Research Affairs / 
Transferring Research Data and Materials


Export ControlTransferring Research Data and Materials

Guidance on Imports


Sharing Confidential Information:  Confidential Disclosure Agreements


Transferring Research Materials:  Material Transfer Agreements


 


Export Controls

Export control laws are federal regulations that control the conditions under which certain information, technologies, and commodities can be transmitted overseas to anyone, including U.S. citizens, or to a foreign national on U.S. soil.

You must contact Research Affairs - Research Integrity immediately if your research involves the transmission of research information or technology to someone overseas, or sharing information or technology with someone other than a U.S. citizen or permanent resident within the United States.  This includes discussing your research with research colleagues or students in your laboratory who are foreign nationals.  

Most LLU research activities will most likely be excluded from export control laws.  But you must consult with Research Integrity to be sure.

Other Helpful Links:


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Guidance on Imports

Guidance on Etiologic Agents

Etiologic agents are those microorganisms and microbial toxins that cause disease in humans and include bacteria, bacterial toxins, viruses, fungi, rickettsiae, protozoans, and parasites.

See CDC's Etiologic Agent Import Permit Program

Guidance on Importing Plant Materials / Organisms That Affect Plants

Permits are required for the importation, transit, domestic movement and environmental release of Organisms that impact plants, and the importation and transit of Plants and Plant Products under authority of the Plant Protection and Honeybee Acts.

The protection of agricultural products is taken very seriously, so it is important to make sure that all requirements are followed.

Where to Start: 

See the U.S. Department of Agriculture site (under the division Animal and Plant Health Inspection Service, also known as APHIS) that describes the regulation of the importation of plant materials.  This is a good place to start looking for the various types of permits and regulations that may be required.   Note:  The U.S. Fish and Wildlife and other agencies may also have additional requirements.

If you have a specific project in mind, please contact Research Affairs - Research Integrity for assistance.

See the following for specific types of permits:

Organism and Soil Permits
Organism Permits include Plant Pests such as insects and snails; Plant Pathogens such as fungi, bacteria, and viruses; Biological Control Agents, Bees, Plant Pest Diagnostic Laboratories, Soil Microbe Isolation Laboratories, Federal Noxious Weeds and Parasitic Plants.

Plant and Plant Product Permits
Plant and Plant Product Permits include Plants for Planting such as nursery stock, small lots of seed; Plant Products such as fruits and vegetable, timber, cotton and cut flowers; Protected Plants and Plant Products such as orchids, and Threatened and Endangered plant species; Transit Permits to ship regulated articles into, through, and out of the U.S.; and Departmental Permits to import prohibited plant materials for research.

Other Helpful Links: 

  • See the USDA website on importing plants, the inspection stations, how to import plants, etc.

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Confidential Disclosure Agreements 

Overview

Confidential Disclosure Agreements (CDAs), also referred to as Non-Disclosure Agreements (NDAs), allow Loma Linda University faculty to exchange confidential information with outside parties under obligations that protect and preserve the confidentiality of that information. Generally CDAs are entered into for the purpose of exploring a potential research collaboration or license agreement.

A CDA serves three purposes:

  • It alerts the receiving party to the confidentiality of the information to be received;

  • It specifies the responsibilities required of the receiving party; and

  • It helps preserve LLU patent rights.  Under United States patent law, there is a grace period of one year in which to file a patent application after the invention has been made known to the public. However, in most other countries a patent application must be filed before the invention is ever disclosed to the public. Executing a CDA before discussing an invention with an outside party prevents public disclosure and preserves the possibility of foreign patent protection.  CDAs can be used as evidence in subsequent patent processing, e.g., to defeat an allegation that the invention is not novel because the inventor treated it as public information. This kind of allegation arises frequently from those contesting a potentially lucrative patent, so a CDA is more than a "mere formality."

CDAs may cover a mutual exchange of information, also referred to as two-way, or may be one-way to cover information disclosed by only one party.

At Loma Linda University, the need for a confidential disclosure agreement usually arises in one of three ways: 

  1. A LLU researcher wishes to share information about an invention with an outside company.  An outgoing CDA will protect the intellectual property (i.e. patent) involved.   
  2. A LLU researcher is receiving confidential information from an outside company that relates to LLU intellectual property or the researcher's ongoing research related to that intellectual property.  An incoming CDA ensures that LLU's intellectual property and research activities remain uncontaminated by the outside entity's confidential information.
  3. A LLU researcher conducting an industry-sponsored clinical trial is required to sign a CDA to maintain the confidentiality of a clinical study protocol and any other study-related information provided by the sponsor.  These types of CDAs are administered by the Clinical Trial Center

Research Affairs - Financial Management is here to help faculty share information to advance their research. The agreements covering these exchanges are legally binding contracts. Once signed, LLU and faculty must comply with the provisions they contain. 

