Table 1 Principles that govern Urea Cycle Disorders Consortium (UCDC)–industry interactions (parenthetical statements in italics were added for the purpose of this paper to amplify or explain the original stated principle)
From: Developing interactions with industry in rare diseases: lessons learned and continuing challenges
1. Collaborations with industry partners are essential to fulfill the mission of the UCDC. (Successful collaborations with industry partners help promote development of new therapeutics, a key goal of the UCDC.) |
2. Policy and processes for industry collaborations will be transparent and equitable. |
3. All collaborative activities must have a potential benefit for patients and families with UCD. |
4. The Industry Relations Committee (IRC) will be empowered to negotiate with potential industry partners and make recommendations to the UCDC leadership and National Institutes of Health (NIH) program officers who will have the final authority for approval. |
5. Confidentiality and intellectual property protection are essential and will be agreed upon and respected. (Confidentiality refers both to patient information and the protection of privacy of the research subjects, and it refers to the industry partners’ legitimate need for confidentiality regarding development programs and business practices.) |
6. Intellectual property developed through these collaborations belongs to the individuals and/or institutions that deliver them. (Prior to the performance of research, the UCDC and pharmaceutical companies must contractually agree about ownership and protection of intellectual property. In most instances this includes an understanding that intellectual property belongs to the institutions that were responsible for generation of data (i.e., data generated by the UCDC is the intellectual property of the UCDC and its member institutions; data generated by or for a company is the intellectual property of the company. Data that builds on the UCDC infrastructure must adhere to NIH data sharing policies.) |
7. The UCDC does not seek any profit from these activities. (Financial profit is not a consideration in evaluating a potential research collaboration.) |
8. Work undertaken on behalf of an industry partner must not be supported by federal funds awarded to the UCDC. |
