Table 3:

Characteristics of Included Studies (k=7)

Author and year	Journal/ Conference	Location	Purpose	Methodology	Women’s Voices Represented?	Findings
Baggaley & van Praag 2000	Bulletin of the World Health Organization	Global	To present a framework for making decisions about interventions where there is a high prevalence of HIV among pregnant women.	Secondary Data. Reviews implementation and implementation of health care	No	PMTCT programs have prioritized the health of the child over the health of the mother. Resource allocation is a challenge in finance-limited settings. It may be more ethically acceptable and rational to devote resources to prevention of HIV infection in future mothers than to treat women living with HIV.
Nataraj 2005	Monash Bioethics Review	India	To examine how the “research enterprise” in PMTCT influenced intervention design and policy; includes women’s voices to explore impacts of research	Primary/Secondary Data. Reviews history of PMTCT; interviews with research participants	Partially. Includes voices of research participants.	PMTCT programs have instrumentalized women to ensure an HIV-free child, under the motivation to reduce costs associated with increasing burden of care. PMTCT programs did not evaluate the impact on women involved. Consideration was not given to risks that mothers may face as research participants: mental trauma, stigma, breakdown of relationships, loss of social status, damage to self-esteem and identity, physical illness from cesarean, drug resistance issues, etc.
Brewster 2011	Journal of Paediatrics and Child Health	Global	To discuss the double standard inherent to global inequity, advocate for contextual ethical reasoning and describe clinical practice ethical issues.	Secondary data. Reviews ethical issues related to clinical practice and health resources.	No	There is enormous inequity in standards of clinical practice and health outcomes, particularly with regard to inequity of access to medicines. As such, there are limitations to ethical guidelines (such as CIOMS, Declaration of Helsinki, Beauchamp & Childress) when taken without consideration to context. Informed consent remains problematic. The choices for a participant may be stark: research with good standard of care vs. admission to general ward with limited nursing and care. Compliance with intensive research regulations does not ensure research with high ethical standards.
Krubiner et al. 2016	AIDS	Global	To learn what HIV experts percieve as barriers and constraints to conducting HIV research among pregnant women.	Primary Data. Qualitative - group and one-on-one consults with 62 HIV investigators and clinicians	No	Safety, efficacy and appropriate dosing information are needed for newer ARVs, preventive strategies, and treatment for co-infections. Trials need to address the needs of pregnant women. There are many challenges, including: ethical concerns, legal concerns, financial/professional disincentives, and analytical and logistical complexities.
Little et al. 2016	Book Chapter	Global	To present lessons learned about research in pregnancy from HIV/AIDS	Secondary Data. Reviews ethical conduct of HIV trials in pregnant women.	No	It is critical to address the health needs of the woman for her own sake, not just the needs of the fetus. We lack appropriate dosing information, safety and efficacy data. The issues of fetal “risk” and “potential benefit” need to be considered carefully. Benefit to the mother is often benefit to the child. Pregnancy does not (by itself) limit the ability to reason or make decisions. Therefore, it may not be appropriate to consider pregnant women to be a vulnerable population.
Little 2018	AIDS 2018	Botswana, Malawi, South Africa, US	To discuss the safety of dolutegravir in pregnancy and contrast the risks and benefits for women living with HIV	Secondary Data. Reviews DTG evidence and WHO recommendations	No	Although dolutegravir improves quality of life and reduces women’s mortality (positive impact on women’s lives), policy does not allow women to choose this option due to concerns of wellbeing for potential children.
Sullivan et al. 2018	Journal of Empirical Research on Human Research Ethics	Malawi, USA	To describe the perspectives of pregnant women living with or at risk of HIV regarding a requirement for paternal consent in biomedical research	Primary Data. Qualitative - in-depth interviews with 140 pregnant women living or at risk of HIV in Malawi and the USA.	Yes. Entirely informed by women’s voices.	Women articulated nuanced and multifaceted opinions on the rule. The majority of women supported paternal consent requirements when the potential benefits of the study are limited solely to the fetuses. Relationship power dynamics play a role in women’s engagement in research requiring paternal consent.