General Interest > Feed Your Head
Group Therapy increasing Drug Risk?????/
Froderik:
--- Quote from: "Dysfunction Junction" ---This issue in now closed.
--- End quote ---
I agree. :suicide:
Whooter:
--- Quote from: "Dysfunction Junction" ---More on this here.
--- Quote from: "WIRB Policy" ---The Certificate of Approval will indicate approval of a consent form.
--- End quote ---
That's it. "Consent form approved." This has nothing to do with continuing review, just pre-research paperwork. Canyon got pre-research approval of their consent forms, but that's where the involvement of the review board ended. Even Canyon doesn't claim any "continuing review." Maybe Whooter should ask them why they didn't submit their study for review and stop making up a story that they did.
This issue in now closed.
--- End quote ---
Consent form is not all they approved:
The Western Institutional Review Board approved consent/assent forms and issued Certificates of Approval for the study.
Here is a copy of their "Certificate of Approval"
Sample 1
Sample 2
at the bottom of page 2 it states:
Federal regulations require that WIRB conduct continuing review of approved research. You will receive Continuing
Review Report forms from WIRB. These reports must be returned even though your study may not have started.
...
Troll Control:
Soo...you don't have any docs related to this study I see. Only "samples."
Of course, I don't expect everyone to be adept at navigating DHHS/FDA rules, but I do work with them in an everyday capacity, so I'll explain it for you. There is no requirement for continuing review for human subject studies when only a self-report form or public data is used. Continuing review is required for clinical trials and behavioral research using methods other than self reporting. This is covered under the "exemptions" rules of DHHS CFR regulations.
I can link to lots of "samples" for lots of things. You might as well have linked to a free sample of Downy fabric softener. It would be just as relevent, lol.
Whooter:
We have come a long way. A few weeks ago many people had never heard of the Residential Treatment Outcome Study performed by Canyon Research. They looked at close to 1,000 children and families and found that the programs studied where up to 80% effective.
Dysfunction junction and myself managed to put the spot light on this study over the past day or two and were able to nail down that the study was indeed independent and was overseen by an independent third party in the form of a Review Board (WIRB). From WIRB’s documents:
The IRB also reviews the consent form (which they did for the Aspen Study) for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. (This is called oversight).
WIRB reviewed the consent forms and approved the study and issued “Certificates of approval” as was pointed out in the study itself and presented to the APA.
Here are some supportive links and information as we stand today:
Residential Treatment Outcome-Study
Canyon Research & Consulting: Independent research company that conducted the study.
** Western Institutional Review Board: Independent board that approved research and audited the study.
The Western Institutional Review Board approved consent/assent forms and issued Certificates of Approval for the study.
Here are copies of their "Certificate of Approval" forms
Sample 1
Sample 2
at the bottom of page 2 it states:
Federal regulations require that WIRB conduct continuing review of approved research. You will receive Continuing
Review Report forms from WIRB. These reports must be returned even though your study may not have started.
The above study was presented at the American Psychological Association (APA) conference 2006. ** As a disclaimer Dysfunction Junction of fornits was mistaken the first time when he said WIRB never heard of the study. What he meant was he called WIRB and they did hear of the study but said they only approved the Questionnaire. So we need to consider DJs' input/opinion against the published facts.
...
Troll Control:
--- Quote from: "Whooter" ---If it approves the research, the IRB continues to review the ongoing research after it starts. (This is called oversight).
--- End quote ---
This statement is false. Continuing review is never required by law for self-reporting or public data. Part of what Whooter doesn't understand is that this is not a clinical trial. It's a self-report study. Whooter doesn't understand the difference, so you'll have to excuse his ignorant repetitive trolling about nonexistent, unrequired, unsolicited, undocumented "continuing review."
And the certificate of approval applies only to the consent/assent forms, nothing more, as stated explicitly in the WIRB policy.
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