Research Affairs / 
Frequently Asked Questions for Researchers


Grants Guide

Contracts Guide


Human Studies Guide


Technology Transfer

 

 


 

GRANTS GUIDE

 

BUDGET DEVELOPMENT

How soon do I need to submit my proposal budget to Research Affairs - Financial Management for review?

Submit a preliminary budget to Financial Management no later than 2 months before the sponsor's submission date.  This will allow you and your assigned Financial Analyst sufficient time to resolve any remaining budget issues and make necessary changes before the final budget is submitted for review and final approval.  The final budgets must be submitted no later than ten working days prior to the potential sponsor submission date.

Who do I contact at Financial Management for help with my proposal budget?

Financial Management has assigned a Financial Analyst to every department or center.  Your assigned Analyst can help. 

What are some of the differences between direct and F&A costs?

Direct Costs are funds used by the Principal Investigator to pay for the costs of performing specific effort for an award, such as PI & research staff salaries and benefits; supplies, equipment, and contractual services. 

F&A Costs are funds used to maintain the institution's research infrastructure, including:  building maintenance and utilities, libraries, centralized administrative costs of managing grants and contracts, and departmental/school/college administrative costs.  See the F&A Primer for more information.

What are the current F&A cost rates for research activities?

See the Budget Planning Rate Guide for current F&A rates for various types of research projects. F&A cost rates are negotiated periodically with the federal government and are based on LLU's actual operating costs, except when capped by federal regulation or sponsor terms.

What are the current fringe benefit rates for research activities?

See the Budget Planning Rate Guide for current fringe benefit rates.

How are a research project’s F&A costs calculated?

The basic procedure for determining the F&A costs is:

1.  Calculate the grant's Total Direct Costs (TDC), which equals the sum of all direct costs, including salaries, supplies, equipment, etc.  Common direct costs are summarized in LLU Budget Categories.

2.  Calculate exemptions, which can include items such as major equipment, off-campus building rental, tuition remission and the portion over $25,000 of subcontracts.

3.  Deduct exemptions from TDC to determine Modified Total Direct Costs (MTDC).

TDC – Exemptions = MTDC

4.  Multiply the MTDC by LLU's current F&A rate (see the Budget Planning Rate Guide for current rates) to determine F&A costs

MTDC x F&A RATE = F&A Costs

How are TOTAL PROJECT COSTS calculated?

Add the TDC to F&A costs to calculate Total Project Costs.

TDC + F&A Costs = Total Project Costs

Can a principal investigator negotiate different F&A rates on a project?

No. However, if the written guidelines for the proposed project include a statement about the F&A rates the agency will pay or if such a statement is available on the agency website, the institution can abide by that policy. Please see the Indirect Cost Waiver or Reduction Request form.

Are all sponsored projects charged facilities and administrative (F&A) costs?

No. However, all sponsored projects incur F&A costs. Some sponsors limit the application of the institutional F&A rate. As a result for the institution there often remains a deficit between what can be recovered by an award versus what F&A costs are expended to support the award. The application of the institution’s facilities and administrative costs is governed by the institutional policy Charging Facilities and Administrative (Indirect) Costs to Sponsored Projects. When working with foundations and nonprofits, Financial Management generally accepts the published policy of the foundation regarding payment of administrative and overhead/indirect costs.

Why should my grant pay for F&A costs?

Investigators should understand that the F&A costs reimburse the institution for overhead costs related to the project and in most cases, don’t cover all of these costs.

How do F&A reimbursements benefit my department?

The PI’s department receives the F&A costs back through research cost recovery allocation. These funds are used at the discretion of the Dean and Chairs to support research in their units.  

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CONTRACTS GUIDE

 

CLINICAL TRIAL AGREEMENTS

What is a clinical trial agreement?

A Clinical Trial Agreement (CTA) is a legally binding contract entered into by two or more parties involved in the conduct of a clinical trial or registry study. The contract serves to outline the rights, obligations and restrictions of the parties.  

At Loma Linda University, federally-sponsored clinical trial contracts are coordinated by the Contracts Analyst in Research Affairs - Financial Management.  Industry-sponsored clinical trial-related contracts are coordinated and processed by the Clinical Trial Center.  More questions about clinical trial agreements and the clinical trial process are answered on the CTC's Helpful Links & FAQs page. 

You might also be interested in CTC's Contracts Guide for Clinical Trials.

When do I start the CTA process?

For federally-sponsored clinical trials, contact the Financial Management Contracts Analyst.  For industry-sponsored clinical trials, see the Clinical Trial Center's processing flowchart for industry-sponsored clinical trials.  This will explain how and when to initiate the CTA process and whom to contact with questions. 

