Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

History History

ofof

Research EthicsResearch Ethics

دکتر فريبا اصغري

مرکز تحقيقات اخالق و تاريخ پزشکي

مممممممممممممممممممممم

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

مبدأ اخالق در پژوهش

قبل از ميالد(400بقراط )

پزشکان بايد از هر اقدام زيان آور و بدسگاالنه اجتناب کنند

اشاره اي به پژوهش بر انسان نکرده است

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

مبدأ اخالق در پژوهش

Thomas Percival (1803)

روشهاي جديد جراحي بايد با روش صحيح)وسواسانه و با قياس صحيح( و توسط فرد

واجد صالحيت انجام شود

اشاره اي به پژوهش بر انسان نکرده است

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

مبدأ اخالق در پژوهش

William Beaumont (1833)

قديمي ترين منبع در مورد اخالق در پژوهش

رضايت داوطلبانه در پژوهش الزم است

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

مبدأ اخالق در پژوهش

Claude Bernard (1865)

“مقدمه اي بر مطالعه پزشکي تجربي ”در کتاب

انجام پژوهشهاي غير زجرآور بر افراد در حال مرگ مجاز است

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

مبدأ اخالق در پژوهش

Reich Health Council (1931)

اصل در انجام پژوهش بر انسان:14–

رضايت آگاهانه

ضرورت ارزيابي سود و زيان

استدالل ضرورت اجراي مطالعه بر گروههاي آسيب پذير

ضرورت مکتوب سازي گزارشات

ضرورت استدالل براي انحراف از پروتکل

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

The Nuremberg Trials )1946-47(

• Their crimes included experiments involving:• High altitude/low pressure• Freezing• Malaria• Sea water• Mustard gas• Twin tests• Sterilization

• The Nazi regime exploited human beings by forcing them to participate in research without consent.

• The mortality rate of these war time research studies was typically 25 - 30%.

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

History

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

The Nuremberg code 1948

• Should include voluntary participation

• Subjects should give consent

• Benefits must outweigh risks

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Declaration of Helsinki 1964

• Research with humans should be based on laboratory and animal experimentation

• Research protocols should be reviewed by an independent committee

• Informed consent is necessary • Research should be conducted by

medically/scientifically qualified individuals • Risks should not exceed benefits

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Henry K. Beecher’s Article)1966(

• Beecher’s 22 examples included withholding antibiotics from men with rheumatic fever, purposely infecting institutionalized children with hepatitis (Willowbrook), injecting live cancer cells into nursing home patients (Jewish Chronic Disease Hospital).

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Tuskegee Study of Syphilis)1932-1972(

• Federally-funded study of natural history of syphilis (TSS)

• 412 infected, indigent blacks enrolled (vulnerable population)

• 1951-penicillin standard treatment; TSS subjects excluded from penicillin

• Told they were being treated for “bad blood

• 1972/74-public disclosure; hearings; financial settlement

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Tuskegee Syphilis Study

128 were died from syphilis or its complications

40 of their spouses were infected

19 babies were born with congenital syphilis

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Tuskegee Study of Syphilis

Herman ShawHerman Shaw

Charlie PollardCharlie Pollard

1932-19721932-1972

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

History

From NIH – Human Participant Protections Education for Research Teams

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

History

From NIH – Human Participant Protections Education for Research Teams

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

Research Ethics Guidelines

• The Nuremberg Code(1947)

• The Declaration Of Helsinki: 7 declarations (1964 – 2004)

• CIOMS/WHO International Ethical Guidelines For Biomedical Research Involving Human Subjects(1993-2004)

ش در ژوهپدر وضعيت رعايت اصول اخالق ايران

تنها در شش مورد شركت كنندگان از اينكه •در يك پژوهش دخالت داشتهاند مطلع

(%8/11بودهاند. )تنها در يك نمونه به موافقت كتبي يا •

)متن .شفاهي اشاره شده است درصد(2موافقتنامه موجود نبود( )

درصد موارد 80 هزينههاي درمان در •.توسط بيمار هزينه شده است

:الريجاني باقررشيديان آرش, ،نامه هاي تحقيقاتي كارآزمايي باليني بررسي ميزان رعايت معيارهاي اخالق پزشكي در پايان

1378 ،مجله علمي نظام پزشكي

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

ش در ژوهپدر وضعيت رعايت اصول اخالق ايران

%( دارونما مصرف شده است 32 مورد )13در •% بوده است. 5كه ميزان آگاهي شركت كنندگان

تنها در يك مورد مركزي براي پرسشهاي احتمالي •بيماران پيشبيني شده بود كه بيمار در صورت نياز

.ميتوانست با تلفن تماس گيرد%( حمايت درماني به عنوان 9/3تنها دو مورد )•

خدمات ارائه شده در ازاي شركت در تحقيق مشهود بود.

:الريجاني باقررشيديان آرش, ،نامه هاي تحقيقاتي كارآزمايي باليني بررسي ميزان رعايت معيارهاي اخالق پزشكي در پايان

1378 ،مجله علمي نظام پزشكي

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

سابقه توجه به اخالق در پژوهش در کشور

1373توجه ويژه به مقوله اخالق در پزشكي از سال •( 1377 تشكيل كميته ملي تحقيقات در پزشكي )•اي اخالق در تحقيقات در هاي منطقه تشكيل كميته•

( 1378دانشگاههاي علوم پزشكي و مراكز تحقيقاتي )(1379پژوهش كشور ) گانه اخالق در26 تدوين اصول•(1384تدوين راهنماهاي اختصاصي اخالق در پژوهش )•

پژوهشهاي ژنتيک–پژوهشهاي حيوانات–پژوهشهاي پيوند عضو و بافت–پژوهش بر گامت و جنين –کارآزماييهاي باليني– پژوهش بر گروههاي خاص–

Medical Ethics and History of Medicine Medical Ethics and History of Medicine Research CenterResearch Center

متشکرم