At a Media Science Café convened by DNDi, IQVIA, and the Kenya Environment and Science Journalists Association in Nairobi on 4 September, researchers, regulators, and journalists explore a critical question: who is health research really designed for?

‘Many of us women do not, even as we speak now in this room, have an “acceptable” contraception. But somehow that assumption is built into research trials.’

Dr Caroline Kithinji, Head of Training at the Science and Ethics Review Unit at KEMRI, was reflecting on a phrase that appears routinely in clinical trial protocols: women of childbearing age must use ‘acceptable contraception’ to participate in a study.

Her point was not about contraception itself. It was about the assumptions researchers make about women’s lives, often without realising it, and what it would take to make research genuinely gender responsive.

Moderated by Dr Fridah Mwendia of IQVIA, the discussion brought together researchers, regulators and funders to explore how health research can better reflect the realities of women’s lives.

‘We need to be gender responsive from the very beginning. Way before the proposals come to us and we review them. Before the PIs sit down and write their proposals. But I wonder how many times we are thinking of the realities of the women who are joining our studies.’

The legacy of the default body

For Mercy Mumo, Communication Manager, and the Gender Communications Lead at DNDi, those assumptions have deep historical roots.

For decades, the standard participant in clinical research was an adult male. Following the thalidomide tragedy in the 1950s and 1960s, regulators sought to protect pregnant women and unborn children from research risks. In 1977, the US Food and Drug Administration restricted the participation of women of childbearing potential in early-stage clinical trials.

‘The intention, of course, was to protect the unborn child,’ says Mumo. ‘And for nearly two decades, women continued to be systematically excluded from trials.’

The result was that many medicines were developed and approved largely on male biology. Excluding women in the name of protection, she argues, often leaves them unprotected once medicines reach the market.

Dr Christabel Khaemba, Deputy Director of Product Safety at Kenya’s Pharmacy and Poisons Board, added that one of the biggest challenges is that gender often enters research discussions too late, when the study is already complete and researchers are analysing the data.

More important questions come afterwards. Were there enough women in the study to draw meaningful conclusions? Can the data be extrapolated to the women who will take the medicine once it receives market authorisation? Which adverse events were picked up, and were they different in women?

She pointed to the thalidomide tragedy as an example of what can happen when evidence gaps go unnoticed.

Those questions remain relevant today. Khaemba points to Kenya’s planned introduction of the RSV vaccine for pregnant women, which helps protect newborns through maternal antibodies.

‘At what point are we carrying out this research in these women?’ she asked. ‘Is it the first trimester? Is it the second? Or is it the last?’

The goal, she argued, is not to exclude pregnant women from research, but to generate the evidence needed to understand when and how interventions can be used safely.

Research recruits realities, not just participants

While Mumo and Khaemba spoke about who gets included in research and when, Kithinji further challenged the room to think about what happens after enrolment.

One example is a phrase she frequently encounters in protocol deviation reports: missed visits.

While researchers document the missed appointment, record corrective actions, and retrain participants, rarely, she said, do they ask why someone missed it.

‘You’ve not asked where she’s coming from, whether she’s eaten, who’s looking after her children, or what is going to happen to that day that she’s not going to be working.’

After more than two decades in research ethics, she says this discussion has forced her to rethink the issue.

‘You are not just enrolling people. You’re enrolling their reality. And if you’re enrolling their reality, then it behoves you to find out what their reality is.’

‘If you want me to come at 8am every two weeks to your clinic, you better understand my reality. And when I don’t come, don’t say it’s my fault. That missed visit is not my fault. That missed visit is your fault.’

The same principle, according to Dearie Okwu, Parasitic Diseases Lead at DNDi, applies to informed consent.

She recalls a 24-year-old woman who joined a study and mentioned that she lived with her parents. Although the research team was not required to involve them, they explained the study to her mother.

Two days later, her father arrived wanting to know why his daughter was enrolled without his knowledge.

For Okwu, the encounter underscores the fact that consent for women is rarely a one-time event in a trial.

‘It’s a living document,’ she said. ‘You have to do it over and over again. And sometimes it’s not just restricted to the participants.’

Bringing communities into the design process

A recurring theme throughout the discussion was that community engagement often happens too late.

Okwu argued that communities should help shape research long before protocols are finalised.

‘It’s not just about scientists writing the protocol and saying, do this,’ she says. ‘Who better to give you the reality than people living it?’

The question, she argues, belongs even earlier, at the point where a new medicine is first being developed.

‘You need to ask yourself, who is it meant for? Questions about gender should be started from that point.’

Kithinji noted that while almost every protocol includes community engagement plans, these often rely on traditional structures that unintentionally exclude women.

‘You see a baraza under a tree, call people, go through the chief. All of those things seem to make sense, right? Until the chief is male, the elders are male, and everyone who shows up is male.’

By the time researchers engage women, she says, many of the key decisions have already been made.

Khaemba offered an example from her own work studying lymphatic filariasis on Kenya’s coast. Because the parasite is detectable at night, blood samples need to be drawn at midnight, often requiring researchers to visit women at home.

‘Maybe the husband doesn’t stay with the wife, and the researcher collecting this data, going to a woman’s house at midnight, is a man,’ she said. ‘When you’re doing your design for this study, these are things you have to put in mind.’

Her team spent significant time engaging communities before recruitment began. Without those conversations, she believes the study would never have succeeded.

‘If we had not done that community sensitization, then probably we would not even have recruited women and did what we did.’

Who gets to lead science?

The discussion moved from research participants to the people leading research itself.

Moses Alobo, who leads programmes at the Science for Africa Foundation, shared a lesson from early in his medical career. While performing dozens of bilateral tubal ligations, women repeatedly told him that after the procedure they felt ‘cold’.

The issue was not temperature. It was about changes in sexuality, self-perception, and lived experience that he, as a male clinician, had failed to recognise.

For Alobo, some biases remain invisible from where men are standing, however well trained they are. Research benefits when women are involved not only as participants, but also as scientists and leaders.

Yet women remain underrepresented in senior scientific leadership, despite career trajectories that are often shaped by childbearing and caregiving responsibilities.

The solution, Alobo argues, is not simply awareness. It is investment.

‘Budget for maternity cover, budget for crèches in workplaces, budget so that when you’re inviting a mother to Lagos, Cape Town, the US, the UK, that you pay for their baby and for a caregiver. Now, if it was a matriarchal society, that would have been done a long time ago. But because it’s a patriarchal society, we are still discussing this,’ he said.

Monique Wasunna, DNDi Africa Ambassador, also made the case for authority rather than presence.

‘For you to have power, you must be a principal investigator. The PI leads the publication, the PI speaks, the PI goes in front. And usually it’s the men.’

Institutions already have senior women in research, she said. ‘Why are they not principal investigators? We can do it now.’

From inclusion to design

Asked what should change immediately, the panellists focused on different points in the research journey.

Kithinji committed to developing guidance to help ethics reviewers assess whether study protocols are genuinely gender responsive.

Khaemba called for community engagement before protocols are finalised.

Okwu emphasised on returning research findings to participants in ways they can understand.

Alobo argued for a sex and gender lens to be embedded from the earliest stages of study design, funding decisions, and hiring processes.

While their responses focused on different stages of the research journey, they pointed to the same conclusion: gender-responsive research is more than inclusion. It shapes who is consulted, who participates, who leads and whose realities inform the evidence that is generated. And the result is not only more equitable research, but better science, better evidence and, ultimately, better medicines for everyone.