Debarment / Administrative Actions Lists
Medicare Regulations Regarding Clinical Trials
Protection From Research Risks
Animal Subjects
Human Subjects
FDA Regulations
PHS / OHRP Regulations
Policies & Regulations Governing Grants, Contracts and Cooperative Agreements
Federal Acquisition Rules and Regulations
Code of Federal Regulations
Federal Register (via GPO)
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MEDICARE REGULATIONS REGARDING CLINICAL TRIALS
Medicare Coverage Policy - Clinical Trials
Quick Reference Guide
Final National Coverage Decision
Coverage Issues Manual - Clinical Trials
FDA List of Disqualified / Restricted Clinical Investigators (PIs must verify that no project staff are on this list)
Firms and Persons Debarred Under Federal Food, Drug and Cosmetic Act (via DHHS)
GSA Debarment List (Searchable)
PHS Administrative Actions List
HUMAN SUBJECTS PROTECTION
Significant Differences Between DHHS and FDA Regulations Governing Human Research (via FDA)
Use Of Human Tissues in Research at MUOT
Guide for Interpreting the Federal Policy for the Protection of Human Subjects (via USAID)
Human Subjects Protection and Financial Conflicts-of-Interest (via HHS)
PHS REGULATIONS & GUIDANCE
Office of Human Research Protections [OHRP]
OHRP Staff Telephone/Fax Numbers & E-Mail Addresses
Human Subjects Regulations Decision Charts (via OHRP)
OHRP Related Resources
OHRP Organization and Responsibilities
Human Subject Protections - Policy Guidance
Educational Materials (via OHRP)
Guidance Topics by Subject (via OHRP)
Updated Guidance on Use of Expedited Review (8/11/2003)
Guidance on the Involvement of Prisoners in Research (5/23/2003)
Guidance on Continuing Review (7/11/2002)
Guidance on Written IRB Procedures (7/11/2002)
Requirement that IRB Review Proposals/Applications, NOT Just Protocols (5/31/2000)
45 CFR 46 (Protection of Human Subjects) [The "Common Rule"]
Compliance Oversight
Human Research Subject Protection Quality Improvement Program (via OHRP)
Human Subject - "Dear Colleague" Letters (via OHRP)
Compliance Determination Letters [Correspondence with NonCompliant Institutions & Investigators]
When Is an Institution [or Individual] Engaged in Research? (1/26/1999 OPRR Memo)
Categories of Research Eligible for Expedited IRB Review (Effective 11/9/98)
Research on Transplantation of Fetal Tissue (Public Law 103-43; June 10, 1993)
Protecting Human Subjects in Genetic Research (via Human Genome Research Institute)
Emergency Use of Investigational Drugs (via FDA)
OHRP Institutional Review Board (IRB) Guidebook (1993 ed)
Tips on Informed Consent (via OHRP)
Informed Consent Checklist (via OHRP)
DHHS OFFICE OF INSPECTOR GENERAL (OIG) REPORTS
NIH Office of Human Subjects Research (OHSR)
(Information From OHSR Is Specific to NIH Intramural Research, But Provides Pertinent Information to All Investigators)Guidelines for the Conduct of Research Involving Human Subjects at NIH
OHSR Information Sheets, Forms, and Checklists
FDA REGULATIONS & GUIDANCEFDA Office for Human Research Trials
FDA Office of Regulatory Affairs (ORA)
Information for Health Professionals
Clinical Trials and Human Subject Protection
FDA Guidance for IRBs and Clinical Investigators (FDA "Information Sheets")
FDA Compliance References: Bioresearch Monitoring
FDA Warning Letters
21 CFR Part 21 (Protection of Privacy)
21 CFR Part 50 (Protection of Human Subjects)
21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
21 CFR Part 56 (Institutional Review Boards)21 CFR Part 58 (Good Laboratory Practice for Non-clinical Laboratory Studies)
21 CFR Part 312 (Investigational New Drug Application)
21 CFR Part 812 (Investigational Device Exemptions)
Compilation of Laws Enforced by the FDA
