General Interest > Feed Your Head
Group Therapy increasing Drug Risk?????/
Troll Control:
--- Quote from: "Whooter" ---
--- Quote from: "Dysfunction Junction" ---
--- 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.â€
--- End quote ---
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?
--- End quote ---
This issue is closed. Whooter is an ignoramus.
--- End quote ---
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.
...
--- End quote ---
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":
--- Quote from: "Whooter" ---...stipulation in the "Certification of approval" and WIRBS own processes...
--- End quote ---
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:
--- Quote from: "Federal Law" ---
§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.
--- End quote ---
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:
--- Quote ---WIRB will provide formal exemption determinations for research under 45 CFR 46.101(b) for a fee.
--- End quote ---
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.
...
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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