解放軍文職招聘考試內(nèi)部控制測(cè)試-解放軍文職人員招聘-軍隊(duì)文職考試-紅師教育
發(fā)布時(shí)間：2017-09-20 10:12:07*----控制測(cè)試的涵義*----控制測(cè)試的程序*----控制測(cè)試的范圍*----控制測(cè)試中應(yīng)注意的問(wèn)題*----------注冊(cè)會(huì)計(jì)師對(duì)內(nèi)部控制的研究和評(píng)價(jià)的步驟有哪些？在對(duì)擬信賴的內(nèi)部控制進(jìn)行測(cè)試后其評(píng)估結(jié)果如何？1、注冊(cè)會(huì)計(jì)師對(duì)于企業(yè)內(nèi)部控制所做的研究和評(píng)價(jià)可分為三個(gè)步驟：（1）了解企業(yè)的內(nèi)部控制情況，并做出相應(yīng)的記錄；（2）實(shí)施控制測(cè)試程序，證實(shí)有關(guān)內(nèi)部控制的設(shè)計(jì)和執(zhí)行的效果；（3）評(píng)價(jià)內(nèi)部控制的強(qiáng)弱，思考題：1.簡(jiǎn)述控制測(cè)試的涵義和程序。2.控制測(cè)試中應(yīng)注意的問(wèn)題有哪些？第四節(jié) 內(nèi)部控制評(píng)價(jià)（一）了解內(nèi)部控制后的初步評(píng)估1、對(duì)內(nèi)部控制的初步評(píng)估實(shí)際上是評(píng)價(jià)企業(yè)會(huì)計(jì)與內(nèi)部控制在防止或發(fā)現(xiàn)和糾正重要錯(cuò)報(bào)或漏報(bào)中有效性的過(guò)程。2、注冊(cè)會(huì)計(jì)師在設(shè)定控制風(fēng)險(xiǎn)低于最大值時(shí)比設(shè)定控制風(fēng)險(xiǎn)為最大值時(shí)需要更多地了解控制程序。3、注冊(cè)會(huì)計(jì)師初步評(píng)估的控制風(fēng)險(xiǎn)水平越低，就應(yīng)獲取越多的關(guān)于內(nèi)部控制設(shè)計(jì)合理和運(yùn)行有效的證據(jù)。4、注冊(cè)會(huì)計(jì)師在什么情況下初步評(píng)估控制風(fēng)險(xiǎn)為高水平或不應(yīng)評(píng)估為高水平？在出現(xiàn)下列情況之一時(shí)，應(yīng)將重要賬戶或交易類別的某些或全部認(rèn)定的控制風(fēng)險(xiǎn)評(píng)估為高水平：（1）企業(yè)內(nèi)部控制失效；（2）注冊(cè)會(huì)計(jì)師難以對(duì)內(nèi)部控制的有效性做出評(píng)價(jià)；（3）注冊(cè)會(huì)計(jì)師不擬進(jìn)行控制測(cè)試。在同時(shí)出現(xiàn)下列情況時(shí)不應(yīng)將控制風(fēng)險(xiǎn)評(píng)估為高水平：（1）相關(guān)的內(nèi)部控制可能防止或發(fā)現(xiàn)和糾正重大錯(cuò)報(bào)或漏報(bào)；（2）注冊(cè)會(huì)計(jì)師擬進(jìn)行控制測(cè)試。思考題：1.如何對(duì)內(nèi)部控制做出評(píng)價(jià)？第五節(jié) 管理建議書*----管理建議書的含義*----管理建議書的內(nèi)容*----管理建議與審計(jì)意見(jiàn)的區(qū)別1、管理建議書的概念（掌握）2、注冊(cè)會(huì)計(jì)師出具管理建議書的必要性：注冊(cè)會(huì)計(jì)師對(duì)審計(jì)過(guò)程中注意到的內(nèi)部控制重大缺陷應(yīng)當(dāng)告知被審計(jì)單位管理當(dāng)局，必要時(shí)，可出具管理建議書。3、管理建議書對(duì)審計(jì)意見(jiàn)是否有影響？管理建議書對(duì)審計(jì)意見(jiàn)沒(méi)有影響，注冊(cè)會(huì)計(jì)師審計(jì)的目的是對(duì)會(huì)計(jì)報(bào)表發(fā)表審計(jì)意見(jiàn)，不是對(duì)內(nèi)部控制發(fā)表審計(jì)意見(jiàn)，管理建議書不能被認(rèn)為是對(duì)內(nèi)部控制整體發(fā)表的意見(jiàn)，也不能減輕或免除被審計(jì)單位管理當(dāng)局建立健全內(nèi)部控制的責(zé)任。思考題：1.簡(jiǎn)述管理建議書的含義和內(nèi)容？教學(xué)組織：1、課堂講授為主、案例分析 （70分鐘）2、教師組織學(xué)生討論 （50分鐘）作業(yè)布置：1. (2002年單選題第15小題)注冊(cè)會(huì)計(jì)師對(duì)有些會(huì)計(jì)報(bào)表認(rèn)定采用較低的控制風(fēng)險(xiǎn)估計(jì)法，則執(zhí)行控制測(cè)試的種類應(yīng)為( )。A.同步控制測(cè)試 B.追加控制測(cè)試C.計(jì)劃控制測(cè)試 D.分析控制測(cè)試2. (2001年單選題第12小題)為了獲取有關(guān)控制風(fēng)險(xiǎn)的證據(jù)，注冊(cè)會(huì)計(jì)師通常選擇的程序是( )。A.分析性復(fù)核 B.函證C.檢查 D.計(jì)算3.