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SUBCONTRACTS

What is a subcontract and what do I need to request from a proposed subcontractor?

A subcontract or sub-award is a formal, cooperative sponsored project relationship with another organization, generally a university or non-profit research center, that is part of a proposal and, if awarded, prime agreement, accepted by LLU.

Learn more about the differences between Sub-Awards and Prime Awards (under Plan the Proposal)

When a subcontract is part of the LLU PI's project, the LLU PI in conjunction with the PI at the subcontracting institution (Subcontractor) will need to develop a work plan for the project. The Subcontractor PI will need to develop a proposal with a work scope and budget. That proposal needs to be submitted to the LLU PI for incorporation into the LLU proposal, but first must be approved by the authorized business official of the Subcontractor.

See the sub-award process when LLU is grantor.

What is the difference between a Consultant and a Subcontractor?

A consultant is a firm or individual who provides professional or highly technical advice or assistance to the institution, over which the institution controls the results but not the manner in which the service is performed. A consulting agreement may be appropriate in the following circumstances:

  • The task is to be accomplished through the efforts of one person who is an established consultant, or of an established consulting firm, and
  • The task is singular in nature and is to be accomplished over a relatively short period of time.

Human Resources Management may require a Contractor vs Employee form to be completed in order to determine the individual's status as a consultant.

A subcontractor is another organization and is responsible for a portion of the work covered by a prime agreement.  Characteristics of a subcontractor are:

  • Performance of the subcontractor is measured against whether the objectives of their portion of the sponsored project are met, and
  • The subcontractor is responsible for making programmatic decisions and is required to adhere to all applicable compliance requirements.

My proposed project includes a sub-contract/sub-award/consortium agreement.  What extra steps will be required in preparing my budget?

First, verify that the proposed subcontractor is not on the Excluded Parties List.  In order to review and approve the budget, Financial Management will also require an attached Subrecipient Commitment form (with associated paperwork) for each sub-contractor.  The budget justification should explain why the work is being subcontracted out and how the subcontractor was selected (e.g. sole source, competitive bid, etc).  For sole source, explain why the selection had to be sole source. 

How do I initiate the subcontracting process once my project is awarded?

Notify the Contract Analyst in Financial Management.  The PI should have already had coordination with the subcontractor during submission process; therefore, most of the commitment should already be set. Once a proposal is awarded, the Contract Analyst will begin drafting the agreement. Notify the subcontractor! You normally want the subcontractor to start working at the same time LLU does, but not before the agreement has been signed by both parties. Provide the subcontractor with LLU’s account number for reference. The subcontractor should submit their invoices to Financial Management for payment according to the contract agreement.

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HUMAN STUDIES GUIDE

 

Is IRB approval needed?

When is IRB approval required?

All proposed research projects involving the living persons or their identifiable data are to be submitted for IRB review if you are a faculty/staff member/student at Loma Linda University or its affiliated entities or you are using LLU facilities, subjects, or their identifiable information.  For further guidance, see What is Human Subject Research.  IRB review and approval of human subject research must be obtained prior to initiation of study activities.

I am just doing a simple survey; do I need to submit to the IRB?

Yes. LLU policy states that no human subject research shall be initiated until approved by the IRB or determined to be Exempt.  For examples of activities that may NOT require IRB review determining if IRB review is required, complete and submit the IRB Request for Determination.  Surveys do involve participation by living persons and may qualify for Exempt status if the survey poses minimal risk, but only the IRB can make that determination.  I do not need any identifying information; do I need to still have to submit for IRB approval?

Yes. ALL research (a systematic investigation) soliciting information from human subjects must be submitted for IRB review. How and when you propose protecting subject identity, such as not collecting or recording identifiers,are appropriate steps toward minimizing risk of breach of confidentiality and will be considered during the IRB’s review. 

I need to review some medical records in order to design my research protocol. Since that involves identifiable information about humans, does that mean I have to submit to the IRB?

No, provision is made under HIPAA rules for “preparatory research” activities without IRB or Privacy Board review. See LLU’s Preparatory to Research Certification.

I will be collaborating with a researcher at another institution; do I need to file for IRB approval at both LLU and the other institution?

Investigators should contact an IRB staff person whenever collaborative research is planned.  Separate applications to both institutions may be necessary, or an IRB deferral agreement may be reached between the two institutions.  Guidance will be provided as to when IRB deferral is possible and how to document the agreement.

Should I wait until my research proposal has been funded to submit a protocol for IRB approval?

No. It's best to submit your IRB protocol at the time your research proposal is submitted to the sponsor so the protocol can be reviewed and approved. Then, when your proposal is funded, you will be ready to conduct the work, and the sponsored funding can be released.  See the Human Studies Life Cycle for more information.

