Division of Digestive Diseases and Nutrition (DDDN)
RFA: DK-03-022:
Ancillary Studies to Obesity-Related Clinical Trials (RFA-DK-03-022):
FREQUENTLY ASKED QUESTIONS AND NEW INFORMATION
LATEST UPDATE: July 20, 2004
This notice announces an update to RFA-DK-03-022: ANCILLARY STUDIES TO OBESITY RELATED
CLINICAL TRIALS, as posted in the NIH guide:
http://grants2.nih.gov/grants/guide/notice-files/NOT-DK-04-007.html.
The update is to inform potential applicants of two changes in RFA-DK-03-022: a
change in the handling of fiscal and administrative costs on subcontracts and the
readiness of three networks to accept ancillary studies.
In summary, the original RFA INCLUDED fiscal and administrative costs on subcontracts
towards the direct cost funding limitation of $1 million per year. This policy will
be changed beginning with the next receipt date for the RFA to EXCLUDE fiscal and
administrative costs on subcontracts from the funding limit, consistent with new
NIH policy (see April 30, 2004 NIH Guide,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).
This addendum also announces the readiness of three trials or networks to conduct
ancillary studies:
1) The Longitudinal Assessment of Bariatric Surgery (LABS) study, formerly know
as the Bariatric Surgery Clinical Research Consortium.
http://www.niddklabs.org
2) The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN).
http://www.nashcrn.com
3) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
http://www.todaystudy.org
Applications for ancillary studies to these trials or networks may be accepted for
the remaining receipt dates, November 19, 2004, and July 19, 2005. All other aspects
of the RFA remain unchanged.
The full text of the RFA, which was published October 22, 2003, can be accessed
at the following location:
http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-03-022.html. An earlier
addendum announcing a name change for the PRIDE study may be found at:
http://grants.nih.gov/grants/guide/notice-files/NOT-DK-04-002
LATEST UPDATE: March 26, 2004
This notice is to inform potential applicants of the current status of two clinical
trials or networks eligible for ancillary study applications under RFA-DK-03-022:
ANCILLARY STUDIES TO OBESITY RELATED CLINICAL TRIALS
http://grants1.nih.gov/grants/guide/notice-files/NOT-DK-04-002.html
Please note that two trials/networks referenced in RFA-DK-03-022 have posted ancillary
studies policies and study descriptions on their websites and now are ready to receive
applications:
1) The Nonalcoholic Steatohepatitis Clinical Research Network (NaSH CRN). The ancillary
studies policy for the network may be found at
http://www.nashcrn.com.
2) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY). Information
about TODAY can be accessed at
http://www.todaystudy.org.
All other aspects of the RFA remain unchanged. As a reminder, the next receipt date
for the RFA is November 19, 2004.
LATEST UPDATE: December 24, 2003
This notice is to inform potential applicants of an ADDENDUM TO RFA-DK-03-022: ANCILLARY
STUDIES TO OBESITY RELATED CLINICAL TRIALS
http://grants1.nih.gov/grants/guide/notice-files/NOT-DK-04-002.html
There have been two changes in RFA-DK-03-022: a change in the name and a change
in the receipt dates for one of the networks.
The name of the "Weight Reduction for Incontinence Network (WIN)", one of the seven
cooperative clinical trials/networks listed in the RFA has been changed to "Program
to Reduce Incontinence by Diet and Exercise (PRIDE)".
Applications for ancillary studies to PRIDE (formerly known as WIN), now may be
accepted for all receipt dates (March 19, 2004, November 19, 2004, and July 19,
2005).
All other aspects of the RFA remain unchanged.
LATEST UPDATE: October 10, 2003
Please check this site often for answers to frequently asked questions and new information
about RFA DK-03-022: Ancillary Studies to Obesity-Related Clinical Trials.
Last Update: 7/28/2004
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