（2003年多選題第6小題）在編制審計(jì)計(jì)劃時(shí)，應(yīng)當(dāng)了解P公司的內(nèi)部控制。了解重要內(nèi)部控制時(shí)，應(yīng)實(shí)施的程序通常包括（ ）。A.詢問(wèn)P公司的有關(guān)人員，并查閱相關(guān)內(nèi)部控制文件B.檢查內(nèi)部控制生成的文件和記錄C.選擇若干具有代表性的交易和事項(xiàng)進(jìn)行穿行測(cè)試D.觀察P公司的業(yè)務(wù)活動(dòng)和內(nèi)部控制的運(yùn)行情況4.（2001年多選題第6小題）當(dāng)注冊(cè)會(huì)計(jì)師發(fā)現(xiàn)被審計(jì)單位存在嚴(yán)重影響會(huì)計(jì)報(bào)表的偷稅、漏稅行為時(shí)，最有可能導(dǎo)致其解除業(yè)務(wù)約定的情況有( )。A.被審計(jì)單位偷稅、漏稅金額巨大B.懷疑被審計(jì)單位最高層管理人員涉及偷稅、漏稅行為C.被審計(jì)單位拒絕采取必要的措施糾正偷稅、漏稅行為D.注冊(cè)會(huì)計(jì)師將控制風(fēng)險(xiǎn)評(píng)估為高水平5. (2002年判斷題第5小題)在執(zhí)行小規(guī)模企業(yè)會(huì)計(jì)報(bào)表審計(jì)業(yè)務(wù)時(shí)，根據(jù)獨(dú)立審計(jì)實(shí)務(wù)公告《小規(guī)模企業(yè)審計(jì)的特殊考慮》的要求，注冊(cè)會(huì)計(jì)師無(wú)需對(duì)相關(guān)的內(nèi)部控制進(jìn)行了解。( )6. (2001年判斷題第8小題)內(nèi)部控制要素可以分為控制環(huán)境、會(huì)計(jì)系統(tǒng)和控制程序，內(nèi)部審計(jì)是控制程序的主要組成部分。( )7. (2000年判斷題第4小題)注冊(cè)會(huì)計(jì)師對(duì)會(huì)計(jì)報(bào)表審計(jì)過(guò)程中注意到的被審計(jì)單位內(nèi)部控制的重大缺陷，應(yīng)出具管理建議書，但不影響應(yīng)當(dāng)發(fā)表的審計(jì)意見(jiàn)。( )8.（2000年簡(jiǎn)答題第2小題，5分）注冊(cè)會(huì)計(jì)師編制審計(jì)計(jì)劃時(shí)，應(yīng)當(dāng)研究和評(píng)價(jià)被審計(jì)單位的內(nèi)部控制。(1)請(qǐng)簡(jiǎn)要說(shuō)明注冊(cè)會(huì)計(jì)師對(duì)內(nèi)部控制研究和評(píng)價(jià)的三個(gè)步驟。(2)請(qǐng)簡(jiǎn)要說(shuō)明在何種情況下，注冊(cè)會(huì)計(jì)師才能將控制風(fēng)險(xiǎn)評(píng)價(jià)為低水平。(1)注冊(cè)會(huì)計(jì)師對(duì)內(nèi)部控制和評(píng)價(jià)的三個(gè)步驟為：①了解被審計(jì)單位的內(nèi)部控制情況；②實(shí)施控制測(cè)試；③評(píng)價(jià)控制風(fēng)險(xiǎn)。(2)注冊(cè)會(huì)計(jì)師只有在確認(rèn)以下事項(xiàng)的情況下，才能將控制風(fēng)險(xiǎn)評(píng)價(jià)為低水平：①控制政策和程序與會(huì)計(jì)報(bào)表認(rèn)定相關(guān)；②通過(guò)控制測(cè)試已獲得審計(jì)證據(jù)證明內(nèi)部控制有效。9.（2001年綜合題第1小題，14分）ABC會(huì)計(jì)師事務(wù)所的A和B注冊(cè)會(huì)計(jì)師接受委派，對(duì)甲上市公司(以下簡(jiǎn)稱甲公司)2000年度會(huì)計(jì)報(bào)表進(jìn)行審計(jì)。甲公司尚未采用計(jì)算機(jī)記賬。A和B注冊(cè)會(huì)計(jì)師于2000年11月1日至7日對(duì)甲公司的內(nèi)部控制進(jìn)行了了解和測(cè)試，并在相關(guān)審計(jì)工作底稿中記錄了了解和測(cè)試的事項(xiàng)，摘錄如下：(1)甲公司產(chǎn)成品發(fā)出時(shí)，由銷售部填制一式四聯(lián)的銷售單。倉(cāng)庫(kù)發(fā)出產(chǎn)成品后，將第一聯(lián)出庫(kù)單留存登記產(chǎn)成品卡片，第二聯(lián)交銷售部留存，第三、第四聯(lián)交會(huì)計(jì)部會(huì)計(jì)人員乙登記產(chǎn)成品總賬和明細(xì)賬。(2)會(huì)計(jì)人員戊負(fù)責(zé)開(kāi)具銷售發(fā)票。在開(kāi)具銷售發(fā)票之前，先核對(duì)裝運(yùn)憑證和相應(yīng)的經(jīng)批準(zhǔn)的銷售單，并根據(jù)已授權(quán)批準(zhǔn)的商品價(jià)目表填寫銷售發(fā)票的價(jià)格，根據(jù)裝運(yùn)憑證上的數(shù)量填寫銷售發(fā)票的數(shù)量。(3)甲公司的材料采購(gòu)需要經(jīng)授權(quán)批準(zhǔn)后方可進(jìn)行。采購(gòu)部根據(jù)經(jīng)批準(zhǔn)的請(qǐng)購(gòu)單發(fā)出定購(gòu)單。