Friday, July 11, 2008

Procedure

It was, I imagine, like trying to interview Madonna.

Crouched on a rickety wooden folding chair, I had my notebook out. Dzame Kitti, whose guest I was, was sitting cross legged in the doorway of her small, mud-walled house. The sun was shining bright, and chickens pecked at the ground near a round rattan mat where corn kernels lay out to dry.

I began to ask a question, and was immediately stopped. Procedure. My companions – Dzame’s handlers – swung into action. Dr. Ally Olotu, who had overseen the early malaria vaccine trial which Dzame’s daughter Jazmilla participated in, brought out a sheaf of papers and began to speak to her in Kiswahili.

The papers were the consent form we had worked out for the interview.

Informed Consent is a key element of clinical trials. Participants are asked to sign forms that indicate they have been told all of the details of the trial, including risks and benefits, and have agreed to take part voluntarily.

The informed consent process extends to interviews. I had come with a Kiswahili translation of a consent form that had been worked out by malaria workers in Tanzania. It was modeled on a form drawn up for an earlier visit by a TV crew, and apparently had some jarring language – “universal distribution rights”, “all media” etc.

This had raised red flags in the KEMRI social research group, which felt that perhaps that Kenyan participants would be signing away too much. So Ally helpfully drew up a new, simpler form, stating that the interview was for Reuters news and was voluntary. This had been cleared by the KEMRI social research team, one of whom was with us and watching with the eagle eye of a Hollywood publicist.

We were good to go.

Dzame – wearing a t-shirt supporting Louisiana State University -- listened carefully as Ally read through the form, and bashfully nodded her assent. I began to ask my first question, and was immediately stopped by the social research worker.

She hadn’t signed yet.

Dzame – rail thin, with two-year-old Jazmilla clinging to her legs – didn’t know how to write. Discussion ensued. We had forgotten to bring the ink pad for a thumb print. Would an “X” suffice? No. More discussion. Eventually Dzame allowed the social research worker to use a ballpoint pen to coat her thumb with ink. Pressed against the consent form, it yielded an acceptable “signature.”

We began. Dzame didn’t have much to say about the malaria vaccine trial, it turns out. Inexpert translation flattened her comments and left me with the feeling that it had all gone well – but no sense of her personality, or the real considerations that went in to her enrolling Jazmilla in the vaccine study.

This obviously is due to my inability to speak Kiswahili, and my ignorance of the local customs and attitudes. A better informed local reporter would have a sense of what was really going on.

But I’m equipped as I am, and this is my project, so we continued.

Toward the end, I asked if I could take a photograph. The social research worker frowned. Photographs had not been mentioned in the consent form. If I wanted to take a snapshot, the entire process would have to be revisited. Dzame has not released visual rights. Would this be for publication? If so we might have to refer to the ethics committee in Nairobi.

I put the camera away.

At the end of the interview, Dzame gathered Jazmilla up in the billowing folds of her colorful wrap, strapping her tightly against the maternal back to get ready for the day’s work. Jazmilla looked at me with a fathomless stare as Dzame offered me some fresh corn from her fields.

Sitting on the stoop of a peasant farmhouse in rural Kenya, the elaborate protocol to get to a simple interview seemed absurd. But I understand why it is there – the KEMRI researchers have, as their paramount responsibility, the welfare of their trial participants. And their main objective is to obtain data on the vaccine – not to publicize the project, or to trot out helpful “spokespeople” for the vaccine enterprise.

Dzame waved as we set off back toward the KEMRI landrover through thickets of corn. Jazmilla had already scrunched the consent form into a ball. But we had followed procedure.