General Interest > Feed Your Head
Group Therapy increasing Drug Risk?????/
Ursus:
--- Quote from: "Whooter" ---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.
--- End quote ---
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:
--- Quote from: "Dysfunction Junction" ---
--- Quote from: "Whooter" ---If it approves the research, the IRB continues to review the ongoing research after it starts. (This is called oversight).
--- End quote ---
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.
--- End quote ---
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:
--- Quote from: "45 CFR 46 101 (b), Exemptions from Continuing Review" ---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.
...
--- End quote ---
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.
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