貨物運(yùn)達(dá)后，驗(yàn)收部門根據(jù)定購(gòu)單的要求驗(yàn)收貨物，并編制一式多聯(lián)的未連續(xù)編號(hào)的驗(yàn)收單，倉(cāng)庫(kù)根據(jù)驗(yàn)收單驗(yàn)收貨物，在驗(yàn)收單上簽字后，將貨物移入倉(cāng)庫(kù)加以保管。驗(yàn)收單上有數(shù)量、品名、單價(jià)等要素。驗(yàn)收單一聯(lián)交采購(gòu)部登記采購(gòu)明細(xì)賬和編制付款憑單，付款憑單經(jīng)批準(zhǔn)后，月末交給會(huì)計(jì)部；一聯(lián)交會(huì)計(jì)部登記材料明細(xì)賬；一聯(lián)由倉(cāng)庫(kù)保留并登記材料明細(xì)賬。會(huì)計(jì)部根據(jù)只附驗(yàn)收單的付款憑單登記有關(guān)賬簿。(4)會(huì)計(jì)部審核付款憑單后支付采購(gòu)款項(xiàng)。甲公司授權(quán)會(huì)計(jì)部的經(jīng)理簽署支票，經(jīng)理將其授權(quán)給會(huì)計(jì)人員丁負(fù)責(zé)，但保留了支票印章，丁根據(jù)已適當(dāng)批準(zhǔn)的憑單，在確定支票授權(quán)人名稱與憑單內(nèi)容一致后簽署支票，并在憑單上加蓋 已支付 的印章。對(duì)付款控制程序的穿行測(cè)試表明A和B注冊(cè)會(huì)計(jì)師未發(fā)現(xiàn)與公司規(guī)定有不一致之處。(5)計(jì)劃部根據(jù)批準(zhǔn)，簽發(fā)預(yù)先編號(hào)的生產(chǎn)通知單。生產(chǎn)部根據(jù)生產(chǎn)通知單填寫一式四聯(lián)的領(lǐng)料單。倉(cāng)庫(kù)發(fā)料后，其中一聯(lián)留存，一聯(lián)連同材料交還領(lǐng)料部，其余兩聯(lián)經(jīng)倉(cāng)庫(kù)登記材料明細(xì)賬后送會(huì)計(jì)不進(jìn)行材料收發(fā)核算和成本核算。(6)甲公司股東大會(huì)批準(zhǔn)董事會(huì)的投資權(quán)限為1億元以下。董事會(huì)決定由總經(jīng)理負(fù)責(zé)實(shí)施?？偨?jīng)理決定由證券部負(fù)責(zé)總而在1億以下的股票買賣。甲公司規(guī)定：公司劃入營(yíng)業(yè)部的款項(xiàng)由證券部申請(qǐng)，由會(huì)計(jì)部審核，總經(jīng)理批準(zhǔn)后劃轉(zhuǎn)入公司在營(yíng)業(yè)部開(kāi)立的資金賬戶。經(jīng)總經(jīng)理批準(zhǔn)，證券部直接從營(yíng)業(yè)部賬戶支取款項(xiàng)。證券買賣、資金存取的會(huì)計(jì)記錄由會(huì)計(jì)部處理。A和B注冊(cè)會(huì)計(jì)師了解和測(cè)試投資的內(nèi)部控制后發(fā)現(xiàn)：證券部在某營(yíng)業(yè)部開(kāi)戶的有關(guān)協(xié)議及補(bǔ)充協(xié)議未經(jīng)會(huì)計(jì)部或其他部門審核。根據(jù)總經(jīng)理批準(zhǔn)，會(huì)計(jì)部已將8000萬(wàn)元匯入該戶。證券部處理證券買賣的會(huì)計(jì)記錄，月底將證券買賣清單交給會(huì)計(jì)部，會(huì)計(jì)部據(jù)以匯總登記。(7)甲公司控股股東的法定代表人同時(shí)兼任甲公司的法定代表人，總經(jīng)理是聘任的。在公司章程及相關(guān)決議中未具體載明股東大會(huì)、董事會(huì)、經(jīng)營(yíng)班子的融資權(quán)限和批準(zhǔn)程序。 經(jīng)了解，甲公司由財(cái)務(wù)部負(fù)責(zé)融資，2000年根據(jù)總經(jīng)理的批示，向工商銀行借入了1億元貸款。(8)甲公司設(shè)立了內(nèi)部審計(jì)部，并直接對(duì)董事長(zhǎng)負(fù)責(zé)，每年對(duì)子公司和各業(yè)務(wù)部進(jìn)行審計(jì)，并出具內(nèi)部審計(jì)報(bào)告。A和B注冊(cè)會(huì)計(jì)師獲取了2000年度所有的內(nèi)部審計(jì)報(bào)告，經(jīng)抽查表明，內(nèi)部審計(jì)報(bào)告指出了內(nèi)控存在的缺陷和改進(jìn)建議。(9)甲公司設(shè)立現(xiàn)金出納員和銀行出納員。銀行出納員負(fù)責(zé)到銀行取送支票等票據(jù)，并登記銀行存款日記賬。月底銀行出納員取得銀行對(duì)賬單并編制銀行存款余額調(diào)節(jié)表。(10)員工根據(jù)公司的批準(zhǔn)手續(xù)報(bào)銷，會(huì)計(jì)部對(duì)報(bào)銷單據(jù)加以審核，現(xiàn)金出納員見(jiàn)到加蓋核準(zhǔn)印章的支出憑據(jù)后付款。(1)根據(jù)上述摘錄，假定未描述的其他內(nèi)部控制不存在缺陷，請(qǐng)指出甲公司內(nèi)部控制在設(shè)計(jì)與運(yùn)行方面的缺陷并提出改進(jìn)建議。(2)根據(jù)對(duì)甲公司的內(nèi)部控制的了解和測(cè)試，請(qǐng)分別指出上述內(nèi)部控制缺陷與哪些會(huì)計(jì)報(bào)表項(xiàng)目或科目的何種認(rèn)定相關(guān)。
解放軍文職招聘考試案例6： 測(cè)試一種殺微生物劑-解放軍文職人員招聘-軍隊(duì)文職考試-紅師教育
發(fā)布時(shí)間：2017-06-03 10:12:51案例6： 測(cè)試一種殺微生物劑Case 6: Testing A Microbicide背景：為了阻止艾滋病這一流行病的傳播，當(dāng)務(wù)之急就是擴(kuò)大婦女能夠用來(lái)預(yù)防性傳播疾病的途徑，其中包括陰道殺菌劑的使用。陰道殺菌劑將為女性提供保護(hù)自己防止感染艾滋病和其它性傳播疾病的可能性。理想的陰道殺菌劑應(yīng)該是安全有效，負(fù)擔(dān)得起，無(wú)色無(wú)味，易于存儲(chǔ)，且可制成各種不同類型，是真正意義上完全由使用者控制的產(chǎn)品。同時(shí)，該殺菌劑應(yīng)存在于避孕和/或非避孕配方中，并且無(wú)需醫(yī)生處方，即可獲得。當(dāng)務(wù)之急是開(kāi)發(fā)一種可以為那些急需此藥劑的女性提供保護(hù)的產(chǎn)品，前提是她們堅(jiān)持使用此藥劑。作為女性的性伙伴，男性同樣可以受到殺菌劑的保護(hù)，而免受感染。過(guò)去的十年間，在殺微生物劑研究和發(fā)展方面，已取得重大進(jìn)展。許多殺微生物劑產(chǎn)品為確定其安全性和毒性，仍處于I期臨床試驗(yàn)。目前，只有一種產(chǎn)品，即nonoxynol-9殺精蟲(chóng)劑，正處于III期臨床試驗(yàn)，以評(píng)估其保護(hù)女性不受艾滋病病毒感染的功效。計(jì)劃中的試驗(yàn)，其目的在于進(jìn)一步評(píng)估該產(chǎn)品的安全性和有效性。這是第一次將是在非性工作者女性人群中展開(kāi)的大規(guī)模的第二期殺微生物劑測(cè)試，而且這次的殺微生物劑的配方無(wú)避孕功效。該測(cè)試將由國(guó)際婦女力量組織（PWI）與其他來(lái)自東道國(guó)一所醫(yī)科大學(xué)的研究者合作完成。此項(xiàng)目的試驗(yàn)地點(diǎn)為兩家計(jì)劃生育診所。國(guó)際婦女力量組織（PWI）資助整修了這兩家準(zhǔn)備用于研究的診所, 為求更新實(shí)驗(yàn)室器械同時(shí)也便于雇傭更多護(hù)理和后勤人員。招募及場(chǎng)地選擇在此研究開(kāi)始之前，來(lái)自國(guó)際婦女力量組織（PWI）的研究人員和東道國(guó)醫(yī)科大學(xué)的代表在即將展開(kāi)此研究的所有診療所舉行了會(huì)議，目的是解釋此項(xiàng)研究并從那些可能成為本研究試驗(yàn)對(duì)象的婦女處得到反饋。參與此試驗(yàn)的女性必須年滿18，加入時(shí)HIV必須顯陰性，在研究開(kāi)始前在當(dāng)?shù)鼐幼⌒铦M一年且一年之內(nèi)無(wú)意離開(kāi)。一名研究人員將征求個(gè)人的知情同意，如若需要，還將安排一名翻譯，同時(shí)，不會(huì)從性伙伴處征求同意。因?yàn)檠芯咳藛T認(rèn)為，這將對(duì)婦女的自主權(quán)造成傷害。研究人員既不鼓勵(lì)也不阻止參于研究的婦女告知其男性性伙伴加入此項(xiàng)研究。大約300位婦女將使用此凝膠或安慰劑，為期一年，且一周至少三次置于陰道，并在性交前也需使用。在加入此項(xiàng)試驗(yàn)后，這些婦女每月將來(lái)診所檢查是否有過(guò)敏跡象，并且接受性傳播疾病測(cè)試：每三個(gè)月，她們將接受HIV測(cè)試，并回答一系列有關(guān)該產(chǎn)品接受程度的問(wèn)題。在這幾次訪談時(shí)，她們也將接受安全性行為咨詢服務(wù)，免費(fèi)獲取避孕套，以及確保她們理解該測(cè)試的要求和目的所進(jìn)行的咨詢服務(wù)。同時(shí)，在接受HIV測(cè)試前，以及如果她們選擇測(cè)試而獲取測(cè)試結(jié)果之前（參與者有權(quán)可以選擇不被告知測(cè)試結(jié)果），她們也將參與測(cè)試前和測(cè)試后的咨詢。如若有參與婦女被檢查出患有可治療的性病時(shí)，她們將接受治療; 如若查出攜帶艾滋病病毒或/和患有其它疾病時(shí)，她將被介紹給當(dāng)?shù)氐姆?wù)機(jī)構(gòu)（即第二或/和第三醫(yī)院或/和社會(huì)工作者）并且鼓勵(lì)她攜其性伙伴同往。確診為HIV陽(yáng)性的參與者，如果她們選擇的話，也可以繼續(xù)參與此試驗(yàn)，因此退出此研究并不表明參與者已攜有HIV病毒。所有參與者都將獲得適度的補(bǔ)償金，每次往返診所的交通費(fèi)和水果點(diǎn)心。來(lái)自當(dāng)?shù)厣鐓^(qū)衛(wèi)生委員會(huì)（該委員會(huì)是有地方選舉、代表社區(qū)衛(wèi)生事務(wù)）的一群婦女，在研究開(kāi)始前的一次會(huì)議上提出了一個(gè)重要問(wèn)題。她們對(duì)研究人員在試驗(yàn)期間無(wú)需征求性伙伴的知情同意的決定持質(zhì)疑態(tài)度。她們的理由是如若性伙伴發(fā)現(xiàn)對(duì)方在沒(méi)有得到自己同意的情況下使用該產(chǎn)品，這將使婦女在性和肉體上可能遭到危險(xiǎn)。