General Interest > Feed Your Head
Group Therapy increasing Drug Risk?????/
Troll Control:
Uh, 45 CFR 46 is the guidelines for research studies, dimwit. Section 101(b) describes continuing review exemption, of which one is any research that uses surveys to gather study data. You have no clue how HHS/FDA compliance works.
I just showed your "we're talking about studies, not surveys" post to a colleague here and she just laughed her ass off and said "That guy is an IDIOT!"
I work in a business that is heavily regulated by HHS/FDA and work with compliance testing and reporting daily. You have no idea of what you speak and it shows. You can't tell the difference between a behavioral study and a clinical trial or even the the difference between a study and data acquisition methods.
Whooter:
--- Quote from: "Dysfunction Junction" ---Uh, 45 CFR is the guidelines for research studies, dimwit. Section 46 describes continuing review exemption, of which one is any research that uses surveys to gather study data. You have no clue how HHS/FDA compliance works.
I just showed your "we're talking about studies, not surveys" post to a colleague here and she just laughed her ass off and said "That guy is an IDIOT!"
I work in a business that is heavily regulated by HHS/FDA and work with compliance testing and reporting daily. You have no idea of what you speak and it shows. You can't tell the difference between a behavioral study and a clinical trial or even the the difference between a study and data acquisition methods.
--- End quote ---
You may be good at having fun around the office but you have trouble understanding Review Boards and their processes. I think they were laughing at you because your link didnt reference anything about studies, DJ. You can name call all you want but until you convince the oversight committee that they dont need to oversee Residential Treatment studies then you 2 are stuck laughing among yourselves.
The rest of us will go with what WIRB states in their own process and that is they oversee all the studies that they give "certificates of approval" to. I have supplied links and you have lied about calling WIRB and trying to make the readers here believe they never heard of the study.
Lets move forward and just stay with the facts as they apply to the study... I need to post that update.. give me a minute.
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Whooter:
The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form 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.
Link to WIRB
Seems pretty straight forward to me.
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Troll Control:
^^For a clinical trial, yes.^^ We all agree the Behrens study is not a clinical trial, or are you now trying to suggest it is? :rofl: I think you may not know the difference, although you've ranted and raved for years how no clinical trials are needed. But guess what? If no clinical trial is needed, neither is a continuing review! You sort of defeated your own rhetoric here, bud.
You must have missed the part on the WIRB page that says "unless the research is exempt," which self-report studies are. :beat: :feedtrolls:
What "samples" will you link us to next? Oreo cookies? Dryer sheets??
--- Quote from: "WIRB policy" ---WIRB will provide formal exemption determinations for research under 45 CFR 46.101(b) for a fee. WIRB will also provide exemption determinations from the FDA regulations (21 CFR Parts 50, 56, 312 and 812) for those exemptions allowed under 21 CFR 56.104. However, WIRB generally does not provide determinations on whether a given research study meets the definition of a “clinical investigation” or a “marketing application.”
--- End quote ---
No wonder this study hasn't been under continuing review...lols.
Don't look for WIRB to classify this as "marketing," which it is, but they do exempt self-report studies from continuing review, contrary to what dum-dum keeps saying. He's clinging to the meme "all approved studies must be reviewed!" which is an obvious fabrication from an ignorant person. :lala:
Hmmmmmmmm....45 CFR 46.101(b)....where have I seen that before?
Whooter:
--- Quote from: "Dysfunction Junction" ---^^For a clinical trial, yes.^^ We all agree the Behrens study is not a clinical trial, or are you now trying to suggest it is? :rofl: I think you may not know the difference, although you've ranted and raved for years how no clinical trials are needed. But guess what? If no clinical trial is needed, neither is a continuing review! You sort of defeated your own rhetoric here, bud.
You must have missed the part on the WIRB page that says "unless the research is exempt," which self-report studies are. :beat: :feedtrolls:
What "samples" will you link us to next? Oreo cookies? Dryer sheets??
--- Quote from: "WIRB policy" ---WIRB will provide formal exemption determinations for research under 45 CFR 46.101(b) for a fee. WIRB will also provide exemption determinations from the FDA regulations (21 CFR Parts 50, 56, 312 and 812) for those exemptions allowed under 21 CFR 56.104. However, WIRB generally does not provide determinations on whether a given research study meets the definition of a “clinical investigation” or a “marketing application.”
--- End quote ---
No wonder this study hasn't been under continuing review...lols.
Don't look for WIRB to classify this as "marketing," which it is, but they do exempt self-report studies from continuing review, contrary to what dum-dum keeps saying. He's clinging to the meme "all approved studies must be reviewed!" which is an obvious fabrication from an ignorant person. :lala:
Hmmmmmmmm....45 CFR 46.101(b)....where have I seen that before?
--- End quote ---
I never said "all" studies need to be reviewed... lol. You guys get all hung up .... "All" programs are evil... "All" programs are ineffective!
What I am saying is this study was reviewed. If you look at the links I provided and read the study you would find out that this study (not all studies) received a "certificate of Approval" from WIRB review board and they over saw the study.
If you want to show this as marketing then provide a link. The problem is that you confuse your opinion with facts, you think this is marketing or a survey or highschool testing or exempt from oversight but it clearly is not. You havent provided proof.
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