Commercial biobanks and genetic research: ethical and legal issues.

Human biological material is recognized as an important tool in research, and the demand for collections that combine samples and data is increasing. For-profit companies have assumed a leading role in assembling and managing these collections. The emergence of commercial biobanks has raised significant ethical and legal issues. The growing awareness of the importance of human biological material in research has been accompanied by a growing awareness of the deficiencies of existing archives of tissue. Commercial biobanks are attempting to position themselves as a, if not the, solution to problems that include a lack of public trust in researchers and lack of financial resources to support the prospective creation of collections that meet the highest scientific and ethical standards in the non-profit sector. Broad social and policy questions surrounding the operation of commercial biobanks have been raised however. International documents, in particular, suggest discomfort with the idea of gain from the mere transfer or exchange of human genetic material and information. Commercial involvement in the development of useful products from tissue is generally not condemned, so long as there is attention to scientific and social norms. Views on the acceptability of commercial biobanks vary. Specific issues that arise when commercial biobanks are permitted--in the areas of consent, recruitment, confidentiality, and accountability--are also relevant to the operation of public and private, non-profit biobanks. Although many uncertainties remain, consensus seems to be forming on a number of issues. For example, there appears to be agreement that blanket consent to future unspecified research uses, with no conditions, is unacceptable. Indeed, many of the leading commercial biobanks have been attentive to concerns about consent, recruitment, and confidentiality. Unfortunately, the binding nature of assurances in these areas is unclear, especially given the risk of insolvency. Hence, accountability may be the most important area of concern in relation to commercial biobanks. A few countries have enacted general legislation providing for comprehensive regulation of biobanks, for example, through licensure. Efforts to achieve harmonization of standards at the international level, and cautions against an approach that focuses on biobanking for genetic research alone, are to be applauded.