Notice Number: NOT-HL-12-145
Key Dates
Release Date:
May 24, 2012
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
On December 7, 2011, the NHLBI issued a Funding Opportunity Announcement (FOA): RFA-HL-13-013 Ancillary Studies in Clinical Trials
https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-003.html
The following correction to this FOA is being made:
Section IV. Application and Submission Information
6. Other Submission Requirements and Information
Special Instructions
Current LANGUAGE:
A brief Protocol Summary of the parent trial and the IRB-approved informed consent documents must be included in item 12 of the SF424 of your application. The draft protocols and draft consent forms for the ancillary study should also be included in item 12 of the SF424. IRB approval is not required at the time of submission for the ancillary study protocol and related documents. Successful applicants will be required to submit this information at the time of award. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.
NEW LANGUAGE:
A brief Protocol Summary of the parent trial and the IRB-approved informed consent documents must be included in item 12 (Other Attachments) of the ‘Research and Related other Project Information’ found in the Mandatory Document section of your application package. The draft protocols and draft consent forms for the ancillary study should also be included in item 12 of this section. IRB approval is not required at the time of submission for the ancillary study protocol and related documents. Successful applicants will be required to submit this information at the time of award. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary.
Inquiries
Inquiries should be directed to:
Suzanne Goldberg, R.N., M.S.N.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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