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Before/During the Review Process

How long does it take to get my IRB application approved?

The estimated review time for research studies depends on the level of review required.  Submissions to the Full Board will be assigned to the next available IRB meeting date as soon as the submission is pre-screened.  Usually this means within 10 days of submission.  Principal investigators receive the results of Full Board review within 3-4 business days after the IRB meeting. 

Studies reviewed administratively (either Exempt or Expedited) are usually submitted to IRB review panels or designated IRB members.  The cycle for this process can be as quick as 3-5 business days or as long as 30-40 days, depending on when the review cycle occurs.  Investigators may contact the IRB office for assistance in planning for a specific review cycle. 

Approval in all cases depends on how well the application anticipates and documents ethical and regulatory requirements, and how quickly the investigator responds to IRB stipulations. 

Who is required to complete the Human Subjects Education (HSE)?

All personnel listed on the IRB application as individuals conducting human subjects research are required to complete human subjects education.  IRB approval for proposed research projects will not be released until this training has been completed and verified by Research Integrity.  Investigators may verify the status of their HSE or find additional guidance on HSE training opportunities on-line at Research Education & Training.

Is the signature of the Principal Investigator (PI) and Department head required on all submissions to the IRB?

Since the PI is responsible for the scientific and ethical conduct of the study, including the protection of the rights and welfare of human subjects, that individual must always be kept informed about status of IRB approval with regard to initial and renewal submissions, change requests, and adverse events. To assure this is either directly supervised by or communicated appropriately with the PI, that individual must sign off on all such submissions to the IRB.

The IRB requires signature of the Department Chair for submission of new protocols, documenting  departmental  review for scientific merit and academic endorsement.  Thereafter, the department may implement its own requirements with regard to review of subsequent submissions.

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After IRB Review

When should a Change Request be submitted?

Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study, including but not limited to, additional surveys/questionnaires, additional participants, a different participant population, a title change, change in investigator, change of funding source, increased time for participant participation.

How do I obtain IRB review of an amendment or change to my approved protocol?

To amend, modify, or add something to your protocol, consent, recruitment, or any other study material on file with the IRB, submit a Change Request form.  This form is available on-line and requires your research ID and password.  (If you need assistance, contact RPP ex. 44531).  When you select the IRB # corresponding to the desired study, the form will pre-populate with existing information about your study.  After completing the Request Form, you will need to print a hard-copy and send to RPP.

Does approval of a Change Request for an approved research study extend the original approval date?

No. The expiration date of the original approval is not changed by the review and approval of a modification. 

How do I renew my project for continued IRB approval?

To request renewal of the approval period, you need to complete and submit the Renewal Report Form.  To prevent expiration of IRB approval, investigators should request extension within 60 days prior to the IRB approval end date.  As a reminder of this responsibility, the PI will receive a copy of the study’s Renewal Report Form, which includes instructions for submission, either to Full Board or Expedited review.  You may also download a copy of the study’s Renewal Report Form at your convenience. (This requires your research ID and password.)

When do I have to report an Adverse Event? 

Reportable events are study-specific and depend on a number of factors.  In 2012 LLU IRB requirements were revised to reflect a reduction in federal reporting requirements, thus reducing the burden on investigators. At the time of IRB approval, the PI is now provided study-specific guidance as to what must be reported and when. For more information, see institutional policy and procedure H-43: Adverse Event/Unanticipated Problem Reporting. Contact RPP at x44531 for further clarification and assistance.


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Informed Consent

What is 'implied consent?

By completing a research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant provides consent to participate in the research. This is an example of a waiver of documented or signed consent. Before granting a waiver, the IRB usually requires the researcher to provide the participants with a written summary or an information sheet about the research, including: (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant.  The text would need to include a final statement indicating the action (i.e., completion and return of the survey) that implies consent to participate in the research.

Can I waive the informed consent?

No, but the IRB can, upon request by the PI with sufficient justification. 

 

There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

  • The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
  • The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews)

A waiver of documentation of informed consent is not a waiver of consent but a scenario in which written documentation of some or all aspects of consent are waived.  Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form.  The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

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TECHNOLOGY TRANSFER & PROTECTING INTELLECTUAL PROPERTY

 

General Technology Transfer Process

What is an invention?

An Invention is any process (way of doing or making things), machine, manufacture, design, or composition of matter, or any new and useful improvement thereof, or any variety of plant, which is or may be patentable under the patent laws of the United States through the U.S. Patent and Trademark Office (USPTO).

Who is an inventor?

