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Grimes v. Kennedy Krieger Institute8/16/2001
lated to that human being that might subsequently result in manipulation of that human being - done with the intent of developing new knowledge and which differs in any form from customary medical (or other professional) practice." Id. at 166 (quoting from a paper by Robert Levine to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). She then states further: "Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective." Id. at 167.
In respect to the difference between research involving treatment and nontherapeutic research, she further notes that:
" ractice represents the utilization of knowledge, while research amounts to its creation. Because experimentation takes place in the realm of the unknown, or at least the `scientifically unproven,' several aspects distinguish it from treatment: risks may be unforeseeable; assumptions are not supported by scientific evidence and expertise is therefore more vulnerable than it is in clinical practice; a subject's consent cannot be based on anticipated benefits; and researchers and subjects may have conflicting interests." Id. at 213 (footnotes omitted) (citing Delgado & Leskovac, Informed Consent in Human Experimentation: Bridging the Gap Between Ethical Thought and Current Practice, 34 UCLA L. Rev. 67, 69 (1986).
Morin, in respect to nontherapeutic research, also postulates that:
"It is essential to recognize that society's interest in knowledge may not coincide with an individual subject's interest; the individual subject stands to gain nothing and lose everything, including his or her right of self-determination. . . .
. . . Some analysts contend that IRB review tends to focus exclusively on consent requirements, rather than fully evaluating the merits of the research. Yet, it is important to recognize that, even before consent becomes an issue, the scientific merits and the acceptability of risks need to be appraised. As at least one author has argued, this aspect of the review may be jeopardized if members who have institutional allegiances are caught between the desire to promote the interests of the institution and the need to protect the subject. . . .
C. Investigator-Subject Relationship
Another notable difference between treatment and experimentation lies in the relationship between physician-patient and investigator-subject. . . .
. . . Indeed, as discussed in relation to the notion of uncertainty, the nature of the information held by the investigator can be very different from that of the information held by a treating physician. . . .
Other than through the difference that relates to the disclosure of information, the relationship between investigator and subject is unique in terms of the purpose for which information is gathered. . . . Data are collected to confirm or revoke a hypothesis, independently of the subject. Finally, investigators' motivations differ from those of treating physicians. The experiment is driven by the investigator's dedication to the advancement of knowledge, and often by a commitment to those who have funded the research; it is also driven by society's interest in future benefits that will flow from medical discoveries. As one author remarks, `the price of a bad outcome is exacted from the individual who suffers the untoward reaction, whereas the benefit of the breakthrough is available to society as a whole.'" Id. at 215-18 (emphasis added) (footnotes omitted).
In arguing that a fuller disclosure should be made when consent is sought for nontherapeutic research, as oppose
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