Medical Lay Language Dictionary

Public Responsibility in Medicine and Research (PRIM&R)

National organization for Institutional Review Boards

IRB Forum

National IRB discussion forum

DHHS / Office for Human Research Protections (OHRP)

Basic DHHS Policy for Protection of Human Subjects

Last update: December, 2005

Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved In Research

Last update: December, 2005

Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure

Last update: December, 2005

Human Subject Regulations Decision Charts

Last update: December, 2005

NIH Guidance Involving Human Embryonic Stem Cells

Last update: December, 2005

OHRP Guidance Involving Human Embryonic Stem Cells

Last update: December, 2005

The Nuremberg Code

The Belmont Report

World Medical Association Declaration of Helsinki

U.S. Department of Health and Human Services (DHHS)

National Bioethics Advisory Commission (NBAC)

Federal Drug Administration (FDA)

FDA / Good Clinical Practice in FDA-Regulated Clinical Trials

FDA / FDA Forms Distribution age for Center of Drug Evaluation and Research (CDER)

FDA Protection of Human Subjects

Last update:

Institutional Review Boards

Last update:

Investigational New Drug Application

Last update:

Investigational Device Exemptions

Last update:

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications

Last update: December, 2000

Inclusion of Women and Minorities as Participants in Research Involving Human Subjects

Last update: September, 2003

Inclusion of Children as Participants in Research Involving Human Subjects

Last update: March, 1998