Corporate Research Agreements

Responsible Office: Division of Sponsored Programs, Research and Innovation
Current Approved Version: 08/20/2020
Policy Type: Administrative

Policy Statement and Purpose

In support of all potential research-related endeavors, Virginia Commonwealth University (VCU) is committed to reviewing a research agreement with a corporate entity for compatibility with VCU’s principles and compliance with applicable laws. Toward that end, this policy outlines the explicit requirements and principles for conducting corporate research at VCU. This policy also provides the requisite procedures for seeking university review, negotiation, and execution of corporate research agreements, including clinical trial agreements, material transfer agreements, non-disclosure agreements, research agreements, and service agreements. In support of VCU’s mission, corporate research projects and the review of these agreements must preserve the public’s trust, support the spirit of shared governance, and contribute to VCU’s commitment to transparency.

Principles

First and foremost, corporate research relationships must conform to VCU policies in support of investigators’ academic freedom and mitigate conflicts of interest that could affect or create a perception of affecting the research itself. Both the individual engaging in corporate research and the agreement setting forth the research relationship must respect the following principles:

1. Compatibility with VCU’s Mission - Corporate research must be consistent with VCU’s comprehensive mission and should be aimed at promoting the health and welfare of people and their communities, and/or providing meaningful public benefit through research outcomes, research training, or other benefits to the university, faculty, students, and/or community. Involvement of students and/or trainees in corporate research is appropriate when in support of the instructional learner-centered mission of the university.

2. Investigator Autonomy - VCU supports faculty who wish to undertake corporate research, provided the research is consistent with the mission of VCU and the research agreement conforms to the policies and procedures of the university. No investigator is required to participate in corporate research. Principal investigators are free to accept or reject a proposal for corporate research.

3. Responsible Conduct of Research - Established principles and procedures related to ethics and scientific integrity of research apply to all research activities, including corporate research

4. Conflict of Interest Considerations - VCU affirms that all research conducted at the university must be consistent with state and federal law related to conflicts of interest and all sponsored projects must comply with university policies (including Conflicts of Interest in Research and Institutional Conflicts of Interest in Research) that define the process for identifying, evaluating, managing, and reporting financial relationships that have or may appear to have an impact on the objectivity and integrity of the research conducted. VCU requires strict adherence to these established policies in the proposing, performing, reviewing, and reporting of research.

5. Conflict of Commitment Considerations - A conflict of commitment could arise when a researcher engages in external activities that interfere with the researcher’s primary obligation and commitment to the university. Researchers, under the supervision of their chairs and deans, should consider potential conflicts of commitment and manage external interests in order to avoid compromising their ability to carry out their primary obligations the university.

Explicit Requirements

A. All corporate research agreements must comply with the following requirements:

1. Administration and Signature Authority – The Division of Sponsored Programs in the Office of the Vice President for Research and Innovation is responsible for the negotiation and administration of agreements for corporate research. The designated signatory is determined by the vice president for research and innovation, in accordance with the Delegation of Signatory Authority policy.

2. Binding Arbitration – Pursuant to Virginia law, VCU employees do not have the authority to enter into binding arbitration or to agree in contract to foreclose any remedies that would otherwise be available by law. Any agreement must provide that any disputes arising under the agreement are resolved amicably or that the university’s available remedies are preserved.

3. Indemnification – Pursuant to Virginia law, VCU may not enter into an agreement to indemnify any person or entity against damages arising from a sponsored project conducted by VCU.

4. Intellectual Property (IP) and Research Data Ownership – Intellectual property created solely by university parties during the conduct of corporate research and the financial proceeds resulting from commercialization of such VCU‐created intellectual property must be addressed consistent with VCU’s Intellectual Property Policy. Research data is governed by the Research Data Ownership, Retention, Access, and Security policy.

5. Non-Disclosure and Confidentiality

a. General: Proprietary or confidential information (which may include corporate entity‐generated information as well as information or data generated by the investigator) may be disclosed prior to or during the conduct of the study and should be appropriately marked or otherwise identified by the discloser as confidential at the time of disclosure. Such information may be received and maintained under a promise of confidentiality for a period as described below. This time period must be agreed upon by both the corporate entity and the principal investigator.

b. Confidentiality Disclosure Agreements: A corporate entity may require the university to enter into confidentiality disclosure agreements for the express purpose of disclosing proprietary or confidential information to the proposed principal investigator to determine their interest in participating in a study. Information disclosed for this purpose may be received under a promise of confidentiality for a period not to exceed seven (7) years from the expiration/termination of the agreement, or alternately, ten (10) years from the date of disclosure.

c. Subsequent corporate research agreements will be negotiated using the preferred confidentiality terms not to exceed seven (7) years from the expiration/termination of the agreement, ten (10) years from the date of disclosure of confidential information as stipulated above, or, for agreements for clinical research studies, five (5) years from the completion of the study at all sites identified by the locking of the database.

d. Restrictions: As a public university, VCU must disclose public records in accordance with the Virginia Freedom of Information Act. All corporate research agreements must be consistent with this legal requirement.

e. VCU will not accept trade secrets.

