Research Compliance: A Resource Library
Focus on what matters most — your research mission.
From economic pressures to new policies and legislation, research institutions are faced with a number of challenges. In order to be effective, industry leaders must focus on essential priorities that help their staff thrive. Huron has published a variety of resources in accordance with the needs of research institutions and the current trends in the industry related to managing and reducing noncompliance.
As COVID-19 continues to affect our world, Huron’s higher education business and research services team are working swiftly to provide updated federal guidance considerations and points of view to support our clients through managing research operations, staying compliant and ensuring business continuity. We’ve developed a COVID-19 resource page that will be updated in real time with relevant guidance to provide you with continued support. You may access this resource page here: Resources for Higher Education Leaders Navigating COVID-19 Response.
As COVID-19 continues to evolve and affect research institutions across the country and world, the Office of Management and Budget (OMB) issued a memorandum authorizing granting agencies to offer flexibility regarding proposal submission practices, post-award management activities and availability of funding for COVID-19 research. Huron provides an overview of what those flexibilities are for major granting agencies, such as the National Institutes of Health (NIH) and National Science Foundation (NSF).
As institutions address the overarching COVID-19 pandemic, sponsored research is faced with the challenge to comply with multiple regulatory authorities while navigating concurrent operational and financial pressures. Huron provides best practices and recommendations for understanding, communicating and implementing recent agency guidance regarding salary and nonsalary sponsored expenditures, sponsor deliverable deadlines and standards for institutional documentation.
The sudden halt of an unprecedented number of studies due to the novel coronavirus — coupled with COVID-19 trials being awarded at breakneck speed — introduced compliance challenges that had to be handled quickly and in alignment with rapidly changing federal guidance. In this webinar, our team of panelists, bringing deep expertise supported by real-world experiences in research compliance, grants management, clinical research and human subject protection, provides actionable approaches to handling the challenges posed by the novel coronavirus.
This series of human research protection program (HRPP) toolkit supplemental documents provides HRPPs with additional resources to manage research during the COVID-19 pandemic. The materials are intended to provide guidance for determining whether study-specific COVID-19 risk mitigation plans are needed for certain studies and, if yes, to provide considerations for the kinds of modifications that may be needed and how the mitigation plans should be documented and communicated to the institutional review board (IRB) and others.
Research Compliance Programs
Does your institution have a research compliance officer? Is this a role or a position? Does this same role have management responsibility for operations? During this webinar, Huron compliance experts Marisa Zuskar and TJ Enno, alongside Luanna Putney, associate chancellor in the Office of Campus Climate and Compliance at the University of California Merced, walk through decision points to help answer these questions and provide options with associated benefits and challenges.
Moderated by Huron compliance experts Leah Guidry and Anne Pifer, with special guest Dr. Timothy J Fournier, senior vice president and chief enterprise risk management, ethics and compliance officer at Rutgers, The State University of New Jersey, this webinar discusses programmatic versus operational compliance.
It has been a big year for higher education compliance in the news: Scandals impacting institutions across the country were on the front page of newspapers and leading segments on the evening news. Higher education leaders who position risk management and compliance as a foundational capability will protect the integrity of their institutions.
Affirmative action sits at the forefront of one of higher education’s most critical compliance issues, posing a challenge for admissions leaders and compliance professionals alike.
Many research institutions are still in the process of building strong research compliance processes. In this two-part podcast series, Huron’s Leah Guidry reviews the state of research compliance, forecasts the biggest issues compliance professionals face and outlines how to plan for them through an effective risk assessment.
What is enterprise risk management (ERM)? Why should institutions pay attention to this topic? This seven minute podcast provides you a high-level overview into what this key area is about within higher education and why your institution may want to adopt this type of risk management approach.
Our research compliance podcast series presents important topics with a conversational spin to keep your institution informed on current events and best practices, preparing you to react to the dynamic higher education compliance environment. Topics include clinical research billing, the impact of foreign influence on research, critical compliance conversations and more.
Learn more about higher education compliance requirements and how institutions can improve their administrative structures, featuring guidance from experts at Huron Consulting Group, Duke University, and the FBI. The piece outlines the steps that some institutions are taking to further strengthen their risk management and compliance programs and mitigate foreign influence risk.
