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<stro<strong>ng</strong>>Maikli<strong>ng</strong></stro<strong>ng</strong>> <stro<strong>ng</strong>>Form</stro<strong>ng</strong>> <strong>ng</strong> <strong>Pahintulot</strong> <strong>na</strong> <strong>Lumahok</strong> <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> Pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> Pag-aaralDa<strong>na</strong>-Farber/ Harvard Cancer Center (DF/HCC)BIDMC/BWH/BCH/DFCI/MGH/Mga Affiliate <strong>sa</strong> NetworkNumero <strong>ng</strong> Protocol: ___________________________Pa<strong>ng</strong>alan <strong>ng</strong> Pa<strong>ng</strong>u<strong>na</strong>hi<strong>ng</strong> Tagasiya<strong>sa</strong>t: ____________________________________________Pa<strong>ng</strong>alan <strong>ng</strong> Nagpapahintulot <strong>na</strong> Tagasiya<strong>sa</strong>t: _______________________________________A<strong>ng</strong> paggamit <strong>ng</strong> “ikaw” <strong>sa</strong> kabuuan <strong>ng</strong> dokumento<strong>ng</strong> ito ay tumutukoy <strong>sa</strong> kalahok <strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik.Tumutukoy rin ito <strong>sa</strong> tao<strong>ng</strong> awtori<strong>sa</strong>do<strong>ng</strong> magbigay <strong>ng</strong> pahintulot para <strong>sa</strong> pakikilahok <strong>ng</strong> subject <strong>sa</strong>pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral <strong>na</strong> ito.<strong>Pahintulot</strong> <strong>na</strong> <strong>Lumahok</strong> <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> Pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> Pag-aaralHinihili<strong>ng</strong> <strong>sa</strong> iyo<strong>ng</strong> lumahok <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral. Ma<strong>ng</strong>yari<strong>ng</strong> huwag madaliin a<strong>ng</strong>iyo<strong>ng</strong> pagpapasya at talakayin ito ka<strong>sa</strong>ma <strong>ng</strong> iyo<strong>ng</strong> pamilya at mga kaibigan.Bago ka suma<strong>ng</strong>-ayon <strong>na</strong> makilahok, dapat <strong>sa</strong>bihin <strong>sa</strong> iyo <strong>ng</strong> tagasiya<strong>sa</strong>t a<strong>ng</strong>:1) Mga layunin, hakba<strong>ng</strong>, at tagal <strong>ng</strong> pa<strong>na</strong><strong>na</strong>liksik;2) Anuma<strong>ng</strong> mga hakba<strong>ng</strong> <strong>na</strong> pa<strong>ng</strong>-eksperimento;3) Anuma<strong>ng</strong> mga peligro, pagkabali<strong>sa</strong>, at paki<strong>na</strong>ba<strong>ng</strong> <strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> makatuwira<strong>ng</strong>maa<strong>sa</strong>han;4) Anuma<strong>ng</strong> potensyal <strong>na</strong> mapapaki<strong>na</strong>ba<strong>ng</strong>a<strong>ng</strong> alter<strong>na</strong>tibo<strong>ng</strong> mga hakba<strong>ng</strong> o pa<strong>ng</strong>gagamot; at,5) Paano papa<strong>na</strong>tilihin a<strong>ng</strong> pagigi<strong>ng</strong> kumpedensyal at paano poprotektahan a<strong>ng</strong> impormasyon <strong>sa</strong>iyo<strong>ng</strong> kalusugan.Ku<strong>ng</strong> <strong>sa</strong>an <strong>na</strong>aa<strong>ng</strong>kop, dapat ri<strong>ng</strong> <strong>sa</strong>bihin <strong>sa</strong> iyo <strong>ng</strong> tagasiya<strong>sa</strong>t a<strong>ng</strong>:1) Anuma<strong>ng</strong> <strong>na</strong>aa<strong>ng</strong>kop <strong>na</strong> kabayaran o