Group Therapy increasing Drug Risk?????/

[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.

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.



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Your ignorance is just...wel...stunning/.  You shouldn't pretend to understand CFR regulations, it just makes you look even more stupid.

Here's the best part.  this is called parapraxis, or in lay terms, a "Freudian slip":

...stipulation in the "Certification of approval" and WIRBS own processes...

You got that part right - it is BS that you're slinging!

Let's see...45 CFR 46 is also called the "protection of human subjects" regulation.  No way that has anything to do with human studies or anything.  Who could be so outrageous to suggest that?  Whooter, you're really, really killing yourself here.

[Whooter]

You are upset because this is a study not a highschool test. lol  

WIRB will provide formal exemption determinations for research under 45 CFR 46.101(b) for a fee.

So WIRB provides exemption if they qualify under 45 CFR 46.101(b) (which we already established that they dont).  But if a research firm does feel their study is exempt from oversight then they need to apply for it, get accepted and pay an extra fee... otherwise after the "Certificate of Approval" WIRB will oversee the rest of the study.

Your own post stipulated this DJ.  So now if you can provide evidence that Canyon Ranch applied for this and was given an exemption under  45 CFR 46.101(b) then bring it to the table.  But we both agree this would be non standard from their normal procedure.  So until you can prove this then we have to go with WIRB standard procedures.



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[Troll Control]

Non-standard?  Dude, you seriously need to educate yourself.  It is standard under law that human research is exempt from continuing review when the data gathering method is a survey.  When survey research is used, continuing review simply doesn't apply.  

All human research falls under 45 CFR 46 and 101(b) is the exemption clause for survey research.  I work with these laws daily.  Most of what I do is FDA/HHS compliance testing for medical devices which are developed through human research.  101(b) submittals are no-brainers that require no review due to the data collection method, usually surveys.  Whooter simply does not understand this system, but he likes to make believe he does.

Let me know when you "refudiate" the federal laws, Whooter. :beat:

§46.101 To what does this policy apply?

(a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.

(1) Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in §46.102(e), must comply with all sections of this policy.

(2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in §46.102(e) must be reviewed and approved, in compliance with §46.101, §46.102, and §46.107 through §46.117 of this policy, by an institutional review board (IRB) that operates in accordance with the pertinent requirements of this policy.

(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) 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.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

It's not that complicated.

Let me guess...Whooter's next argument will be "These aren't human subjects, DJ.  They're children.  Ha, Ha, Ha.  This is product research."

[Whooter]

WIRB will provide formal exemption determinations for research under 45 CFR 46.101(b) for a fee.

So you need to determine if 1st the study qualifies for an exemption and second if Canyon Research applied for and was granted an exemption and paid the extra fee to be exempt.



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[Whooter]

Interesting tidbit from the study:

Ninety-five percent had prior treatment and 85% were
treated for multiple presenting problems, the most common of which were disruptive behavior,
mood, and substance abuse problems.

Many here at fornits were under the impression that these kids didnt receive local services prior to going to a Residential Treatment Center.



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[Whooter]

A few more thoughts on this Exemption Discussion:

Another thing to consider is that companies charge a fee to investigate whether or not a study qualifies for an exemption under  45 CFR 46.101 (b).  We cannot determine this sitting here on the internet.  There is no evidence that they applied for an exemption.

For example:   If their survey forms (if that’s what they called them) contained the peoples names, childs names  or any  slight identifiers which could trace the survey back to them then they would not qualify for an exemption under the law.  There are many other factors which would disqualify a study from being exempt.  Without seeing the study design and forms we could not possibly determine this.

Another thought,  It would be a little absurd to seek third party oversight from WIRB and then ask for an exemption against it, don’t you think.

As you read through their web site it becomes clear that people hire them to help them and to oversee their study and that is the whole intent of this.  If people come along and try to argue that they sought exemption from it then they need to provide proof.



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[Troll Control]

Several of the programs in the study have problems with child abuse and one was closed for "systematic child abuse."

The study actually concludes that child abuse is beneficial to children.  We all understand that conclusion invalidates the research.

I see Whooter has now abandoned his latest claim that federal regulations protecting human subjects don't apply to children.  That's progress, but the rest of what he's saying is still plain old bunk.  He now claims to be an expert on laws he never heard of yesterday.  It's laughable.

[Whooter]

I think we have exhausted the discussion on oversight and we have not found any evidence that the study was determined to meet 45 CFR 46.101 (b) exemption.  So we need to conclude that oversight to the study was done as per WIRBs normal procedures.

I think this is a good point to start discussing the study as DJ has begun.

[Whooter]

Some clips from an interview with the Behrens who conducted the research


Ellen explained that what makes this outcome study unique is that it is longitudinal with a large sample size and included multiple programs. "Therefore, it has given us our first glimpse into the outcomes of private parent-choice residential care, and we think it's fairly indicative of what happens in a treatment setting. We found that the types of youth we tend to serve appear to be those with multiple problems. In fact approximately 85 percent of the youth in this sample had more than one serious problem for which they were treated and tended to be equally male and female. This is noteworthy because there is an assumption in the published literature that residential programs do not have a good gender balance. In reality from the multiple programs in our study, there was a good balance. About 95% of the youth in our study had received and "failed" prior treatment at other levels of care and/ or types of treatment."



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[Troll Control]

This work used two self-report surveys, the YSR (Youth Self Report), and the CBCL (Child Behavior Check List), each of which consist of a ten minute checklist.  These checklists were given to the kids (YSF) and parents (CBCL) while the kids were still in the program which is poor methodology to say the least, especially considering many of these kids were abused and neglected in the programs and self-preservation would motivate them to say anything to get out and the parents had no routine ability to observe and report on their child's behavior.  

