The University of Toledo : Federal Policies & Regulations

Research at UT

Federal Policies & Regulations

GSA Office af Government-Wide Policy

Federal Law (Via GSA)

Centers for Medicare And Medicaid Services (Formerly HCFA) Laws & Regulations

Medicare Regulations Regarding Clinical Trials

Medicare Coverage Policy - Clinical Trials

Quick Reference Guide

Final National Coverage Decision

Coverage Issues Manual - Clinical Trials

Medicare Reimbursement Manual - Part I - Chapter 5 "Research Costs"

Federal Debarment / Administrative Actions Lists

FDA List Of Disqualified / Restricted Clinical Investigators

Firms and Persons Debarred Under Federal Food, Drug and Cosmetic Act (Via DHHS)

GSA Debarment List (Searchable)

PHS Administrative Actions List

Federal Regulations Governing Research with Human and Animal Subjects

Human Subjects Protection

Significant Differences between DHHS and FDA Regulations Governing Human Research (via FDA)

NIH Primer: Research and Privacy

Guide for Interpreting the Federal Policy for the Protection of Human Subjects (via USAID)

Human Subjects Protection and Financial Conflicts-of-Interest (via HHS)

NIH Office of Human Subjects Research (OHSR)

Guidelines for the Conduct of Research Involving Human Subjects at NIH

OHSR Information Sheets, Forms, and Checklists

*PHS Regulations & Guidance*

Office of Human Research Protections [OHRP]

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)

45 CFR 46 (Protection of Human Subjects) [The "Common Rule"]

Compliance Oversight

Protecting Human Subjects in Genetic Research (via Human Genome Research Institute)

Emergency Use of Investigational Drugs (via FDA)

Tips on Informed Consent (via OHRP)

Informed Consent Checklist (via OHRP)

FDA Regulations & Guidance

FDA 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

Good Clinical Practice in FDA-Regulated Clinical Trials

Protecting Human Guinea Pigs

Additional FDA Information, Regulations and Forms

Humanitarian Device Exemption (HDE) Regulations Questions and Answers (via FDA)

Animal Subjects

NIH Office of Laboratory Animal Welfare (OLAW)

OLAW Index to Guidance Regarding Implementation of the PHS Polic

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

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

Health Research Extension Act OF 1985 [PUBLIC LAW 99-158, November 20, 1985]

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

Policies & Regulations Governing Grants, Contracts And Cooperative Agreements

All Federal Agencies

"Fly America" Act

U.S. Flag Air Carriers (via Travel-On)

Office of Management and Budget (OMB)

NIH

Extramural Policy Announcements & Notices

NIH Grants Policy and Guidance Page

Extramural Policy Notices

NSF

NSF Grant and Agreement Conditions

Federal Acquisition Rules and Regulations

Federal Acquisition Regulations (FAR) (via Acquisition.Gov)

Federal Acquisition Jumpstation

Department of Defense Contracting Regulations (DFARS) (via DOD)

HHS Acquisition Regulations (HHSAR) (via DHHS)

NASA Regulations, Documents, Forms & Handbooks (via NASA)

Code of Federal Regulations

Searchable CFR (via National Archives)

HHS CFR Title 45 (via DHHS)

Page updated: April 15, 2008

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Research at The University of Toledo : Federal Policies & Regulations