Medical IRB Study # 112233 Consent Form Version Date: ___12-1-13__ itle o!

Study: The Efficacy of Guava Leaf Decoction in the Treatment of Otomycosis versus Clotrimazole "rinci#al In$esti%ator: Dr. Genevieve Labuyo Central Medical Center "&one num'er:(33-(333 Co-In$esti%ators:Dr. Jaime Kilayo S#onsor: )*)+

IN O!"ED CON#ENT
,ou are 'ein% as-ed to ta-e #art in t&is researc& study 'ecause you &a$e a !un%al in!ection o! t&e ear called otomycosis. &e in$esti%ators listed a'o$e are in c&ar%e o! t&e study/ ot&er #ro!essional #ersons may &el# t&em or act !or t&em. What are some general things you should know about research studies? Researc& studies are desi%ned to %ain scienti!ic -no0led%e t&at may &el# ot&er #eo#le in t&e !uture. ,ou may not recei$e any direct 'ene!it !rom #artici#atin%. &ere may also 'e ris-s associated 0it& #artici#atin% in researc& studies. ,our #artici#ation is $oluntary. ,ou may re!use to #artici#ate1 or may 0it&dra0 your consent to #artici#ate in any study at any time1 and !or any reason1 0it&out 2eo#ardi3in% your !uture care at t&is institution or your relations&i# 0it& your doctor. I! you are a #atient 0it& an illness1 you do not &a$e to #artici#ate in researc& in order to recei$e treatment. Details a'out t&is #articular study are discussed 'elo0. It is im#ortant t&at you understand t&is in!ormation so t&at you can decide in a !ree and in!ormed manner 0&et&er you 0ant to #artici#ate. ,ou 0ill 'e %i$en a co#y o! t&is consent !orm. ,ou are ur%ed to as- t&e in$esti%ators named a'o$e1 or sta!! mem'ers 0&o may assist t&em1 any 4uestions you &a$e a'out t&is study at any time. What is the purpose of this study? &e #ur#ose o! t&is researc& study is to !ind out i! %ua$a lea$es 0&en made into a 'oiled solution can 'e used as an alternati$e treatment !or otomycosis 0&ic& is a !un%al in!ection o! t&e ear. In t&e #ro$inces1 %ua$a lea$es are routinely used !or $arious s-in in!ections includin% !un%al in!ections. It is usually #re#ared 'y 'oilin% t&e lea$es !or 3-5 minutes and t&e solution is directly a##lied onto t&e area. 6necdotal re#orts &a$e said t&at cure &a##ens 0it&in 2 0ee-s o! t&e solution 'ein% a##lied daily. &e researc& &o#es to $alidate t&is anecdotal re#ort. I! $alidated1 suc& solution 0ould #ro$ide a c&ea# alternati$e to t&e standard anti-!un%al solutions 0&ic& can 'e 4uite costly. Suc& a solution is not commercially a$aila'le 'ut &as under%one initial tests t&at s&o0 it is sa!e !or use in &umans. It is currently not FD6 a##ro$ed. How many subjects will participate in this study? I! you decide to #artici#ate1 you 0ill 'e one o! a##ro7imately 38 su'2ects in t&is researc& study. How long will your participation last? ,our #artici#ation in t&is study 0ill last !or a##ro7imately 2 0ee-s What will happen if you take part in the study? Durin% t&e course o! t&is study1 t&e !ollo0in% 0ill occur:

