Choosing questions, study designs and methods

This chapter explores how gender analysis can be incorporated into health systems implementation research. This is the process of analysing how gendered power relations influence the implementation of an intervention, as well as the extent to which the research process itself progressively transforms gendered power relations, or at least does not exacerbate them. Gender is defined as the “socially constructed roles, behaviours, activities, and attributes that a given society considers appropriate for men and women”. Gender is different from sex, which refers to the biological chromosomal characteristics that distinguish males, females, and intersex people. The meaning of gender can therefore extend beyond men and women to include a range of gendered identities while also varying over time and across contexts. As well as analysing differences between men, women, and people of other genders, gender analysis also explores differences among these categories. It takes an intersectional approach which examines “gender in relation to other social stratifiers, such as class, race, education, ethnicity, age, geographic location, (dis)ability and sexuality, etc., how these markers dynamically interact, [and] how power plays out at multiple levels and through diverse pathways to frame how vulnerabilities are experienced”.

Morgan R., Theobald S., Hawkins K., Waldman L. and Elsey H. (2016) Incorporating gender analysis into health systems implementation research, in A Practical Guide to Implementation Research, Future Health Systems

There has been a recent swell in activity by health research funding organizations and science journal editors to increase uptake of sex and gender considerations in study design, conduct and reporting in order to ensure that research results apply to everyone. However, examination of the implementation research literature reveals that attention to sex and gender has not yet infiltrated research methods in this field.

The rationale for routinely considering sex and gender in implementation research is multifold. Sex and gender are important in decision-making, communication, stakeholder engagement and preferences for the uptake of interventions. Gender roles, gender identity, gender relations, and institutionalized gender influence the way in which an implementation strategy works, for whom, under what circumstances and why. There is emerging evidence that programme theories may operate differently within and across sexes, genders and other intersectional characteristics under various circumstances. Furthermore, without proper study, implementation strategies may inadvertently exploit or ignore, rather than transform thinking about sex and gender-related factors. Techniques are described for measuring and analyzing sex and gender in implementation research using both quantitative and qualitative methods.

The paper describes the application of methods for integrating sex and gender in implementation research. Consistently asking critical questions about sex and gender will likely lead to the discovery of positive outcomes, as well as unintended consequences. The result has potential to strengthen both the practice and science of implementation, improve health outcomes and reduce gender inequities.

Tannenbaum C., Greaves L. and Graham I.D. (2016) Why sex and gender matter in implementation research, BMC Med Res Methodol. 2016; 16: 145

Implementation research (IR) is growing in recognition as an important generator of practical knowledge that can be translated into health policy. With its aim to answer questions about how to improve access to interventions that have been shown to work but have not reached many of the people who could benefit from them, IR involves a range of particular ethical considerations that have not yet been comprehensively covered in international guidelines on health research ethics. The fundamental ethical principles governing clinical research apply equally in IR, but the application of these principles may differ depending on the IR question, context, and the nature of the proposed intervention. IR questions cover a broad range of topics that focus on improving health system functioning and improving equitable and just access to effective health care interventions. As such, IR designs are flexible and often innovative, and ethical principles cannot simply be extrapolated from their applications in clinical research. Meaningful engagement with all stakeholders including communities and research participants is a fundamental ethical requirement that cuts across all study phases of IR and links most ethical concerns. Careful modification of the informed consent process may be required in IR to permit study of a needed intervention. The risks associated with IR may be difficult to anticipate and may be very context-specific. The benefits of IR may not accrue to the same groups who participate in the research, therefore justifying the risks versus benefits of IR may be ethically challenging. The expectation that knowledge generated through IR should be rapidly translated into health policy and practice necessitates up-front commitments from decision-makers to sustainability and scalability of effective interventions. Greater awareness of the particular ethical implications of the features of IR is urgently needed to facilitate optimal ethical conduct of IR and uniform ethical review.

Gopichandran V. et al (2016) Developing the ethics of implementation research in health, Implementation Science, 2016, 11:161

Based on the presumption that certain kinds of ethical issues may be particularly relevant to and salient in health systems research, this chapter explores several of these issues. We outline eight areas of ethical relevance that are particularly salient in health systems research (though not unique to health systems research) that may require special attention during ethics review, especially in LMICs. These include research subjects, informed consent, units of intervention and observation, risk assessment, defining benefits and beneficiaries, nature of interventions and appropriate controls and comparisons.

Rattani A. and Hyder A.A. (2016) Ethical considerations in health systems research, in A Practical Guide to Implementation Research, Future Health Systems