FDA List of Disqualified / Restricted Clinical Investigators (PIs must verify that no project staff are on this list)
Good Clinical Practice in FDA-Regulated Clinical Trials
Good Clinical Practice (GCP) Consolidated Guidelines from International Conference on Harmonisation (ICH)
Comparisons of ICH GCP Guidelines with FDA Regulations
Informed Consent (ICH E-6 vs 21 CFR Part 50)
Institutional Review Boards (ICH E-6 vs 21 CFR Part 56)
Protecting Human Guinea Pigs
Additional FDA Information, Regulations and Forms
Humanitarian Device Exemption (HDE) Regulations Questions and Answers (via FDA)
ANIMAL SUBJECTS
NetVet (World Wide Web IACUC Resources via Wash. U. St. Louis)
PHS REGULATIONS
NIH Office of Laboratory Animal Welfare (OLAW)
Institutions with PHS Assurances (via OLAW)
Domestic Institutions
Foreign Institutions
OLAW Index to Guidance Regarding Implementation of the PHS Policy
Clarification Regarding Use of Carbon Dioxide for Euthanasia of Small Laboratory Animals (7/17/2002) (via OLAW)
Published Articles From Staff of OLAW
Index to Guidance Regarding Implementation of PHS Policy
Guide for the Care and Use of Laboratory Animals (7th Edition, 1996)
Frequently Asked Questions About the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Lab Animal, Oct., 2003)
Animal Welfare - "Dear Colleague" Letters
PHS Policy on Humane Care and Use of Laboratory Animals
Tutorial: NIH Policy on Humane Care and Use of Lab Animals
Sample Documents for Implementation of NIH Policy on Humane Care and Use of Lab Animals
Sample Animal Study Protocol
Health Research Extension Act OF 1985 [PUBLIC LAW 99-158, November 20, 1985 - "Animals In Research"]
REQUIRED REPORTS
Semi-Annual Program and Facilities Review Checklist
Semi-Annual Report to Institutional Official
Institutional Annual Report to OLAW
USDA REGULATIONS
U.S. Department of Agriculture (USDA)
USDA Animal & Plant Health Inspection Service (APHIS)
USDA Animal and Plant Health Inspection Animal Care Policy Manual
Animal Health
Animal Care
Animal Care Questions
Animal Welfare Act [Text Format] [
Definition of Terms
Regulations
Standards
ALL FEDERAL AGENCIES
"Fly America" Act
U.S. Flag Air Carriers (via Travel-On)
Office of Management and Budget (OMB)
OMB Circulars
Circulars A-21 - "Cost Principles for Educational Institutions"
Circular A-110 - "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations"
NIH
Extramural Policy Announcements & Notices
PHS Grants Policy (Rev. April, 1994) [For All DHHS/PHS Agencies Other than NIH (e.g., HRSA)] [FOR GRANT AWARDS PRIOR TO 10/1/2006]
HHS Grants Policy Statement (Rev. January 1, 2007) [For All HHS Agencies Other than NIH (e.g., HRSA)] [FOR GRANT AWARDS AFTER 10/1/2006]
NIH Grants Policy and Guidance Page
Extramural Policy Notices
NIH Grants Policy Statement
NIH Grants Policy Statement (Rev. 12/1/2003) [HTML Format] [For Grants with Budget Period Start Dates ON or AFTER 12/1/2003]
NIH Grants Policy Statement (Rev. 3/1/2001) [HTML Format] [For Grants with Budget Period Start Dates Prior to 12/1/2003]
NSF
NSF Grant and Agreement Conditions
FEDERAL ACQUISITION RULES AND REGULATIONS
Federal Acquisition Regulations (FAR) (via Acquisition.Gov)
Alternate FAR Site (via Hill AFB)
Federal Acquisition Jumpstation
Department of Defense Contracting Regulations (DFARS) (via DOD)
Alternate DFAR Site (via Hill AFB)
DFARS Clause Locator (Searchable) (via UCOP)Defense Acquisition Deskbook (via DOD)
HHS Acquisition Regulations (HHSAR) (via DHHS)
NASA Regulations, Documents, Forms & Handbooks (via NASA)
NASA FAR Supplements (NFS) Clause Locator (Searchable) (via UCOP)
Searchable CFR (via National Archives)
HHS CFR Title 45 (via DHHS)
via Government Printing Office
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