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To successfully meet its objective to analyze biospecimens from a large number of cancer patients with high quality clinical data to improve cancer outcomes, ICGC ARGO has identified the need to establish strong partnerships with private biomedical and pharmaceutical companies. Partnerships between academia and industry have become especially relevant in translational cancer research, based on the need for interdisciplinary approaches and the growing complexity of scientific and economic challenges faced by the research community. Although the research motivations of universities and private industry may differ, at times, the important role of industry in enabling clinical research that improves outcomes for cancer patients is recognized. The opportunity exists for ICGC ARGO to collaborate with commercial partners of a variety of scales, including large companies, small businesses and non-profit organizations, as well as government agencies, to accomplish a common set of goals. Such endeavours can be mutually beneficial and have the potential to promote synergistic innovation; pool resources; break down barriers to intellectual property rights; and, enable the development of therapeutic products for the benefit of society.
The vast potential of public-private partnerships does not mean that these collaborations should proceed arbitrarily. The choice of industry partners made by ICGC ARGO will affect its public image and this reality should be given due consideration. Importantly, data misuse and of conflicts of interest, publicised by the media, can feed into public scepticism of industry research and undermine trust in science. To avoid such breaches of scientific integrity, ICGC-ARGO needs to adopt a responsible attitude to collaborating with industry by adhering to a robust ethical framework that proactively addresses the ethical, legal and social issues.
The objective of this Ethical Framework for Partnership with Industry is to establish guidelines that will facilitate equitable and principled collaborations between ICGC-ARGO and its commercial partners and, more generally, ensure a climate conducive to the success of these partnerships. The Framework should be interpreted in light of applicable national laws and ethics guidelines and, ICGC-ARGO Goals, Structure, Policies and Guidelines as updated.
This Framework applies to both ICGC-ARGO and to any industry partner that has obtained membership status or, otherwise entered into a major partnership, with the Consortium, regardless of the type of membership. It does not apply to individual ICGC-ARGO academic researchers or academic collaborators unless specifically mentioned.
The Core Principles of this Framework are complementary and interdependent. They should inform the application of the guidelines and be used to help resolve any novel issues raised by ICGC-ARGO partnerships with industry that are not addressed by a specific guideline.
- Reciprocity: The practice of exchanging materials, methods and advantages with others for mutual benefit. Reciprocity requires a proportional distribution of the benefits and charges of the collaboration between partners.
- Transparency: A sustained commitment to honesty, integrity and openness of management structures, practices and objectives. Respecting this principle entails full disclosure of any potential or perceived conflicts of interest.
- Accountability: Willingness to provide explanations, justifications, and, more generally, to assume responsibility for one’s actions, omissions, judgments and intentions
- Benefit to society: This principle acts as an important reminder that partnerships should be established with the best interests of society in mind and, ultimately, improve cancer care for the benefit of future and current patients. It also requires that special attention be given to the needs of the more vulnerable or poorer groups of society.
- Academic Freedom: A commitment by AEGC and its partners to protect the freedom of scientific researchers and students to study and conduct research without unreasonable interference or restriction from institutional regulations, contractual arrangements or other undue pressure. Similarly, the right of scientists and students to publish their data and conclusions without control or censorship needs ought to be preserved.
- a) ICGC ARGO shall designate an individual (Compliance Officer) to be responsible for the implementation of this Framework. This position, entailing a two years non-renewable mandate, should be filled by a principal investigator from the public sector that is not, at that time, a member of the ARGO Consortium. This individual should not have any conflict of interest involving ARGO’s current industry. The Compliance Officer should rapidly declare any emerging conflicts of interest and step down, temporarily or permanently, if such conflict has arisen. A temporary Compliance Officer, meeting the same criteria, can be appointed to act on matters where the regular officer is in conflict.
- Every industry partner will need to submit to the Compliance Officer the Expression of Interest for ICGC-ARGO document (appendix 1), which should delineate clearly the contribution(s) that the industry partner will make to ICGC ARGO and the resources committed towards this. Contribution(s) must participate in the accomplishment of ICGC-ARGO’s mission as formulated in the ICGC ARGO Goals, Structure, Policies and Guidelines document.
- ICGC ARGO partnerships should never limit the capacity of ICGC ARGO or its members to initiate, or continue to collaborate, with any other qualified group, person, or entity.
- Partnerships should not unduly hinder the academic freedom of members of ICGC-ARGO to research and publish on scientific questions related to the mission of the consortium.
- Industry partners must follow the ICGC ARGO Goals, Structure, Policies and Guidelines document.
- National ICGC ARGO project should declare any existing partnerships with industry when joining the Consortium. This declaration should be updated on a yearly basis or more frequently if needed.
- Industry partners of national ICGC ARGO project may be exempt from following the ICGC Framework. To decide whether an exemption is justified ICGC-ARGO steering committee should consider the extent of the partnership and its impact on ICGC-ARGO. The Steering Committee should consult the Compliance Officer before making a decision.
- ICGC-ARGO and industry partners shall establish procedures for frequent and effective communication from the onset of any partnerships.
- ICGC-ARGO shall adopt rules to clearly outline industry partners’ rights, obligations, and contributions to the consortium. These rules could be part of the present framework or their location should be indicated in this framework.