See also:  Frequently Asked Questions for Confidential Disclosure Agreements.

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Incoming CDAs: Receiving Confidential Information from another Institution or Company

To receive confidential or proprietary information from another institution or company, please forward the following information to the Financial Management Contract Analyst (Note:  If the information is from a clinical trial sponsor, then follow the procedure outlined by the Clinical Trial Center.)

  1. A completed CDA Request Form
  2. An electronic version of the provider’s CDA (preferably in MS Word format). Note: A CDA is normally supplied by the provider.  You should obtain that CDA prior to initiating the request. 
  3. Name of company or outside party with contact name, phone number or email address
  4. Subject matter to be discussed – brief description
  5. Purpose of the disclosure or exchange of information

Financial Management will review this information to determine if the terms are acceptable under LLU policy.  If acceptable, Financial Management will obtain the necessary signatures to execute the CDA. If the terms are not acceptable, Financial Management will negotiate with the provider to revise the unacceptable terms.

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Outgoing CDAs: Sharing Confidential Information with Another Institution or Company

To share confidential or proprietary information with another institution or company, please forward the following information to Director of Research Affairs - Financial Management.

  1. A completed CDA Request Form
  2. Name of company or outside party with contact name, phone number or email address
  3. Subject matter to be discussed – brief description
  4. Purpose of the disclosure or exchange of information
  5. Type of agreement needed –mutual or one-way

At this point:

  1. Financial Management will negotiate terms of the agreement with the recipient.
  2. Financial Management will obtain necessary signatures to execute the CDA.
  3. Upon execution you will receive a copy of the fully executed agreement via email.
  4. At that time the provider may share the information with the recipient you.

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Material Transfer Agreements

Overview

When transferring or receiving tangible research material or raw datasets with another researcher or company, whether non-profit or commercial, an advance agreement is necessary.

 

A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes.

 

A Data Transfer Agreement (DTA) is an agreement requesting a disclosure of protected health information (PHI) contained in a limited data set.

 

MTAs/DTAs set out the protections, rights, and obligations of both parties. The Research Affairs - Financial Management (RAFM) Contracts Analyst reviews and approves these agreements for both the transfer of outgoing material and data requests as well as the transfer of all incoming material and data requests. Our goal is to ensure that MTAs/DTAs do not restrict your academic freedom or hinder future research, protect potential LLU inventions and intellectual property, and that they include HIPAA (Health Insurance Portability and Accountability Act) regulations.

 

Types of material requests may include biological materials such as reagents, cell lines, plasmids, and vectors (including DNA, live animals, and clinical specimens), chemical compounds, databases and software codes. Types of data requests may include data derived from human subject research or HIPAA-protected information.

Why is an agreement required for material transfer?

Most providers of material and data require an agreement so that there is a common understanding of how the materials or data will be used and set limitations on its use. However, both parties involved in the exchange will benefit from the arrangement.

 

Transfers done without a MTA/DTA offer no protection for either the providing institution or the receiving institution. An agreement establishes ownership to any potential inventions which may be developed by the use of the materials or data. Such issues as confidentiality, publication rights, ownership and licensing rights of any intellectual property, limitations on use of the requested material/data, liability and indemnification are addressed in a MTA/DTA. Companies may ask to own all rights to inventions arising from use of the material/data or prohibit your ability to publish the results of your research. In addition, if the transfer includes material/data that is owned by a third party, further transfer of that material/data is commonly restricted by the MTA/DTA. Violation of that requirement may provoke litigation. However, it is often possible to transfer the material/data, if the new recipient agrees, in an agreement, to honor the obligations imposed by the original provider.

 

Every MTA/DTA is different because materials being transferred in or out of the institution all have specific properties, specific risks and specific applications. Therefore, these agreements must be reviewed individually to reach a mutual understanding on the terms and conditions, the investigator's obligations to the provider, and the use the investigator plans for the material/data.

For these reasons, Financial Management reviews, negotiates, and approves all MTAs/DTAs. The agreements covering these exchanges are legally binding contracts. Once signed, LLU and faculty must comply with the provisions they contain.

See also:  Frequently Asked Questions for Material Transfer Agreements.

Research Affairs - Financial Management is here to help faculty acquire materials and data to advance their research.

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INCOMING MTAs: Receiving Material/Data from another Institution or Company

LLU faculty must have a MTA/DTA in place before receiving materials or data from another academic institution, nonprofit entity or industry.

Materials from Academic / Non-Profit / Government Institutions

To obtain materials from another academic, non-profit, or government institution, please forward the following documents to the Contract Analyst at racontracts@llu.edu:

  1. A completed Contract Request Form.
  2. An electronic version of the provider’s MTA (preferably in MS Word format). Note: An MTA is normally supplied by the provider of the material. You should obtain a copy prior to initiating the request.

