Group Therapy increasing Drug Risk?????/

[Troll Control]

By the way, I don't even read your posts and I don't think anyone else does either.

Oh, you hurt my feelings.  You did a ton of responding for someone who doesn't read my posts.  Is this another lie?  Hmmmm.  Well anyway ..

so lets recap.

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 above study was presented at the American Psychological Association (APA) conference 2006. ** 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.

Whooter, could you possibly quote exactly where it says that the Western Institutional Review Board "approved research and audited the study?"

Perhaps I'm missing something, which is certainly possible, but the only reference I was able to find in all 21 pages of this presentation ("Report of Findings from a Multi-Center Study of Youth Outcomes in Private Residential Treatment," by Ellen Behrens and Kristin Satterfield; 114th Annual APA Convention; August 12, 2006) as uploaded onto Scribd.com was ... the following emphasized sentence in the Methods section (page 3):

METHOD
Participants.

The sample consisted of 993 adolescents, admitted to one of 9 programs located in the Eastern and Western United States, between August 2003 and August 2005, who, along with their parents or guardians (hereafter referred to as “parents”) agreed to participate in the study and who completed measures at admission and/or discharge. The Western Institutional Review Board approved consent/assent forms and issued Certificates of Approval for the study.

The contribution of each of the 9 residential programs to the sample was relatively equal and ranged from 9% to 16%. This sample consisted of a mean of 55% (range 37-75%) of the adolescents admitted to the residential programs during the time period. Demographic information (i.e., gender, age) from admission data provided by the residential programs indicated the sample was roughly representative of students enrolled in the programs during the same time period.[/list][/list]

To tell you the truth, it isn't even clear (to *me*) whether they even had anything to do with the questionnaire, just with the participant consent/assent forms.

Again, I may be missing something. If so, I'd appreciate anyone's clarification/insight. Thanks.

Here's an interesting fact about the Certificate of Approval: it only refers to the consent/assent forms prior to the study start and has nothing to do whatsoever with the results of the study, which appear never to have been submitted to WIRB, as they have no record of the study.

The Certificate of Approval will indicate approval of a consent form.

So, there's the extent of the WIRB involvement - they approved the consent/assent forms and nothing more.

I've been asking for the same thing for a couple of days, Ursus.  Obviously, it isn't there and Whooter made it up.  You have correctly pointed out the fact that WIRB had nothing whatsoever to do with "oversight" or "auditing" of this study, as they told me when I called.  They don't claim that, Canyon/Behrens don't claim that...only Whooter claims that.  He got burned behind that statement and now he's just throwing a hissy.

Now he's back to claiming "third-party oversight" and he doesn't name who "oversaw" the study, of course, because that's just made up, too.  He was formerly claiming it was WIRB, but that is proven false, so now he just makes the claim with no attribution whatsover.

This guy is as phony as it gets and will say anything to try to market Aspen, even if it means publicly pooping in his own pants over and over.  It appears that "fiduciary interest" he has in Aspen Education has clouded his judgment.  Remember, he's in it for the money, not the truth.

[Whooter]

DJ, I think we need to drop you down from your claimed PhD to a masters degree (and even that is sagging a bit).  You have not done your homework on Studies and their oversight Review Board.

Once the Study has been approved (Which WIRB did with this study).  They continue to review the study and its progress.... "Oversight".  Didnt you ask these questions during your phone call?  Did you not read up on third party oversight by a review board?



so lets recap.

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 above study was presented at the American Psychological Association (APA) conference 2006. ** 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]

The Western Institutional Review Board approved consent/assent forms and issued Certificates of Approval for the study.

The Certificate of Approval will indicate approval of a consent form.

You'll have to provide some evidence of your claim of continuing review.  WIRB only reviews what is submitted and Canyon Research/Ellen Behrens only submitted the consent/assent form.  That's it.  No continuing review whatsoever.  even the researcher don't make the claims you're making.  Just you and Aspen's marketing department do.  Hmmmm....

I'm sure, if you really try hard, you can provide a link to something that bolsters your obviously made up claims.  Until then, this issue has been closed.  Thanks for playing.

[Whooter]

The Western Institutional Review Board approved consent/assent forms and issued Certificates of Approval for the study.

The Certificate of Approval will indicate approval of a consent form.

You'll have to provide some evidence of your claim of continuing review.  WIRB only reviews what is submitted and Canyon Research/Ellen Behrens only submitted the consent/assent form.  That's it.  No continuing review whatsoever.  even the researcher don't make the claims you're making.  Just you and Aspen's marketing department do.  Hmmmm....

I'm sure, if you really try hard, you can provide a link to something that bolsters your obviously made up claims.  Until then, this issue has been closed.  Thanks for playing.

