>According to the lawyer who sat on our IRB, surveys typically did not
>require IRB approval as the potential respondent could always choose NOT to
>respond. The legal notion was that, by responding to a survey, the
>individual was providing implicit consent by her/his behavior.
>My experience is that some IRB committees take it upon themselves to be a
>bit more powerful than they are/or have to be for protecting subjects from
>"reasonable risks".
>I spoke with a colleague whose research using FDA approved (as safe) odors
>was rejected because it was possible that some subjects might have a
>negative reaction to the odors. Isn't this always true? Does that mean that
>all odor research should be discontinued?
>My point here is that the priority of IRBs should be protection of subjects
>indeed. But there is NO research which is completely risk-free.
>I know some of these comments are off the original topic... but I think
>they're worth a second thought.
>
>Cheers,
>
>Steven M. Specht, Ph.D.
>Associate Professor of Psychology
>Psychology Department
>Utica College of Syracuse University
>1600 Burrstone Rd.
>Utica, NY 13502
>(315) 792-3171
>
>"To teach is to learn twice". - Joseph Joubert (1754-1824)
Steven,
The best thing for anyone to do is check with their institution's
policy on what needs to be reviewed. The federal guidelines indicate
that some research may qualify for "exempt from review" status but
that such should not be at the researcher's discretion but determined
by the institution's IRB. Issues of "informed consent" are separate
from whether or not a research protocol should be reviewed. You may
wish to bring this to the attention of the attorney on your IRB who
should be familiar with the guidelines. I forwarded a similar message
off-list to Rob. All federal guidelines can be found at;
http://ohrp.osophs.dhhs.gov/g-topics.htm
the relevant passage is at;
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc95-02.htm
"Research activities involving human subjects that are exempt from
IRB review are identified in 45CFR 46.101(b)(1)-(6). (Institutions
and IRBs may not create new categories
of exempt research under 45 CFR Part 46.) Institutions should have a
clear policy in place on who shall determine what research is exempt
under .46.101(b). Those persons
who have authority to make a determination of what research is exempt
are expected to be well-acquainted with interpretation of the
regulations and the exemptions. In addition,
the institution should be prepared to reinforce and review, as
necessary, the method of determining what is exempt. OPRR advises
that investigators should not have the
authority to make an independent determination that research
involving human subjects is exempt and should be cautioned to check
with the IRB or other designated
authorities concerning the status of proposed research or changes in
ongoing research.
Institutions may elect to review all research under the auspices of
the institution even if the research qualifies for exemption under
.46.101(b). An institution with a Multiple
Project Assurance (MPA) or Cooperative Project Assurance (CPA) should
indicate in its Assurance if and how exempt research is reviewed. It
is incumbent on the institution
to advise investigators and others involved in the conduct and
administration of research involving human subjects of the
institutional policies for reviewing exempt research."
George Goedel
IRB chair at NKU
--
George D. Goedel
Professor & Chairperson
Department of Psychology
Northern Kentucky University
Highland Hts., KY 41099-2000
(859) 572-5574
fax (859) 572-6085
[EMAIL PROTECTED]
