Group Therapy increasing Drug Risk?????/

[Whooter]

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:

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.

...

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 coooked.

DJ, nice try, but we are talking about studies here (your link doesnt cover that).  We have demonstrated that this study attained a "Certificate of Approval" from an Independent Review Board.  Their own documents indicate that they continue to review the study throughout.

Maybe you should make another phone call and let them know they dont have to provide oversight.  But I am sure the APA feels happier knowing the study was overseen by a third party.  People here on fornits feel that the studies should be overseen by a third party so why shouldnt they be?



...

[Troll Control]

LOLS!  That's rich.  Whooter, you may want to believe you're fooling some people, but you ain't fooling me.  

It is a study.  A self-report study.  It's exempt from continuing review.  I have worked with human research for many years including Medical Device Reporting and I know that you know that I know that you have no idea what you're talking about.

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.

...

[Whooter]

LOLS!  That's rich.  Whooter, you may want to believe you're fooling some people, but you ain't fooling me.  

It is a study.  A self-report study.  It's exempt from continuing review.  I have worked with human research for many years including Medical Device Reporting and I know that you know that I know that you have no idea what you're talking about.

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.

...

Look, DJ, with that whole lying thing about you calling WIRB and them saying they never heard of this study I dont think many here will take your word on anything.  But tell you what, if you can get WIRB to buy into your definition then maybe they will save some money by not having to spend time overseeing educational tests.
 But according to their own process definition once they give a certificate of approval for the STUDY (lol), they continue to oversee it until it is done.  Its just they way they do it.
You cant go against what their own process says.  I have shown you, via links, that they provided oversight.



...

[Troll Control]

LOLS!  That's rich.  Whooter, you may want to believe you're fooling some people, but you ain't fooling me.  

It is a study.  A self-report study.  It's exempt from continuing review.  I have worked with human research for many years including Medical Device Reporting and I know that you know that I know that you have no idea what you're talking about.

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.

...

It's clear what the law is and it's clear that Behrens had only a certificate of approval for the consent/assent forms, as stated in the study.  The law states that data acquired by self-reporting is oversight exempt and nobody pays the oversight fees when they're not required.  It's not my word.  It's the law.  You've proven yourself only to be an ignoramus and a buffoon.

This issue has been closed and repetitive trolling won't change the facts.

[Whooter]

LOLS!  That's rich.  Whooter, you may want to believe you're fooling some people, but you ain't fooling me.  

It is a study.  A self-report study.  It's exempt from continuing review.  I have worked with human research for many years including Medical Device Reporting and I know that you know that I know that you have no idea what you're talking about.

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.

...

It's clear what the law is and it's clear that Behrens had only a certificate of approval for the consent/assent forms, as stated in the study.  The law states that data acquired by self-reporting is oversight exempt and nobody pays the oversight fees when they're not required.  It's not my word.  It's the law.  You've proven yourself only to be an ignoramus and a buffoon.

This issue has been closed and repetitive trolling won't change the facts.

Your link doesn't even come close to describing "Residential Treatment Outcome Studies".  Anyone who reads it knows it doesn't apply, DJ.  Its a poor attempt to take the focus off the study and onto some educational Test requirements.

We need to stick with the definitions and facts as applied to the study by the Review Board.  I think we should get back to the study at hand.  I will update our status and see where we are at.



...

[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]

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.

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.



...

[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.

...

[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??

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.”

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]

^^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??

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.”

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?

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.



...

[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]

^^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??

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.”

No wonderudy 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?

This issue is closed.  Whooter is an ignoramus.

[DannyB II]

^^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??

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.”

No wonderudy 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?

This issue is closed.

[/size][/color]

Really, Yeah!!!!!!!!!!!!!!!!!!!!

[Whooter]

^^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??

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.”

No wonderudy 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?

This issue is closed.  Whooter is an ignoramus.

We already established earlier that this is a study, DJ, and therfore doesnt fall under 45 CFR 46.101.  Your name calling clearly shows that you are frustrated that my facts hold up and you are just reaching for straws.  Calm down, read the study and the stipulation in the "Certification of approval" and WIRBS own processes and you will see the facts clearly.

Sorry, DJ, but this wasnt a highschool interview or a test... This was a "Residential treatment outcome study" involving a 1,000 kids and families.  An exemption means it is non-standard.  If you can prove they were exempt then be my guest.

But from your own post is shows the WIRBs' standard protocol after the "certificate of approval" is given is for WIRB to provide oversight.  Unless you can provide proof otherwise then we have to go with the facts and procedures as they are presented.

I can provide another recap in a few minutes.



...

[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.



...

We can end it here if you like  Unless DJ wants to produce evidence that they applied for and received an exemption.  Then we can pick it up again.