So at least we can agree that WIRB approved the study.  So the study was approved by an independent third party.  When the study is approved they issue a "Certificate of Approval".  Once this is submitted they have approved the study and continue to review the research projects.  I believe it is a federal requirement that the review board continues to review it.   Did you ask them this question DJ?  Oh, wait you said they never heard of this study lol.

[Troll Control]

More on this here.

The Certificate of Approval will indicate approval of a consent form.

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.

[Froderik]

This issue in now closed.

I agree.   :suicide:

[Whooter]

More on this here.

The Certificate of Approval will indicate approval of a consent form.

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.

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]

If it approves the research, the IRB continues to review the ongoing research after it starts. (This is called oversight).

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.

[Ursus]

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.

Interesting language in that "page 2" of "Sample 2" you reference, Whooter. Here is the whole of it, colored emphasis added...

Are we to understand that "consent has been waived" for a questionnaire which inherently involves, by definition as well as through timing, coercion and undue influence?

-------------- • -------------- • --------------

ALL WIRB APPROVED INVESTIGATORS MUST COMPLY WITH THE FOLLOWING:

1. Conduct the research in accordance with the protocol, applicable laws and regulations, and the principles of research ethics as set forth in the Belmont Report.

2.

Unless consent has been waived, conduct the informed consent process without coercion or undue influence, and provide the potential subject sufficient opportunity to consider whether or not to participate.
 

a. Use only the most current consent form bearing the WIRB "APPROVED" stamp.

b. Provide non-English speaking subjects with a certified translation of the approved consent form in the subject's first language. The translation must be approved by WIRB.

c. Obtain pre-approval from WIRB for use of recruitment materials and other materials provided to subjects.

[/list]

3. Obtain pre-approval from WIRB for any planned deviations and any changes in the research activity. The only exception is when changes are necessary to eliminate apparent immediate hazards to subjects. Immediately report to WIRB any such emergency changes implemented.

4. Promptly report to WIRB any new information that may adversely affect the safety of the subjects or the conduct of the trial.
 

a. Report to WIRB all adverse events that are serious, unexpected and related, within 10 days of the investigator becoming aware of them. Other unexpected adverse events that involve risks to study subjects or others are to be submitted with continuing review reports.
b. Promptly report to WIRB other unanticipated problems involving risks to human subjects or others. These events do not readily fit the formal definition of Adverse Event, but could impact human subject safety and/or rights. Examples include theft of a computer containing private identifiable subject information, or study staff getting ill from inhaling a study agent.
c. Provide reports to WIRB concerning the progress of the research, when requested.

5. Report to WIRB any unplanned protocol variance that could adversely affect the safety or welfare of subjects, or the integrity of the research data, within 10 days of becoming aware of the variance. Other unplanned variances may be recorded on a log and submitted with continuing review reports.

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.[/list]

DISTRIBUTION OF COPIES:

Contact · Company Name
Sherry L. Aliotta BSN, R.N. · Case Management Society of America (CMSA)
Susan A. Rogers BSN · Case Management Society of America (CMSA)
Jeanne Boling · Case Management Society of America and Pfizer, Inc.
David Day · Case Management Society of America and Pfizer, Inc.
Liza Greenberg · Case Management Society of America (CMSA)
 
SITES: If the PI has an obligation to use another IRB for any site listed below and has not submitted a written statement from the other IRB acknowledging WIRB's review of this research, please contact WIRB's Client Services department.

Address
Suite 230, 8201 Cantrell Road, Little Rock, Arkansas  72227

Page 2 of 2[/list]

Copyright ©2005 Western Institutional Review Board, Inc. All rights reserved.[/list][/list]

[Troll Control]

While interesting, Ursus, considering that MBA was one of the facilities examined (shut down by state authorities for systematic child abuse, including coerced participation), self-report studies are exempt under the law from continuing review.  This form is not applicable to Behrens' work in any way.

I did, as an aside, submit an email and documentation to WIRB regarding MBA's closure by authorities along with the investigation report to WIRB and asked if they were aware this program involves coersion and abuse as well as Behrens' connection to Aspen and NATSAP to see if that was properly disclosed.  I hope to get a response soon and will share it when I do.

[Dr. Acula]

:dose:

[Whooter]

If it approves the research, the IRB continues to review the ongoing research after it starts. (This is called oversight).

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.

Sorry Dj, I am providing links to everything we have talked about.  You claim to have made phone calls to WIRB and you told us that they told you they were not involved in the study at all.  So at this point, in order to maintain some credibility, I think it best to provide links.

From WIRB:

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an "institutional review board," or "IRB." IRBs are made up of scientists, doctors, non-scientists and community members. 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



...

[Troll Control]

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.