Consent? When You Consider This, Consider the Research Paper

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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 outright deception and shows great disrespect for research participants.

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A key issue at stake in the Havasupai case is effective delivery of informed consent, in terms of doing due diligence. 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….....

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