These facts are readily admitted by the researchers.  For example, they state that youth and parents have tendencies to underreport problems.  That is, the kids "fake it to get out,"  and the parents need to justify the expenditure.

...parents are often confronted  by clinical staff if they discharge an adolescent against program advice, they, along with their adolescent,  may have a conscious or unconscious motivation to underreport problems.

The majority of subjects were in programs only six months, that is, pulled early against program protestations.

Additionally, the YSR and CBCL are both data acquisition tools that are exempt from continuing review under 45 CFR 46 101(b), so these findings have never been reviewed or analyzed.

Considering that several of these facilities have also been charged with child abuse and neglect, the survey results are unreliable.  This is likely why this study has never been reviewed or published except as a marketing tool for Aspen Education.

[Troll Control]

A number of issues warrant further research attention...this study did not use a control group.

No control group?  What did they measure against?

Future research in private residential treatment needs to address the question of post-discharge maintenance of treatment gains.  The residential treatment literature indicates that a significant portion of adolescents who function well at discharge subsequently experience a decline when transferred to a lower level-of-care (Curry, 1991; Epstein, 2004; Hair, 2005).  The second phase of this study will explore that issue using the private residential data of the present study as the point of comparison.

It has been almost six years since this study was performed.  Why has the "second phase" never been conducted?

Aspen got the marketing tool it wanted from the first, deeply flawed project which has no scientific validity, as admitted in the work itself.  Just read it.  Why would they pay for a second phase when they know the kids take a nose-dive after the program (e.g. Whooter's daughter, et al)?

[Whooter]

This work used two self-report surveys, the YSR (Youth Self Report), and the CBCL (Child Behavior Check List), each of which consist of a ten minute checklist.

It doesnt appear that you are too familiar with the Youth Self Reports.  These collect a little more information than just a check list, there is also a written section to elaborate on their stay , concerns etc.

Additionally, the YSR and CBCL are both data acquisition tools that are exempt from continuing review under 45 CFR 46 101(b), so these findings have never been reviewed or analyzed.

The exemption would be denied if they applied for it if the YSR and/or CBCL had any ID# or the childs name which could trace a child back to the report that was submitted.  WIRB would need to review the process used and the YSR/CBCL to see if they comply with this condition (and others) before they can be considered for exemption.  I haven't seen it stated anywhere in this study where they applied and/or took this exemption.

Example: 46.101(B)
(2) 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.



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[Whooter]

The majority of subjects were in programs only six months, that is, pulled early against program protestations.

DJ you are misquoting and misinterpreting the study left and right.  Lets be careful, here is a quote from the study:

The study states:
The average length of stay was 8.6 months for those discharged with maximum benefit
and 6.5 months for who were discharged with partial benefit or against program advice. The
majority discharged with program approval: 53% with maximum benefit, 19% prematurely but
with approval, 15% against program advice, 8% needed treatment beyond the scope of the
program, and 3% “other” discharge status.



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[Troll Control]

Time required:
Approximately 10 minutes.

That's right from the instructions.  I tend to believe the test designer over an anonymous poster.

As far as average length of stay is concerned, I made no representation whatsoever.  How could I have "misrepresented" something I never even mentioned?  That makes no sense.  

I would hope, being a smart guy and all, you understand that the average tells nothing of the distribution above and below it.

You could have 10 kids stay for one month and five kids stay for 24 months and the average would be 8.6 months with the vast majority of kids staying less than 1 month and 1 day.  It's called mathematics.  You should look it up.  I wonder how you claim to have such vast experience with statistics and not even understand the concept of an average? :bs:

Regarding YSR reporting...It is exempt because the children's names or identities are mentioned nowhere in the study nor can their identities be inferred from any information in the study.  They would be recorded in the data set by the researcher as "Subject 1," "Subject 2" or "Reporter 1," or "Reporter 2."  Show me a study that says "the subjects were John Smith, Jane White" etc.  It's not done that way and I think we all know that by now.

Yesterday you said 45 CFR 46 doesn't even pertain to this study because "it's a study, not a high school test," an obvious lie that shows your ignorance on the subject as well, and now you're claiming to understand exemptions under the title.  :roflmao:   You were saying yesterday high school tests are subject to federal regulations, but studies aren't. :roflmao:   You've no idea what you're talking about and quite obviously have never had any experience with human research.

[Whooter]

Regarding YSR reporting...It is exempt because the children's names or identities are mentioned nowhere in the study nor can their identities be inferred from any information in the study. They would be recorded in the data set by the researcher as "Subject 1," "Subject 2" or "Reporter 1," or "Reporter 2." Show me a study that says "the subjects were John Smith, Jane White" etc. It's not done that way and I think we all know that by now.

DJ, nobody would list the names of the 1,000 kids in the body of the study itself.  They are concerned that the kids identities remain safe.  Read the requirements again:

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, (i) unless:
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.

YSRs ask for the persons name (it is not anonymous) and it is set up to link to identifiers via an id system.  In order to be exempt they would have to adopt a system which keeps the people being surveyed completely anonymous so that the children can remain safe.  The review board would have to look at how the names are handled to determine if the parents names and those of their childrens will remain safe from being linked to "Subject 1".."Subject 2"   etc. before they allowed exemption.  



Here is a sample of the Youth Self Report , you will see that they ask for the childs name and there is an id number assigned to connect each report to the childs name.  You will also notice it is more than just as checklist (as you claimed).  They capture written feedback from each person surveyed.


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