Human Research Educational Materials, Regulations and Policy Guidance
by Topic
University of Kentucky Human Research Protection Program Comprehensive Plan [PDF, 23 pgs.] Advertising (see also Recruitment)
AIDS (see also HIV/AIDS)
- Reporting Requirements for Diseases and Conditions in Kentucky [PDF]
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]
- 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 and Patients’ Rights Program – UK Healthcare web page [HTML]
Biological Specimens (see also Coded Private Information)
- OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 22.7KB]
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]
- 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]
- Clinical Research Development & Operations Center (CR-DOC) [HTML]
- Registration of Clinical Trials - NIH Guide Notice [HTML]
- Registration of Clinical Trials - Frequently Asked Questions [HTML]
- Non-Indemnification Policy/Risk Management Committee (RMC) [HTML]
Coded Private Information (see also Biological Specimens)
- OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 22.7KB]
Common Rule (see also Federal Regulations)
- Department of Health and Human Services (HHS) [HTML]
- 45 CFR 46 ("The Common Rule" - Human Subject Protections) [HTML]
- Comparison of FDA and HHS Human Subject Protection Regulations (by FDA) [HTML]
- OHRP Compliance Oversight Activities: Determinations of Noncompliance - 2/4/09 [PDF]
- Privacy vs. Confidentiality - What's the Difference? [PDF]
- Certificate of Confidentiality Summary Sheet [PDF]
- Conflict of Interest/Financial Disclosure Policy (OSPA) [HTML]
Consent (see Informed Consent)
- Guidance to Criteria for IRB Approval [PDF]
- Resources on Data and Safety Monitoring [HTML]
Decision Charts - OHRP Human Subject Regulations Decision Charts [HTML]
Education Options [PDF] Revised 9/24/09
This document provides a summary of the University of Kentucky’s and Veterans Affairs Medical Center’s human subject protection educational initiatives.
- Use of Investigational Drug/Device for Treatment Purposes: UK Medical IRB Requirements [PDF]
Engagement in Research (see also Off-site Research)
- OHRP's web site for "Engagement of Institutions in Research" Memo [HTML]
Ethical Principles [HTML]
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) [HTML]
- 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
859-257-2861Larry Iten, Associate Director
aliten@uky.edu, 859-257-2978
Federalwide Assurance (FWA) (see also Assurance Information)
- Terms of Assurance [HTML]
- UK's sample IRB Authorization Agreement [PDF]
- UK's Assurance Information through OHRP web site [HTML]
- OHRP-Approved UK IRB registration [PDF]
Finder’s Fees (see also IRB (UK) Policies)
- Finder’s Fees - University of Kentucky Medical IRB Policy [PDF]
- Issues to be Addressed in Obtaining Informed Consent Involving DNA Banking and Genetic Research [PDF]
HIV/AIDS (see also AIDS)
Human Research Accreditation Training (see Case Studies)
- 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 Non-Medical Research [PDF]
- Assessing Consent Capacity in Clinical Research: New Directions [PDF]
- 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]
- Lay Terms [PDF]
- OHRP Frequently Asked Questions on Informed Consent [HTML]
- OHRP Compliance Activities: Common Findings and Guidance – 7/10/2002 (45) Documentation of Informed Consent for Non-English Speakers [PDF]
- Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF]
- Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [PDF]
- Office for Human Research Protections (OHRP)
International Issues [HTML]
OHRP: Institutional Review Board Guidance, Chapter 6, Section K on INTERNATIONAL RESEARCH [HTML]
OHRP Compliance Activities: Common Findings and Guidance – 7/10/2002 (45) Documentation of Informed Consent for Non-English Speakers [PDF]
International Compilation of Human Subject Research Protections [PDF] - This compilation focuses on those countries that are major recipients of US government research funding. To use the Compilation, go to page 3 of the document and then click on the country of interest. Then click on the Key Organizations and laws of that country.
- 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]
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]
IRB Reporting to Federal Agencies
- Serious or Continuing Noncompliance or Unanticipated Problems Involving Risks: IRB Reporting to Federal Agencies [PDF]
IRB Resource Guide [PDF, 2MB, 356 pgs., Revised June 2009]
The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.
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)
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 Activities: Determinations of Noncompliance - 2/4/09 [PDF]
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 U.S. Department of Education [HTML]
- National Archives and Records Administration Code of Federal Regulations [HTML]
- National Institutes of Health (NIH) [HTML]
- National Bioethics and Advisory Commission (The President's Council on Bioethics) [HTML]
- International Conference on Harmonisation (ICH) [HTML]
- Public Responsibility in Medicine and Research (PRIM&R) [HTML]
- PHS 398 Grant Application [HTML]
Recruitment (see also Advertising)
- PI Guide to Identification and Recruitment of Human Subjects for Research [PDF]
- Research Advertising [PDF]
- University of Kentucky Research Risk Assessment Guidance [PDF]
Specific Findings Requiring IRB Documentation [under revision]
- What Constitutes Study Personnel on a Protocol Involving Human Subjects? [PDF]
- Issues to be Addressed in Obtaining Informed Consent Involving Specimen Collection for Tissue/Specimen Repositories [PDF]
Waiver of Informed Consent Requirements
- Veteran Affairs Research and the UK IRB [HTML]
- Veterans Affairs Research Consent Form (10-1086) [HTML]
- VA Form 10-1223 Report of Subcommittee on Human Studies to include with IRB application submission [HTML]
- Forms and Guidance for Protocol Submissions to the VA Research & Development Committee (R & DC) (CRDOC web site) [HTML]