Compliance Issues: Lessons Learned from the Researcher Guidebook
June 4, 2024
—For professionals in university-industry research partnerships, ensuring all research practices comply with necessary guidelines and regulations is vital to fostering innovation while protecting researchers, results, and processes. Navigating compliance and adhering to regulations, ethical guidelines, and data security frameworks is crucial for the success and integrity of research partnerships and outcomes.
Common compliance issues
One crucial area for university-industry partnerships is adherence to industry-specific standards. For example, in pharmaceuticals and in medical devices, research practices should adhere to Good Manufacturing Practices or Good Laboratory Practice standards, which have detailed requirements that not all research-performing organizations meet. In research partnerships, ensure all parties can meet industry standards and involve compliance officers early in the discussion to reduce the potential for regulatory challenges.
Another significant compliance area is ethical research, especially that involving human and animal subjects. Any organization receiving federal research funds has staff who ensure ethical and responsible research in this area, as well as an institutional review board or an institutional animal care and use committee. To maintain regulatory compliance, it’s essential to know who in the organization understands and is responsible for applicable compliance issues, what approvals are required, and what actions may be needed before the project begins.
Additionally, a large area of concern is export control. These laws exist to restrict the export of goods, technologies, and related information that may harm U.S. interests. Export controls can impact a variety of research functions, such as administration, publishing, intellectual property, and working with colleagues outside the United States. For more information on export control and fundamental research exclusions, see UIDP Contract Accord 7.
Contemporary concerns
With new research practices and technological advances, there are new frameworks for research compliance. One such consideration is data and research security, which protects research assets and results from misuse or unauthorized interference. (See NSF’s research security page.) Governments around the world have issued guidance on how to best protect against threats, and some government funding may even require researchers to undergo research security training. Similarly, data used in research must be protected, especially if the data contains any potentially identifiable information. HIPAA, General Data Protection Regulation, and FERPA are some regulatory requirements that pertain to data. For additional information on data, research security, and other compliance issues, see the UIDP Contract Accords, or the Insights for Researchers Learning Path.
New technologies have also posed new challenges for compliance issues, particularly that of artificial intelligence (AI). While a useful tool that can help to streamline processes and enhance research functions, AI technology also poses a threat if not used correctly. Last fall, the White House released a draft policy on AI usage in federal agencies, which was open for public comment, as well as an executive order mandating the safe, secure, and trustworthy development and use of AI. While many organizations have internal policies for AI, current regulations are managed by a mix of federal, state, and local agencies. The near future will likely see more formalized, overarching policies and regulations surrounding the use of AI in research. In the meantime, it’s important to comply with any existing organizational or governmental mandates surrounding the use of AI in research functions.
Why it matters
The research landscape is always changing, and with it, compliance issues. While some regulations and frameworks will remain stable, others will change with advancements in technology and processes, like that of AI. Keeping up with regulations and frameworks, as well as maintaining connections to organizational compliance offices, can help participants avoid potential pitfalls in research partnerships.
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The 3-Minute Read is a UIDP member information piece and does not represent the opinions of our members or representatives. We welcome your comments on our LinkedIn profile.
This 3-Minute Read is part of a series based on the Researcher Guidebook, a public resource published by UIDP. Our members have access to a sequential learning path and Quick Guide developed to help researchers tap into our collective knowledge and clearly understand their pivotal role in cross-sector research partnerships.