Mathews DJ, Donovan P, Harris J, Lovell-Badge R, Savulescu J, Faden R. Science and law: Integrity in international stem cell research collaborations. Science. 2006 Aug 18;313(5789): 921-2.
The authors discuss the legal and ethical implications of international collaboration. They discuss the difference in laws pertaining to stem cell research between countries and contend that countries should not exert extraterritorial jurisdiction over scientists. The authors emphasize the importance of submitting stem cell lines with sufficient data to international depositories to both advance the field and promote scientific integrity. The importance of ethical integrity of research is also emphasized and it is suggested that scientists should be ready to provide protocols and consent documents that give information on the ethical integrity of their work.
Eisenberg RS, Rai AK, Harnessing and Sharing the Benefits of State-Sponsored Research: Intellectual Property Rights and Data Sharing in California’s Stem Cell Initiative. Berkeley Technology Law Journal. 2006;21(3): 1187-1214.
The authors address the possibilities for data sharing in the field of stem cell science. They refer to the initiatives made by the California Institute for Regenerative Medicine to address IP and data sharing norms in this field. They also refer to a number of data sharing initiatives in other biomedical sciences to discuss the way in which stem cell science can address and manage the following issues: (1) incentives to contribute data; (2) who gets access and under what conditions; (3) what gets deposited and when; and (4) database architecture, maintenance, and curation.
*Taylor PL. Research sharing, ethics and public benefit. Nature – Biotechnology. 2007 Apr;25(4): 398-401.
The author discusses the ISSRC guidelines recommendation that researchers share data. The ISSCR guidelines are described as “defining strong, clear requirements that researchers have reasonable universal access to data, materials, rights and results, and that diagnostic and therapeutic innovations are widely available on just terms for the public benefit”. Taylor uses empirical evidence to describe the current problems with sharing within scientific communities and suggests that such a situation is unethical as it undermines the social value of science.
Stephenson EL, PR Braude, and Mason C. International community consensus standard for reporting derivation of human embryonic stem cell lines. Regenerative Medicine, 2007 July. 2(4): 349-362.
To address the lack of standardization and variable reporting of the number and quality of hESC derivation, the authors consulted international teams regarding a “community consensus on the minimum data currently required to create a meaningful standard for reporting the derivation of hESC lines.” The consensus process involved six key steps and specified a list of criteria for minimum information reporting on hESC lines. “A number of future steps are planned in order to ensure that this standard evolves with the field and remains relevant and up-to-date… This article is an open-access publication in order to make the convention freely available to the international community and encourage universal participation.”
*Luong MX, Smith KP, Stein GS. Human embryonic stem cell registries: value, challenges and opportunities. Journal of Cellular Biochemistry. 2008 Oct 15;105(3): 625-32.
The authors provide an introduction to the basics of stem cell science, and the IP and regulatory challenged currently being faced by the field. They then go on to outline the need for a comprehensive registry of stem cell science which would include: “Information on the provenance of hESC lines; IP information; availability; published (and unpublished) characterization data; methodologies for each cell line.” The authors describe a number of stem cell registries (such as the International stem cell forum, the European hESC registry and the NIH registry) but stress the need for an integrated and complete registry to allow for efficient data exchange.
Andrews PW, et al. Consensus guidance for banking and supply of human embryonic stem cell lines for research purposes. Stem Cell Review. 2009 Dec;5(4): 301-14.
The International Stem Cell Forum developed the International Stem Cell Banking Initiative to allow hESC distribution centers to converge on best banking and distribution practices of these cells. This document details the recommendations developed at the first ISCBI meeting in October 2007.
*Borstlap J, Luong MX, Rooke HM, Aran B, Damaschun A, Elstner A, et al. International stem cell registries. In Vitro Cellular and Developmental Biology – Animal. 2010 Apr;46(3-4): 242-6.
The authors discuss three existing stem cell data registries; the European hESC registry, the providing information on the history of their establishment, The ISSCR Registry of Human Embryonic Stem Cell Line Provenance, and the International Stem Cell Registry at the University of Massachusetts Medical School. The type of information contained in these registries, as well as their structure and their directions for the future are described. The authors conclude that although these registries provide a valuable tool for researchers, efforts should be made to create one complete registry or create links between existing ones to allow researchers to more efficiently search and add to these repositories of stem cell lines.
*Note: entries are presented in chronological order within each category. Entries marked with an asterisk are those that we found to be particularly helpful as we developed materials for this project.
Proprietary Challenges in Stem Cell Research 