6. Publication Rights – VCU affirms the right of investigators, faculty, students, and trainees to publish results of their research in a timely manner without constraint or interference from any party. University parties must be free to share, publish, or publicly present their research results. Corporate research agreements with VCU must explicitly provide for the open communication of research results and not be subject to the corporate entity’s permission for publication. VCU recognizes a corporate entity’s obligation to protect its confidential and proprietary information. In addition,

a. All corporate research agreements, including service agreements, may not prohibit the publication of general scientific results. VCU may permit a corporate entity to review research materials that include a corporate entity’s proprietary information prior to publication, given the following parameters:

• Reviews by corporate entities generally should not delay submission for publication for more than one hundred twenty (120) days. This time frame is for review of materials and for the purpose of securing patent protection as needed.

• Multi‐site clinical research agreements may include publication delays not to exceed twenty-four (24) months to permit data coordination among the multiple sites.

7. Retention of Documents – Documents created or received under this policy are subject to the Virginia Public Records Act (§§ 42.1‐77 and 42.1‐86.1 of the Code of Virginia). Documents must be retained for a minimum of five (5) years as set out in the Library of Virginia’s Records Management General Schedules for State Agencies; however, longer retention periods may be required if otherwise stipulated by contractual or federal obligations.

B. Corporate-Initiated research agreements must comply with the following additional requirements:

1. Full Cost Recovery – All corporate-initiated research must recover the full costs (all costs associated with research activities sponsored), including the direct and facilities and administrative (F&A) costs.

2. Research-Related Injury Coverage in Clinical Research – In accordance with elements of informed consent (21 CFR §50.25 (6-7)), VCU agreements with corporate sponsors of corporate-initiated clinical research involving greater than minimal risk must include clear and appropriate provisions for ensuring adequate compensation for medical care in the case of research-related injury.

Corporate agreements for clinical research studies where the corporate entity holds the Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) and controls the study protocol should stipulate that the corporate entity will fund medical care costs for research-related injury. Incidences of research-related injury must be determined to be probably or definitely related to the research study, wherein the condition would not have existed outside of participation in the research. Such determinations must be made by VCU, together with the corporate entity.

VCU may execute contracts where research-related injury is defined with study-specific exclusions, such as injury or illness which is:

• Primarily due to a participant’s underlying medical condition or progression of disease

• Associated with the known risks of routine patient care portions of the study

• Attributable to the negligence or willful misconduct on the part of the university

Noncompliance with this policy may result in disciplinary action up to and including termination. VCU supports an environment free from retaliation. Retaliation against any employee who brings forth a good faith concern, asks a clarifying question, or participates in an investigation is prohibited

Who Should Know This Policy

All university parties involved in or contemplating a corporate research agreement are responsible for knowing this policy and familiarizing themselves with its contents and provisions.

Definitions

Agreement

A generic name for a grant, contract, or other written arrangement which is enforceable by law and must be executed in accordance with the VCU policy entitled Delegation of Signatory Authority.

Clinical Trial

A type of a clinical research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (Source: National Institutes of Health [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html]).

Conflict of Commitment

Activities outside of the workplace, either paid or unpaid, that affect or appear to affect an individual’s primary obligation to the university or performance of university responsibilities.

Corporate Entity or Corporate Research

A for‐profit organization providing full or partial support for a research activity. Additional conditions include:

• Corporate Initiated – where the corporate entity initiates the research activity.

• Corporate Sponsored – where the corporate entity fully covers all costs associated with the research activity. In a clinical trial, this would include all research-related clinical care costs.

• Corporate Support – where the corporate entity supports a portion of the project in the form of materials, financial support, or other resources.

Facilities and Administrative (“F&A”) Costs

Facilities and Administrative costs, also referred to as indirect costs, are those costs incurred in support of many activities and that cannot be identified with a single sponsored project. The cost of operating and maintaining buildings, use of equipment, general and departmental administrative expenses, sponsored projects’ administration, and library costs are usually considered F&A costs. These costs are essential in the support of sponsored program activities. In accordance with regulations and principles promulgated by the Federal Office of Management and Budget (“OMB”), institutions of higher education are permitted to recover F&A costs associated with supporting sponsored programs.

Intellectual Property

Any new and useful process, machine, composition of matter, article of manufacture, software, or any original work of authorship subject to copyright protection.

