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Helpful Links to Outside Informational Resources

Medical Library

The reference staff of the Coy Carpenter Medical Library can provide expert advice in literature searching as you develop a protocol.  The Medical Library reference staff can also teach time-saving techniques to monitor emerging literature related to proposed and approved protocols.

Biomedical Databases

 

Clinical Trials

• CenterWatch: Clinical Trials Listing Service
• NIH Clinical Center Studies
• clinicaltrials.gov

Drug Information

• FDA Center for Drug Evaluation and Research (CDER)

Regulations

• Office for Human Research Protections (OHRP)
• 45 CFR 46: Protection of Human Subjects
• 21 CFR 50: FDA Protection of Human Subjects
• 21 CFR 56: FDA Institutional Review Boards
• National Institutes of Health (NIH) Regulations
• Certificate of Confidentiality (NIH)

Organizations/Agencies

• Centers for Disease Control (CDC)
• National Cancer Institute (NCI)
• National Library of Medicine

Publishers

• OXFORD University Press Journals
• The New England Journal of Medicine

Reports by Health and Human Services, Office of Inspector General (HHS OIG)

• FDA Oversight of Clinical Investigators (OEI-05-99-00350; 6/00) Recruiting Human Subjects:
• Pressures in Industry-Sponsored Clinical Research (OEI-01-97-00195; 6/00)
• Sample Guidelines for Practice (OEI-01-97-00196; 6/00)

International Research

• Harvard School of Public Health Global Research Ethics
• 2008 International Compilation of Human Subject Protections

Department of Defense

• Department of Defense Research 32CFR 219
• Department of Defense Directive 3210.07
• Department of Defense Directive 3216.02
• Department of Defense Instruction 6200.02
• Air Force human research protections

Background Materials

• The Belmont Report
• The Declaration of Helsinki
• The Nuremberg Code
• NIH's Bioethics Resources on the Web
• Dept. of Health and Human Services FAQ for the Requirement for Education on the Protection of Human Subject  

Other Resources

• Health Insurance Portability and Accountability Act (HIPAA)
• Protecting Research Subjects -- What Must Be Done New England Journal of Medicine, September 14, 2000, Vol. 343, No. 11
• Office for Human Research Protections (OHRP) - the successor to OPRR
• International Compilation of Human Subject Protections - 2008 edition
• Food & Drug Administration (FDA)
• FDA - Investigations Operations Manual
• National Institutes of Health (NIH) Regulations
• Nuremburg Code
• HHS YouTube Videos