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Contracts and Agreements

Wake Forest University Health Sciences (WFUHS) encourages and supports our faculty in seeking industry-funded research. 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 WFUHS and its public service and economic development mission. Please consult the WFUHS policies on industry contracts

WFUHS authorizes the Office of Sponsored Programs (OSP) to negotiate and to accept sponsored agreements on its behalf. OSP negotiates contracts that provide extramural support from industry, federal, foundation, state and local sponsors; material transfer agreements for receiving materials; material transfer agreements for providing materials to non-profit entities; and confidentiality agreements related to discussions involving possible research projects. 

Only authorized institutional representatives may execute contracts on behalf of the institution. Faculty members may not sign contracts in the name of the institution. WFUHS 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.

Make sure to submit all required routing documents to the Office of Sponsored Programs. OSP cannot begin negotiations until all required documents are received. Please review the Guidelines for Sponsored Programs Requiring Internal Review, as some sponsors may necessitate additional steps in the process. 

Clinical Trial Agreements

Clinical Trial Agreements are contracts that govern rights and obligations of WFUHS and the research partner in conduct of a clinical trial. Conducting clinical trials is an integral part of our institution’s mission by improving the health of our region, state and nation through the generation and translation of knowledge to prevent, diagnose and treat disease.

Clinical Trial Agreements protect the institution, faculty, research personnel and study subjects; protect the academic freedom (publication), non-profit status, intellectual property and financial resources of WFUHS; outline financial terms; and are the basis for how the study is conducted, managed and paid for from a legal standpoint.

Master/Standard Clinical Trial Agreements

Clinical Trials

A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

If you have a question about whether your study fits this qualifying definition, please contact Robyn Gore at 716-2846 or rgore@wakehealth.edu.

Relevant Policies

Additional Resources

For help navigating ClinicalTrials.gov, please contact Issis Kelly Pumarol at ikellypu@wakehealth.edu or (336) 716-8372.

Confidentiality Agreements

Confidentiality Agreements are contracts that manage the use and disclosure of confidential or proprietary information. Other names for these contracts include Confidential Disclosure Agreement, Non-disclosure Agreement (NDAs) or Secrecy Agreements.

Master/Standard Confidentiality Agreements

When Will I Need a CDA?

Examples of discussions where CDAs are commonly signed include:

  • receiving a protocol from a company or other institution to evaluate participation in a clinical trial or research project;
  • submitting a protocol to a company to request financial and/or product support;
  • submitting a protocol to a collaborator to consider participating in a clinical trial or research project; or
  • discussing a possible collaboration, such as a grant to be submitted, with another institution.

Points to Consider

CDAs require an authorized institutional signature which is provided by the Office of Sponsored Programs. Investigators are not authorized to sign on behalf of the institution.

Principal Investigators will often be asked to sign a CDA as “Read and Acknowledged”. This does not make the Principal Investigator a party to the agreement; rather it is a way for the Sponsor and the Institution to protect their interests and to ensure that the Principal Investigator is aware of his/her obligations of confidentiality prior to the disclosure of proprietary information.

Note: If the disclosing of confidential information is related to licensing or commercialization of technology, the CDA is managed by Product Innovation and Commercialization Services.

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Cooperative Group Arrangements

Cooperative Group Agreements have historically been put into place by sponsors who want to fund a specific area of research and utilize the power of multiple institutions and sites to achieve the best research knowledge. Many cooperative group arrangements are funded by federal funds (NCI). Please note that Cooperative Groups do not include multi-center consortiums or multisite clinical trials as seen in many typical industry funded trials.

These arrangements have typically been put into place under a structure of a master agreement which describes the overall intent of the collaborative group, how interactions and memberships will be handled and the structure under which a site can choose to participate in one of the individual studies.

WFUHS involvement in Cooperative Group Arrangements is evolving in response to sponsor changes, economic climate and institutional priorities. Resources will be added to this site as they become available.

