Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will launch a novel Ethics and Law initiative as part of the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Harvard Catalyst, led by Lee Nadler and housed at Harvard Medical School, began in 2008 with support from a National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA), as well as Harvard University and its affiliated hospitals. The CTSA program aims to catalyze improvements across the entire spectrum of translational research through efforts to broadly develop, demonstrate, and disseminate health interventions. It serves as a connector to engage key partners including other NIH institutes and centers, patient groups, communities, health care providers, industry, and regulatory organizations.

In October, NIH announced that it will provide funding to extend Harvard Catalyst’s work over the next five years, enabling it to continue breaking new ground in clinical and translational research at Harvard and beyond, and providing the opportunity for the Petrie-Flom Center to get involved. “Science and technology are progressing at an unprecedented pace, and the CTSA program—which represents NIH’s largest single investment in clinical research—is helping researchers harness these innovations and deliver improved diagnostics, treatments, and cures for disease,” said NIH Director Francis S. Collins.

The Petrie-Flom Center’s Ethics and Law initiative will be led by I. Glenn Cohen, professor of law at HLS and faculty co-director of the Center, and Holly Fernandez Lynch, the Center’s executive director.

“Our initiative will seek to develop innovative, practical solutions to stubborn ethical and legal quandaries that currently hinder research,” said Lynch. “We’ll be using a working group model to generate new ideas aimed at structural change and we anticipate all sorts of output, from best practice statements and guidance documents, to workshops, trainings, and advocacy. Specific projects will be determined in consultation with key stakeholders, including researchers, Institutional Review Boards, and regulatory/compliance officials, but key areas of interest will likely include subject recruitment, results return, and aspects of research review.”

Said Cohen, “We are thrilled about this collaboration with Harvard Catalyst, and excited to be working with our regulatory colleagues who have already made tremendous strides over Catalyst’s first five years toward minimizing burden for investigators and promoting cooperation and interoperability through coordination of the diverse processes of inter-institutional research. We look forward to teaming with Harvard Catalyst leaders to address emerging issues and barriers to clinical and translational research.”

Appointed to the Harvard Law School faculty in 2008, Cohen teaches courses in bioethics, health law, and Civil Procedure. In 2012, he was selected as a Greenwall Foundation faculty scholar in bioethics, and from 2012-2013, was a Fellow at the Radcliffe Institute for Advanced Study at Harvard University. Cohen was previously a member of the Institutional Review Board at The Fenway Institute and worked on cases related to clinical research while in practice at the Department of Justice.

Lynch joined the Petrie-Flom Center as Executive Director in 2012. She previously sat on The Fenway Institute’s Institutional Review Board, staffed President Obama’s Commission for the Study of Bioethical Issues, served NIH’s Division of AIDS as a bioethicist in the human subjects protection branch, and practiced in the pharmaceuticals and biotechnology group of a major DC area law firm. Along with Cohen, she is the editor of Human Subjects Research Regulation: Perspectives on the Future (MIT Press, forthcoming Aug. 2014). For more information, visit the Center’s website and blog.