An inventor is the one who first conceives of an invention, in detail, and with enough specificity that one skilled in the field could construct and practice the invention. Those who translate the concept into practice are not considered co-inventors unless they add to the original concept of the invention. With the agreement of the inventor(s), however, they may share in financial benefits of the invention.

Who owns an invention produced by LLU research?

According to institutional policy and the California Labor Code, Loma Linda University owns all inventions created through LLU research.  This ownership remains in effect 6 months after a researcher’s employment ends. As a condition of employment at Loma Linda University, all employees agree to assign the intellectual property rights to inventions made in the normal course of their work to the institution. This includes all faculty, staff, fellows, and graduate students who have an appointment at Loma Linda University.  In return, LLU arranges for protection of those rights, and for marketing and licensing of the invention.  LLU then arranges for royalty distributions to the inventor(s).   See LLU’s Intellectual Property policy (section 3.4.10) in the Faculty Handbook for more information.

What if I co-created the invention with someone from another institution or company?

Research Affairs - Technology Transfer will work with the other institution to determine ownership of the invention and resulting intellectual property, including any materials that were developed.  The co-owners may choose to amalgamate their rights through an inter-institutional agreement and license co-owned rights together, or in the United States, co-owners also have the ability to separately pursue commercialization opportunities.  The co-owners will evaluate these options, and pursue the one that makes sense for each individual technology.

What is Technology Transfer?

Academic technology transfer involves the transfer of a wide variety of outputs from research projects to industry for commercial development. In 1980, the passage of the Bayh-Dole Act encouraged universities to take a more active role in technology management. The provisions of the Act mandate that universities report all inventions arising from federally supported research and agree to diligently pursue intellectual property protection and commercialization for new technologies that are commercially promising.

What is the technology transfer process at LLU?

Click here to see the LLU technology transfer process

How long does the process take?

The process can take from six months to several years. Many factors affect the process, including development stage of the technology, time for patent prosecution, the availability of suitable licensees, demand for the potential product or service, and the health of the local and regional economy.

How can an inventor facilitate the technology management process?

As a LLU investigator, you can facilitate the technology management process by:

  • As soon as you think you have an invention, disclose it to the Office of Research Affairs using an Invention Disclosure Form.
  • Indicate any and all companies and contacts you believe may be interested in licensing the invention.
  • Promptly respond to Technology Transfer and patent counsel requests.
  • Keep Technology Transfer informed of upcoming presentations, publications and interactions with companies that relate to your invention.
  • Contact Technology Transfer with any questions or concerns.

My research was sponsored by a federal agency (NIH, NSF, etc).  How do I comply with Federal Reporting Requirements for inventions?

Supply the following information in the form of a written report to allow LLU to comply with federal reporting regulations:

  • Names of the inventor(s);
  • A detailed description of the invention that is sufficiently complete to convey a clear understanding of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the invention at the time of disclosure;
  • Any publication, sale, or public use of the invention;
  • Any manuscript describing the invention submitted for publication, and whether it has been accepted for publication at the time of the disclosure.

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Disclosing an Invention

What is an Invention Disclosure and why is it important?

Invention disclosure is the act of sharing sufficient information for another person to carry out or duplicate your invention. In order to begin the process of protecting your invention you must first disclose it to Research Affairs using the Invention Disclosure form.

"Public disclosure" of your invention through publication, presentation at conferences, poster sessions, web site postings, classroom discussions, etc. will result in losing all rights to patenting in foreign countries. Failure to file a patent application with the U.S. Patent and Trademark Office within one year of a public disclosure results in complete loss of patenting rights.

What is public disclosure of an invention?  Does public disclosure affect the ability to get my invention patented?

Public disclosure of an invention can be any public written or oral discourse that describes the invention in detail. Publications that are “enabling” (allow one with ordinary skill in the art to arrive at the same invention without due experimentation) can disqualify one from receiving a patent.

Legally, “publication” is broadly interpreted to include journal articles, posters, slides, talks, conference proceedings, abstracts on the Web, theses and dissertations that are available to the public, and discussions with corporate researchers and company personnel. Research group meetings that are not open to the public, communications with one’s granting agency that are not made public, and confidential discussions, including disclosing your invention to Research Affairs - Technology Transfer, are not deemed to be public disclosure.

In the U.S., there is a one-year grace period after an enabling public disclosure during which an invention is still eligible for patent protection. In most foreign countries, however, there is no grace period; if the invention was made publicly known before a patent was applied for, the patent protection is lost. Thus, before publicly disclosing any invention or discovery, investigators should first discuss intellectual property issues with Technology Transfer.

Can I still publish my findings?

