Frequently Asked Questions
General
- What services and resources are available to faculty and departmental administration?
- Why must I have the industry relations section review these documents?
- What legal entity should be used for agreements?
- How do I know when I should have an industry research agreement versus a personal consulting agreement?
- Will the industry relations section review and negotiate personal consulting agreements?
- If I’m an employee of the institution, do I have to assign my intellectual property rights to the institution?
- If I choose not to publish, is it necessary to have publication language in an agreement?
- What steps do I need to take if there is a conflict of interest?
- What is Clinical Trials.gov, and how do I register for a trial?
Confidential Disclosure Agreements
- What is a confidential disclosure agreement?
- How long does it typically take to negotiate a CDA?
- How will I know when it is completed?
- Who is authorized to sign a CDA on behalf of the institution?
- What if a sponsor asks me to sign a non-disclosure/confidential agreement?
Material Transfer Agreements
- What is a material transfer agreement?
- What if I want to receive material from a company, what do I do?
- What if I want to receive material from a collaborator at another university, what do I do?
- What if I want to send material to a company, what do I do?
- What if I want to send material to a collaborator at another university, what do I do?
- How do I know when my MTA is completed?
- What if I have intentions of using material from another source with the material I am requesting? What additional information do I need to provide?
- How long does it typically take to negotiate a MTA?
- If I’m using NIH dollars to fund my research project, what other information is required before the MTA can be processed?
- What additional information can I provide to expedite processing of MTA?
- Who is authorized to sign a MTA on behalf of the institution?
Research Agreements
- What is a research agreement?
- What documents are required to initiate negotiations of a research agreement?
- Is it necessary to route an industry research agreement?
- What circumstances would warrant a research agreement not getting signed?
- How do I know when the agreement has been resolved so that I can start my study?
- Who owns the data that is generated from an industry research agreement?
- How are inventions developed under a research agreement handled? What if a sponsor refuses to accept WFUHS intellectual property language under a research agreement?
- Will I be able to publish the results from the work I will be performing?
- Can I start work on a project if I feel it is taking too long to negotiate?
Budgets and Financial Information
- Who is responsible for negotiating the budget?
- Who reviews and signs budget letter agreements?
- What fees should I request upfront in order to start my study?
- Who should the checks be made payable to?
- Where should the checks be sent?
- What steps do I need to take in order to close out a study?
Answers
General
1. Q. What services and resources are available to faculty and departmental administration?
A. Industry Relations (IR) reviews and approves all research-related agreements for research supported by industry, as well as some research-related agreements with other academic institutions. This includes confidentiality, incoming material transfer, basic and clinical trial agreements, as well as subcontracts, with industry. It also includes both incoming and outgoing material transfer agreements, non-federal or foundation funded subcontracts, and collaborations with academic institutions. IR also reviews and approves all budgets for industry supported research to ensure appropriate fees and facility and administration assistance is also available.
2. Q. Why must I have the industry relations section review these documents?
A. Industry Relations is charged with ensuring that all agreements that are entered into are consistent with the institutions polices and all fiscal and regulatory requirements are met.
3. Q. What legal entity should be used for agreements?
A. All contracts are entered into by Wake Forest University Health Sciences.
4. Q. How do I know when I should have an industry research agreement versus a personal consulting agreement?
A. Faculty members should always use an industry agreement when the resources of the institution are being committed to complete all or part of the scope of work. In most cases, a personal consulting agreement is appropriate when a faculty member is performing work on his/her own time and outside contractual commitment and not using institutional resources.
5. Q. Will the industry relations section review and negotiate personal consulting agreements?
A. Industry Relations does not review or negotiate personal consulting agreements. Individuals should seek legal counsel to review these arrangements. These agreements must not conflict with an individual’s obligations to the university or obligate the university. IR can answer questions to confirm whether any university polices conflict with the proposed agreement or if it obligates the university.
6. Q. If I’m an employee of the institution, do I have to assign my intellectual property rights to the institution?
A. The university’s invention policy (O&P Manual, Section IV) provides that all employees are required to assign (transfer ownership) any inventions developed using institution resources as part of employment to the university.
7. Q. If I choose not to publish, is it necessary to have publication language in an agreement?
A. All research agreements require that the university retain the right to publish the results of its research due to the university’s status as a tax-exempt, non-profit institution.
