Investigational Drugs

• Access to Investigational Drugs: Questions and Answers
  National Cancer Institute
• Frequently Asked Questions on Drug Development and Investigational New Drug Applications
  U.S. Food and Drug Administration
• Investigational Drugs
  Developmental Therapeutics Program, National Cancer Institute
• Investigational New Drug (IND) Application Process
  U.S. Food and Drug Administration

• IRB Guidebook Office for Human Research Protections
  U.S. Department of Health and Human Services
• Office for Human Research Protections
  U.S. Department of Health and Human Services
• Office of Research Integrity
  U.S. Department of Health and Human Services
• Research Integrity Officers
  U.S. Department of Health and Human Services
• Books
• Kornetsky, Susan; Applied Research Ethics National Association.
  Study Guide for Institutional Review Board : Management and Function
  Sudbury, Mass. : Jones and Bartlett, c2003
• Dawson, John; Foley, Mary; Peart, Nicola
  Research Ethics Commmittees
  In: Law of Research : a guide
  Dunedin, N.Z. : University of Otago Press, 2003.
• Bankert, Elizabeth A; Amdur, Robert J; Amdur, Robert J
  Institutional Rreview Board : Management and Function, 2nd ed.
  Sudbury, Mass. : Jones and Bartlett, c2006.
• ECRI
  Institutional Review Boards : Regulatory and Risk Management Overview
  In: Healthcare Risk Control V. 2, Risk Analysis
  Plymouth Meeting, Pa. : ECRI, c2005.
  

• Rozovsky, F.A.; Adams, Rodney K
  Clinical Trials and Human Research : A practical guide to regulatory compliance, 1st ed.
  San Francisco : Jossey-Bass, 2003
• Code of Federal Regulations
• Title 21--Food and Drugs
  Chapter I--Food and Drug Administration
  Department of Health and Human Services
  Subchapter A--General Part 50 Protection of Human Subjects
• Title 45 -- Public Welfare
  Department of Health and Human Services
  Part 46
  Protection Of Human Subjects
• 1 CFR Part 210, [Docket No. 2005N–0285]
  Food and Drug Administration, HHS.
  Direct final rule.
  Current Good Manufacturing Practice Regulation and Investigational New Drugs (PDF, 65 KB)
  Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / Rules and Regulations
• 1 CFR Part 312, [Docket No. 2000N–1663], RIN 0910–AA61
  Food and Drug Administration, HHS.
  Direct final rule
  Investigational New Drugs: Export Requirements for Unapproved New Drug Products (PDF, 100 KB)
  Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations
• 1 CFR Parts 201, 314, and 601, [Docket No. 2000N–1269] (formerly Docket No. 00N–1269), RIN 0910–AA94
  Food and Drug Administration
  Final Rule
  Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (PDF, 65 KB)
  Fed Register. 2006 Jan 24;71(15):3921-97
• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
  U.S. Food and Drug Administration
• Guidances / Guidelines / Points to Consider
  U.S. Food and Drug Administration
• HIPAA Privacy Rule and Its Impacts on Research
  National Institutes of Health
• Historical Information
• The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  Office of Human Subjects Research, National Institutes of Health
• World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
  Office of Human Subjects Research, National Institutes of Health
• Nuremberg Code – Directives for Human Experimentation
  Office of Human Subjects Research, National Institutes of Health
• Office for Human Research Protections (OHRP) Policy Guidance
  U.S. Department of Health and Human Services
• Quick Reference Guide
  Developmental Therapeutics Program
  National Cancer Institute

PDF formats are best viewed with Adobe® Acrobat® Reader™.

Disclaimer: Reference to an external Internet resource on this server does not constitute a recommendation or endorsement by the National Library of Medicine of the services or views described in that resource.