Yes, findings can still be published, and disclosing the invention to Research Affairs should not alter your publication timetable. However, since publishing can affect the ability to obtain a patent, especially a foreign patent, it is best to submit an Invention Disclosure Form prior to publishing or communicating your findings in a public forum.

When should I submit an Invention Disclosure form?

It is best if inventors submit a disclosure between eight and 12 weeks before publication so that, if necessary, actions can be taken to protect both U.S. and foreign rights. Once publicly disclosed, an invention may not be patentable outside the United States. To be safe, inform Technology Transfer of any imminent or prior presentations that include the IP.

What happens after I complete the Invention Disclosure Form?

After the Invention Disclosure Form has been completed, Technology Transfer will contact you to discuss the invention and to explain Loma Linda’s patent process and procedures.

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Protecting an Invention

Patents

What is a Patent and what are the criteria the United States Patent and Trademark Office use to determine whether an invention is patentable?

A patent for an invention is the grant of a property right by the government, which allows the patent holder to exclude others from working the invention. Patents are issued by the U.S. Patent and Trademark Office (USPTO) and by similar government offices in foreign countries.

In legal language, what is granted is “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. Note that a right is not granted to make, use, sell, offer to sell, or import the invention--only the right to exclude others from doing so.  Sometimes the patent holder must license other patents in order to be able practice their invention.

An invention is considered by the USPTO to be patentable if it is new (it provides the public with something it did not previously possess); useful (it must have the effect claimed, and that effect must be useful to society, at least in principle); and non-obvious (it must be something that another person “of ordinary skill in the art” would not have been able to easily deduce; this can be subjective and is sometimes difficult to prove).

Sometimes an invention is patentable, but obtaining a patent is not necessarily the most effective intellectual property strategy for a particular invention. The market potential and commercialization strategy must also be considered in order to determine if it is appropriate to apply for a patent.

Why is LLU interested in patents?

LLU, as owner of inventions made by its faculty, students, and staff, can license patents to companies that know how to turn the invention into commercial products or services. Ideally, developing an invention into products and services desired by the public creates jobs, increases government tax revenues, and provides additional revenue to the inventor and university through patent licensing fees.

Who is considered an inventor on a patent and how is this determined?

Anyone who intellectually contributed to the conception of an inventive idea and/or the reduction to practice of the invention must be included as an inventor. A person who merely carried out the inventor's instructions during the reduction to practice stage, or acted only as a pair of hands does not qualify as an inventor. Similarly, the inventor’s supervisor (e.g., lab director) does not become a co-inventor merely because he or she is responsible for the lab. Accurately identifying all the inventor(s) is a prerequisite for a valid U.S. patent. Research Affairs - Technology Transfer does not make this determination. It is the patent attorney who prepares the application who assists with determining inventorship. It is important to clarify inventorship before a patent application is filed.

What are the benefits of patenting my invention?

One important benefit is that a patent secures LLU’s ability to market the invention to corporate or non-profit entities that further invest in its development, manufacture, and distribution. The period of exclusivity provided by the patent is an incentive to commercial development since it allows for a return on the investment a licensee makes in developing the technology. Transfer of the technology into the marketplace benefits the public by providing new goods and services.

Patenting benefits investigators by (1) demonstrating the uniqueness and value of their innovative work; (2) returning revenue to investigators and their departments, colleges, and schools; (3) helping investigators start companies around their inventions; and (4) providing the satisfaction of knowing they have benefited society by contributing new information that may lead to new or improved goods and services.

What is the patenting process at LLU?

Click here to review the LLU patenting process.

Who decides whether to file a patent application?  What criteria are used?

The decision to file a patent application is made by the LLU Vice President for Research Affairs (VPRA), in consultation with the inventor(s), Technology Transfer, and the recommendations of Intellectual Properties Committee. 

The VPRA does not pursue patent protection for all inventions/inventions disclosed to the institution. The determination is based on the scope of the invention, its commercial merit, and whether a patent is the appropriate intellectual property protection strategy given the commercial potential.

Other factors that argue against pursuing a patent include: (1) it would be easy for someone to work around the patent; (2) a patent would be unenforceable; or (3) more significant patentable material will result from developing the invention further.

Who prosecutes patents on behalf of Loma Linda University?

Technology Transfer uses outside patent counsel to prosecute patent applications.

What is prior art?

Prior art is relevant past technology that may be considered by the U.S. Patent and Trademark Office in evaluating novelty and non-obviousness.  If a patent application is filed in the U.S. , anything that has been published, used in public, offered for sale or sold by anyone before the inventor(s) made the invention, or more than one year before the application is filed, becomes a part of the prior art for that application.  The inventor’s own publications made within a year prior to the filing of the patent application do not prevent the innovator from obtaining a U.S. patent.  However, such publications do prevent foreign patents from being obtained, because of the requirement for absolute novelty.

