PubMed · 7997870
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M M Cohen, B S Emanuel. 1994-12-16. Expressed sequence tags.. https://doi.org/10.1126/science.7997870
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Biomarkers are potentially powerful tools for use in research and regulation. Their derivation from biologic specimens collected from human subjects does, however, present many ethical implications. Ethical issues are relevant in almost each facet of human biomarker research studies: design, identification and recruitment of subjects, handling and use of the data, and interpretation and communication of results. Researchers also face a number of dilemmas when considering the use of human biologic specimens and new biomarkers. The mere fact that such markers are the result of measurements in human specimens gives the appearance of being more accurate than traditional sources of information such as questionnaires or environmental monitoring; yet, this may not always be the case. The meaning of the results of biomarker studies may be unclear because the purpose of the study is usually for research rather than clinical purposes. There generally are no established normal ranges for biomarkers and the interpretation of findings are often difficult. Researchers may not communicate these results to subjects or consider followup action because the task may be too difficult or undefined, or the reaction of the subject cannot be anticipated. A wide range of practices in this regard exists among researchers. Many questions remain unanswered about the use of biologic specimens. These include questions of ownership and access to specimens. Related to this is the question of whether specimens collected for one research purpose can be used for an entirely different research purpose. This is still an open question.(ABSTRACT TRUNCATED AT 250 WORDS)
This article reports the findings of a survey of 148 academically based and commercial DNA diagnostic labs regarding DNA banking (defined as the storage of individual DNA samples in some form with identifiers for later retrieval). The population surveyed consisted of all laboratories listed with HELIX, a national directory of DNA diagnostic labs that includes a fairly comprehensive listing of clinical service labs as well as a large number of research labs. The survey was concerned primarily with the legal and ethical issues that the long-term storage of DNA may raise. The survey inquired into the respondents' policies and procedures concerning (1) the extent of DNA banking and of interest in developing DNA banking in academia and industry and (2) the degree to which DNA banks had developed written internal policies and/or a written depositor's agreement (a signed document defining the rights and obligations of the person from whom the sample was taken and the bank) designed to anticipate or prevent some of the ethical and legal problems that can arise from the long-term retention of DNA. Our research suggests that (1) the activity of DNA banking is growing, particularly in the academic setting, and (2) most academically based DNA banks lack written internal policies, written depositor's agreements, or other relevant documentation regarding important aspects of this activity.