medikal <strong>na</strong> pa<strong>ng</strong>gagamot ku<strong>ng</strong> may maga<strong>na</strong>p <strong>na</strong> pin<strong>sa</strong>la<strong>sa</strong> katawan;2) Posibilidad <strong>ng</strong> mga hindi i<strong>na</strong>a<strong>sa</strong>ha<strong>ng</strong> peligro;3) Mga sitwasyon ku<strong>ng</strong> <strong>sa</strong>an maaari<strong>ng</strong> ihinto <strong>ng</strong> tagasiya<strong>sa</strong>t a<strong>ng</strong> iyo<strong>ng</strong> pakikilahok;4) Anuma<strong>ng</strong> mga dagdag <strong>na</strong> gastos <strong>sa</strong> iyo;5) Magigi<strong>ng</strong> resulta ku<strong>ng</strong> magpasya ka<strong>ng</strong> ihinto a<strong>ng</strong> pakikilahok;6) Kailan ka <strong>sa</strong><strong>sa</strong>bihan tu<strong>ng</strong>kol <strong>sa</strong> mga bago<strong>ng</strong> kaalaman <strong>na</strong> maaari<strong>ng</strong> makaapekto <strong>sa</strong> iyo<strong>ng</strong>kagustuha<strong>ng</strong> lumahok;7) Ila<strong>ng</strong> tao a<strong>ng</strong> makikilahok <strong>sa</strong> pag-aaral; at,8) Para <strong>sa</strong> mga pagsubok <strong>sa</strong> klinika: Magigi<strong>ng</strong> available a<strong>ng</strong> i<strong>sa</strong><strong>ng</strong> paglalarawan <strong>ng</strong> pagsubok <strong>sa</strong>klinika <strong>na</strong> ito <strong>sa</strong> www.ClinicalTrials.gov, tulad <strong>ng</strong> iniaatas <strong>ng</strong> Batas <strong>ng</strong> U.S. Hindi mag<strong>sa</strong><strong>sa</strong>maa<strong>ng</strong> Web site <strong>ng</strong> impormasyon <strong>na</strong> makakapagpakilala <strong>sa</strong> iyo. I<strong>sa</strong><strong>ng</strong> buod la<strong>ng</strong> <strong>ng</strong> mga resultaa<strong>ng</strong> maaari<strong>ng</strong> i<strong>sa</strong>ma <strong>sa</strong> Web site. Maaari ka<strong>ng</strong> magha<strong>na</strong>p <strong>sa</strong> Web site <strong>sa</strong> anuma<strong>ng</strong> oras.Ku<strong>ng</strong> <strong>sa</strong><strong>sa</strong><strong>ng</strong>-ayon ka<strong>ng</strong> makilahok, bibigyan ka <strong>ng</strong> may lagda<strong>ng</strong> kopya <strong>ng</strong> dokumento<strong>ng</strong> ito ati<strong>sa</strong><strong>ng</strong> kopya <strong>ng</strong> form <strong>ng</strong> pahintulot <strong>sa</strong> wika<strong>ng</strong> I<strong>ng</strong>les para <strong>sa</strong> pag-aaral.Maaari ka<strong>ng</strong> makipag-ug<strong>na</strong>yan <strong>sa</strong>/kay<strong>sa</strong>anuma<strong>ng</strong> oras <strong>na</strong> mayroon ka<strong>ng</strong> mga tano<strong>ng</strong> tu<strong>ng</strong>kol <strong>sa</strong> pag-aaral o pin<strong>sa</strong>la <strong>sa</strong> katawa<strong>ng</strong> <strong>na</strong>uug<strong>na</strong>y<strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik.Pahi<strong>na</strong> 1 <strong>ng</strong> 2


<stro<strong>ng</strong>>Maikli<strong>ng</strong></stro<strong>ng</strong>> <stro<strong>ng</strong>>Form</stro<strong>ng</strong>> <strong>ng</strong> <strong>Pahintulot</strong> <strong>na</strong> <strong>Lumahok</strong> <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> Pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> Pag-aaralDa<strong>na</strong>-Farber/ Harvard Cancer Center (DF/HCC)BIDMCBIDMCIBWH/BCHIDFCIIMGHIMga Affiliate <strong>sa</strong> NetworkMaaari ka ri<strong>ng</strong> makipag-ug<strong>na</strong>yan <strong>sa</strong> Institutio<strong>na</strong>l Review Board <strong>ng</strong> Da<strong>na</strong>-Farber Cancer Institute <strong>sa</strong>numero <strong>ng</strong> telepono<strong>ng</strong> (617) 632-3029 ku<strong>ng</strong> mayroon ka<strong>ng</strong> mga tano<strong>ng</strong> tu<strong>ng</strong>kol <strong>sa</strong> iyo<strong>ng</strong> mgakarapatan bila<strong>ng</strong> i<strong>sa</strong><strong>ng</strong> subject <strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik.A<strong>ng</strong> pakikilahok mo <strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> ito ay ku<strong>sa</strong><strong>ng</strong>-loob, at hindi ka paparu<strong>sa</strong>han o mawawalan<strong>ng</strong> anuma<strong>ng</strong> mga paki<strong>na</strong>ba<strong>ng</strong> ku<strong>ng</strong> ikaw ay tuma<strong>ng</strong>gi<strong>ng</strong> makilahok o magpasya<strong>ng</strong> huminto.A<strong>ng</strong> paglagda <strong>sa</strong> dokumento<strong>ng</strong> ito ay <strong>na</strong><strong>ng</strong>a<strong>ng</strong>ahuluga<strong>ng</strong> pa<strong>sa</strong>lita<strong>ng</strong> inilarawan <strong>sa</strong> iyo a<strong>ng</strong>pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral, kabila<strong>ng</strong> <strong>na</strong> a<strong>ng</strong> impormasyon <strong>sa</strong> itaas, at ku<strong>sa</strong><strong>ng</strong>-loob ka<strong>ng</strong>suma<strong>ng</strong>-ayon <strong>na</strong> makilahok.Lagda <strong>ng</strong> KalahokO Ki<strong>na</strong>tawan <strong>na</strong> Pi<strong>na</strong>pahintulutan <strong>ng</strong> BatasPet<strong>sa</strong>Kaug<strong>na</strong>yan <strong>ng</strong> Ki<strong>na</strong>tawan <strong>na</strong> Pi<strong>na</strong>pahintulutan <strong>ng</strong> Batas <strong>sa</strong> KalahokLagda <strong>ng</strong> Interpreter/SaksiPet<strong>sa</strong>Pahi<strong>na</strong> 2 <strong>ng</strong> 2


Addendum <strong>sa</strong> <stro<strong>ng</strong>>Maikli<strong>ng</strong></stro<strong>ng</strong>> <stro<strong>ng</strong>>Form</stro<strong>ng</strong>> <strong>ng</strong> <strong>Pahintulot</strong> <strong>na</strong> <strong>Lumahok</strong> <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> Pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> Pag-aaralDa<strong>na</strong>.-Farber/ Harvard Cancer Center (DF/HCC)BIDMCBIDMCIBWH/BCHIDFCIIMGHIMga Affiliate <strong>sa</strong> NetworkNumero <strong>ng</strong> Protocol: ______________________________Pa<strong>ng</strong>alan <strong>ng</strong> Pa<strong>ng</strong>u<strong>na</strong>hi<strong>ng</strong> Tagasiya<strong>sa</strong>t: _________________________________________Pa<strong>ng</strong>alan <strong>ng</strong> Nagpapahintulot <strong>na</strong> Tagasiya<strong>sa</strong>t: ____________________________________A<strong>ng</strong> paggamit <strong>ng</strong> “ikaw” <strong>sa</strong> kabuuan <strong>ng</strong> dokumento<strong>ng</strong> ito ay tumutukoy <strong>sa</strong> kalahok <strong>sa</strong> pa<strong>na</strong><strong>na</strong>liksik.Tumutukoy rin ito <strong>sa</strong> tao<strong>ng</strong> awtori<strong>sa</strong>do<strong>ng</strong> magbigay <strong>ng</strong> pahintulot para <strong>sa</strong> pakikilahok <strong>ng</strong> subject <strong>sa</strong>pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral <strong>na</strong> ito.Addendum para <strong>sa</strong> Mga Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaralHinihili<strong>ng</strong> <strong>sa</strong> iyo<strong>ng</strong> lumahok <strong>sa</strong> ila<strong>ng</strong> opsyo<strong>na</strong>l <strong>na</strong> pag-aaral. Ku<strong>ng</strong> magpasya ka<strong>ng</strong> huwagmakilahok <strong>sa</strong> alinman <strong>sa</strong> mga opsyo<strong>na</strong>l <strong>na</strong> pag-aaral, maaari ka pa ri<strong>ng</strong> makilahok <strong>sa</strong> pa<strong>ng</strong>u<strong>na</strong>hi<strong>ng</strong>pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral. Ma<strong>ng</strong>yari<strong>ng</strong> huwag madaliin a<strong>ng</strong> iyo<strong>ng</strong> pagpapasya at talakayin itoka<strong>sa</strong>ma <strong>ng</strong> iyo<strong>ng</strong> pamilya at mga kaibigan.A<strong>ng</strong> pakikilahok mo <strong>sa</strong> opsyo<strong>na</strong>l <strong>na</strong> pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> ito ay ku<strong>sa</strong><strong>ng</strong>-loob, at hindi ka paparu<strong>sa</strong>han omawawalan <strong>ng</strong> anuma<strong>ng</strong> mga paki<strong>na</strong>ba<strong>ng</strong> ku<strong>ng</strong> ikaw ay tuma<strong>ng</strong>gi<strong>ng</strong> makilahok o magpasya<strong>ng</strong>huminto.Ma<strong>ng</strong>yari<strong>ng</strong> i<strong>sa</strong>ad ku<strong>ng</strong> <strong>na</strong>is mo<strong>ng</strong> makilahok <strong>sa</strong> mga opsyo<strong>na</strong>l <strong>na</strong> pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> pag-aaral ohindi.Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #1: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #2: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #3: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #4: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Pahi<strong>na</strong> 1 <strong>ng</strong> 2


Addendum <strong>sa</strong> <stro<strong>ng</strong>>Maikli<strong>ng</strong></stro<strong>ng</strong>> <stro<strong>ng</strong>>Form</stro<strong>ng</strong>> <strong>ng</strong> <strong>Pahintulot</strong> <strong>na</strong> <strong>Lumahok</strong> <strong>sa</strong> i<strong>sa</strong><strong>ng</strong> Pa<strong>na</strong><strong>na</strong>liksik <strong>na</strong> Pag-aaralDa<strong>na</strong>-Farber/ Harvard Cancer Center (DF/HCC)BIDMCIBWWBCHIDFCI/MGH/Mga Affiliate <strong>sa</strong> NetworkOpsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #5: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #6: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #7: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #8: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #9: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Opsyo<strong>na</strong>l <strong>na</strong> Pag-aaral #10: Hindi <strong>na</strong>aa<strong>ng</strong>kop Oo _________________________ Mga Inisyal Pet<strong>sa</strong> Hindi _________________________ Mga Inisyal Pet<strong>sa</strong>Lagda <strong>ng</strong> KalahokO Ki<strong>na</strong>tawan <strong>na</strong> Pi<strong>na</strong>pahintulutan <strong>ng</strong> BatasPet<strong>sa</strong>Kaug<strong>na</strong>yan <strong>ng</strong> Ki<strong>na</strong>tawan <strong>na</strong> Pi<strong>na</strong>pahintulutan <strong>ng</strong> Batas <strong>sa</strong> KalahokLagda <strong>ng</strong> Interpreter/SaksiPet<strong>sa</strong>Pahi<strong>na</strong> 2 <strong>ng</strong> 2

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