Include HIV+ pregnant women in in clinical trials- Dr Mary Kasule.(part 2)
SunHealth continues discussion with former Assistant Director Research Research Ethics at the University of Botswana, Dr Mary Kasule, on a study she undertook aimed at finding ethical solutions solutions to advance research involving pregnant women especi
Tell us again how you became involved with the Pregnancy & HIV/ AIDS: Seeking Equitable Study (PHASES) project?
I applied for a Wellcome Trust grant during the 11th Global Forum for Bioethics (GFBR) Conference that was held in Buenos Aires, Argentina, 3-4 November 2016 whose theme was “Ethics of Research in Pregnancy”
What was your role in the Study? I was the Botswana Principal Investigator on this study Who were the participants in the study?
Participants involved 60 stakeholders in Botswana with experience in experimental and clinical research involving pregnant women. These included clinicians involved in HIV research with pregnant women, clinicians who care for HIV pregnant women, IRB members, policymakers, and Community Advisory Board members.
May you discuss some of the key findings you uncovered during the study?
Stakeholders identified research gaps in key priority areas like HIV management, co-infections and comorbidities as well as HIV prevention and other cross cutting priorities. They also identified numerous challenges like socio-cultural/economic especially the cultural protection of pregnant women, tension between Botswana traditions and western medicine and lack of male involvement. Fear of foetal harm as a professional risk to funders, research organisations, Ethics Committees and policy makers that could damage reputation as well as ethical, legal and policy related challenges.
What were the barriers you noted and how do we overcome them?
The main barrier identified was the tension between cultural norms regarding the protection of pregnant women versus western medicine especially the lack of autonomy by the pregnant women because of the
Botswana patriarchal society.
Culturally, pregnant women are described as needing protection, which sometimes, though not always, overlapped with descriptions of vulnerability.
Like one stakeholder said “In our culture, a pregnant woman is like a jewel, so precious, protected from all angles with whatever we have at our disposal”.
On the other had the researchers compared data from studies involving pregnant women as a “diamond” but without proper guidance they have to take risks to include pregnant women in research.
For example one researcher said, “It’s like you jump on a tree, a big tree and then you say “no I just want to go and see that shiny stone that is there.” And you just jump.
When you see it, it looks very nice. It might be diamond…You jump and don’t break your leg and discover diamond…When people think about ok, ok you want to jump…These are the risks.
And then when you get the diamond then of course everyone will celebrate with you.” Other barriers included lack of ethical and legal guidance as well as policy guidance on research involving pregnant women.
How do you suppose these findings will benefit Botswana?
The findings will form part of the global guidance document on how to conduct ethical and responsible research with pregnant women.
Already Botswana has proved itself able to conduct research with pregnant women through the success story of its Mother–to-Child- Transmission (PMTCT) Programme.
So this would be the right place to inform the global guidelines.
The guidelines will ensure that the ethical principles of conducting research involving human participants are followed, namely according the pregnant women their autonomy, ensuring justice and through providing pregnant women access to and benefit from drugs like other populations as well as being protected through research and not from research!
Why do you suppose it is common practice to exclude pregnant women from clinical trials?
Historically, international and local ethics guidelines for health research involving humans have categorized pregnant women as a vulnerable group although this is changing.
The vulnerability arises from the fact that the pregnant women and the foetus may be exposed to risks from the experimental research which results in an automatic cause for exclusion even where the risk is minimal. This is sometimes amplified in certain cultural contexts with a more general stance of paternalist protectionism towards pregnant women.
Secondly lack of training and experience in designs for approaching issues raised by pregnancy, including specifics on trial insurance, protocols to allow admission or retention on study drug, and personnel needed for including pregnant women in research trials may cause exclusion from experimental research.
While regulations require protocols to justify the eligibility of pregnant women’s enrolment or retention, no justification is required for excluding them.
This practice means that any reason or no reason at all can suffice for exclusion, and fails to distribute the research community’s collec