of LGBTQI+ Participants in Human Subjects Research [HTML]
• Northwestern Evidence-based Recommendations for Ethical Research Practices with SGM Adolescents [HTML]

• IRB Application “Study Drug Form” (Use of Any Drug Being Tested in Research ) [F1.0900] [PDF]
• IRB Application Instructions for Study Drug [F1.0950] [HTML]
• ORI Guide for IRB Review of Phase I Drug Trials [D136.0000] [PDF]
• UK ORI FDA Interactive Flow Chart: Drug/Biologic Trials [HTML]
• Summary of FDA Regulations on Exemption from IND Requirements [D46.0000] [PDF]
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [D44.0000] [PDF]
• 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 [D34.0000] [PDF]
• ORI Dietary Supplement Study FAQ [D122.0000] [PDF]
• UK Investigational Drug Service [HTML]
• Investigational Drug Service/IRB Coordination SOP [C6.0350] [PDF]
• Expanded Access Program (EAP) for Drugs SOP [C3.0300] [PDF]
• Food and Drug Administration (FDA) Resources [D116.0000] [PDF]
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs – Determining Whether Human Research Studies Can Be Conducted Without an IND [T30.0000] [PDF]
• FDA Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer 2004 [PDF]
• Individual Patient Expanded Access Applications: Form FDA 3926 [HTML]
• Expanded Access Program Search Navigator [HTML]
• FDA Expanded Access Website [HTML]
• FDA Expanded Access Instructional Videos [HTML]

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

• UK Human Research Education Options [D48.0000] [PDF]
• Human Research Related Educational Video or Broadcast Recordings (list of resources) [D103.0000] [PDF]
• 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]
  • What Constitutes Study Personnel on a Protocol Involving Human Subjects? [D28.0000] [PDF] 
  • Principal Investigator Q & A Guide [D121.0000] [PDF]
• IRB Members
  • IRB Members/ORI Staff Training SOP [C1.0250] [PDF]
  • IRB New Member Orientation Module [D41.0000] [PDF]

• Emergency Use SOP [C3.0250] [PDF]
• Emergency Use Checklist [F8.0000] [PDF]
• Expanded Access Program (EAP) for Drugs SOP [C3.0300] [PDF]
• FDA Emergency and Early/Expanded Access Program for Drugs and Devices [D34.0000] [PDF]
• FDA Expanded Access Instructional Videos [HTML]
• Individual Patient Expanded Access Applications: Form FDA 3926 [HTML]
• Expanded Access Program Search Navigator [HTML]
• FDA Expanded Access Website [HTML]

• UK HealthCare Bioethics Program [HTML]
• 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.

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

• Exemption Certification Request (application) (Log in to E-IRB)
• Exempt Review SOP [C2.0200] [PDF]
• Issues to be Addressed When Conducting Exempt Review [D37.0000] [PDF]
• Exempt Review Decision [HTML Interactive Tool]
• UK ORI New Common Rule Exemption Categories Tool [PDF]

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

• Medical IRB Expedited Review Application [F1.0000 & F3.0050] (Log in to E-IRB)
• Nonmedical IRB Expedited Review Application [F2.0000 & F3.0050] (Log in to E-IRB)
• Expedited Initial Review SOP [C2.0150] [PDF]
• Issues to Address when Conducting Expedited Reviews [D39.0000] [PDF]
• OHRP Guidance on the Use of Expedited Review Procedures [T13.0000] [HTML]
• Guidance on Expedited Review of Minor Changes in Previously Approved Research [D38.0000] [PDF]
• Criteria for IRB Approval: Reviewer Checklist [F26.0000] [PDF]
• Expedited Reviewer Signature Page [F20.0000] [PDF]

• Faculty Advisor Responsibilities [HTML Video, 05:02 minutes]
• A Mentor’s Guide to the IRB: A Faculty Advisor Workshop [Video, 44:22 minutes]

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" [HTML] including ORI tools to help your students succeed with human subject research.

FDA-Regulated Research webpage [HTML]

• Summary of Requirements for Department of Defense Supported Human Research [D107.0000] [PDF]
• Department of Defense Supported Research: Checklist [D108.0000] [PDF]
• Department of Defense IRB/ORI Coordination SOP [C6.0850] [PDF]
• Summary of Department of Education (DoED) Requirements [D111.0000] [PDF]
• Summary of Department of Energy (DoE) Requirements [D112.0000] [PDF]
• 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) [F35.0000] [PDF] 
• Summary of Environmental Protection Agency (EPA) Requirements [D114.0000] [PDF]
• Environmental Protection Agency (EPA) Research: IRB Reviewer Checklist [F33.0000] [PDF]
• Summary of Department of Justice (DoJ), National Institute of Justice (NIJ), and Bureau of Prisons (BoP) Requirements [D113.0000] [PDF]
• Department of Justice (DOJ), National Institute of Justice (NIJ), and Bureau of Prisons Supported Research: IRB Reviewer Checklist [F34.0000] [PDF]
• Federal Agency “Specific” Requirements IRB/ORI Coordination SOP [C6.0900] [PDF]

