1. Introduction

Deemed export rules in collaborative research laboratories regulate the transfer of controlled technology, technical information, scientific knowledge and research materials to foreign nationals or foreign entities, even when the transfer takes place within the same country.

The concept is particularly important in biotechnology, pharmaceutical research, genetic engineering, artificial intelligence, nanotechnology, defence-related research, nuclear science and advanced medical laboratories.

A deemed export may occur without any physical shipment of goods across an international border. For example, when an Indian laboratory, a US university or a private biotechnology company gives a foreign national access to restricted technical information, the applicable export-control legislation may treat that disclosure as an export.

The central legal issue is that collaborative scientific research must remain open to legitimate international cooperation while complying with national security, technology-control, confidentiality and intellectual-property requirements.

There are two important legal meanings of deemed exports:

United States: Release of controlled technology or source code to a foreign person in the United States may be treated as an export to that person's country of nationality under the Export Administration Regulations (EAR).

India: Deemed exports under the Foreign Trade Policy generally concern specified supplies of goods manufactured in India that do not physically leave India but qualify for designated export benefits.

These meanings should not be confused. The following discussion focuses primarily on foreign-national access to collaborative research laboratories under the US export-control framework, with a separate discussion of the Indian framework.

2. Legal framework governing deemed exports in US collaborative laboratories

The principal legal framework is the Export Administration Regulations (EAR) administered by the US Department of Commerce's Bureau of Industry and Security (BIS).

The important provisions include:

Under § 734.13, releasing controlled technology or source code to a foreign person within the United States can constitute a deemed export. The relevant destination is generally the person's most recent country of citizenship or permanent residence.

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2.1 Meaning of release of technology

A release does not require the formal transfer of a research document.

It can occur through:

Providing access to confidential laboratory protocols.

Demonstrating controlled manufacturing techniques.

Sharing restricted genetic-engineering methods.

Giving access to technical drawings or engineering specifications.

Providing controlled source code.

Allowing access to equipment where the applicable technical information is thereby released.

Explaining restricted production or development processes.

For example, suppose a US biotechnology laboratory is developing a controlled biological manufacturing technology. A foreign doctoral researcher is invited to participate in the project. If the researcher receives access to controlled technical information, the laboratory must determine whether a licence is required before that disclosure.

2.2 Foreign-national status

The EAR generally distinguishes between foreign persons and certain exempt categories.

US citizens, lawful permanent residents and protected individuals are generally outside the deemed-export foreign-person licensing requirement.

A foreign student, visiting scientist, postdoctoral researcher or foreign research employee may fall within the definition of a foreign person.

Importantly, nationality alone does not automatically mean that a licence is required. The laboratory must examine the controlled technology, applicable classification, destination-country licensing requirements and available exceptions.

3. Fundamental research exclusion

One of the most important protections for collaborative research is the fundamental research exclusion under 15 CFR § 734.8.

Fundamental research means basic or applied research in science, engineering or mathematics whose results are ordinarily published and broadly shared within the scientific community, without restrictions accepted for proprietary or national-security reasons.

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Conditions for the exclusion

The following conditions are particularly important:

The research should be intended for publication.

Researchers should ordinarily be free to communicate scientific findings.

The institution should not accept restrictions on publication for proprietary or national-security reasons.

Foreign researchers should not be excluded from participation through project-specific access restrictions.

Example: A university conducts an international genome-sequencing research project. Researchers from India, Japan, Germany and the United States collaborate. The results and methods are intended for publication, and there are no national-security restrictions on the research results.

The resulting research information may qualify for the fundamental research exclusion.

However, the exclusion does not automatically cover every physical material, biological agent, piece of equipment or pre-existing controlled technology used in the project.

3.1 When fundamental research protection is lost

The exclusion can become unavailable where the university accepts restrictions on publication or specific access and dissemination controls.

For example:

A defence agency restricts access to specified technical information.

A pharmaceutical company prevents publication of research results for proprietary reasons.

