>>Rob Weisskirch wrote;
>>
>>Here is my rationale for passive consent:
>>
>>1. The school district has accepted passive consent. With the support of
>>the school, they are going to back up any parental objections.
That's great but, I would get in writing that they will assume all
legal liabilities and provide you with legal representation at no cost to
you. I would also have it notarized and run by an attorney. Just because a
local school district is unaware or non-compliant with federal regulations,
that will likely not protect you or your institution, especially when you
and your institution are aware of them.
>>2. The federal guidelines standard of "no minimal risk" would apply in this
>>case.
As an IRB chairperson, I am pretty familiar with the regs but am
not aware of the term "no minimal risk" in the guidelines. However, the
"minimal risk" provision in the federal guidelines still require parental
consent for this protected (i.e., determined to be vulverable) class.
However, it indicates that consent of only one parent may be sufficient in
such determinations. Further, for this special "protected" class of
subjects, federal regulations permit IRB's to approve research that is of
minimal risk (but not individual researchers who believe their research is
of minimal risk). Investigations involving such subjects that "present
significantly greater than minimal risk without direct benefit to them must
be reviewed by the Secretary of Health and Human Services, in consultation
with appropriate experts." (OPRR guidelines, 6-1).
>>3. This procedure is common practice in schools where they send something
>>home notifying parents of a happening in school. There is no way to be
>>absolutely sure something gets home, but when it's seriously important (like
>>consent for sex ed classes) they do ask for a signature. Our innocuous
>>questionnaire is not intrusive enough to merit parental approval.
I'm certain this would go a long way in a courtroom to expain your
failure to gain IRB approval. ;-)
Were I a litigating attorney, my question to you would be whether you made
this determination yourself or whether it was made by your IRB, and, as a
university employee, whether submission of research to your IRB for prior
approval is a matter of policy at your institution.
>>4. The child's has an assent form as well and can back out at any point.
Any IRB would likely require this, given that it was determined
that your participants understand the form and are capable of assent.
>>5. The relationship between schools and university research is already
>>tenuous. Asking the school to assume the burden of distribution and
>>collection may risk the relationship for research purposes.
Sorry, I don't find that in the guidelines as a justification for
not obtaining parental consent. Besides, the researcher usually assumes the
burden of distribution and collection.
>>6. Protection of the institution is an interesting point. So, if I have
>>the school and the school district approval, the university is going to be
>>afraid that a parent is going to go after them? I know I live the
>>litiginous state of California, but this paranoia of cover your behind seems
>>a little extreme. You can sue anybody for anything! But, let's look at
>>what is most risky. Research always assumes a risk to the participant. The
>>best I can do is reduce the risk.
I suspect your institution may have the "deepest pockets". Why
should they take any risk, particularly that of litigation and/or loss of
federal support ? You might ask them if they think "this paranoia of cover
your behind seems a little extreme". But then, in your original post, I
thought you did, sort of, but didn't like their reply.
Generally Rob, when a horse dies, folks get off. I think this horse may be
dead. ;-)
George Goedel
Professor and Chair
Dept. of Psychology
Northerbn Kentucky University
Highland Hts., KY 41099-2000
[EMAIL PROTECTED]
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