What’s the inventor’s role in patenting?

Inventors will have ongoing communication with staff from Technology Transfer and the patent attorney during the patenting process. Also, inventors will need to review drafts of documents, sign assignments and other legal documentation.

How long does it take to obtain a patent?

From the date a patent application is filed to the date a patent is issued can take two to six years or more.

How much does it cost to obtain and manage a patent and who incurs the cost of patenting?

Obtaining and managing patent rights for an invention is very expensive; a U.S. patent can cost $30,000 to $50,000 over its 20 year life. Thus, universities are reluctant to pursue patenting unless cost recovery can be reasonably assured from a licensee. In almost all cases, LLU goes ahead with patenting when a commercial partner has been identified to pay the patenting costs. When there is no commercial partner, LLU may choose to incur the costs with the goal of recouping them from licensees as part of a commercialization agreement.

Who owns the patent?

Under LLU Intellectual Property Policy (section 3.4.10) in the Faculty Handbook, LLU inventors are required to assign the rights to any patents on inventions made using LLU resources to the institution. In exchange, LLU manages and licenses the patent on the inventor’s behalf, and pays inventors a share of the royalties earned from commercialization of the patented technology.

When will I begin to see revenue from my patented invention?

Investigators can expect to see revenue from the licensing of a patented technology when a licensee (such as an established company) commercializes the patented technology and returns revenue to LLU in the form of licensing fees paid and royalties earned from the sale of the technology. This can be a long process, taking from two to 10 years or more. See Royalties & Income for more details.

How much revenue can I expect to see?

The amount of revenue received from a patented and commercialized technology depends upon the current market for the technology, the conditions set forth in the licensing agreement, the type of technology being commercialized, and many other factors. The inventor/s will receive 1/3 of the revenue, after 10% has been paid to the institution for reimbursement of direct patenting and licensing costs.  See Royalties & Income for more information. 

What is a provisional patent application?

A provisional patent is a type of U. S. national patent that establishes an early effective filing date over the prior art.  A provisional patent application lasts 12 months from the date the provisional application is filed.  A corresponding non-provisional patent application must be filed during the 12-month provisional period in order to benefit from the earlier filing of the provisional application.  A provisional patent can be thought of a “place-holder” at the U.S. Patent and Trademark Office (USPTO), until a non-provisional application is filed.

What is a PCT application?

The Patent Cooperation Treaty or PCT is an international agreement for filing patent applications having effect in up to 117 countries.

Although the PCT system does not provide for the grant of an international patent, the system:

  • simplifies the process of filing patent applications;
  • delays the expenses associated with applying for patent protection in other countries;
  • and allows the inventor more time to assess the commercial viability of his/her invention.

Under the PCT, an inventor can file a single international patent application in one language with one patent office in order to simultaneously seek protection for an invention in up to 117 countries throughout the world. 

Is software patentable?

Software by itself is not patentable. However, there are many instances where patents may be obtained for various aspects of the software’s context, which can have much the same result as patenting the software:

  • The process the software performs or embodies;
  • A device the software emulates or helps create;
  • A device of which the software is an integral part (such as an innovative media product);
  • A new, non-obvious use for previously existing software.

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Copyrights

What is a copyright and what kinds of inventions/inventions have copyright protection?

Copyright is a form of protection grounded in the U.S. Constitution and granted by law for original works of authorship that are fixed in a tangible medium of expression. Digital media, software, databases, content, and images are all eligible for copyright protection.

When is my software or digital work protected by copyright?

Although your software or digital invention is under copyright protection the moment it is created and fixed in a tangible form, Research Affairs - Technology Transfer may suggest that copyright be federally registered for your work. Technology Transfer will discuss this option with you.

When is it useful to register copyright?

Taking the additional step of registering a copyright with the U.S. Copyright Office may be useful because:

  • Registration allows the copyright owner to sue for infringement and receive the statutory protection and compensation for damages and legal fees under the Copyright Act;
  • Registration notifies the world of the copyright and helps ensure author attribution to the copyrighted work;
  • Registration helps to define the duration of the copyright.

Where can I find more information on copyrighting?

For more information on copyright, visit the U.S. Copyright Office Website

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Confidential Disclosure Agreements

What are Confidential Disclosure Agreements and why are they important?

