The Collaboration for Research Integrity and Transparency (CRIT) at Yale University, a new initiative launching in July 2016, received a $3 million grant from the Laura and John Arnold Foundation (LJAF) to promote open access to high-quality data in health.
CRIT is jointly led by the Yale Global Health Justice Partnership (GHJP), the Media Freedom & Information Access Clinic (MFIA) at Yale Law School, and the Yale Open Data Access (YODA) Project within the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital and the Yale School of Medicine.
The initiative aims to ensure that data about medical products are both rigorous and reliable by promoting open access to all clinical trial information and by supporting independent research and analysis of those data. It will also work to achieve a legal and regulatory environment that supports the production and sharing of high-quality data.
“Yale has the resources to link leading legal academics with some of the nation’s best freedom of information lawyers, and with leading medical researchers and academic experts on open access to knowledge and scientific data,” said Amy Kapczynski, professor of Law and GHJP faculty director. “With this combined expertise, we are uniquely situated to build a collaborative effort to strengthen research integrity in the U.S.”
“Decisions about medical care are some of the most important decisions that individuals make in their lives,” said Joseph Ross, M.D., associate professor of medicine and co-leader of the YODA Project. “The clinical recommendations and reimbursement decisions made about the use of particular drugs and medical devices have serious public health and economic implications for millions of Americans. It is vital that the evidence base for this decision-making — for patients, clinicians, and policy-makers —is accurate, comprehensive, and accessible. Many studies, however, are not available for independent scrutiny, and much primary data of available studies is not accessible.”
CRIT will produce research that will inform policy debates on research integrity, explore legal action to promote open access to high-quality data, draft policy papers, and train investigators focused on the interface of public health, medicine, and law. “This is just the kind of cutting-edge interdisciplinary work that the Yale Law School wishes to support and encourage,” said Yale Law School Dean Robert Post. “We are proud of the work CRIT will be accomplishing.”
CRIT’s core leadership team includes Kapczynski; Ross; Harlan Krumholz, professor of medicine and director of CORE; Gregg Gonsalves, lecturer in law and GHJP co-director; and David Schulz, clinical lecturer in law and co-director of the MFIA.
About GHJP: The Global Health Justice Partnership, hosted by Yale Law School and Yale School of Public Health, was established in 2012 to promote interdisciplinary, innovative, and effective responses to global health disparities. Building on Yale’s institutional assets, the GHJP trains students in law, public health, global affairs, and other fields to undertake collaborative, real-world research and advocacy to promote health justice.
About MFIA: The Media Freedom and Information Access Clinic at Yale Law School is a legal services clinic dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression through impact litigation, direct legal services, and policy work. The clinic is an initiative of the Information Society Project at Yale Law School and the Abrams Institute for Freedom of Expression.
About YODA Project: The Yale Open Data Access Project advocates for the responsible sharing of clinical research data. The project is committed to open science and data transparency and supports research attempting to produce concrete benefits to patients, the medical community, and society as a whole. The mission of the YODA Project is to not only increase access to clinical research data, but to promote its use to generate new knowledge.
About LJAF: The Arnold Foundation is a private foundation that is working to address our nation’s most pressing and persistent challenges using evidence-based, multi-disciplinary approaches. Its investments are currently focused on criminal justice, education, evidence-based policy and innovation, research integrity, and science and technology. LJAF has offices in Houston; Washington, D.C.; and New York City. Laura Arnold ’00 J.D., and John Arnold established the Foundation in 2008.