來(lái)自東道國(guó)的合作研究人員同樣出席了那次會(huì)議，他們爭(zhēng)辯道如果男性得知對(duì)方在使用殺微生物劑后，他們將不會(huì)允許對(duì)方參與此項(xiàng)研究，所以索求男性的知情同意就會(huì)使該研究的另一目的化為泡影，即這項(xiàng)研究旨在測(cè)試一種女性控制的方法。1.研究人員是否應(yīng)該向男性性伙伴征求知情同意？為什么？2.如果試驗(yàn)證明這種凝膠有效的話，研究人員是否有義務(wù)使進(jìn)行研究的社區(qū)的所有婦女都獲得這種產(chǎn)品？甚至是整個(gè)國(guó)家的婦女？Case 6: Testing a MicrobicideBackgroundA critical need in stemming the spread of the HIV/AIDS pandemic is to expand the range of methods that women can use for the prevention of all sexually transmitted infections, including vaginal microbicides.A vaginal microbicide would offer the potential for women to protect themselves from HIV and other sexually transmitted infections (STIs). To be truly female controlled, the ideal microbicide would be effective, safe, acceptable, affordable, colourless, odourless, tasteless, easy to store and use, and available in a variety of preparations. It should also be available in contraceptive and non-contraceptive formulations and obtainable without a prescription. However, because the first microbicide to be developed is unlikely to be an ideal product with all these characteristics, the immediate priority is to develop a microbicide that provides protection if used consistently by those who need it most.The protective benefits of microbicides for male partners have not been studied but researchers believe that a woman s male partner would also be protected from infection. Microbicides have been shown to be effective against many sexually transmitted pathogens in vitro and they appear to be most effective in vivo as prophylaxis against cervical infection by N.gonorrhoeae, C. trachomatis and vaginal infection by T. vaginalis.The prospects for developing microbicides are promising. There is growing consensus that developing a microbicide should be technically feasible, and there has been significant progress in microbicide research and development over the last ten years. Many microbicide products are still in the stage of phase I and II testing in order to establish their safety and toxicity. Currently, only one product, nonoxynol-9 (N-9) is being tested in phase III trials to assess its efficacy in protecting women from HIV infection.Despite the established need for a female controlled barrier method, many scientists, pharmaceutical companies and investors remain skeptical about the feasibility of achieving this goal. In part, this uncertainty derives from the