A Confidential Disclosure Agreement (CDA) is a legal document for the protection of proprietary information. Such a document is necessary before any transfer of proprietary information is made from one party (such as a university researcher) to another (such as a corporate representative). Otherwise, the transfer of proprietary information, even in a casual conversation, could legally be considered a public disclosure. In the worst case, such a disclosure could allow the individual or company to whom this information was disclosed to use or transmit to others your confidential information, thus placing the invention in the public domain. This would preclude the possibility of obtaining intellectual property protection and would even violate federal regulations.

It is important to contact Research Affairs - Financial Management before disclosing any confidential proprietary information to another party.

What is the CDA process at LLU?

See the process for both incoming and outgoing CDAs.  

Note:  Confidential Disclosure Agreements that are related to clinical trials are processed by the Clinical Trial Center (CTC). See the Clinical Trial Center's processing flowchart for industry-sponsored clinical trials.  This will explain how and when to initiate the CDA process and whom to contact with questions. 

You might also be interested in CTC's Contracts Guide for Clinical Trials.

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Trademarks and Service Marks

What is a trademark?

A trademark is “a word, phrase, symbol or design, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party (such as a manufacturer or seller) from those of others.” In short, a trademark is a brand name.

When is a trademark useful?

Trademarks can help you establish your product in the eyes of a consumer.  Trademarks help consumers know and recognize your product or service.  Trademarks can be registered at the state and federal level.

Do I register a trademark with the State or Federal Government?

Trademarks can be registered at the state and federal level.  Thus it is possible to have parallel protection for a trademark at the state and federal level.  State laws generally do not require registration, but have very limited protection.  Federal law requires registration, but grants trademark protection on a national level. 

To register a trademark in the state of California:  Visit the Secretary of State website at http://www.sos.ca.gov/business/ts/.

To register a trademark at the federal level:  Visit the U.S. Patent and Trademark office website at www.uspto.gov.

When is it useful to federally register a trademark?

Registering a federal trademark is a good idea as it establishes rights in a mark based on legitimate use of a mark.  Owning a federal trademark registration on the Principal Register, the list on which distinctive trademarks and service marks approved for federal regulation are placed, provides several advantages:

  • Constructive notice to the public of the registrant's claim of ownership of the mark;
  • A legal presumption of the registrant's claim of ownership of the mark and the registrant's exclusive right to use the mark nationwide on or in connection with the goods and/or services listed in the registration;
  • The ability to begin an action concerning the mark in federal court;
  • The use of the U.S. registration as a basis to obtain registration in foreign countries;
  • The ability to file the U.S. registration with the U.S. Customs Service to prevent importation of infringing foreign goods.

When can I use the trademark symbols TM, SM, and ®?

Any time you claim rights in a mark, you may use the “TM” (trademark) or “SM” (service mark) designation to alert the public to your claim, regardless of whether you have filed an application with the USPTO.  However you may use the federal registration symbol “®” only after the USPTO actually registers a mark and not while an application is pending.

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Licensing an Invention

What is a License?

Generally speaking, a license is a legally binding written document in which one party, having definable rights in a property, transfers or grants all or some part of those rights to another entity for some type of consideration.

What’s the inventor’s role in Licensing?

Research Affairs - Technology Transfer takes the lead on licensing LLU technologies, but the inventor will be consulted on the business terms of the license and will be informed of its progress. 

Further, the inventor’s expertise is often critically important to transfer the technology and related know-how to the licensee. When more than minimal time and effort is necessary to complete the transfer, however, the licensee should negotiate a separate consulting arrangement with the inventor.

What effect does a license have on my ability to do research?

You can still continue research using a licensed invention, even if it is exclusively licensed. The University retains the right to use a licensed invention in its academic research and teaching.

What is Open Source?

In the software community, Open Source is a forum in which multiple unaffiliated parties have access to the source code of a software program for the purposes of collaborative development. People who participate in the open source believe that more scrutiny brings greater reliability and that software is an evolving entity that can achieve its fullest potential without the restrictions of commercial sale.

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Royalties & Income

How are royalties and income from licensed inventions/inventions distributed between the institution and the inventor?  What LLU policy governs this?

When an invention, software or other intellectual property is successfully licensed or commercialized, the revenues are distributed according to the institutional Intellectual Property policy (section 3.4.10) in the Faculty Handbook

  • One-third (1/3) to the inventor(s);
  • One-third (1/3) to the school (the dean consults with the department and determines how it will be further distributed); and
  • One-third (1/3) to the University for support of research activities.

The Vice President for Research Affairs is ultimately responsible for equitable distribution of royalties and income and can negotiate variances from this policy on a case-by-case basis.  But variances must also have the approval of the school dean and the University Officers.

What is a Memorandum of Understanding for Royalty Distribution?

A Memorandum of Understanding for Royalty Distribution is a legal document in which multiple inventors on a patent agree among themselves to a particular distribution of royalty revenue obtained by licensing intellectual property.