A government-funded project restricts foreign-national participation.

A laboratory imposes security controls on particular technical data.

The institution must distinguish between restrictions on the research results and restrictions on access to pre-existing controlled technology.

A project may contain both excluded fundamental research information and separately controlled technical information.

4. Application to collaborative research laboratories

Collaborative laboratories create special legal risks because multiple institutions, researchers and funding organisations may share responsibility for research activities.

4.1 University–industry collaboration

When a university collaborates with a biotechnology company, the company may provide proprietary manufacturing information or restricted equipment.

The university must determine whether the information is:

Publicly available;

Fundamental research information;

Proprietary but not export-controlled;

Controlled technology under the EAR; or

Controlled under another regulatory regime.

A confidentiality agreement does not automatically create an export-control violation. However, restrictions that prevent publication may affect the fundamental research exclusion.

4.2 International joint laboratories

An international laboratory may include researchers from several countries.

Legal questions include:

Which country's export-control legislation applies?

Which institution owns the research data?

Can foreign researchers access restricted equipment?

Can technical data be uploaded to an overseas server?

Does remote access constitute a controlled transfer?

Can visiting researchers take technical information home?

A laboratory cannot assume that a project is exempt simply because all researchers work at the same physical location.

4.3 Biological and genetic research

Special attention is required for biological research involving pathogens, toxins, genetic engineering, advanced vaccine platforms and sensitive manufacturing methods.

The BIS has issued specific guidance concerning deemed exports and fundamental research involving biological and chemical items. It explains that research information may qualify for the fundamental research exclusion while physical biological materials remain subject to separate export controls.

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5. Important case laws and judicial principles

The following cases illustrate how courts and enforcement authorities approach controlled research information, access by foreign nationals and unlawful technology transfers.

Case 1: United States v. John Reece Roth (2011)

Citation: United States v. Roth, 628 F.3d 827 (6th Cir. 2011).

Highly relevant research case

Facts:

Professor John Reece Roth worked on an Air Force-funded project involving plasma technology for military aircraft. The project was conducted through Atmospheric Glow Technologies.

During the project, foreign-national graduate students from China and Iran obtained access to controlled technical information and equipment.

The prosecution alleged that Roth also took controlled technical information to China without the necessary authorisation.

Legal issues:

Whether controlled technical information could be disclosed to foreign-national students.

Whether academic research status provided a defence against export-control restrictions.

Whether the professor could be held criminally responsible for unauthorised disclosure.

Whether the technical information was subject to defence export controls.

Judgment:

The Sixth Circuit affirmed Roth's convictions under the Arms Export Control Act.

Legal principles:

Academic freedom does not automatically override export-control legislation.

Research conducted under a military contract may attract special restrictions.

A university professor can face criminal liability for unauthorised transfers of controlled technical information.

Physical disclosure within the United States can create serious export-control consequences.

Relevance to collaborative laboratories:

A professor cannot assume that a foreign doctoral researcher may access all laboratory information simply because the researcher is enrolled at an American university.

The institution must assess whether the project involves controlled defence technology and whether the necessary authorisation exists.

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Case 2: United States v. Shih (2023)

Court: United States Court of Appeals for the Ninth Circuit.

Citation: United States v. Shih, 73 F.4th 1067 (9th Cir. 2023).

Facts and legal background:

The case concerned the interpretation and application of the Export Administration Regulations to technology-related items and the meaning of regulatory requirements governing export-controlled products.

Legal significance:

The Ninth Circuit examined the proper interpretation of the EAR and rejected an overly broad interpretation of the regulatory language.

The court emphasised that export-control regulations must be interpreted according to their actual statutory and regulatory wording.

Relevance to collaborative laboratories:

Research institutions should not classify every experimental prototype or research output as automatically export-controlled. They must examine the actual regulatory classification and applicable exclusions.

This case is relevant to the interpretation of export-control boundaries, although it is not a direct ruling on foreign-national access to university laboratories.

