解放军文职招聘考试案例6： 测试一种杀微生物剂

 案例6： 测试一种杀微生物剂
Case 6: Testing A Microbicide

背景：
为了阻止艾滋病这一流行病的传播，当务之急就是扩大妇女能够用来预防性传播疾病的途径，其中包括阴道杀菌剂的使用。
阴道杀菌剂将为女性提供保护自己防止感染艾滋病和其它性传播疾病的可能性。理想的阴道杀菌剂应该是安全有效，负担得起，无色无味，易于存储，且可制成各种不同类型，是真正意义上完全由使用者控制的产品。同时，该杀菌剂应存在于避孕和/或非避孕配方中，并且无需医生处方，即可获得。当务之急是开发一种可以为那些急需此药剂的女性提供保护的产品，前提是她们坚持使用此药剂。作为女性的性伙伴，男性同样可以受到杀菌剂的保护，而免受感染。过去的十年间，在杀微生物剂研究和发展方面，已取得重大进展。许多杀微生物剂产品为确定其安全性和毒性，仍处于I期临床试验。目前，只有一种产品，即nonoxynol-9杀精虫剂，正处于III期临床试验，以评估其保护女性不受艾滋病病毒感染的功效。
计划中的试验，其目的在于进一步评估该产品的安全性和有效性。这是第一次将是在非性工作者女性人群中展开的大规模的第二期杀微生物剂测试，而且这次的杀微生物剂的配方无避孕功效。该测试将由国际妇女力量组织（PWI）与其他来自东道国一所医科大学的研究者合作完成。此项目的试验地点为两家计划生育诊所。国际妇女力量组织（PWI）资助整修了这两家准备用于研究的诊所, 为求更新实验室器械同时也便于雇佣更多护理和后勤人员。

招募及场地选择
在此研究开始之前，来自国际妇女力量组织（PWI）的研究人员和东道国医科大学的代表在即将展开此研究的所有诊疗所举行了会议，目的是解释此项研究并从那些可能成为本研究试验对象的妇女处得到反馈。
参与此试验的女性必须年满18，加入时HIV必须显阴性，在研究开始前在当地居住需满一年且一年之内无意离开。一名研究人员将征求个人的知情同意，如若需要，还将安排一名翻译，同时，不会从性伙伴处征求同意。因为研究人员认为，这将对妇女的自主权造成伤害。研究人员既不鼓励也不阻止参于研究的妇女告知其男性性伙伴加入此项研究。
大约300位妇女将使用此凝胶或安慰剂，为期一年，且一周至少三次置于阴道，并在性交前也需使用。在加入此项试验后，这些妇女每月将来诊所检查是否有过敏迹象，并且接受性传播疾病测试：每三个月，她们将接受HIV测试，并回答一系列有关该产品接受程度的问题。在这几次访谈时，她们也将接受安全性行为咨询服务，免费获取避孕套，以及确保她们理解该测试的要求和目的所进行的咨询服务。同时，在接受HIV测试前，以及如果她们选择测试而获取测试结果之前（参与者有权可以选择不被告知测试结果），她们也将参与测试前和测试后的咨询。如若有参与妇女被检查出患有可治疗的性病时，她们将接受治疗; 如若查出携带艾滋病病毒或/和患有其它疾病时，她将被介绍给当地的服务机构（即第二或/和第三医院或/和社会工作者）并且鼓励她携其性伙伴同往。确诊为HIV阳性的参与者，如果她们选择的话，也可以继续参与此试验，因此退出此研究并不表明参与者已携有HIV病毒。所有参与者都将获得适度的补偿金，每次往返诊所的交通费和水果点心。
来自当地社区卫生委员会（该委员会是有地方选举、代表社区卫生事务）的一群妇女，在研究开始前的一次会议上提出了一个重要问题。她们对研究人员在试验期间无需征求性伙伴的知情同意的决定持质疑态度。她们的理由是如若性伙伴发现对方在没有得到自己同意的情况下使用该产品，这将使妇女在性和肉体上可能遭到危险。
来自东道国的合作研究人员同样出席了那次会议，他们争辩道如果男性得知对方在使用杀微生物剂后，他们将不会允许对方参与此项研究，所以索求男性的知情同意就会使该研究的另一目的化为泡影，即这项研究旨在测试一种女性控制的方法。
 
问题

1.研究人员是否应该向男性性伙伴征求知情同意？为什么？

2.如果试验证明这种凝胶有效的话，研究人员是否有义务使进行研究的社区的所有妇女都获得这种产品？甚至是整个国家的妇女？

Case 6: Testing a Microbicide
Background
A 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 selection
Before 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.

Questions
1.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?