National Institute of Diabetes & Digestive & Kidney Diseases

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.

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).

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.