More Information

Resources originally posted 1/1/2015. Last updated 3/20/2015.

Material Transfer Agreements

Material Transfer Agreements (MTAs) are contracts that govern the transfer of tangible research materials or animals between two organizations, when the recipient intends to use it for his or her own research purposes.  The purpose of a MTA is to define the rights of the provider and the recipient to the materials and any derivatives.  

Master/Standard Material Transfer Agreements

When Will I Need a MTA? 

MTAs are used when tangible research materials are shared between two institutions. Examples of research materials may include:

  • reagents
  • cell lines
  • plasmids
  • vectors
  • chemical compounds
  • animals 
  • software.

If the transfer is part of a clinical trial, collaboration, or basic research project under a grant or contract, the transfer may be covered in the project contract and a separate MTA may not be necessary.  Contact the Office of Sponsored Programs if questions on whether a MTA is needed. 

Points to Consider

  • MTAs for live animals must have protocol(s) reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).
  • MTAs for human tissue must have protocol(s) reviewed by the Institutional Review Board (IRB).
  • MTAs for hazardous materials and/or select agents must follow EH&S compliance procedures.
  • MTAs require an authorized institutional signature which is provided by the Office of Sponsored Programs.  Investigators are not authorized to sign on behalf of the institution.

Note: If the transfer of materials/animals is to a for-profit entity, the transfer is managed by Product Innovation & Commercialization Services.

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Master Agreements

A Master Agreement is a pre-negotiated contract that can be used for multiple studies and that manages the relationship between the sponsor or other entity who is supporting the study/project by providing study drug or device, financial support, proprietary information or some combination of these items.  The advantage of having a Master Agreement in place with a pharmaceutical or medical device company is that it speeds up the contractual process for each individual study by requiring only the negotiation of study-specific requirements (i.e. budget, number of subjects to be enrolled, etc.).

The Office of Sponsored Programs (OSP) has pre-negotiated Master Agreements for various types of projects. If an Investigator wishes to work with one of the entities in which we have a Master Agreement in place, the specific study information, including the Required Routing documents should be submitted through InfoEd to the Office of Sponsored Programs so that OSP can provide assistance in order to execute a study specific addendum to the applicable Master Agreement.

Generally speaking, the OSP evaluates whether or not to engage a pharmaceutical company or medical device company in Master Agreement negotiations based on the frequency in which it negotiates research or clinical trial agreements with a given company. If you would like to inquire as to the feasibility of a Master Agreement with a specific company, contact Robyn Gore at rgore@wakehealth.edu or 336-716-2846.

List of Agreements

Research Collaboration Agreements

Research Collaboration Agreements are contracts that govern rights and obligations of WFUHS and research partners in conduct of directed, collaborative, or joint research of mutual interest to the researcher and the company (or other supporting entity or collaborator). These agreements include shared rights and access to the results. Conducting collaborative research is an integral part of our institution’s mission by improving the health of our region, state and nation through the generation and translation of knowledge to prevent, diagnose and treat disease.

Research Collaboration Agreements

  • Protect institution, faculty and research personnel
  • Protect academic freedom (publication), non-profit status, intellectual property and financial resources of WFUHS
  • Outlines financial terms
  • Basis for how the study is conducted, managed and paid for from a legal standpoint

Master Research Collaboration Agreements

Subcontracts

Subcontracts are legally binding documents that set forth the terms and conditions between the parties. All terms and conditions of the Prime award or contract must be included in the subcontract. Money flows out under the subcontract. Signature of acceptance of the subcontract terms by the sub-recipient institution official is required. 

The Office of Sponsored Programs negotiates the following subcontracts: 

  • all incoming and outgoing subcontracts from industry, federal, foundation, state and local sponsors; 
  • all outgoing subcontracts with industry funding or non-financial support; 
  • all outgoing subcontracts to industry partners with federal, foundation, state, or local funding.

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