8. Q. What steps do I need to take if there is a conflict of interest?
A. If you have a conflict of interest, contact the assistant director of Conflict of Interest to discuss the process required to evaluate your conflict. If you are unsure if you have a conflict of interest, please review the Conflict of Interest section of the Office of Research website or contact the assistant director of Conflict of Interest.
9. Q. What is Clinical Trials.gov, and how do I register a trial?
A. This document contains instructions for Clinical Trials.gov
Confidential Disclosure Agreements
1. Q. What is a confidential disclosure agreement?
A. A Confidential Disclosure Agreement (CDA) is an agreement that allows for the sharing of confidential or proprietary information. These agreements define the information to be shared and how the information may be used. CDA’s may also be referred to as Non-disclosure Agreements or NDA’s.
2. Q. How long does it typically take to negotiate a CDA?
A. Industry Relations reviews CDA’s as they are received. The time it takes to negotiate or approve for signature depends on the terms contained in the proposed CDA. At times CDA’s may restrict publication and affect future invention rights, potentially requiring a lengthier negotiation process.
3. Q. How will I know when it is completed?
A. Once a CDA is completed and signed by WFUHS and the company/other institution, a copy will be sent to the PI/coordinator.
4. Q. Who is authorized to sign a CDA on behalf of the institution?
A. All contracts must be signed by an authorized institutional representative of WFUHS.
5. Q. What if a sponsor asks me to sign a non-disclosure/confidential agreement?
A. Faculty members are not authorized to sign CDA’s on behalf of WFUHS. If a faculty member signs a CDA, it obligates the faculty member individually. If a company asks you to sign a CDA, route it to IR for review and approval.
Material Transfer Agreements
1. Q. What is a material transfer agreement?
A. A material transfer agreement is an agreement that provides for the transfer of materials such as cell lines, reagents or animals.
2. Q. What if I want to receive material from a company, what do I do?
A. If a company agrees to provide you with materials, they will normally require a MTA. Send the MTA along with a completed Material Transfer Agreement Questionnaire - Incoming to IR for review and approval.
3. Q. What if I want to receive material from a collaborator at another university, what do I do?
A. If a collaborator agrees to provide you with materials, send the MTA along with a completed Material Transfer Agreement Questionnaire – Incoming to IR for review and approval.
4. Q. What if I want to send material to a company, what do I do?
A. Contact the Office of Technology Asset Management (OTAM). All materials being sent to a company are managed by OTAM under a license or appropriate agreement.
5. Q. What if I want to send material to a collaborator at another university, what do I do?
A. Send a completed Material Transfer Agreement Questionnaire – Outgoing to Industry Relations. IR will draft a MTA and discuss its terms with you and negotiate an appropriate agreement with the other institution.
6. Q. How do I know when my MTA is completed?
A. Once IR has received a fully-executed MTA from the other institution, a copy will be providing to you and you will be able to ship the materials.
7. Q. What if I have intentions of using material from another source with the material I am requesting? What additional information do I need to provide?
A. Using materials from two different sources requires IR to be sure the terms of each MTA do not conflict, for example, invention rights. If you intend to use materials from multiple sources, please indicate on the questionnaire each material, the source and whether it was received under a MTA.
8. Q. How long does it typically take to negotiate a MTA?
A. Negotiation times for MTA’s vary depending on the materials and the provider’s requirements. Academic institutions are encouraged to use the Uniform Biological Material Transfer Agreement (UBMTA). If this is used, it is a short document that is quickly processed as no negotiations are necessary. MTA’s from companies may be very restrictive. All MTA’s need to be in conformance with university policies, especially related to publications and inventions. There are various factors within an individual’s research project that can affect the issues to be negotiated and thus the length of time to complete an MTA.
9. Q. If I’m using NIH dollars to fund my research project, what other information is required before the MTA can be processed?
A. If government funding is used to support research, the invention language must be in conformance with Bayh-Dole. We cannot grant ownership rights to a third party and the government must retain rights to use the inventions. It is important that IR be aware of funding being used to support research and be sure the university is in compliance with these regulations.
10. Q. What additional information can I provide to expedite processing of MTA?
A. To facilitate the review process, please be sure that the appropriate questionnaire is provided, along with any additional information that may be helpful about the project. If there are particular provisions you have concerns with in the proposed MTA, please note that information as well.
11. Q. Who is authorized to sign a MTA on behalf of the institution?
A. All contracts must be signed by an authorized institutional representative. IR will obtain signature of appropriate individuals as part of its processing of the MTA.
Research Agreements
1. Q. What is a research agreement?
A. A research agreement is a contractual document that outlines the scope of the project, the terms and conditions under which the project will be conducted, and the financial support to be provided.