Ninth Circuit Court of Appeals

Case 3: In re Universities Space Research Association (2025)

Authority: US Department of Justice.

Related criminal proceeding: United States v. Jonathan Yet Wing Soong, No. 3:22-cr-00372.

Facts:

Jonathan Soong, an employee of Universities Space Research Association (USRA), facilitated the unauthorised export of flight-control and optimisation software to a restricted Chinese university.

The software was subject to the EAR and the recipient university appeared on the Commerce Department's Entity List.

Soong pleaded guilty and received a 20-month prison sentence.

USRA discovered the violations, voluntarily disclosed them and cooperated with the investigation. The Department of Justice subsequently declined to prosecute USRA.

Legal significance:

This matter demonstrates:

The importance of restricted-party screening.

The legal consequences of transferring controlled research software.

The importance of internal compliance monitoring.

The value of prompt voluntary disclosure and cooperation.

The potential distinction between individual wrongdoing and institutional enforcement decisions.

Relevance:

Collaborative laboratories should screen foreign research partners, software recipients, visiting researchers and institutional collaborators before granting access to controlled technology.

United States Department of Justice+1

Case 4: Atmospheric Glow Technologies export-control enforcement

This enforcement matter is associated with the Roth litigation.

The US export-control authorities treated the transfer of controlled military technical information to foreign-national graduate students as a serious regulatory matter.

Its importance lies in demonstrating that university laboratories are not automatically exempt from defence-related export controls.

The case also illustrates the need for cooperation between university research administrators, export-control officers and government agencies.

Eastern District of Tennessee+1

6. Relationship between EAR and ITAR

Collaborative laboratories may be subject to two separate US export-control systems.

The Roth litigation is particularly important for understanding ITAR restrictions, whereas the Soong proceeding demonstrates the application of the EAR to controlled software.

A research institution must identify the applicable regime before permitting access.

7. Institutional liability and accountability

Collaborative laboratories may face legal consequences where their personnel improperly disclose controlled information.

Potential consequences include:

Civil administrative penalties.

Criminal prosecution for wilful violations.

Suspension or denial of export privileges.

Loss of research contracts.

Government investigation.

Institutional reputational damage.

Contractual disputes with research sponsors.

An institution should not assume that an employee's misconduct automatically creates identical criminal liability for the university. Individual and institutional liability depend on the applicable statutory requirements and the facts.

Institutional accountability measures

A proper laboratory compliance programme should include:

Appointment of an export-control compliance officer.

Classification of controlled research technology.

Verification of foreign collaborators and research institutions.

Documented access permissions.

Training for laboratory employees and visiting researchers.

Controlled access to technical documents and software.

Periodic compliance audits.

Incident reporting and corrective action.

8. Indian legal position: Deemed exports in collaborative research laboratories

India uses the expression deemed exports in a substantially different legal sense.

Under Chapter 7 of the Foreign Trade Policy 2023, deemed exports generally refer to specified supplies of domestically manufactured goods that do not leave India but qualify for designated export benefits.

The policy identifies specified categories of supplies, including certain supplies against Advance Authorisations, supplies to Export Oriented Units and specified project-related supplies.

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8.1 Foreign Trade Policy 2023

The relevant provisions are:

A collaborative biotechnology laboratory does not automatically qualify as a deemed-export transaction merely because it receives equipment or research materials from an Indian manufacturer.

The transaction must fall within the notified categories and satisfy the relevant conditions.

8.2 GST treatment

Section 2(39) and Section 147 of the Central Goods and Services Tax Act, 2017 are relevant to the GST meaning of deemed exports.

The GST concept is distinct from the Foreign Trade Policy concept. Not every transaction qualifying under the FTP automatically qualifies for GST deemed-export treatment.

Where a supply qualifies under the applicable GST notification, the relevant tax and refund conditions must also be fulfilled.

CBIC+1

8.3 SCOMET controls

India also regulates certain sensitive goods, materials, equipment and technologies through the SCOMET framework under its Foreign Trade Policy.

