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  • 8/16/2019 1 Introduction to Good Research Practice

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    INTRODUCTION TO GOOD RESEARCH PRACTICEGOAL

    • An enhanced awareness of the importance of health research ethics and an improved capacity forparticipation in the research ethics review system as research stakeholders

    • An enhanced awareness of the importance of health research ethics and an improved capacity forparticipation in the research ethics review system as research stakeholders

    OBJECTIVES OF THIS SESSION• 1. Trace the development of research ethics and international guidelines in health-related research• 2. To familiarie medical students on the ethical principles in health research

    Defnitions• !esearch "refers to a class of activity designed to develop or contribute to generalizable knowledge (e

    theories, principles or relationships, or the accumulation of information on which they are based that cbe corroborated by accepted scientic methods of observations and inference. (CIO!, "##"$

    • #ealth !esearch " medical and behavioral studies pertaining to human health. (CIO!, "##"$• #ealth "related !esearch % studies that impact the well&being of individuals and communities• $thics % is doing the right thing %-deals with the concept of what is &good' as a goal and what is &right

    a course of action or s the )usti*ed claim or entitlement+.• !esearch $thics " is setting good goals and de*ning right processes in the conduct of health research• ,ood linical ractice " & a standard for the design , conduct, performance, monitoring, auditing,

    recording, analysis, and reporting of clinical trials that provides assurance that the data and reportedresults are credible and accurate and that the rights, integrity and condentiality of trial sub'ects are

     protected.(IC)&*C+,--$ • ,ood !esearch ractice " standard for the design. Conduct, data recording and analysis and reporting

    research studies that ensures credibility of results and the protection of the rights of study participants

    and other stakeholders. (/0 +roposal 121 "#3$ Historical Notes in te De!elo"#ent o$ Researc Etics

    • 1. The Nai $/periments and the Nurem0erg Trials --Nurem0erg ode 13 ---#elsink4eclaration 156.2718

    • 2. The 9illow0rook and Tuskegee linical $/perimentsThe :elmont !eport 13

    • 8. 4rug Trials in 4eveloping ountries IO;< %ouncil for International Organiations of ;edical 9#O standards and Operational ,uidelines for $thics !eview of #ealth-!elated !esearch with #umanarticipants %2711+

    Nai $/periments $/posed during the Nurem0erg Trials %15+• 28 ,erman doctors committed crimes against humanity for &performing medical e/periments upon

    concentration camp inmates and other human su0)ects without their consent'.The $/periments

    • On limits of human endurance in high altitudes %

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    • ro/y consent for human participants who cannot give consent for themselves• Te Helsin4i Declaration ./0A1 2 )*5+6 )*,36 )*786)*7*6 )**56 9:::69::96 9::+69::76 9:)

    • ro/y onsent• $thical !eview 0y an independent committee•

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    •

    - $arly su0)ects fed e/tracts of stools from infected individuals- Hate su0)ects received puri*ed virus preparations• De$ense> ;a)ority of the children will ac?uire the infection at 9illow0rook so its 0etter for them to 0e infected und

    carefully controlled research conditions• T%s4e'ee Clinical Trial .)*89@)*,91• NI# %National Institute for #ealth + "sponsored@ Ala0ama@ G To determine the clinical course of untreated syphilis S%&=ects> 577 men with syphilis• 0eto(olo'?>  877 randomied to treatment•   @ 877 randomied to NO treatment• No clear endpoints@ no information@ no permission• !esultsC Gntreated patients fared poorly@ many died• %NN@ ;ay 15@ 13C u0lic Apology from G< res. linton@


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