- In establishing these rules ICGC-ARGO should pay particular attention to clearly delineate the respective liability of ICGC-ARGO and its commercial partners and, to establish sufficient safeguards to avoid any adverse impact due to unexpected ending of a partnership.
- In establishing these rules, ICGC-ARGO should also consider the need to achieve a reasonable balance between promoting open science in research, facilitating access to clinical trials for participants and respecting the freedom to operate and generate revenues of its commercial partners. Facilitating access to clinical trials also include communicating information and results from these trials to patients.
- ICGC-ARGO should identify scientific measurements and benchmarks capable of providing common ground for both public and private sector research goals.
- The Ethical Framework for Partnership with Industry, as well as the names of any industry partners that adhere to it, should be communicated to the public via the ICGC-ARGO website.
- Detailed information regarding all industry partnerships developed by ICGC-ARGO should be available to members of the Consortium upon request to the Compliance Officer.
- Potential industry partners should make an initial Declaration of conflicts of interest at the time of submission of the Expression of Interest for ICGC-ARGO Document. If they are accepted within the Consortium this Declaration must be renewed as often as is necessary and, at the minimum, on a yearly basis.
- A Declaration of conflict may be a sufficient measure in itself in some circumstances, in other situations additional measures may need to be implemented by ICGC-ARGO’s Steering Committee following recommendations from the Compliance Officer.
- All members of ICGC-ARGO’s Steering Committee should make a similar declaration of any conflicts of interest.
- An updated Declaration of conflicts of interest including new conflicts shall be promptly submitted to the Compliance Officer. If the Compliance Officer decides additional action is needed, she should communicate the Declaration to the ICGC ARGO Steering Committee along with any recommendations.
- Industry partners must follow the ICGC-ARGO Publication Policy for all publications developed in the context of their collaboration with ICGC ARGO and/or, using the ICGC-ARGO data.
- Industry partners must follow the data access rules implemented by the ICGC-ARGO Data Access Compliance Office (DACO), formulated in the ICGC-ARGO Goals, Structure, Policies and Guidelines document and in the DACO Data Access Agreement.
- The confidential nature of the controlled access data should be preserved at all time.
- Industry partners must agree not to deposit any patents on the ICGC-ARGO data. Downstream innovations developed using the ICGC-ARGO data can be patented. ICGC-ARGO encourages the adoption of broad licensing practices for any patent resulting from research made using ICGC-ARGO data.
- Representatives of ICGC-ARGO industry partners are welcome to participate in all of ICGC ARGO committees. However, industry representation on any single ICGC-ARGO committee shall be limited to two members. This rule does not apply to the ICGC-ARGO Industry Partnership Committee.
- The ICGC-ARGO Independent Advisory Board together with the Management Committee shall formally assess the efficiency, effectiveness and achievements of all partnerships on an annual basis. Due consideration should be made to the identified scientific objectives and benchmarking in this assessment.
- A written summary of this assessment shall be communicated to the ICGC-ARGO compliance officer.
- If the ICGC-ARGO Compliance Officer is of the opinion, upon reading the written summary, that the partnership is not progressing as expected, she shall communicate a copy of the summary along with any recommendation to the ICGC-ARGO Steering Committee.
- Prior authorisation and consultation with the Management Committee is required before any use of the name of ICGC–ARGO or that of any industry partners in any public communications, or any public websites, or for promotional activities involving industry partners.
- Such authorisations could be granted more routinely, ahead of time, through contract or via a specific ICGC ARGO policy to that effect.
- Meslin E-M, et al. Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest. 2015; 4:36. doi: 10.1186/s40169-015-0077-y. [Clin Transl Med]
- National Research Council (US), et al. Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct. https://www.ncbi.nlm.nih.gov/books/NBK208714/ Accessed 2002.
- AAUP. Summary of Recommendations: 56 Principles to Guide Academy-Industry Engagement. https://www.aaup.org/sites/default/files/files/Principles-summary.pdf
- Hernandez-Aguado I, Zaragoza GA. Support of public–private partnerships in health promotion and conflicts of interest. . BMJ Open 2016;6:e009342. doi:10.1136/bmjopen-2015-009342. [BMJ]
- CDC.Report submitted to the CDC Advisory Committee to the Director Spring, 2016.Ethical Considerations for Public Private Partnerships Workgroup. https://www.cdc.gov/about/pdf/advisory/ethicalconsiderationsppprecommendationsacd.pdf. Accessed 2016
- CDC. CDC’s Guiding Principles for Public-Private Partnerships: A Tool to Support Engagement to Achieve Public Health Goals - https://www.cdc.gov/partners/pdf/partnershipguidance-4-16-14.pdf. Accessed April 2018
- NSI. Promoting Ethics when Partnering with the Private Sector for Development. http://www.nsi-ins.ca/wp-content/uploads/2014/09/Promoting-Ethics-when-Partnering-with-the-Private-Sector-for-Development-August-2014.pdf. Accessed August 2014
- Rowe S, Alexander N, Kretser A, et al. Principles for building public-private partnerships to benefit food safety, nutrition, and health research. Nutr Rev. 2013;71(10):682–691. doi:10.1111/nure.12072. [PMC]
- Nishtar S. Public – private 'partnerships' in health – a global call to action. Health Research Policy and Systems 2004, 2:5 doi:10.1186/1478-4505-2-5. [BMC]