 

Incoming Material Process

  1. The Contract Analyst will review these documents to determine if the terms are acceptable under LLU policy
  2. The Contract Analyst will obtain safety approval from the Institutional Biosafety Committee (IBC).
  3. If acceptable, the Contract Analyst will prepare the MTA for execution.
  4. If the terms are not acceptable, the Contract Analyst will negotiate the terms with the provider.
  5. The Contract Analyst will obtain necessary signatures.
  6. Upon execution you will receive a copy of the fully executed MTA via email.
  7. At this time you are permitted to accept the material.



For Materials from Industry

Industrial sponsors may freely distribute its materials to academic institutions with the expectation of acquiring patent rights and new intellectual property. This may create a conflict when the company providing the materials has not provided funds for the research that will be performed by the faculty member.

To obtain materials from Industry, please forward the following documents to the Contract Analyst at racontracts@llu.edu:

  1. A completed Contract Request Form.
  2. An electronic version of the provider’s MTA (preferably in MS Word format). Note: An MTA is normally supplied by the provider of the material. You should obtain that MTA prior to initiating the request.
  3. A statement of work or research proposal describing the intended research you plan to conduct with the requested materials (unless this information is already provided in the MTA itself). This statement of work should be specific to the planned research giving the steps and anticipated outcome of the research. It is important to avoid broad, vague descriptions such as “experiments in mice” or “study of breast cancer”, etc., as we are often granting rights to inventions developed in your research, thus a specific description is always preferred.

Incoming Industry Material Process

  1. The Contract Analyst will review the MTA to determine if the terms are acceptable under LLU policy.
  2. The Contract Analyst will obtain safety approval from the Institutional Biosafety Committee (IBC).
  3. If acceptable, the Contract Analyst will prepare the MTA for execution.
  4. If the terms are not acceptable, the Contract Analyst will negotiate the terms with the provider.
  5. The Contract Analyst will obtain necessary signatures.
  6. Upon execution you will receive a copy of the fully executed MTA via email.
  7. At this time you are permitted to accept the material.

 

NOTE: MTAs with industry may vary greatly and must be reviewed carefully to ensure that the terms and conditions protect the academic freedom of the PI and provide the necessary protections for the institution. Nearly all Industry MTAs will require that the Contract Analyst negotiate the terms of the agreement. Please be aware that these agreements cannot be signed as they are received and that time will be needed to review and modify the document before it is approved and signed.

For Data from Academic / Non-Profit / Government Institutions

To obtain data from another academic, non-profit or government institution, please forward the following documents to the Contract Analyst at racontracts@llu.edu:

  1. A completed Data Transfer Request Form.
  2. An electronic version of the provider’s DTA (preferably in MS Word format). Note: An DTA is normally supplied by the provider of the material. You should obtain a copy prior to initiating the request.

Incoming Data Process

  1. The Contract Analyst will review these documents to determine if the terms are acceptable under LLU policy.
  2. If acceptable, the Contract Analyst will prepare the DTA for execution.
  3. If the terms are not acceptable, the Contract Analyst will negotiate the terms with the provider, if needed.
  4. The Contract Analyst will obtain necessary signatures.
  5. Upon execution you will receive a copy of the fully executed DTA via email.
  6. At that time you are permitted to accept the data.

 

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OUTGOING MTAs: Transferring Material/Data to Another Institution or Company

LLU faculty must have an agreement in place before transferring materials or data that s/he has created at LLU to another academic institution, nonprofit entity or industry.

To send Material to another institution, non-profit or government institution, please forward the following documents to the Contract Analyst at racontracts@llu.edu:

  1. A completed Contract Request Form
  2. The Scope of Work (SOW) of the recipient

Outgoing Material Process

  1. The Contract Analyst will draft an appropriate MTA and forward to the recipient.
  2. The Contract Analyst will obtain export control approval from Research Integrity
  3. The Contract Analyst will negotiate the terms of the MTA with the recipient, if needed
  4. The Contract Analyst will obtain necessary signatures.
  5. Upon execution you will receive a copy of the fully executed MTA via email.
  6. At that time you are permitted to send the materials to the recipient.

To send Data to another institution, non-profit or government institution, please forward the following documents to the Contract Analyst at racontracts@llu.edu:

  1. A completed Data Transfer Request Form.
  2. The Scope of Work (SOW) or protocol, if applicable, of the recipient

Outgoing Data Process

  1. The Contract Analyst will draft an appropriate DTA and forward to the recipient.
  2. The Contract Analyst will negotiate the terms of the DTA with the recipient, if needed
  3. The Contract Analyst will obtain necessary signatures.
  4. Upon execution you will receive a copy of the fully executed DTA via email.
  5. At that time you are permitted to send the data to the recipient.

 

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