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In Vivo
First Person

Research Adventures  in Foreign Lands

From left: Ralph Sacco, Rafael Lantigua and Research Coordinator Edison Sabala push a stalled taxi in the Dominican Republic where they went to enroll individuals into a research study.

From left: Ralph Sacco, Rafael Lantigua and Research Coordinator Edison Sabala push a stalled taxi in the Dominican Republic where they went to enroll individuals into a research study.

By Edison Sabala

The first time I visited my native Dominican Republic (DR) as the Coordinator of the Northern Manhattan Family Study, the PI, Dr. Ralph Sacco, ended up pushing a stalled taxi designated to transport us around Santo Domingo. That was in October 2002, when we were there scouting medical facilities that would support our research activities. Since then, we have made two additional trips to the Caribbean country to recruit 139 Dominican subjects.

The primary aim of the Family Study is to identify the heritability of stroke risk factors such as increased thickness of the intima-media of the carotid arteries, hypertrophy of the left ventricle of the heart, high levels of homocysteine, obesity, metabolic syndrome, and others among Caribbean Hispanic families living in Northern Manhattan. Since families provide the best source of data about hereditary risk factors and because more than 85 percent the participants enrolled to date have many family ties in the DR, it is essential to our work to travel to the DR to collect DNA and enlist family members into the study. Initially, this was not such an easy task.

In the Beginning

Soon after the approval of this National Institute of Neurological Disorders and Stroke (NINDS) grant in May 2002, our first step in getting to the DR was to find people with experience working with Dominicans. Although Dr. Sacco had studied stroke risk factors in this community of Caribbean Hispanics, he had never traveled to the DR. We were fortunate to count on the experiences of, among other great advisers, Drs. Richard Mayeux and Rafael Lantigua, both from Columbia, whose work on the genetics of Alzheimer's disease in the DR had been well established since 1998.

During one meeting just before our first trip, we reviewed the entities in the DR most likely to collaborate with us and whom we should contact regarding internal regulations. Once we had explored our options, it occurred to the eager and industrious Research Coordinator (Yours Truly) that the best way to begin a dialogue with the principals was to have our people contact their people to try to set up a meeting. My brilliant idea was met with a resounding "No" from Dr. Lantigua. "If you call them in advance they won't answer and you'll never get there. The thing to do is to show up at their doorstep." Having emigrated from the DR steeped in the ceremonious and formal teachings of Doña Violeta, my dear grandmother, but lacking exposure to the local political mores, I thought Dr. Lantigua's suggestion was a bit unorthodox. When the time came, however, we did just show up, knocked, and the right people opened the doors.

The Regulations

You are probably familiar with the workings of our own Institutional Review Board. But things are onerously more opaque when you try to comply with the requirements of NINDS in the DR. As our team prepared for our first recruitment trip to the Caribbean, an 11th hour e-mail from NINDS brought our plans to an abrupt halt. We didn't know that we had to file a Foreign Clearance Form with the NIH branch dealing with regulations that apply to domestic grants with a foreign component. The form itself was straightforward, but this new requirement unearthed two more steps that raised the barometer of our resolve to new heights. I will not bore you with the administrative details, but it took persistence and the better half of 2003 to accomplish these ends.

At the same time, we also had to comply with the mandates of the local bioethics committees in the DR and learn a new lexicon akin to that of a U.N. diplomat: "Dear" gave way to "Your Very Excellency," "Your Honor," and "Most Distinguished and Revered Dr. Such and Such," to assure that the appropriate paperwork was completed. We "Kindly Asked," as if it was not the seventh time, if we could be of assistance in filling out this or that form.

The two local committees responsible for reviewing and approving our protocol were the government's Comité de Bioética Nacional in Santo Domingo and El Comité de Bioética del Instituto Oncólogico Reginal del Cibao in Santiago. When dealing with this last committee, things moved very expeditiously: They asked questions and we addressed them, all very timely and orderly.

When dealing with the Santo Domingo government, however, we encountered entanglements we couldn't avoid. Shortly after the committee met for the first time to discuss our project, the presidential elections happened and the ruling party was voted out. Unlike in the United States, where the political beheadings occur mostly at the executive level, in the DR almost the entire government is turned over to allow the incoming party and their partisans the chance to lead. Thus, the members of the committee (mostly politicians), knowing that their days as public servants were vanishing quicker than ice cubes in a glass of rum and coke, turned their attention to more urgent matters. Had one of our local collaborators and I not forced a meeting to plead our case with the chairman of the committee in a hotel lobby where he was attending a conference, we probably would have had to wait another year before starting recruitment. The meeting was brief but three days later we were notified that an approval letter was waiting at the Department of Health.

All's Well

Our success thus far (owing in no small measure to the labor of committed research assistants past and present), the warm reception of the Dominican people, and the embrace of the medical community in the DR, has more than compensated for the initial hassles. On the administrative end, we are now obliged to periodically report our study results much like what is required from our IRB or NIH.

Barring inclement weather, presidential elections, or a coup d'état, I look forward to our next trip later this year and to continuing this pioneering research to the exhilarating rhythm of perico ripiao (the folkloric music of the Dominican Republic that has an exhilarating rhythm and is hard to dance to unless you are in very good shape!).

Edison Sabala is a senior staff associate in the Department of Neurology and is enrolled in the Executive MPH program at the Mailman School of Public Health.

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