How is Equity distributed?

Some companies, particularly start-up companies, will offer equity in lieu of cash payments.  Equity from a license is shared with inventors when it is cashed in by LLU.  However, once the licensee is obtaining revenues on the product, LLU will expect a portion of these revenues.

What are the tax consequences of royalties and income?

Licensing revenues are considered taxable income. The University reports licensing revenue paid to inventors as income on Form 1099. Your tax advisor can provide specific advice.

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Transferring Research Materials (Material Transfer Agreements)


 

What are Material Transfer Agreements (MTAs)?

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. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. MTAs protect the liability of both the investigator and the institution, and also protect any Intellectual Property rights on the research material.

Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. Each type calls for different terms and conditions.

A MTA is required before a LLU investigator may provide research materials to and from our institution.

What types of materials require MTAs?

Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds, and non-biological materials.

Why are MTAs important?

MTAs are important because they protect LLU intellectual property rights, limit LLU liability, and fairly credit the developer of the materials.

What is the MTA process at LLU?

Research Affairs Financial Management (RAFM) handles MTAs for the transfer of incoming and outgoing materials. See the MTA process for both incoming and outgoing research material. If the transfer is related to a clinical trial, the Clinical Trial Center will process the MTA.

What are potential Issues in MTAs

Confidentiality: When confidential information is exchanged along with the material, the company may request that such information not be further disclosed. If the information is necessary for interpretation of the research results obtained using the material, that same information may also be required for publication of those results. Having agreed to hold the information confidential could prohibit an investigator from ever publishing the results of work using the company’s material.

Delay in publication: In order to protect potentially patentable inventions, companies often demand a review period for the investigator’s manuscripts, abstracts or hard-copies of presentation materials. This demand may jeopardize the timeliness of publication.

Use of materials in sponsored research projects: Many industry MTAs contain language that prohibits the use of the material in research that is subject to licensing or consulting obligations to any third party, including the sponsor of the research project.

Definition of material: The industry provider may propose a definition of material that includes not only the original material, but also modifications or derivatives made from the material that incorporate the investigator’s original ideas or concepts. If the provider also claimed ownership of the modified material, the provider could own the results of the investigator’s research. The investigator could be prevented from using research results in further research, transferring them to other organizations, meeting obligations to research sponsors, or ensuring that the results are made public.

Loss of control of intellectual property: If MTAs preempt ownership rights; investigators may be restricted in their ability to interact with a future sponsor or may have conflicts with obligations to current sponsors. Intellectual property restrictions may prevent the institution from obtaining or conveying rights to future licensees.

Conflicts with existing agreements: Industrial MTAs may contain obligations that conflict with obligations in a preexisting agreement. Also, the material may be used in conjunction with a separate material received under another MTA. These situations could result in granting two or more parties conflicting rights to the same invention. When MTAs are used in conjunction with federally funded research, the federal government has certain rights to resulting inventions (Bayh-Dole Act).

What are the compliance issues?

MTAs for live animals or custom antibodies must have protocol(s) reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).

MTAs for human tissue require an Institutional Review Board (IRB) Approval or Exemption.

MTAs for stem cell lines require Stem Cell Research Oversight Committee (SCRO) approval.

MTAs for hazardous materials and/or select agents must follow the Environmental Health & Safety (EH&S) compliance procedures.

MTAs where the decision to undertake the research is based on receiving access to the material(s) from a nongovernmental provider must follow Conflict of Interest Committee requirements for financial disclosure.

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Transferring Data(Data Transfer Agreements)


 

What are Data Transfer Agreements (DTAs)?

A Data Transfer Agreement (DTA) is an agreement requesting a disclosure of protected health information (PHI) contained in a limited data set. Software and databases are protected by copyright, and require a specialized transfer agreement. DTAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data and data security measures that must be met in order to ensure that the data is kept secure.

What types of data require DTAs?

Types of data that require DTAs include data derived from human subject research or Health Insurance Portability and Accountability Act (HIPAA) protected information.

Why are DTAs important?

DTAs are used to prevent the inappropriate use of protected or confidential information that could cause harm to research subjects, the investigator or the institution.

What is the DTA process at LLU?

Research Affairs Financial Management (RAFM) handles DTAs for the transfer of incoming and outgoing data. See the DTA process for both incoming and outgoing research materials. If the transfer is related to a clinical trial, then the Clinical Trial Center may be responsible for the DTA.

What are the compliance issues?

DTAs involving human subjects require an Institutional Review Board (IRB) Approval or Exemption.

DTAs involving stem cell lines require Stem Cell Research Oversight Committee (SCRO) approval.

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