This is particularly relevant to:

Biotechnology equipment.

Sensitive biological materials.

Advanced chemical technologies.

Dual-use scientific instruments.

Controlled technical information and related transfers.

The Indian laboratory must separately consider applicable export authorisations, including where research materials or technology are transferred to foreign collaborators.

Important distinction: Indian FTP deemed-export benefits are not equivalent to US foreign-national deemed-export licensing. The Indian laboratory's supply-chain and SCOMET obligations must be examined separately.

9. Legal challenges in collaborative research laboratories

Several difficult legal questions arise when international researchers work together.

A. Conflict between academic freedom and national security

Universities generally support open scientific communication. However, national security restrictions can limit access to certain technologies. The legal challenge is balancing research freedom against legitimate security controls.

B. Ownership of research data

Collaborating institutions may disagree over ownership of research results, laboratory records, genetic databases and technical information.

Export-control compliance must be distinguished from intellectual-property ownership. Ownership of information does not itself authorise its export or disclosure.

C. Remote laboratory access

Foreign researchers may access controlled technical information through cloud servers, remote laboratory systems or shared research databases.

Institutions must assess whether the particular access constitutes a controlled release or transfer.

D. Visiting researchers and temporary access

Short-term visiting scientists must not automatically be treated as exempt from export-control requirements. Their access should be assessed before they receive controlled information.

E. Artificial intelligence and biotechnology

AI-assisted drug discovery, synthetic biology and automated genetic engineering create additional challenges because controlled technical information may be embedded in software, technical models and research databases.

Institutions should examine whether the relevant technology or source code falls within the EAR or another applicable export-control regime.

10. Recommended compliance framework

A collaborative research laboratory should adopt the following procedure:

Research laboratory compliance process

Project classification

Identify controlled technology, software, materials and technical information.

Research exclusion assessment

Determine whether the project qualifies for fundamental research or another applicable exclusion.

Researcher verification

Verify researcher status, institutional affiliation and relevant destination-country requirements.

Licence determination

Determine whether an export licence or other authorisation is required.

Access management

Establish appropriate controls over laboratories, equipment, software and research records.

Monitoring and auditing

Maintain access logs, training records, transfer documentation and incident reports.

11. Important statutory and regulatory references

12. Conclusion

Deemed export rules play an important role in protecting sensitive technology in collaborative research laboratories. They recognise that the disclosure of technical information to foreign nationals can create export-control consequences even when no physical goods cross an international border.

The US EAR and ITAR frameworks require universities, research institutions and biotechnology companies to examine controlled information, foreign-national access, licensing obligations and research exclusions.

The decisions in United States v. Roth, United States v. Shih and the Soong export-control proceedings demonstrate the importance of regulatory classification, controlled access and institutional compliance.

In India, the expression deemed exports principally concerns specified domestic supplies under the Foreign Trade Policy and GST framework. It should not be confused with the US concept of deemed exports involving foreign-national access to technology.

Ultimately, effective governance requires a balance between scientific collaboration, academic freedom, intellectual-property protection and national security.

13. Research and examination significance

The subject is particularly important for advanced biotechnology-law research because it connects five major areas:

International research collaboration and technology transfer.

National security and export-control accountability.

Foreign-national participation in scientific research.

Protection of biological materials and genetic information.

Institutional liability for unlawful research disclosures.

Case-law qualification: The US cases discussed above provide relevant judicial and enforcement principles, but they do not establish that every foreign-national researcher requires an export licence. I have not identified a directly equivalent Indian reported judgment concerning foreign-national access to collaborative laboratory technology under the Indian FTP deemed-export provisions.

Primary sources for further study:

US BIS – What Is a Deemed Export?

US EAR – Part 734

BIS – Deemed Exports and Fundamental Research Involving Biological Items

India – Foreign Trade Policy 2023, Chapter 7

United States v. Roth (2011)

This is an academic legal explanation, not a determination of whether a particular laboratory project requires an export licence.