This article discusses the Department of Education’s increased efforts to monitor colleges’ and universities’ compliance with Section 117 of the Higher Education Act of 1965. Due to concerns surrounding potential foreign interference in U.S. research efforts, Congress has proposed legislation to reduce the reporting threshold from $250,000 to $50,000.
By now, universities and colleges are very aware of the increased federal and state scrutiny around relationships between U.S.-funded researchers and foreign entities. Many institutions have taken or are considering taking steps to strengthen controls for conflicts of interest and commitment disclosures, information security and export controls, and the foreign gifts and contracts reporting process.
As more institutional research moves to the remote environment, some institutions are rethinking the need to provide dedicated physical space for research faculty, staff and administrators who don’t require labs or special equipment on campus. But cost savings and conveniences realized in this new model will not come without an abundance of complicated considerations for the deployment of dedicated virtual facilities that are required for personnel who operate off campus.
As global collaboration increases and instances of questionable influence by foreign entities over federally funded research continue to surface, institutions are being called to enhance compliance programs to mitigate this evolving risk. This intensified spotlight on compliance with shifting regulatory demands has created a complex and high-stakes environment in which failure to adhere to federal mandates may lead to formal inquiries and civil or even criminal charges.
Compliance program planning is an iterative exercise; academic research leaders need to regularly reevaluate planned compliance activities to keep pace with noncompliance incidents, revised regulations or emerging focus areas. One growing focus area for regulators and institutions is foreign influence in research.
This alert provides clarification and guidance around what the NIH considers Other Support and Foreign Components. Huron will continue to follow developments in this area and across the foreign influence landscape, providing updates and added perspective as we see how this notice resonates and is put into practice in the research community.
Sponsored Programs and Federal Compliance
In the absence of specific direction from the federal government — or interpretation of the requirements in the form of major audit findings — organizations have independently developed policies and procedures to develop necessary internal controls that support compliance. As best practices continue to evolve, there are immediate actions institutions can take to support subrecipient monitoring requirements, which are described in this resource.
Maintain smooth research operations in 2020 by reviewing Federal Acquisition Regulation (FAR) rules and brushing up on the updated terms and conditions that impact federal contracts.
Institutions have swiftly shifted sponsored program administration practices in response to the COVID-19 pandemic, most especially to account for the administrative flexibilities authorized by Office of Management and Budget (OMB) memorandums M-20-11, M-20-17 and M-20-26 and new CARES Act funding. However, with flexibility comes accountability, and institutions can expect that their adapted practices and internal controls will be reviewed as part of their annual Single Audit, or potential sponsor or award-specific audits, to provide assurance of compliance with the administrative flexibilities in conjunction with the standard Uniform Guidance regulations and award-specific terms and conditions.
How effective are your institution’s internal controls? This abbreviated guide is designed to provide a starting point for evaluation and discussion, highlighting one sample consideration for each Single Audit compliance requirement against the five components of internal control.
This guide aims to provide context and illustrative examples of internal controls to assist your institution with the examination of its own internal controls in consideration of the framework provided by Part 6 of the Compliance Supplement. It is designed to provide a starting point for evaluation and discussion, given the increased attention and expectations for internal controls in the current regulatory environment, as well as the Single Audit.
Clinical Research Compliance
A coverage analysis, or a Medicare coverage analysis, is an integral part of clinical research compliance programs. Huron’s Leah Guidry provides her expert insight on why an institution should conduct a coverage analysis and some of the best practices and common pitfalls when doing so.
Together with Huron, Mehzabin Khan, Children’s National program lead of clinical trials, revenue cycle and systems, discusses why Children’s National defers to Medicare billing rules for pediatric clinical trials, how it made the change, and what challenges it encountered internally and with sponsors during implementation.
Human Subjects Research Compliance
Pennsylvania State University (Penn State) is recognized as one of the country’s leading research universities, boasting an $968 million research program. Huron helped Penn State transform its HRPP to achieve a significant decrease in turnaround times as well as increased consistency in reviews, morale and satisfaction.
The NIH recently released a final policy stating that all domestic sites of multisite, NIH-funded studies must use a single institutional review board (sIRB) of record for nonexempt human subject research. One key challenge in implementing the policy will be operationalizing an electronic IRB system that can effectively support institutions serving as the IRB of record for multisite studies, relying on external IRBs as the IRB of record.
Huron’s experience spans all of the top 100 U.S. research universities, bringing best practices and thought leadership to the industry’s unique environment.Contact Us