[Show abstract][Hide abstract] ABSTRACT: To explore the views of university-based investigators conducting genetic research with human specimens regarding ownership and retention of specimens, and knowledge of related institutional review board and university policies.
Data were collected in three phases: a qualitative pilot study of 14 investigators; a web-based survey taken by 80 investigators; and follow-up, in-depth interviews with 12 survey respondents.
Investigators named a variety of single or multiple owners of human specimens and often expressed confusion regarding specimen ownership. Most associated ownership with rights to control, and responsibilities to maintain, specimens. Investigators viewed specimens as "precious" resources whose value could be increased through long-term or infinite retention, particularly in light of anticipated technological advances in genome science. Their views on ownership and retention were shaped by perceptions of institutional review board policies as immortalized in subject informed consent documents, rather than knowledge of actual policies.
Long-term retention of human specimens makes confusion about ownership particularly problematic. Given findings that investigators' views on ownership and retention are largely guided by their perception of university policies, the need for clear, consistent policies at the institution level is urgent.
Genetics in medicine: official journal of the American College of Medical Genetics 06/2011; 13(6):569-75. · 3.92 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A biobank may be defined as the long-term storage of biological samples for research or clinical purposes. In addition to storage facilities, a biobank may comprise a complete organization with biological samples, data, personnel, policies, and procedures for handling specimens and performing other services, such as the management of the database and the planning of scientific studies. This combination of facilities, policies, and processes may also be called a biological resource center (BRC) ( www.iarc.fr ). Research using specimens from biobanks is regulated by European Union (EU) recommendations (Recommendations on Research on Human Biological Materials. The draft recommendation on research on human biological materials was approved by CDBI at its plenary meeting on 20 October 2005) and by voluntary best practices from the U.S. National Cancer Institute (NCI) ( http://biospecimens.cancer.gov ) and other organizations. Best practices for the management of research biobanks vary according to the institution and differing international regulations and standards. However, there are many areas of agreement that have resulted in best practices that should be followed in order to establish a biobank for the custodianship of high-quality specimens and data.
[Show abstract][Hide abstract] ABSTRACT: Genomic science represents a new frontier for health research and will provide important tools for personalizing health care. Biospecimen-based research is an important mechanism for expanding the genomic research capacity, and indigenous peoples are a target of biospecimen-based research due to their relative isolation and the potential to discover rare or unique genotypes. This study explored Native Hawaiian perceptions of and expectations for biobanking. Ten discussion groups were conducted with Native Hawaiians (N = 92), who first heard a presentation on biobanking. Six themes emerged: (1) biobank governance by the Native Hawaiian community, (2) research transparency, (3) priority of Native Hawaiian health concerns, (4) leadership by Native Hawaiian scientists accountable to community, (5) re-consenting each time specimen is used, and (6) education of Native Hawaiian communities. Considered together, these findings suggest that biobanking should be guided by six principles that comprise "G.R.E.A.T. Research" (Governance, Re-consent, Education, Accountability, Transparency, Research priorities). These recommendations are being shared with biobanking facilities in Hawai'i as they develop protocols for biobanking participation, governance, and education. These findings also inform researchers and indigenous peoples throughout the world who are working on biobanking and genomic research initiatives in their nations.
Journal of Cancer Education 03/2014; · 0.88 Impact Factor
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