Markeshia Ricks Photo
Parent Kirsten Hopes-McFadden, who came concerned, left impressed.
After a detailed explanation of how it works and how it protects children’s rights, a Yale University research project connected to the genetic testing of some students is back in good standing with at least two members of the Board of Education.
Board members Mayor Toni Harp and Joe Rodriguez, co-chairs of the Board of Ed’s Learning and Teaching Committee, heard that presentation Wednesday from the New Haven Lexinome Project. They heard how many students are participating, the rigorous consent process, how their genetic information is protected, and what kind of intervention they’re receiving. Then Rodriguez and Harp agreed to forward a recommendation to the full board to accept $600,000 from the project and have it continue.
Dr. Jeffrey R. Gruen, principal investigator for the New Haven Lexinome Project.
The presentation was delivered by Jeffrey R. Gruen, the principal investigator for the project and professor of pediatrics, genetics and investigative medicine at the Yale School of Medicine. He presented at the Board of Ed’s 54 Meadow St. headquarters just a week and a half after Board members voted unanimously to table accepting the grant. They made that decision amid concerns over the historic abuses of minority communities for scientific gains and even profit. (Read more about that here.)
The New Haven Lexinome Project studies the genetics of the common reading disability dyslexia with an eye toward developing a simple and inexpensive test that would help identify it early and what kinds of interventions work best. With the explicit consent of their parents, a saliva sample is collected from the children in the study.
Gruen explained to board members that the saliva sample taken from students is not used specifically to diagnose dyslexia or some other reading problem in the children currently in the study. Instead, students who score in the bottom 20 percent or below on the Benchmark Assessment System, or BAS, testing in the first grade are the students in the study who are identified as “at-risk” for dyslexia. At least half of the 477 students in the study are not considered at-risk and have a better score on the BAS and do not receive an intervention.
“It’s not used to label or diagnose students in any way,” he said. The DNA will be analyzed toward the completion of the study to test the hypothesis in future studies that genetics can play a role in informing more individualized, precise interventions for students with learning disabilities, he said.
He noted that only the study researchers who work directly with the participants have access to the de-identified data, which means it can’t be connected to a particular individual. The DNA samples are archived in Gruen’s lab and can’t be sent out, or sold to other entities for use in other studies.
Seven years after the study ends all ID numbers for individual participants will be destroyed, permanently separating the data and the participant.
The study also doesn’t change student’s DNA, and no cell lines are created from the DNA, he said.
Cell lines can’t be created because the preservative in the collection tubes destroys potential cells in the saliva on contact and the DNA extraction process destroys any residual cells, Gruen said. Every year parents get a summary report of their child’s performance on assessments throughout the study that they can share with their child’s teacher if they choose.
Dyslexia is a common, genetic reading disability that affects both girls and boys equally, though girls often go undiagnosed. Fifty percent of students are undiagnosed, Gruen said. Researchers know that 75 percent of children with dyslexia who receive high-quality intervention before fourth grade see significant improvement, reading on grade level just two years later. But there is a quarter of children who don’t respond to that intervention, he said. And 75 percent of children who receive that intervention late in say middle and high school also don’t see improvements.
Gruen said the Lexinome Project is trying to figure out if genetic variants can tell early on which kids will need help, and what kind of help would work best, hopefully pushing the percentages of children who see improvement up to 80 percent or more.
“No one’s ever done these studies before on any demographic or in any country,” he said. “We’re the first and we’re doing it right here in New Haven.”
Intervention
Mayor Harp.
Two groups of New Haven public school children, chosen in 2015 and 2016, have been in the seven-year longitudinal study since they were in the first grade and are being followed through fifth grade. Harp and Rodriguez learned Wednesday that 477 students are from four schools — Strong, Columbus, Bishop Woods and Roberto Clemente.
The parents of the children in the study had to endure a four-step consent process that includes the review of a nine-page consent form that researchers must be sure participants understand. It is provided in both English and Spanish and bilingual study personnel are available to assist. Parents also know they can withdraw from the study at any time. If they withdraw their child, all the information connected to that child is destroyed.