Principal Investigator (PI)

The individual with overall responsibility for the conduct of research or other activity described in a proposal, protocol, or an award, and/or the individual with fiduciary responsibility for award management.

Research Data

Recorded information, regardless of form or the media on which it may be recorded, which constitute the original observations and methods of a study and the analyses of these original data that are necessary for reconstruction and evaluation of the report(s) of a study made by one or more investigators. Research data also includes all such recorded information gathered in anticipation of a report. Research data differ among disciplines. The term may include, but is not limited to, technical information, computer software, laboratory and other notebooks, printouts, worksheets, other media, survey, memoranda, evaluations, notes, databases, clinical case history records, study protocols, statistics, findings, conclusions, samples, physical collections, other supporting materials created or gathered in the course of the research, tangible research property, unique research resources such as synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA as well as genetic sequences and mapping information, crystallographic coordinates, plants, animals and spectroscopic data, and other compilations formed by selecting and assembling preexisting materials in a unique way. The term does not include information incidental to research administration such as financial, administrative, cost or pricing, or management information.

Research Development Advisory Council (ReDAC)

Inaugurated in 2006, its members are associate/assistant deans for research or individuals who hold comparable responsibilities for research development within their respective college/school. Council members represent the research interests of each of the schools and colleges at VCU for their constituencies, and serve as a conduit of information from, and resource asset to, the Office of the Vice President for Research and Innovation (OVPRI). The council meets regularly with the vice president for research and innovation and the associate vice president for research development to address topics of specific interest to the VCU research enterprise and to identify resources and supports necessary for increasing the strength and competitiveness of VCU as a research university.

Trade Secret

Information, including a formula, pattern, compilation, program device, method, technique, or process, that: (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use; and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

University Party [f/k/a "University Member"]

Any person engaged, participating in, or directly or indirectly supervising a university research-related activity, including but not limited to a full‐ or part‐time faculty or staff member; VCU official; student assistant; student, fellow, or trainee; visiting faculty member or researcher; volunteer; agent of VCU or the VCU Health System; or, when covered by a sponsored program agreement or other contractual arrangement, a contractor, subcontractor, subawardee, or their respective employees.

Contacts

The Division of Sponsored Programs officially interprets this policy. The Division of Sponsored Programs is responsible for obtaining approval for any revisions as required by the policy Creating and Maintaining Policies and Procedures through the appropriate governance structures. Please direct policy questions to the director, Industry and Clinical Trials, in the Division of Sponsored Programs.

Policy Specifics and Procedures

The VCU Division of Sponsored Programs is responsible for the review, negotiation, and execution of corporate research agreements. In support of an expeditious agreement process, corporate entities are encouraged to consider VCU requirements in advance of offering a research agreement. Individuals are encouraged to share this document in advance with any and all corporate entities.

Exception Process – Requests for exceptions are initiated by the Division of Sponsored Programs in consultation with the principal investigator.

The vice president for research and innovation may consider limited requests for exceptions to policy requirements on a case-by-case basis. When doing so, the vice president for research and innovation will inform the Research Development Advisory Council (ReDAC) of the vice president for research and innovation’s intention to allow an exception in a pending agreement. A ReDAC review of any planned exception will be initiated if such a request is made by a majority of its members. In certain cases, the vice president for research and innovation may request that ReDAC provide a review. Following their review, the ReDAC will provide an official recommendation to the vice president for research and innovation. ReDAC has the right and responsibility to recruit and engage faculty experts in their review of any agreements. The vice president for research and innovation will report to the Faculty Senate on a regular basis about review activities and decisions that fall outside the norms of this policy. The vice president for research and innovation will make the final decision on acceptance or rejection of corporate research agreements undergoing the exception process, in consultation with ReDAC.

Concerns - If any university party believes that any proposed corporate research agreement has the potential to be in conflict with the mission and goals of the university or otherwise potentially negatively impact the university, they should submit a letter of concern to the ReDAC member of the respective school. The ReDAC member may request to have that potential project reviewed by the vice president for research and innovation and/or ReDAC. Alternatively, university parties may utilize the VCU Helpline and/or contact the Office of the Ombudsperson.

Forms

There are no forms identified for this policy and procedures.

Revision History

This policy supersedes the following archived policies:

Approval/Revision Date	Title
05/15/2009	Policy on Corporate‐Sponsored Research Agreements
11/11/2010	Policy on Corporate‐Sponsored Research Agreements
04/05/2012	Policy on Corporate‐Sponsored Research Agreements
01/23/2017	Corporate Research Agreements [4/13/2018: minor revision to adjust contract negotiation timeframes to match operational changes]

FAQ

There are no FAQ associated with this policy and procedures.

Policy Program

Integrity & Compliance Office