Regulatory Requirements - What Researchers Need to Know

Navigating Compliance in Research

As research becomes increasingly data-driven, researchers must be cognizant of and abide by the complex regulatory landscape to ensure compliance with security, privacy, and ethical standards. Numerous regulations come into play depending on the nature of the research covering personal health information, controlled unclassified information, or sensitive electronic records.

It is well documented that failure to comply with these regulations can lead to legal consequences, data breaches, and even reputational damage, making it crucial for researchers to understand and implement the necessary safeguards.

Key Regulatory Frameworks in Research

The regulatory landscape varies based on jurisdiction and the type of data. Some of the most critical frameworks that researchers may need to comply with include:

NIST 800-171, which went into effect on January 25, 2025, protects Controlled Unclassified Information (CUI) in non-federal systems and organizations by establishing stringent security requirements. This is particularly important for research funded by U.S. federal agencies.

21 CFR Part 11 regulates electronic records and electronic signatures in FDA-regulated research, ensuring digital documentation meets the same standards as traditional paper records.

HIPAA (Health Insurance Portability and Accountability Act) mandates strict controls over healthcare data privacy and security for research that involves patient information. Researchers handling such data must ensure encryption, controlled access, and audit trails.

PHIPA (Personal Health Information Protection Act, Ontario) applies to healthcare-related research in Ontario, ensuring that personal health information is handled with privacy and security.

PIPEDA (Personal Information Protection and Electronic Documents Act, Canada) impacts private-sector research across Canada. It governs how personal information is collected, used, and shared. Research teams are required to obtain consent and ensure relevant data protection measures.

SOC 2 Type II is a voluntary, widely recognized standard for SaaS (Software as a Service) providers, ensuring that organizations handling sensitive data maintain strict security, availability, and confidentiality controls.

NIST Cybersecurity Framework (CSF) provides an outlook on the best practices for managing cybersecurity risks, helping researchers strengthen their data security posture.

What Researchers Need to Do to Stay Compliant

With an excess of regulations to follow, we believe researchers must be proactive in adopting compliance best practices. Here are five ways we believe how.

Identify Relevant Regulations – Compliance frameworks are project-specific. Researchers should assess the relevant regulations based on data type, funding sources, and jurisdiction.
Implement Security Controls – Encryption, multi-factor authentication, and role-based access will help ensure the protection of sensitive data.
Maintain Documentation & Audit Trails – Compliance frameworks often require detailed records of data handling, access logs, and security measures.
Use Trusted Data Storage & Collaboration Tools – Cloud-based platforms that comply with SOC 2, HIPAA, and NIST 800-171 can help researchers securely store and share data. Good RDM tools can substantially reduce the risks of non-compliance but researchers must still take responsibility for the methods and procedures designed to support their research.
Ensure Ethical Compliance – If human or animal participants are involved, securing Research Ethics Board (REB) approval is crucial to align with regulatory requirements.

Is It Easier to Use SaaS Solutions for Compliance?

Managing multiple compliance requirements can be overwhelming. This is why many research teams rely on internal IT to support their research needs. However, this is often a cumbersome, inefficient, and error-prone approach.

Increasingly, many researchers are turning to SaaS solutions that integrate security, collaboration, and regulatory compliance into a single platform.

We believe a well-designed research management platform should provide secure data storage, maintain audit trails, and enable secure collaboration across teams while enabling access control and simplifying compliance with HIPAA, SOC 2, and NIST CSF frameworks.

Conclusion

At myLaminin, we understand that regulatory compliance can be a complex and time-consuming challenge for researchers. Our platform is designed to simplify this process by integrating robust security measures with FAIR (Findable, Accessible, Interoperable, Reusable) principles.

myLaminin was designed and built with compliance in mind, with secure data management, and seamless collaboration features. Our platform reduces the administrative burdens associated with regulatory compliance while enhancing data integrity allowing researchers to focus on breakthroughs not bureaucracy leading to more discoveries and innovation.

References:

SP 800-171 Rev. 3, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations | CSRC

FDA 21 CFR Part 11 Compliance

Summary of the HIPAA Security Rule | HHS.gov

SOC 2 for SaaS Providers

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