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46 . 47 48 49Research ethics guidelines and regulations

International

WHO Good Clinical Practice Guidelines

ICH Good Clinical Practice

ICH Guidelines on control groups

TDR Operational Guidelines for Ethics Committees

UNAIDS Guidance Document on HIV vaccine trials

50EuropeanConvention on Human Rights and Biomedicine, Council of EuropeExplanation to Convention on Human Rights and BiomedicineConvention on Data Protection, Council of EuropeData Protection Directive, European UnionDirective on good clinical practice in the conduct of clinical trials, EUNuffield Council ReportEuropean Group Ethics: Ethical Aspects of Clinical Research in Developing CountriesEthical Conduct for Research Involving Humans51USBelmont ReportUS Federal GuidelinesNBAC report: Ethical and policy issues in international research: Clinical trials in developing countriesOthersEthical guidelines for Biomedical Research on Human Subjects of the Indian Council of Medical ResearchCanada's Tri-Council's Policy Statement SAUDI NCBE GUIDELINES52

53 : : ( ) : : : : : ( )

54 55 56 FABRICATION

FALSIFICATION

PLAGIARISM

5859