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¶ … consent? When you consider this, consider the two senses referenced in the lecture notes (slide 49). Were both senses of informed consent met?
In the case of the Havasupai, informed consent was given, and approval received, but only to study the blood samples of tribe members for diabetes. All the IRB and the individual researchers had to do was to rephrase the informed consent agreement to read something like, "Your blood sample and DNA material may be used for scientific research in a range of fields." As Harmon (2010) points out, "Studies have estimated that most individuals -- perhaps more than 90% -- are willing to allow their data to be used for a range of biomedical research. It is when they are not asked that problems arise," (Harmon). Based on the standard definitions of informed consent, as outlined in slide 49, informed consent was not properly achieved in the Havasupai case. Informed consent can only be waived when it is "impracticable" to do so; and it may be shortened only when to do so makes sense. In the Havasupai case, "shortening" informed consent to insinuate that the research would only be on diabetes amounts to...
The researchers might have given the Havasupai people a paper to sign, and may have even translated the scientific and legal jargon to imply that the DNA would be reviewed for the study of diabetes. However, what the researchers failed to disclose was that cloaked in the agreement was an assumption that the tribe members and research participants did not care what else was done with their biological material. It was assumed that surrendering their DNA to science meant that science would retain full ownership of the material. In fact, the tribe members were led to believe that the DNA would only be used to study one particular disease and no others. Neither sense of informed consent was met: as clarity and full disclosure were not offered to the participants.
2. Thinking of the review of this research, did the IRB miss something in its consideration of risks and benefits?
The IRB demonstrated a remarkable lack of cultural…
References
Harmon, A. (2010b). Indian tribe wins fight to limit research of its DNA. The New York Times. April 21, 2010. Retrieved online: http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all
Harmon, A. (2010). Where'd you go with my DNA? The New York Times. April 24, 2010. Retrieved online: http://www.nytimes.com/2010/04/25/weekinreview/25harmon.html?_r=1&pagewanted=all
Consent for and Ethics Reflection Consent Form Study Title: The Next President Prospective Research Participants: The research participants for this study should be at least 18 years of age, literate, and have voted in at least one election. The purpose of this study is to determine which fictitious candidate people would vote for based on various media articles and video presentations about the candidates. Each candidate will view the video presentations and read the
Although the San Francisco police do not carry stun guns they do carry Tasers, and Tasers work on the same mechanism as those of stun guns shooting darts that deliver electric shots to stun suspects. It is said that 334 individuals died from these electric shots during the years 20001 to 2008. If that is so, the AHRP can publish the results on its page pointing out that the
They have no formal oversight authority. Practices regarding informed consent are inconsistent. This poses a major concern for patient safety while using CAM. Complimentary and alternative medicine (CAM) has been criticized for a lack of standards in the delivery of services. Holexa and Caspi (2005) found that this lack of standards extends into the practice of informed consent. Patients often do not have access to proper information during the decision-making
Other states, in the case of medical research, mandate that a more stringent standard is applied -- that of the reasonable person standard (Edwards 2008). In other words, would a reasonable person consider the nature of the research ethical and acceptable? This seems fairer -- but is also more intensely subjective. And when conducting research in a different cultural context, it may be difficult for the researcher to evaluate
consent embodies the idea that as a matter of ethics and law patients are entitled to be exposed to all of the relevant information that would influence and guide their decision making concerning what treatment that they should follow. However, should clinicians provide medical information to terminally ill patients when they suspect that such information could potentially be used to facilitate their suicide? The issues surrounding full disclosure, beneficence,
Question #5: Yes. Small samples are totally justifiable however, the statistical tool selected to analyze the data must be able to accommodate small sample size. The statistical techniques employed for small sample size is what applied statisticians call "robust statistics" or certain parametric types such as the t Test. Although the parametric tool is more robust that the non-parametric counterpart, parametric statistical tools with real small samples may produce misleading