Interesting that this question shoudl arise when I have just learned of
an NIH policy concerning human subjects. I don't recall seeing a notice
to this effect. I quote below a section of a note one of my faculty
members received today:

" There was a change in the NIH definition of human subjects for all
applications submitted after January 10, 2005.  Human subjects are not
considered to be involved if the proposed research uses only coded
private information
or specimens, and

a) the private information or specimens are not collected specifically
for the proposed research through an interaction or intervention with
living individuals, and

b) the investigator cannot ascertain the identity of the individual to
whom the coded private information or specimens pertain.

If the human subjects data in your research plan already exist and have
been derived from sources/investigators that are not involved in the
application, then section 4 on the face page should be marked NO for
human subjects.  If these conditions are not met, then section 4 should
likely be marked YES.  There are rare cases where Exemption 4 applies.

When coded, private human specimens/information are involved and
section 4 is marked no, the institutional official serves as witness to
the agreement that anonymity will not be breached. For more details
please
see the PHS 398 instructions
(http://grants.nih.gov/grants/funding/phs398/phs398.html)."

I am at the department level and so know what is being done. I am able
to direct faculty in the correct boxes to check. But since NIH uses the
"just in time" approach to IRB approvals, we do not require approval at
submission time. I do, however, recommend that faculty begin the process
as soon after the NIH deadline as possible so that when the award notice
arrives, everything is ready to go. At the same time, our institutional
approval sheet does ask about human subjects, animal use, biohazards and
ethics training.

Elsa G. Nadler, EdD
Grants Manager
Department of Community Medicine
1 Medical Center Drive
PO Box 9190
West Virginia University
Morgantown, WV 26506-9190

Tel: 304/293-3546
Fax: 304/293-6685

>>> xxxxxx@WPI.EDU 03/24/06 3:05 PM >>>
Hello all,

I have a question regarding institutional policies and procedures on
research
proposals where human subjects may be involved--perhaps this is more of
an
"informal" survey of "best practices."

During proposal development, do any of you have a formal process
and/or
procedure to screen research proposals for possible human subject
involvement?

For example, do you rely primarily on the PI to identify human subject
involvement in his/her research on your internal proposal coordination
or
proposal routing form, and then direct the PI to seek IRB approval?
Or,
alternatively, does your sponsored programs office screen proposals
prior to
submission and notify the PI to seek IRB approval?

Thank you,

Tina

Christina DeVries
Research Administration
Worcester Polytechnic Institute

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