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 [D12.0000] [PDF]
• UK's Assurance Information through OHRP website (search "U of Kentucky") [HTML]

• Federal Regulation Tracker [D86.0000] [HTML Interactive Tool]
• UK ORI Revised Common Rule Webpage [HTML]
• Food and Drug Administration (FDA) Resources [D116.0000] [PDF]
• 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:
      • 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]
      • Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
        Notice Number: NOT-OD-12-129 [HTML]
  • Food and Drug Administration (FDA) [HTML]
    • 21 CFR 812 (Investigational Device Exemptions) [HTML]
    • 21 CFR 312 (Investigational New Drugs) [HTML]
    • 21 CFR 56 (Institutional Review Boards) [HTML]
    • 21 CFR 50 (Protection of Human Subjects) [HTML]

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

• Medical IRB Full Review Application [F1.0000] (Log in to E-IRB)
• Nonmedical IRB Full Review Application [F2.0000] (Log in to E-IRB)
• Initial Full Review SOP [C2.0100] [PDF]
• Criteria for IRB Approval: Reviewer Checklist [F26.0000] [PDF]

• Primary Research & Future Use [HTML Interactive Video]
• UK ORI Secondary Use Research Tool [HTML Interactive Tool]
• UK ORI Retrospective and Prospective Record Review: IRB Implications [D126.0000] [PDF]
• UK Fact Sheet – Final NIH Policy for Data Management and Sharing [PDF]
• Research Data Services at UK: Data Management and Sharing Plan [HTML]

HIPAA in Research [HTML] - Comprehensive webpage that provides additional tools and information including Covered Entities

Select Forms/Guidance:

• HIPAA in Research SOP [C2.0450] [PDF]
• HIPAA at UK [HTML Video, 04:27 minutes]
• HIPAA Instructions for all IRB Applications [F1.0600] [PDF]
• HIPAA Forms [HTML]
• HIPAA Authorization Regulations [D19.0000] [PDF]
• HIPAA Guidance for Requesting and Completing the Waiver of Authorization [D20.0000] [PDF]

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

• University of Kentucky Adults with Impaired Consent Capacity Policy [D62.0000] [PDF]
• Protection of Vulnerable Subjects SOP [C3.0100] [PDF]
• Informed Consent SOP [C3.0050] [PDF]
• 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] [HTML]
• IRB Application Instructions for “Form T” [F1.1500] [HTML]
• Assessing Consent Capacity in Clinical Research: New Directions [D95.0000] [PDF]
• Advice to Legally Authorized Representatives of Adult Participants in Medical Research [D87.0000] [PDF]
• Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [D88.0000] [PDF]

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

• Informed Consent SOP [C3.0050] [PDF]
• IRB Application Instructions - Non-English, Foreign Culture (recruitment of Non-English speaking subjects) [F1.0500] [HTML]
• Single IRB Reliance/Off-Site [HTML]
• OHRP International Issues [HTML]
• OHRP:  IRB Guidebook Chapter 6, Section K [T17.0000] [PDF]
• NIH ClinRegs: Clinical research regulations from around the globe [HTML]
• FDA Guidance for Institutional Review Boards and Clinical Investigators 1998 Update: Non-English Speaking Subjects [HTML]

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

Select Forms/Guidance:

• A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [D9.0000] [PDF]
• OHRP Investigator Responsibility Frequently Asked Questions [HTML]
• FDA Guidance for Industry: Investigator Responsibilities [PDF]
• Investigator Qualifications and Provision of Medical Oversight [D128.0000] [PDF]

Investigators Who Are Also Considered Sponsors

• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug [D44.0000] [PDF]
• Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [D45.0000] [PDF]

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

Select Forms/Guidance:

• Modification - IRB Review of Changes SOP [C2.0300] [PDF]
• Modification Reviewer Signature Page [F29.0000] [PDF]

• 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]

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

• 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]
  • Office of Good Clinical Practice [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 [HTML] - Comprehensive webpage that provides additional links to other Human Research review committees at UK.

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]

• 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) [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]

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]

• 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]

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]

• 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]

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

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]

• 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]

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

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

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

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

Suicide Ideation or Behavior Among Research Participants [PDF]

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

• Informed Consent for Survey Research [HTML]