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Re: Informed or Uninformed or Misinformed Consent

Posted by Dr. Bob on October 15, 2014, at 16:17:59

In reply to Uninformed Consent or Misinformed Consent, posted by bryte on September 14, 2014, at 0:28:15

> Dr. Hsiung says "The mean number of attempts before eventually passing was 2.1." With a total of 31 possible answers to 10 questions, the mean number of attempts required to match 10 options with guesswork would be 3.1 -- even if the options were meaningless signals such as shapes, numbers or digits.

2.1 is significantly less than 3.1, so that would seen to be evidence that the options aren't meaningless signals.

> Social media forums -- at least those operated as public message boards are seldom if ever considered treatment for which informed consent is required.

This isn't treatment, but there are risks. I think an informed consent process protects prospective participants.

> USDHHS rules say "No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights." 45 CFR 46.116
>
> As an example of prohibited exculpatory language in informed consent documents, the USHHS offers "By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research."

And as an example of acceptable language they offer:

> > By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.

http://www.hhs.gov/ohrp/policy/exculp.html

> (Revised and reposted to correct punctuation errors resulting from Web formatting, along with additional typographical and readability corrections)

Thanks for time and effort you invested in your critique. I welcome different points of view. Would you be interested in participating in a panel at a conference?

Bob


a brilliant and reticent Web mastermind -- The New York Times
backpedals well -- PartlyCloudy


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