GUIDANCE DOCUMENTS ----------------------------------------------------------------------------------------------------- Belmont Report Canada Tri-Council Policy Ethical Conduct for Human Research Computerized Systems Used In Clinical Trials, April 1999 Declaration of Helsinki Drug Study Designs Electronic Records; Electronic Signatures Compliance Policy Guide Evaluation of Gender Differences FDA Information Sheets for IRBs & Clinical Investigators Financial Disclosure by Clinical Investigators - Draft Guidance Good Clinical Practice (ICH Guideline E6) Nuremberg Code

INFORMED CONSENT ----------------------------------------------------------------------------------------------------- Exculpatory Language in Informed Consent - Examples Guide to Informed Consent- FDA Information Sheet Informed Consent - Non-English Speakers Informed Consent Checklist Informed Consent Tips Informed Consent--Legally Effective and Prospectively Obtained Waiver or Alteration of Informed Consent Requirements Emergency Research Informed Consent Requirements

PEDIATRIC ASSENT GUIDANCE ----------------------------------------------------------------------------------------------------- Assent of Children Elements of Informed Consent - FDA Info Sheet Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations