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CASE STUDY INFORMED CONSENT

A microbicide study was taking place in an African country. Focus groups in the community have shown
that many women are interested in a microbicide because they are not able to negotiate condom use with
their partners. Many women are coming to the study clinic to enrol in the trial. A community advisory
group is formed with community leaders and representatives. A male member of the group says that he
does not approve of the study because the women are not required to get the consent of their partners to
enrol.
A local womens group expresses concern that a woman who enrols in the trial without telling their
partner risks being harmed if her partner finds out she is participating.
In some settings it is generally expected that a womans husband has the right and authority to make
decisions regarding her health care.
1. In this instance, how should one balance respect for person with respect for culture?
2. Should sexual partners be involved? Are there creative strategies for encouraging partner
engagement?
3. What might you recommend as an appropriate way to respect both of these values in this
instance?

Microbicides refers to an array of products used to prevent the transmission of HIV and other sexually
transmitted diseases. In their simplest form, microbicides would function as a substance that could be
used during sexual intercourse to stop HIV infection from taking place, even when one of the partners is
infected. More broadly, microbicides could come in the form of gels, creams, suppositories, films, or in
sponges or rings.
Microbicides might work against HIV transmission through five possible approaches: 1) microbicides
could inactivate the pathogens causing these viruses; 2) microbicides could create barriers between the
pathogen and tissue; 3) microbicides could strengthen the bodys natural defenses; 4) microbicides could
inhibit viral entry; and/or 5) microbicides could inhibit replication HIV.
The complexity of microbicide research in developing countries is augmented by a host of unique ethical
concerns. In the haste to develop an urgently needed microbicide, some of these concerns, especially
those related to safety have either not been anticipated or fully explored. The development of guidelines
pertaining to the ethics of microbicide research is important to investigators and ethics committees alike
internationally. Both formative and empirical research is required to resolve these dilemmas to ensure
participant protection without obstructing the conduct of urgent and important HIV preventive research.
In this instance, how should one balance respect for person with respect for culture?
Respect for persons may give rise to an obligation to obtain informed consent, but it also suggests that
more is required of us than simply respecting an individuals right to make autonomous decisions. But as
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H. Tristram Engelhardt, Jr. emphasized that obtaining informed consent represents a form of respect in
that subjects self-determination, or negative liberty right to make free and rational choices, is preserved.
In respect for cultural diversity, the importance of autonomous decision making is more common in
Western communities. The argument is that not all communities, particularly non-Western communities,
value autonomous decision making and that it is therefore disrespectful to impose our Western values on
subjects from other cultures.
The Council for International Organizations of Medical Sciences (CIOMS) 2002 International Ethical
Guidelines for Biomedical Research Involving Human Subjects aims specifically to address ethical
concerns in multinational research. While the CIOMS insists on the moral authority of respect for
autonomy and argues for the universal application of the requirement for informed consent, it maintains
that informed consent can be obtained while respecting the values and practices of the subjects culture.
As with the case study in microbicide research, an investigator may enter a community to conduct
research or approach prospective subjects for their individual consent only after obtaining permission
from a community leader, a council of elders, or another designated authority. Such customs must be
respected. In no case, however, may the permission of a community leader or other authority substitute
for individual informed consent. Sponsors and investigators should develop culturally appropriate ways to
communicate information that is necessary for adherence to the standard required in the informed consent
process.
This effectively expands the principle of respect for persons to include respect for the cultural
environment within which different persons live. Respecting different cultures requires a recognition and
consideration of various cultural or community customs as well as the active participation of communities
in the research design, execution, and implementation. The CIOMS specifically requires that research
undertaken in communities with limited resources is responsive to the health needs and priorities of the
population or community in which it is to be carried out; and that any intervention or product developed,
or knowledge generated, will be made reasonably available for the benefit of that population or
community. This requirement addresses issues of justice, but it also expresses a commitment to the idea of
respect.
Should sexual partners be involved? Are there creative strategies for encouraging partner engagement?
The philosophy underlying microbicide trials relates to the empowerment of women to protect themselves
from a life-threatening disease in settings where they are unable to negotiate safe sex. Given this
rationale, it seems almost antithetical to consider obtaining agreement or consent from male partners.
However, in clinical trials where both partners are exposed to an experimental vaginal gel, partner
agreement/consent and couple consent as opposed to female participant consent only is an important
consideration.
Several arguments have been advanced for excluding men from microbicide trials. In patriarchal
communities where men are the primary decision-makers on most issues including matters relating to
sexual intercourse and intimacy, researchers fear that male partners will prevent women from
participating in clinical trials and from using microbicide products. It may be impractical to get male
partners to attend research sites due to competing commitments related to employment. The inclusion of
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men will significantly increase the costs and resources required for such trials in research studies that are
poorly supported by the pharmaceutical industry. Finally, where female participants have multiple male
partners, it may be logistically difficult to include all partners in the trial.
Equally compelling arguments can be advanced for the inclusion of male partners in microbicide trials.
Firstly, male partners are being exposed to an investigational agent and are exposed to physical risk. Since
pre-clinical testing of microbicides includes testing for "penile toxicity", clinical testing should also
involve male partners with their consent to assess for acute and long term local effects. Failure to do so
could have legal ramifications in the long term especially if chronic use of these investigational products
is later found to be associated with penile toxicity or if these products are found to increase risk of HIV as
has been documented in women. The World Health Organisation (WHO) guidance on reproductive health
research and partner involvement favors respect for individual participant autonomy in all situations.
However, partner agreement should be made a condition of recruitment only if the research will "so
immediately affect the partner as to make him or her comparable to a subject of the research". This is
applicable to microbicide gels in general especially those with systemic absorption. As such, partner
notification is justified only when there is physical risk to the partner such as infection or infertility
according to the WHO guidelines.
While microbicide development has been targeted primarily at women, some acceptability studies have
included men. Several of these studies have shown male partner interest in microbicide research. While
microbicide development has been fueled by the hope that women will be empowered to protect
themselves from their partners covertly with their own vaginal gel, many women in developing countries
actually prefer to involve their partners. This is often the case in settings where autonomy is not expressed
in an individualistic sense and where communal conceptions of personhood may require couple or family
consent as opposed to individual consent. In recognition of this socio-cultural preference in some
developing countries the WHO, in its guidance on reproductive research, makes provision for partner
agreement when required. This is, however, the exception rather than the rule as the WHO, in general,
regards partner consent as inappropriate and as a violation of participant autonomy.
Where women prefer not to tell their partners, covert use may be very difficult. Most microbicides
increase lubrication. Covert use is hence not possible in populations with a preference for dry sexual
practices. Furthermore, covert use could result in mistrust and deception in developing countries and male
partners may develop antagonism towards these products that will parallel their antagonism towards male
condoms. More importantly, covert use of microbicides by women could result in domestic violence.
There is hence an emotional cost linked to covert use. Finally, the testing of vaginal microbicides in
pregnancy mitigates against the exclusion of male partners in the consenting process of clinical trials. The
possibility of testing microbicides during pregnancy will require re-consenting women and their male
partners or the father of the potential child.

