Law, Public Policy and Social License for Next-Generation Regenerative Medicine

We are exploring important policy issues that play a critical role in how regenerative medicine research moves into real treatments that can help people while addressing potential risks. 

Our team of researchers are experts in law and public policy research.  Our work has led to peer reviewed publications, presentations, graduate student research, and public facing content. This page contains resources produced by our working group, developed to support our ongoing work and to share insights, tools, and findings with a wider audience. We invite you to explore and make use of the content provided here.

Highlighting global innovations and challenges of regenerative medicine to create a harmonized regulatory framework

There is a need to develop clear and robust regulations to guide the translation of regenerative medicine (RM) research into interventions that improve public health. While regulatory frameworks exists for clinical trials and marketing of RM products, attention is needed to address the specific challenges posed by these emerging technologies. Our work examines RM policy and governance across regions of the Global South to understand the regulatory approaches, innovations, and challenges that RM brings. By focusing on under examined areas in literature, this study aims to contribute to global discussions on RM governance and support the development of inclusive and well suited regulatory frameworks.

Promoting trustworthy oversight of regenerative medicine by understanding the role of professional regulation and its challenges

Groups that regulate professionals, like the ones that oversee doctors, are meant to protect the public. However, because RM is a new and developing field, there can be important questions about what protecting the public really means and requires in this context. Also, who or what is responsible for overseeing a new RM treatment will often depend on whether that treatment is considered to be a drug, a medical device, or a type of clinical innovation, and on whether it is being provided as a part of a research study or in a different context. A challenge is that the boundaries between these different concepts are not always clear. Our work is exploring these and related areas, with the goal of informing future policy to help ensure that the clinical progress of RM is supported by strong and well-fitting systems of oversight.

Understanding the misinformation landscape in regenerative medicine

In this evolving information landscape, there is a need to develop an accurate and detailed understanding of how misinformation is spread. Despite the efforts being made to curb the spread, misinformation is spreading quickly, and clinics are offering unproven RM therapies. A strong understanding of how misinformation is spread can inform better policy responses and help counter its harmful effects. In our work, we analyze existing policy and oversight options, and suggest ways these established regulatory frameworks, and other strategies can be used to manage the spread of misinformation.