Archived
Recommendations for HHS and NIH Research Regulatory Reform
The document critically examines the expanding regulatory and administrative burdens faced by U.S. academic research institutions engaged in federally funded research, particularly under the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). Despite a series of expert and congressional reports since the late 1990s recommending streamlining and harmonization
Discussion Points on Facilities and Administrative Costs and Regulatory Reform
The document discusses the intersection of facilities and administrative (F&A) costs with ongoing efforts to reform research regulations in the United States. It emphasizes that while research institutions and academic medical centers support reducing unnecessary federal regulations to improve the use of research funds, any anticipated reduction in F&A costs tied to decreased regulatory bu
June 2017 Presentation: Key ClinicalTrials.gov Reporting Requirements
The document provides a detailed overview of ClinicalTrials.gov, emphasizing its role as a public registry and results database for clinical studies involving human participants, encompassing interventional trials, observational studies, and expanded access programs across more than 200 countries. Managed by the National Institutes of Health (NIH), ClinicalTrials.gov facilitates transparency, acco
F&A Frequently Asked Questions
The document provides an in-depth explanation of Facilities and Administrative (F&A) costs—also known as indirect costs—associated with federally sponsored research at U.S. universities. F&A costs are essential for maintaining the infrastructure and administrative support required to conduct high-quality research, including laboratory facilities, data management, compliance with health and
F&A Talking Points
The document addresses concerns raised by federal officials and the media regarding the proportion of National Institutes of Health (NIH) grant funding allocated to indirect, or facilities and administrative (F&A), costs—often referred to as overhead. It clarifies that both direct and indirect costs together represent the full expenses of conducting federally sponsored research. F&A costs
F&A Primer
The document provides a thorough overview of Facilities and Administrative (F&A) costs, also known as research operating or indirect costs, within the context of sponsored research at universities. It outlines the distinction between direct costs—such as salaries, lab supplies, and equipment, which are the primary focus of research funding—and F&A costs, which are essential infrastructural
Frequently Asked Questions: Uniform Guidance July 2017
This document, issued by the Council on Financial Assistance Reform (COFAR) in July 2017, is a comprehensive set of Frequently Asked Questions (FAQs) designed to clarify the Office of Management and Budget’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200), commonly known as the Uniform Guidance. Serving as supplemental guidance, the docum
Research Regulatory Reform: Recent Legislation and the New Administration
The document provides a detailed overview of recent legislative and executive actions impacting federal research regulation as of early 2017, focusing on their implications for regulatory reform in the research sector. It highlights key legislation, notably the 21st Century Cures Act, the American Innovation and Competitiveness Act (AICA), and the National Defense Authorization Act (NDAA), each pr