What might you recommend as an appropriate way to respect both of these values in this instance?
The informed consent process is pivotal in microbicide research. Providing information to trial
participants in a focussed, locally-appropriate manner, using a participatory, multi-method, continuous
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informed consent process developed in consultation with the community, and within a continuous
informed-consent framework resulted in high levels of comprehension and message retention in this
setting. This approach may represent a model for researchers conducting HIV prevention trials among
other vulnerable populations in resource-poor settings. Issues related to pregnancy prevention need to be
clearly outlined in consent documents. Reliable and safe contraceptive methods must be specified and
made available at trial sites. The informed consent process must also be clear about the possibility of
increased risk of HIV infection. In the event of such an outcome, clear procedures must be in place for
tracing of participants, provision of treatment and notification of partners. Balancing womens autonomy
and male partner engagement in microbicide introduction is crucial. Women have the right to choose
whether they inform their partners of their microbicide use, and health providers need to support women
in making the decision that is appropriate for them. At the same time, educating men about microbicides
may help increase acceptability and adherence and foster couples communication about sex and HIV
protection. Microbicide introduction programs must take care to position women as the gatekeepers to
their male partners involvement. Finally, responsible media coverage is essential to prevent
sensationalisation of microbicide research and to minimize the negative impact on enrollment. Most
important, to reduce the incidence of HIV infection globally, we must work with women and men at the
community level to promote trust and identify the best ways to use the effective methods we already have.
Sources:
Council for International Organizations of Medical Sciences (CIOMS), International Guidelines for
Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002).
Dickert, N. W.(2009). Re-Examining Respect for Human Research Participants. Kennedy Institute of
Ethics Journal 19(4), 311-338. The Johns Hopkins University Press. Retrieved March 3, 2016, from
Project MUSE database.
H. Tristram Engelhardt, Jr., Basic Ethical Principles in the Conduct of Biomedical and Behavioral
Research Involving Human Subjects, in Appendix, vol. 1, The Belmont Report (Washington, D.C., U.S.
Government Printing Office, 1979), chap. 8.
Hughes, D., M., Nkandu, M., L., H., & Rice, M. (2012). Cultural differences in acceptability of a vaginal
microbicide: A comparison between potential users from Nashville, Tennessee, USA, and Kafue and
Mumbwa, Zambia. HIV HIV/AIDS - Research and Palliative Care, 73.
Moodley, K. (2007). Microbicide research in developing countries: Have we given the ethical concerns
due consideration? BMC Medical Ethics BMC Med Ethics, 8(1), 10.
Vallely, A., Lees, S., Shagi, C., Kasindi, S., Soteli, S., Kavit, N., . . . Programme, T. M. (2010). How
informed is consent in vulnerable populations? Experience using a continuous consent process during the
MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Medical Ethics BMC Med Ethics, 11(1),
10.