Adverse Event Reporting

National Institutes of Health:

• Genetic Modification Clinical Research Information System (GeMCRIS)

Clinical Trial Monitoring

European Medicines Agency:

• Guideline on Data Monitoring Committees

World Health Organization:

• Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards

Human Tissues and Specimens in Research

Public Responsibility in Medicine and Research

• Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group

Informed Consent

National Institutes of Health:

• CRpac: Annotated Compendium of NIH Resources on Informed Consent ( Nov. 28, 2007)
• National Cancer Institute: A Guide to Understanding Informed Consent
• Office of Biotechnology Activities: Informed Consent in Gene Transfer Research

Models of IRB Review

National Institutes of Health:

• NCI Central IRB

Department of Health and Human Services:

• Alternative Models of IRB Review: Workshop Summary Report (November 2005)
• National Conference on Alternative IRB Models: Optimizing Human Subject Protection (November 2006)

Clinical Trial Design

National Institutes of Health:

• Proceedings from the conference, "Considering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues"

Other Clinical Research Policy Resources and Information

Bioethics

• Bioethics Resources on the Web (NIH)

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (NIH)
• Timeline of Laws Related to Human Subjects Protections (compiled by the Office of NIH History, NIH)