She marked an “X” on the signature line of the consent form, indicating that she agreed to participate in the study. Although she’s unable to read, Marie Maude was excited to partake in the research. “The information is important for Haitian women. I have two daughters and two sisters. They could both use this study,” she said with a slight smile, before adding, “I have two granddaughters too!”
Gabrielle, the nurse study coordinator, initiates the consent process for the patients. Sometimes she talks to the women as a group, explaining the study to everyone in the chemotherapy ward. Other times, she holds private discussions with individual patients. Either way, patients and family members have the opportunity to deliberate and ask questions.
About 10 percent of the patients are completely illiterate, and a significant portion of the rest do not appear to be able to read, but can sign their own name. For those who cannot read, they still must actively join in the consent process. In addition to giving their oral assent to participate, they check or “X” through four separate boxes, each affirming a separate section of the study. The last box acknowledges they understand and accept what they are agreeing to do — a final affirmation added for those who are illiterate.
One patient forgot how to form a few letters of her name as she wrote on the line — significant time had passed since she last needed to write anything, even her name. Gabrielle explained with a smile how to form the loops and crosses of the forgotten letters. She explained the date as “12 slash 4 slash 14” like a school teacher, full of patience and understanding.
In medical contexts, Haitians typically defer decisions to family members, preferring instead to concentrate on getting better. Older patients have their adult children or grandchildren make decisions for them, husbands decide for wives. When I speak to patients and ask their opinion, family members will answer all questions, re-ask the same questions, or translate my Creole. The illiterate patients always request to defer their “X” to the signature of their literate children, but for us, the patient’s active involvement in the process is more important than what the signature looks like.
Some of the questions for the study are seemingly absurd and expose the limitations of a study designed by one culture to be carried out in a foreign location. We’re studying the genetics of cancer and trying to give a social context to genetic mutations. But asking Haitians about their race and country of origin proves challenging. I often have to repeat the question “Were you born in Haiti?” for the patient to understand the inquiry. I add qualifiers or emphasize the word “born” or use the word “here” instead of “Haiti.” For a woman who has never been more than 20 miles from the location of her birth in her lifetime, the question does not make any sense, doesn’t have any context. Similarly, the question of race doesn’t carry the same significance as in the US. While skin color has been used to discriminate in Haiti as much as anywhere else in the world, the divisions between races are more blurred than one would expect. When asked about her race, Marie Maude giggles before responding simply, “I am Haitian.”
“If you agree with the statement, check the box next to it,” Gabrielle says quietly. Gabrielle had no formal education or prior experience with research, but has taken to the task like a seasoned professional, giving the patients time and space to think when she sees a look of consternation.
Usually, Gabrielle opens the consent process and broaches the subject of testing for BRCA 1/2, the gene mutation that leads to breast cancer in upwards of 80 percent of carriers, recently in the news after Angelina Jolie publicly shared her decision to pursue prophylactic double mastectomy to decrease the chances of developing cancer. After Gabrielle has discussed the basics of what a gene is and how it can be passed from a mother to a child, I address more complex issues if needed. I used to start by reviewing all the topics, but quickly realized that Gabrielle had held thorough genetic discussions. Now I’ve switched to probing, testing their knowledge, ensuring that they could pass a multiple choice test on the subject of BRCA 1/2.
“Why are we doing this test? What does it mean?” I ask Marie Maude.
“We’re testing to see if I have the cancer in my ‘blood’ since it will increase my chances of developing cancer in my healthy breast. If I have it, I could have passed the gene to my daughter — but we can test her as well,” Marie Maude responds.
“Correct,” I encourage her while smiling at Gabrielle.
“But she’s only 10 years old now. We’ll have to wait until she gets older to test her. I’m not sure that I want her knowing this information yet,” she adds pensively and then smiles at me, the corners of her mouth curling up sharply. She understands the power of a genetic test, but also comprehends the limitations and the ethical dilemmas surrounding it — truly informed consent.
Vincent DeGennaro is an internal medicine doctor and a global public health specialist at the University of Florida’s Division of Infectious Diseases and Global Medicine and works half time in Haiti with the nonprofit Project Medishare. See his An American Doctor in Haiti blogs.