1. Fres&ly made 'oiled %ua$a lea! solution 0ill 'e !iltered a!ter it &as 'een cooled to room tem#erature and #laced in a 'ottle dis#enser similar to t&e one used 'y ma-ers o! ear dro#s. &is 0ill 'e done usin% sterile tec&ni4ues. 2. *n your !irst $isit1 #rior to t&e start o! treatment1 you 0ill 'e e7amined and a sam#le o! t&e disc&ar%e !rom your ear 0ill 'e ta-en to con!irm t&at you do &a$e a !un%al in!ection in t&e ear or 0&at is -no0n as otomycosis. 3. *nce con!irmed1 you 0ill 'e %i$en ear dro#s. ,ou 0ill &a$e a 589 c&ance o! recei$in% t&e %ua$a lea! solution or Clotrima3ole li4uid solution 0&ic& 0ill 'e in an identical 'ottle dis#enser. &e assi%nment to eit&er treatment 0ill 'e decided in a manner similar to a coin toss. )eit&er you nor your doctor 0ill -no0 0&ic& dro#s 0ere assi%ned to you. :. ,ou 0ill 'e instructed to #lace t&e 3 ear dro#s in t&e a!!ected ear and let it stand !or 15 minutes a!ter a##lication in t&e manner t&at 0ill 'e demonstrated to you 'y t&e #erson conductin% t&is in!ormed consent. ,ou 0ill a##ly t&is 37 a day !or a 0ee- and t&en return !or a !ollo0-u# $isit. 5. *n your !ollo0 u# $isit1 your ear 0ill 'e e7amined and your ear cleaned o! any de'ris or disc&ar%e 0&ic& is #art o! routine care !or otomycosis. (. ,ou 0ill return any unused ear dro#s durin% t&is $isit and t&is 0ill 'e re#laced 'y a !res& 'ottle o! ear dro#s o! t&e same -ind. ;. ,ou 0ill a%ain a##ly t&e ear dro#s in t&e same manner as descri'ed a'o$e in ste# : and return a!ter a 0ee- !or a !ollo0-u# $isit. <. 6 s0a' o! your ear canal 0ill 'e o'tained on t&is second $isit to c&ec- !or #ersistence o! any !un%al in!ection. &is mar-s t&e end o! t&e study. =. Durin% t&ese t0o 0ee-s1 you 0ill 'e as-ed to record any sym#toms you may !eel 0it& t&e use o! t&e ear dro#s in a diary t&at 0ill 'e %i$en to you. ,ou 0ill su'mit t&is diary durin% 'ot& !ollo0-u# $isits. 18. o ensure t&at you are cared !or ade4uately1 i! any in!ection #ersists as noted 'y a !indin% o! continued #resence o! !un%us t&rou%& t&e s0a' result1 you 0ill 'e %i$en anot&er anti!un%al medication called itracono3ole. ,ou 0ill a##ly t&is medicine !or anot&er 0ee- in t&e manner descri'ed in Ste# : and treated until your condition is com#letely cured re%ardless o! &o0 lon% it 0ill ta-e. ,our attendin% +) doctor 0ill 'e in c&ar%e o! your care !rom 'e%innin% to end o! t&e mana%ement o! your otomycosis. Are there any reasons you should not participate? ,ou s&ould not #artici#ate in t&is study i! you &a$e #&ysical #ro'lems t&at 0ill #re$ent you !rom administerin% t&e dro#s in t&e #rescri'ed manner >e.%. %ross tremors1 se$ere osteoart&ritis? aller%y to Clotrima3ole or %ua$a1 any aller%ic s-in conditions1 &a$e a #er!orated ear drum1 or are 'elo0 1< years old. What are the possible risks or discomforts? &is study mi%&t in$ol$e t&e !ollo0in% ris-s and@or discom!orts to you: Common: Stin% on a##lication o! ear dro#s Sense o! 0armt& 0it& a##lication Itc&iness o! t&e ear canal Rare "er!oration o! t&e tym#anic mem'rane Se$ere aller%ic reaction 0it& in!lammation o! t&e canal Secondary 'acterial in!ection In addition1 t&ere may 'e uncommon or #re$iously unreco%ni3ed ris-s t&at mi%&t occur.

