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Genetic Research with Stored Biological Materials: Ethics and Practice (In the Field) (Report)

IRB: Ethics & Human Research 2010, March-April, 32, 2

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Description

Many biomedical advances--particularly advances involving genetics--have only been achieved through research with human biological materials. (1) Such research has been critical in identifying genes and gene changes associated with disease or disease susceptibility, (2) determining causes of mortality and morbidity, (3) deriving cell lines for further research, (4) and developing new approaches to therapy such as pharmacogenetics. (5) Complete mapping of the human genome and improved ability to conduct genetic and genomic analyses expand enormously the potential value of biological materials for medicine and science. (6) Although scientifically rewarding, genetic research with stored biological materials raises several ethical concerns. DNA obtained from stored biological material is stable and specific to an individual; furthermore, genetic/genomic test results have become easier to link to specific individuals, even among pooled DNA. (7) Genetic testing may reveal information about individuals'--and, in some cases, their family members'--present and future susceptibility to illness. (8) Moreover, individuals may not even be aware that their biological materials were collected and stored for future research. (9) Even when individuals gave explicit consent for research with their biological materials, concerns have been raised about the validity of such consent for use of the materials in future, unspecified studies. (10) Finally, whether and under what conditions research results should be disclosed to research participants raises concerns about potential psychological harm to individuals, as well as to groups, if findings create or reinforce negative stereotypes about socially identifiable groups, and about the clinical validity and utility of genetic information obtained in the research context. (11) Several advisory commissions, government bodies, professional organizations, and commentators have issued recommendations and guidance regarding the collection, storage, and use of biological materials for research. (12) The key ethical issues addressed in this body of literature include, but are not limited to, the scope of informed consent, the content in consent documents, the nature of research risks, the confidentiality of research data, the scope of research, and the disclosure of research results. Yet to date, only a few studies have empirically examined how investigators and institutional review boards (IRBs) address these ethical issues, particularly with regard to genetic research with stored biological materials. IRB policies vary regarding the requirement for and scope of consent, the disclosure of research results, and whether researchers can contact individuals again for additional health information. (13)

Genetic Research with Stored Biological Materials: Ethics and Practice (In the Field) (Report)
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  • $5.99
  • Available on iPhone, iPad, iPod touch, and Mac.
  • Category: Health & Fitness
  • Published: Mar 01, 2010
  • Publisher: Hastings Center
  • Seller: The Gale Group, Inc.
  • Print Length: 31 Pages
  • Language: English
  • Requirements: To view this book, you must have an iOS device with iBooks 1.3.1 or later and iOS 4.3.3 or later, or a Mac with iBooks 1.0 or later and OS X 10.9 or later.

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