lack of conclusive scientific data demonstrating that, as a class, female barrier methods have the potential to reduce the transmission of STIs. Without results from well-controlled clinical trials that test the efficacy of female barrier methods, their potential role in an overall program of HIV prevention will remain subject to debate.Power to Women International (PWI), a US based non-profit research organisation, with a strongly feminist agenda, is planning a study of a microbicide in China. Laboratory tests show that the product blocks HIV attachment to target cells in vitro. The phase I testing of this product was conducted in five countries and results indicated that the product caused no significant signs of irritation and that the women generally found it acceptable and easy to use. It should be noted however, that these women only used the product for 10 days and were not sexually active during this time.The proposed trial is designed to further assess the safety and effectiveness of this product. This is the first large-scale phase II microbicide trial to be done in a population of women who are not sex workers and with a microbicide formulation that is non-contraceptive. It will be conducted by PWI with co-investigators from a medical university in the host country. The project sites are two family planning clinics. PWI has funded the renovation of the two clinics that will be used for the study in order for the laboratory facilities to be upgraded and for more nursing and support staff to be employed.Recruitment and site selectionBefore the start of the study, the researchers from PWI and representatives from the host country university hold meetings in all the clinics in which the study will take place, in order to explain the study and elicit feedback from potential participants.To participate in this trial women must be 18 years or older, HIV negative when they enroll, and resident in the community for at least one year prior to the study, with no intention of leaving for another year. Individual informed consent will be sought from each participant by one of the researchers with the aid of a translator if necessary. Consent will not be sought from male partners as the researchers felt that this would undermine women s autonomy. They neither encouraged nor discouraged the women from informing their partners of their