S&ould any o! t&ese occur1 #lease in!orm your doctor immediately t&rou%& t&e contact num'ers #ro$ided 'elo0 . I IS 6AS* "*SSIBA+ B6 ,*CR * *M,C*SIS DIAA )* IM"R*V+ DI B B+ M+DIC6 I*). What are the possible benefits? &e 'ene!its to you o! #artici#atin% in t&is study may 'e t&at your otomycosis 0ill 'e cured. ,our #artici#ation in t&is study 0ill also 'ene!it society in %eneral as it #ro$ides -no0led%e a'out 0&et&er or not %ua$a lea$es does &a$e &ealin% #ro#erties !or otomycosis. If you choose not to participate, what other options do you have? ,ou do not &a$e to #artici#ate in t&is researc& study in order to recei$e treatment. *t&er treatments t&at are a$aila'le are use o! esta'lis&ed anti!un%als 0&ic& your attendin% #&ysician is !ully a0are o! and can #rescri'e !or you What if we learn about new risks during the study? ,ou 0ill 'e %i$en any ne0 in!ormation %ained durin% t&e course o! t&e study t&at mi%&t a!!ect your 0illin%ness to continue your #artici#ation. How will your privacy be protected? )o su'2ects 0ill 'e identi!ied in any re#ort or #u'lication a'out t&is study. 6lt&ou%& e$ery e!!ort 0ill 'e made to -ee# researc& records #ri$ate1 t&ere may 'e times 0&en la0s may re4uires t&e disclosure o! suc& records1 includin% #ersonal in!ormation. &is is $ery unli-ely1 'ut i! disclosure is e$er re4uired1 Central Medical Center 0ill ta-e all ste#s allo0a'le 'y la0 to #rotect t&e #ri$acy o! #ersonal in!ormation. ,our #ersonal records 0ill 'e -e#t in a se#arate dra0er t&at is loc-ed and t&e only #ersons 0it& access to t&is 0ill 'e t&e #rinci#al in$esti%ator1 &er co-in$esti%ator and desi%nated mem'ers o! t&e researc& team as 0ell as mem'ers o! t&e Institutional re$ie0 'oard. *nce you si%n t&e in!ormed consent1 an identi!ication num'er 0ill 'e %i$en to you and your records 0ill only 'e encoded usin% t&is identi!ication num'er Because t&is study could a!!ect your medical care1 a co#y o! t&is consent !orm 0ill 'e #laced in your medical record. &is 0ill allo0 t&e doctors carin% !or you to o'tain in!ormation a'out 0&at dru%s or #rocedures you are recei$in% in t&e study and treat you a##ro#riately1 i! you &a$e ot&er &ealt& #ro'lems or needs durin% t&e study. Will you be paid for participating? ,ou 0ill recei$e "288 !or your #artici#ation in t&is study 0&ic& 0ill 'e %i$en to you at t&e end o! t&e t0o 0ee-s. I! you discontinue t&e study 'e!ore t&e t0o 0ee-s1 a #ercent o! t&e "288 0ill 'e %i$en to you commensurate to your len%t& o! stay in t&e study Will it cost you anything to participate? &e costs o! t&e la'oratory e7ams 0ill 'e s&ouldered 'y your insurance com#any. I! you &a$e no insurance1 t&e cost o! t&e la'oratory results 0ill 'e s&ouldered 'y t&e in$esti%ator. ,ou 0ill not &a$e to #ay !or t&e study ear dro#s durin% t&e duration o! t&e study. I! a!ter t0o 0ee-s1 &o0e$er1 you still need to 'e treated1 t&e cost o! t&e itracona3ole solution and all ot&er la'oratory e7#enses 0ill 'e #aid !or 'y you. Who is sponsoring this study? &is researc& &as no !undin% a%ency.

What will happen if you are injured by this research? 6ll ty#es o! researc& in$ol$e #ossi'le ris-1 some includin% t&e ris- o! #ersonal in2ury. In s#ite o! all #recautions1 you mi%&t de$elo# com#lications !rom #artici#atin% in t&is study. I! suc& com#lications arise1 t&e researc&ers 0ill assist you in o'tainin% a##ro#riate medical treatment. I! t&e com#lications arise !rom t&e use o! t&e study medications1 t&e #rinci#al in$esti%ator 0ill s&oulder t&e costs unless it can 'e esta'lis&ed t&at t&e medications 0ere a##lied ina##ro#riately. )o additional com#ensation !or in2ury 0ill 'e %i$en. What if you want to stop before your part in the study is complete? ,ou can 0it&dra0 !rom t&is study at any time1 0it&out #enalty. &e in$esti%ators also &a$e t&e ri%&t to sto# your #artici#ation at any time. &is could 'e 'ecause you &a$e &ad an une7#ected reaction1 or &a$e !ailed to !ollo0 instructions1 or 'ecause t&e entire study &as 'een sto##ed. What if you have questions about this study? ,ou &a$e t&e ri%&t to as-1 and &a$e ans0ered1 any 4uestions you may &a$e a'out t&is researc&. I! you &a$e !urt&er 4uestions1 or i! a researc&-related in2ury occurs1 you s&ould call Dr. Eene$ie$e Aa'uyo at 8=1;-<<3<<33 or (33-(333 or Dr. Faime Gilayo at 8=22-<<3<<33 or ;25;252 What if you have questions about your rights as a subject? &is researc& &as 'een re$ie0ed and a##ro$ed 'y t&e +t&ics Committee on t&e "rotection o! t&e Ri%&ts o! Buman Su'2ects at t&e Central Medical Center?. I! you &a$e any 4uestions or concerns re%ardin% your ri%&ts as a researc& su'2ect1 you may contact t&e C&airman o! t&e Committee at 8=1<-=(113:: or (25-(;<8 -----------------------------------------------------------------

#ub$ect%s &'reement(
I &a$e read t&e in!ormation #ro$ided a'o$e. I $oluntarily a%ree to #artici#ate in t&is study. _________________________________________ _________________ Si%nature o! Researc& Su'2ect Date _________________________________________ "rinted )ame o! Researc& Su'2ect _________________________________________ _________________ Si%nature o! "erson *'tainin% Consent Date _________________________________________ "rinted )ame o! "erson *'tainin% Consent _________________________________________ _________________ "rinted )ame and Si%nature o! Ditness Date _________________________________________ _________________ "rinted )ame and Si%nature o! Ditness Date V6AID I) Adapted from: University of North Carolina-Chapel Hill Consent Form