They also learned that the grant pays for the full salaries of six public schoolteachers. They provide the high-quality reading interventions that children in the study are receiving, Gruen said.
This is the fourth year of the grant. Each year it has come before the board for approval. The memorandum of understanding that governs the partnership between the school system and Yale has been before the board at least twice. In the last three years, the district has received a total of just over $1.5 million to cover those teacher salaries.
Strong School teacher Gina Algilani talks about the Empower intervention Wednesday.
That intervention comes in the form of two intensive intervention programs: Reading Recovery and Empower.
All the at-risk students in the study get Reading Recovery, an intervention chosen by NHPS, in the first grade. It provides between 12 and 20 weeks of one-on-one reading instruction. In second grade, the students also receive help from a teacher trained in Empower, which teaches them strategies for interpreting words they’ve never encountered. They work with teachers like Gina Algilani in small groups for 45 minutes to an hour every day throughout the school year. Gruen said it provides 70 to 100 hours of contact for the year.
Algilani, who works at Strong School, said she’s seen the techniques be “extremely successful” in helping children learn how to break down words to increase their vocabulary and learn to read long stories.
Lynn Brantley, the district’s curriculum supervisor for reading, said Strong School and the three others were chosen because they were high needs schools that didn’t have many resources.
The 57 children in the first study group who have been identified as at-risk and receive Empower saw a 32 percent improvement in their reading skills over similar students who don’t receive that intensive intervention, according to Gruen. He noted that the students in the group mirror the school district when it comes to gender, race, and ethnicity.
Sustainability
Lynn Brantley, curriculum supervisor for reading.
Several people who came to the meeting alarmed about the possibility of genetic testing in schools left impressed. They said they hope such interventions will make their way to all the district’s elementary schools.
Parent Kirsten Hopes-McFadden was one of those people.She said she’d initially come to the meeting concerned that the school system had given Yale carte blanche in the genetic testing of students with no concern for what the university might do with the information or how it might be used to label students. She left satisfied that that was not the case and she was even impressed.
“The program sounds excellent,” she said. “I think the community outcry is around the DNA testing. I’m satisfied that the cells are destroyed and that they’re not identified so that even the people who are looking at it don’t know who it applies to. I think that needed to be clarified.”
She said had one of her sons, now a high school student, been young enough, she might have considered opting into the study — but only after going through the consent process and feeling sure she understood everything.
The long-term sustainability of the interventions provided by the study, particularly the Empower program, is a concern because of the expense.
“We’ve got two more years,” Mayor Harp noted. “What happens after that?”
Gruen said that depends on the funding. The project currently receives the majority of its money from a private foundation grant. The National Health Institutes also provides a small grant. The project is trying to leverage additional grants. He said his group is trying to figure out how to move forward and to disseminate what they learn from the interventions beyond the four schools.
Harp said she felt comfortable making a recommendation to her colleagues on the board in favor of the grant now that she’d heard the details. She said the information that was provided to the Finance and Operation Committee, which heard the item before it was presented at the last board meeting, wasn’t sufficient and some members were just hearing about it for the first time.
“Evidently it had been passed by previous boards without much discussion,” she said. “Maybe they got better information that we weren’t given.”
Board member Joe Rodriguez said given that he’d been on the board only since March, the information was completely new to him.
“I’m not a member of the Finance and Operations Committee, nor is the mayor, so we didn’t attend that particular meeting and I was not privy to any of the questions or concerns or that information.”
“Unfortunately, the way the format is for our full board is it doesn’t allow for a detailed presentation,” he added.
I am puzzled by the NHI's assertion that minorities have been abused "for profit". The prior article mentions the Tuskegee syphilis project, which likely harmed participants by deterring them from getting actual treatment, but the project was a government, not a for-profit scheme. It also mentions the HeLa cell line, which caused no harm to Ms. Lacks, and the scientist whose method kept her cells replicated gave them away, making no profit. Unmentioned were the human plutonium experiments, scary to be sure, but not done for profit, and which ultimately seemed not to have harmed any of the subjects. https://fas.org/sgp/othergov/doe/lanl/pubs/00326640.pdf. The case of Ebb Cade is the most disturbing, yet there was no profit involved, at least monetary profit.