involvement in the study.Approximately 300 women will use the gel or placebo for approximately one year by applying it vaginally at least three times weekly as well as before intercourse. After enrolling in the trial, women will come to the clinic monthly to be examined for signs of irritation and tested for sexually transmitted infections; every three months they will be tested for HIV and asked a series of product acceptability questions. At these visits the women will receive safer-sex counselling, free condoms, and counselling to ensure that they understand the trial requirements and objectives. Prior to being tested for HIV and receiving their results if they choose (women have the option not to get their results), they will engage in pre- and post-test counselling. If a woman is found to have a treatable STD she will receive treatment; if she is found to have HIV or another condition she will be referred to health and support services (secondary/tertiary hospitals or social workers) available in the local area and will be encouraged to take her partner with her. Women diagnosed as HIV positive can continue to participate in the trial if they choose, so that leaving the trial does not signify HIV serostatus. All participants will receive modest monetary compensation for time and transport for each visit, as well as refreshments.A group of women from the community health committee, a locally elected body that represents the community in health matters, raises an important concern during one of the pre study meetings. They disagree with the decision of the researchers not to get informed consent from the male partners of women in the trial. They reason that this might place women at risk for sexual and physical abuse if their partner discovers that they are using the product without their consent.The co-investigators from the host country, also present at the meeting, argue that if the men are informed about the microbicide, they will not allow their partners to take part in the study. Seeking male consent would also negate one purpose of the study, which is to test a female controlled method.Questions1.Should investigators seek informed consent from male partners? Why?2.If this gel proves to be effective, do the researchers have any obligation to make it available to all women in the study communities? All women in the country?
