General Interest > Feed Your Head
Group Therapy increasing Drug Risk?????/
Troll Control:
--- Quote from: "Whooter" ---unless:
information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects
--- End quote ---
This means how the researcher records the data, not what the subject writes on the form, dingbat. What's written on the form is the information obtained not the recorded data. Of course, since you know nothing, you don't know this either.
Interesting how you skipped the whole bit about statistics, too. You don't even understand basic math and you're going to hold yourself out as an expert on federal regulations regarding human subject research?
You're the same guy who was saying yesterday that 45 CFR 46 101(b) has nothing to do with "studies." Everyone's BS detector is going off when you post.
--- Quote from: "Whooter" ---
--- Quote from: "Dysfunction Junction" ---Yeah, the only problem is that you have no idea what you're talking about. What you posted is for clinical trials, Whooter, and the forms you linked to were for clinical trials. Behrens did a self-report questionaire, which is vastly different. You's jus' a ig'nant wretch. You don't know no better. :rofl:
Here's the law:
--- Quote from: "45 CFR 46 101 (b), Exemptions from Continuing Review" ---Categories of Research Exempt from Committee Review
45 CFR 46 101(b)
...
2. Surveys/Interviews; Standardized Education Tests; Observation of Public Behavior
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.
...
--- End quote ---
So, despite Whooter's protestations, anybody familiar with human research knows that surveys (e.g. self-report forms) and interviews are exempt from review. It's "Research 101" and Whooter needs to register for the class.
Two days of embarassing yourself has thankfully come to an end, Whooter. Your "case" is cooked.
--- End quote ---
DJ, nice try, but we are talking about studies here (your link doesnt cover that).
--- End quote ---
Oh, really now? You're...well...an idiot.
Of course the federal regulations governing human research studies don't cover human reseach studies. How absurd! ::) :agree:
Whooter:
--- Quote from: "Dysfunction Junction" ---
--- Quote from: "Whooter" ---unless:
information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects
--- End quote ---
This means how the researcher records the data, not what the subject writes on the form, dingbat. What's written on the form is the information obtained not the recorded data. Of course, since you know nothing, you don't know this either.
Interesting how you skipped the whole bit about statistics, too. You don't even understand basic math and you're going to hold yourself out as an expert on federal regulations regarding human subject research? You're the same guy who was saying yesterday that 45 CFR 46 "has nothing to do with studies." Everyone's BS detector is going off when you post.
--- End quote ---
Look, DJ, you have reduced yourself to name calling because you failed to show that the study was exempt from oversight. The data collection clearly links the childs name to an Identifier (As I presented in the link sample). This problem needs to be cleared up before anyone would grant exemption. You have not proved anything. In fact the use of the YRS enforces that they did record the childrens names and utilized an identifier.
What we have is a Certificate of approval which states WIRB provides continuous involvement in the study. We also have links to WIRBs' own process which shows they continue to observe the study. Everything points to oversight except in your own mind.
If you personally feel the study did not receive oversight that is okay. But you have not demonstrated this.
...
Troll Control:
I just explained data recording versus information obtained. Go back and read again if you missed it. If you did read it, then you're too dumb to understand it and should look for a new hobby.
As far as continuing review...none was done and none claimed by the researcher.
--- Quote from: "WIRB Policy" ---The Certificate of Approval will indicate approval of a consent form.
--- End quote ---
That's all it means. Nothing more. Straight from the WIRB site. Taake note, this is their policy statement not a sample clinical trial form which has nothing to do with a self-report survey study. The consent form was approved before the study and the study was never submitted for review.
--- Quote from: "Whooter" ---We also have links to WIRBs' own process which shows they continue to observe the study.
--- End quote ---
No, we don't. We have a link to a sample form for a clinical trial from "Google Docs" and not the WIRB website. You are trying to mislead people by saying this is from the WIRB website. As stated above the Certificate of Approval, by WIRB policy, is the approval of the consent form.
--- Quote from: "WIRB Statement of Compliance" ---WIRB Statement of Compliance
Western Institutional Review Board (WIRB) is duly constituted, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable. WIRB is registered with OHRP/FDA; our IRB registration number is IRB00000533, parent organization number is IORG0000432 (effective through September 16, 2012).
--- End quote ---
"Continuing review" is explicitly stated to be for "clinical trials" and clinical trials only. Funny what you see when you view the source and not sample forms from Google docs.
Froderik:
I'm as stoned as an old testament hooker in a synagogue full of rabbis.
Whooter:
Look, DJ, like I stated the childs name is being recorded along with an identifier which can be traced back to each survey form. You cannot be exempt if the names are recorded and traceable.
Here take a look at the regulation again:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
The Youth Self Report records the childs name and assigns an identifier.
YSR Sample
So it can not be exempt by definition. Thats why WIRB has a determination process which was shown in a earlier post.
They are recording childrens names. They don’t qualify for an exemption. I highlighted it on red for you. If you are observing people or interviewing people without taking their personal information then yes I am sure you could get an exemption from oversight.
Sitting behind your computer and not seeing the recording process there is no way you can tell if the childrens names are being protected... thats why they have a determination process to insure their identity and safety is protected. You should know this stuff, DJ.
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