2. Q. What documents are required to initiate negotiations of a research agreement?
A. To initiate review of a research agreement, a routing package consisting of a completed Route Form, a Research Agreement Questionnaire, a copy of the Protocol, the proposed contract, if received, your internal budget, the external budget and, for clinical trials, a copy of the proposed consent form should be submitted. At a minimum, the Route Form, Questionnaire and Protocol need to be submitted for review to be initiated. If the budget is still in negotiation, this information can be indicated on the Route Form and submitted once finalized.
3. Q. Is it necessary to route an industry research agreement?
A. Yes, all research agreements must be routed to IR for review and approval. IR is charged with making sure all research contracts are in compliance with fiscal and regulatory requirements and institutional polices.
4. Q. What circumstances would warrant a research agreement not getting signed?
A. Negotiations of a research agreement vary depending on the scope of the project and whether the company is willing to agree to our institutional requirements. There are certain obligations as an academic, non-profit institution that all research agreements must be in conformance with. Additionally, WFUHS has established certain policies for the protection of the institution, its research personnel and research subjects. Agreements must also be in conformance with those requirements. Non-agreement to any of these particular requirements by a company could mean we are unable to execute an agreement.
5. Q. How do I know when the agreement has been resolved so that I can start my study?
A. Once a research agreement is fully-executed and all institutional approvals are obtained, IR will provide a copy of the agreement to the investigator and his research administrator or study coordinator. All studies require institutional approval (e.g., IRB or ACUC) and a fully-executed agreement before initiation.
6. Q. Who owns the data that is generated from an industry research agreement?
A. WFUHS policy provides that WFUHS owns all data generated by research conducted here.
7. Q. How are inventions developed under a research agreement handled? What if a sponsor refuses to accept WFUHS intellectual property language under a research agreement?
A. WFUHS policy provides that any inventions arising out of research conducted here are owned by WFUHS. If a sponsor insists upon own inventions, IR will consider making an exception to this policy. However, there are other restrictions that may govern our ability to make an exception such as Bayh-Dole and IRS regulations governing WFUHS due to the use of bond funding for construction and renovation of buildings. Any such exception will also be considered in discussion with the investigator for the project.
8. Q. Will I be able to publish the results from the work I will be performing?
A. Yes. As an academic, non-profit institution, the university is required to retain its right to publish the results of the research without consent or approval of any sponsors. Periods of review and minimal delays, especially in multi-center studies, may be agreed to.
9. Q. Can I start work on a project if I feel it is taking too long to negotiate?
A. No. A study cannot be initiated until both appropriate institutional approvals (IRB/ACUC) are in place and a contract is executed. Doing so can put the institution and any subjects, if in clinical trials, in jeopardy.
Budgets and Financial Information
1. Q. Who is responsible for negotiating the budget?
A. The Principal Investigator is responsible for negotiations of the budgets in conformance with institutional requirements. IR can assist with gathering information, answering questions about our Facilities & Administration (F&A) policy, and negotiating the budget.
2. Q. Who reviews and signs budget letter agreements?
A. Because the Principal Investigator is responsible for the negotiations of the budgets, he/she executes the budget letter. If the budget letter includes any information other than budget and payment terms, contact IR for assistance. Budget letters should not contain any terms other than budget amounts and payment terms. At times companies may request an institutional signature in addition to the Principal Investigator’s signature on budget agreements. If that is the case, please route to IR for review.
3. Q. What fees should I request upfront in order to start my study?
A. To make sure you have the funds available to initiate a study, an upfront, non-refundable payment should be requested. The amount of this payment will vary depending on the amount of the total budget, the project and length of the study. Things to consider in calculating this amount include: effort to prepare the study for regulatory submission, expenses to prepare for screening/enrolling initial subjects and other expenses consistent with preparing for and initiating a study. For assistance, please contact IR.
4. Q. Who should the checks be made payable to?
A. Checks should by made payable to Wake Forest University Health Sciences.
5. Q. Where should the checks be sent?
A. All checks are required to be sent to IR for processing. IR ensures checks are applied to the account specific to the study so that all funding and expenditures are appropriately tracked for each study.
6. Q. What steps do I need to take in order to close out a study?
A. If a study is completed or terminated; contact Industry Relations, the Controller’s office and IRB/ACUC, as appropriate. If the close out requires assistance with collecting remaining sums due or a request for over payment by the company, IR can assist.