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3. πà“ —߇°μÕ’°«à“ ·π«ªØ‘∫—μ‘©∫—∫π’ȉ¡à „π«ß°“√«‘®—¬„π¡πÿ…¬å„πª√–‡∑»‰∑¬π—Èπ ·∑â®√‘ß

Õâ“ßÕ‘ß·π«∑“ß “°≈«à“¥â«¬®√‘¬∏√√¡°“√«‘®—¬∑’Ë ·≈⫇ªìπ·π«ªØ‘∫—μ‘∑’Ë®”‡æ“–‡®“–®ß ”À√—∫°“√«‘®—¬
‡°’ˬ«¢âÕß°—∫ ÿ¢¿“æ„π¡πÿ…¬å (International Ethi- ∑“ߧ≈‘π‘° ‡æ◊ËÕ°“√¢÷Èπ∑–‡∫’¬π¬“∑’Ë„™â„π¡πÿ…¬å ®÷ß

cal Guidelines for Health-related Research §«√»÷°…“À≈—°‡°≥±åÀ√◊Õ·π«∑“ߪؑ∫—μ‘Õ◊Ëπ Ê ‡æ◊ËÕ
Involving Humans) ¢Õß ¿“Õߧ尓√ “°≈¥â“π ¢¬“¬∑—»π–¢Õß«ß°“√«‘®—¬„π¡πÿ…¬å„πª√–‡∑»‰∑¬
«‘∑¬“»“ μ√å°“√·æ∑¬å (Council for International „Àâ°«â“ߢ«“ߢ÷Èπ ·π«∑“ߪؑ∫—μ‘∑’Ë¥’„π°“√¥”‡π‘π°“√

Organizations of Medical Sciences: CIOMS) «‘®—¬¢Õߧ‘ß å§Õ≈‡≈®≈Õπ¥Õπ‡ªìπ·π«∑“ß∑’Ëπà“»÷°…“
∑’ËÕâ“ßՑ߇ªìπª√–¥ÿ®§—¡¿’√å»—°¥‘Ï ‘∑∏‘Ï„πª√–‡∑»‰∑¬ πÕ°®“°‡æ√“–§«“¡‡ªìπ¡À“«‘∑¬“≈—¬™—Èππ”¢Õß‚≈°

√«¡∑—Èß·π«ªØ‘∫—μ‘¢Õ߉մ’‡Õ™¥â«¬ «‘∏’°“√‡¢’¬π∑’Ë –∑âÕπ√–∫∫°“√»÷°…“¢Õß À√“™
4. ·π«ªØ‘∫—μ‘©∫—∫π’È Õâ“ß∂÷ß·π«∑“ߢÕß Õ“≥“®—°√∑’ˇπâπ°“√‡√’¬π (learning) ¡“°°«à“°“√ Õπ
μà“ߪ√–‡∑» 2 ©∫—∫®“°‡¥π¡“√å°·≈– À¿“æ¬ÿ‚√ª (teaching) ¬—ßπà“ π„® §«√∑’Ë«ß°“√«‘®—¬„π¡πÿ…¬å

·μà‰¡à°≈à“«∂÷ß√“¬ß“π‡∫≈¡Õßμå (Belmont Report) ·≈–«ß«‘™“°“√¢Õߪ√–‡∑»‰∑¬®–‰¥âÕ¿‘ª√“¬∂°
´÷Ëß«“ß√“°∞“πÀ≈—°®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å 3 ‡∂’¬ß„À⇰‘¥§«“¡ßÕ°ß“¡∑“ߪí≠≠“¬‘Ëß Ê ¢÷Èπ‰ª
ª√–°“√ §◊Õ (1) °“√‡§“√æ„π∫ÿ§§≈ (2) º≈ª√–‚¬™πå
‡Õ° “√Õâ“ßÕ‘ß
(3) §«“¡¬ÿμ‘∏√√¡
1. Research Institute for the Protection of Human Research.
5. ·¡â¡‘‰¥âÕâ“ßÕ‘ß∂÷߇հ “√∑’Ë°≈à“«∂÷ß„π¢âÕ Guidelines for the ethics committee to review
biomedical research. Bangkok: Sam Charoenpan
3 ·≈– 4 „π à«ππ’È ¬àÕ¡¡‘‰¥âÀ¡“¬§«“¡«à“ ‡Õ° “√
(Bangkok) Co., Ltd., 2000.
‡À≈à“π’ȉ¡à¡’§«“¡ ”§—≠À√◊Õ‰¡àμâÕߧ”π÷ß∂÷ß ∑—Èßπ’È 2. Chokevivat V. A critique of the draft Research in Human
Act, B.E.....: Drug System Monitoring are Development
‡æ√“–·π«ªØ‘∫—μ‘©∫—∫π’ȇ¢’¬π‰«â™—¥‡®π„π¢âÕ 10.1 «à“
Center (DHD), et al. Nonthaburi: Mata Printing Co.,
√“¬°“√∑’Ë√–∫ÿ‰«â 32 √“¬°“√π—Èπ¡‘„™à ç√“¬°“√∑—ÈßÀ¡¥é
Ltd., 2017.
(exhaustive list) 3. Council for International Organizations of Medical
Sciences. International ethical guidelines for Health-
related research involving humans. Geneva, 2016.
∫∑ √ÿª
4. International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
‚¥¬∑’Ë ç°“√ªØ‘∫—μ‘°“√«‘®—¬∑“ߧ≈‘π‘°∑’Ë¥’¢Õß
Human Use (ICH). ICH Harmonized Tripartite Guideline:
‰Õ´’‡Õ™é ´÷Ëß¡’°“√Õâ“ßÕ‘ß·≈–¬÷¥∂◊ÕÕ¬à“ß°«â“ߢ«“ß Guideline for Good Clinical Practice