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Re: discussion

Posted by pontormo on September 1, 2014, at 12:24:44

In reply to Re: discussion, posted by bryte on September 1, 2014, at 5:29:42

I guess the issues you raise would require a pretty long and detailed (ie footnoted and bibiographed) paper to address.

But I do think on one fundamental, I would disagree with you, which is whether Bob is doing research on "human subjects" as defined by CFR 45 part 46.102(d) and (f).

As the document, and your quote define it,
------

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information."

To further interpret this, one could add that "definitions" in secton (f), as quoted by you here, explains that:
---
"Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. "

As I wold read it, and as I assume Bob reads it, Bob neither collected data through physical procedures, or manipulation of the subject's environment-- ie we never enter any environment created by Bob, that is being "manipulated" by him-- (ie I don't think Babble constitutes an environment ie place in that sense)-- it would seem that these measures do not apply to what he does here. But you may interpret it differently.

-----
Of course, you make many points, and many of the judgments about these points could be debated-- and, given that neither of us is expert about these, to say the least, or has time, or access to the rulings pertinent to these questions, we can't really make educated arguments about them. At best, we can make naive readings -- not to say that we are not entitled to do so--

but we are, again, in the end, forced to decide whether we trust or don't trust Bob's understanding and good faith in subscribing to the requirements of research that legitimately apply and to giving us the protections we are deserving of.

This ultimately is the subtext of our understandings here. I basically trust Bob and you perhaps do not, or at least question reliability or judgment.

Bob did post an announcement of his presentation above on this page, and no one except alexandra responded. So I guess we can assume that no one who reads this page was disturbed by the information. After all, those who read this page could be considered a more concerned or advance minority of gatekeepers for the rest of the community.

But perhaps we should ask Bob to give us a bit more information about his decision-- or to share the text of his study-- so that we can arrive at further conclusions.

Also, I would add that from my conversation with Bob, he never directly contacts anyone or any locality about anyone for whom he has reason to think there is an emergent situation. He regards all identifying information as completely private and inviolable.

But again, perhaps if you queried him privately about your concerns, or perhaps more specifically publicly, he might be able to answer or direct you to answers, that would give you better insight into his thinking.


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poster:pontormo thread:1070154
URL: http://www.dr-bob.org/babble/admin/20140304/msgs/1070626.html