We will develop policies and practices to provide a framework for the conduct of health systems research in an ethical manner and in compliance with federal and state regulations. Another important role of the regulatory/ethics core is to identify areas of uncertainty and aid the Collaboratory and its Network in resolving uncertainty through dialogue or empirical research when needed. These policies and practices will be developed with our Collaboratory colleagues through the Regulatory/ Ethics Working Group. We believe that the ethical and regulatory issues are sufficiently intertwined that the combined Working Group will be our dominant focus, while specific issues will be dealt with by designated content experts.


The ongoing work of our Core Team will enable us to bring numerous materials to the Knowledge Repository at the initiation of the project. We will draw on these experiences and materials to achieve Aim 1 in the context of ethical/regulatory oversight. There are a number of key ethical and regulatory issues that the Regulatory/Ethical Working Group must address. Using the inherent collaboration with CTTI and the Sentinel project, we will work with the FDA to proactively create pathways by which health system research using EHRs, registries and PROs can become a “mainstream” approach to answering critical questions at a lower cost. For example the CTTI organization worked with its 60 stakeholders and the FDA, including the Office of Scientific Investigation to develop principles of quality by design to guide trialists in how to focus the assessment of the quality of clinical trials. Such an effort will be critical when Collaboratory trials require FDA oversight of regulated products. The Sentinel network and the HMORN will provide a ready source to examine strategies that will lead to streamlined regulatory pathways.

Demonstration Project Regulatory and Ethics Support Documentation

This page contains links to minutes and supplementary materials summarizing a series of discussions about NIH Collaboratory pragmatic clinical trial Demonstration Projects from regulatory and ethical perspectives. These discussions, which took place as teleconferences, included representation from study principal investigators and study teams, members of the Collaboratory Regulatory/Ethics Core, NIH staff, and Collaboratory Coordinating Center personnel, with additional input provided by representatives from the Office of Human Research Protections.