Working with Industry

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Wake Forest School of Medicine (d/b/a Wake Forest University Health Sciences) encourages and supports our faculty in seeking industry-funded research. Wake Forest School of Medicine (WFSM) authorizes the Office of Research to negotiate and to accept sponsored agreements on its behalf. The University has received national and international recognition in many areas. We are a major research center that averages 1000 research studies and clinical trials at any given time. Partnering with business and industry is important to WFSM and its public service and economic development mission. Read our letter to sponsors.

WFSM is a separate legal entity from Wake Forest University (WFU) and negotiations for agreements that include WFU must be conducted with its own authorized representatives.

Please use the agreement principles below to familiarize yourself with the policies of Wake Forest School of Medicine.

Authority to Contract

Faculty and staff are encouraged to discuss ideas for potential research projects with industry representatives. Actual work should not begin on a project until the appropriate documents are submitted through the WFSM's internal review process and both parties sign a mutually acceptable agreement. The Office of Research is authorized by WFUSM to negotiate and legally accept sponsored agreements on behalf of the University. Faculty members cannot obligate WFSM in this manner.

Parties 
Agreements shall be between the company and Wake Forest School of Medicine and not with the investigator personally.  Faculty members cannot be a party to agreements.

Confidentiality
While confidentiality provisions may assure sponsors of some protection against dissemination, WFSM is a place of open exchange among researchers and students in order to foster learning and to develop knowledge. The obligation to maintain secrecy and confidentiality is not “second nature.”

WFSM can agree to protect the sponsor's confidential information in the same way that it protects its own, assuring that it will not be published or presented publicly. However, to limit its liability, WFSM asks that sponsors restrict disclosure to essential information and clearly identify confidential information as confidential. WFSM also asks for an express limitation of its liability in the unlikely event of a breach of confidentiality; that is, the amount of money received by WFSM for its work on the project.

Data Ownership
As an academic institution, WFSM must ensure the data and information generated during the course of research remain widely available for academic dissemination and scientific validation.  As the grant recipient and the party obligated, through the investigator, to perform the research and to generate the raw data, WFSM is the legal owner of such data, with full rights to use and to publish them accordingly.  Retaining such rights in research projects allows WFSM to ensure that its faculty can pursue their research without undue impediments. Conceding study data ownership may impair the faculty member’s ability to publish the research.

Publications
The academic mission of WFSM and its status as a tax-exempt, nonprofit organization require that the faculty must be free to publish the results of their research in a timely manner and without censorship.  Because certain information supplied to WFSM during a study may be confidential and proprietary to the sponsor, sponsors will ordinarily be granted the right to review a proposed publication, normally not more than 30 days. This right is confined to review and comment and not to approve, to consent to, or to edit the publication. Sponsors may be given a limited right to delay publication in order to obtain protection for its confidential or proprietary information, however, such a delay should not normally be more than 60 to 90 days.

Intellectual Property  
WFSM owns inventions and discoveries, including copyrightable software, made by faculty and staff as part of sponsored research. The University can grant the sponsor the first opportunity, under commercially reasonable terms, a royalty-bearing exclusive license to the invention or discovery for commercialization under a limited term option. If the company insists on a longer option period, funding of continued research during such a period could be negotiated.

Indemnification
Research by nature is unpredictable and inherently involves some risk.  University research is conducted on a “best efforts” basis and without guarantee of successful results. WFSM requests that sponsors indemnify the university against all claims, damages, liabilities, costs, fines, penalties, losses, and expenses, except where WFSM engages in gross negligence or willful misconduct. The sponsor should represent that it has adequate insurance (or self-insured programs) to cover this indemnity and should agree to provide WFSM with evidence of such insurance.

Warranty
WFSM makes no representations or warranties, express or implied, under any agreement with respect to the services it performs thereunder and any deliverables resulting from such performance, including their condition, conformity to any representation or description, the existence of any latent or patent defects therein, and their merchantability or fitness for a particular use or purpose.

Governing Law

WFSM requires that North Carolina law govern all research agreements, since they are entered into and performed in North Carolina.  The university will also consider contractual silence regarding this issue.

Termination

Generally, either party may terminate the research agreement provided that either party determines that the research project is no longer academically, technically or commercially feasible.  However, WFSM cannot incur financial losses resulting from termination.  In the event an agreement is terminated, the sponsor will be expected to reimburse WFSM for all project costs incurred through the date of termination, including non-refundable start-up expenses, IRB fees, if applicable, and non-cancelable obligations.

Facilities and Administration Expenses
WFSM Facilities and Administration (F&A) rate is governed by our negotiated rate with the Department of Health and Human Services (DHHS).  The institution must charge industry the same rate as is applicable to all government-funded research, except for industry-sponsored clinical trials which have an established for-profit clinical trials rate. 

Quick Reference

Office of Research

Main Line 336-716-4548
Concern Hotline
877-880-7888

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Last Updated: 04-03-2014
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