You need to be careful about what you call human subjects research. I
found out only recently that NIH no longer considers research with
publicly available datasets--what used to be category 4--to be research
with human subjects. I think this also includes deidentified data, but I
can't find the file I was looking for. So...if you are using that kind
of data, you would answer "no" to the question about human subjects.
Other exempt research has an exemption approval attached to it (and we
get a letter from an administrator), so I use that date if the research
has been through some kind of administrative process and has been
approved for exemption; otherwise approval is pending.
 Elsa

>>> Anna Dore <xxxxxx@BC.EDU> 06/01/06 3:45 PM >>>
I have a related question:

When a project is exempt from IRB review, how do you answer the
question
"Is IRB review pending?"

When I answer "No,"  the IRB approval date becomes a required field.
I
tried entering "N/A," but was told that it was an "invalid entry" -
seems it will only accept a date.  Ultimately, I answered "Yes" as
that
seemed my only option.

The helpdesk hasn't responded adequately to my inquiry and the G.g
application guide instructions don't address this either.  Has anyone
else encountered this dilemma?  How have you handled it?

Thanks so much for your replies, and all the information posted here
daily.  I've learned so much by just watching!

Anna Dore
Boston College

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On
Behalf Of Patricia Byers
Sent: Thursday, June 01, 2006 11:52 AM
To: xxxxxx@HRINET.ORG
Subject: Re: [RESADM-L] Human subjects e-applications to NIH

We also got an warning message stating that our FWA number didn't
match
what was in the eRA Commons.  The problem is that  the field for this
number on the application form is not long enough for the complete
number.  We left out one of the zeros in the middle thinking that this
would be better than loosing the last number....and then just ignored
the warning.  Not a good solution, but we just didn't' now what to do.
Pat

Charlie Hathaway wrote:

Help.

What format should be used for the human subject assurance number
(Item
1a, Research and Related Other Project Information) in PureEdge for an
NIH proposal?

We have discovered conflicting guidelines concerning inclusion or
exclusion of the FWA prefix.

When we left it out we got a warning.

When we left it blank (by accident) there were no errors or warnings
(??!!  so helpful)

Am about to keep the FWA but would like comments

thanks

Charlie Hathaway

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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
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