Sub-study and Ancillary Study Proposals

Process and Format

Revised: 15 Sept 2008

For all proposals submitted to the Natural History and Pathogenesis Committees Definitions

• “Sub-studies” are investigator-initiated studies that utilize previously collected data or samples from ARDSnet clinical trials. The studies may be related to the clinical issues addressed in the original trial, but the existing data and samples may also be used to address other questions.

• “Ancillary studies” are investigator-initiated studies that involve an extension of the main goals of an ARDSnet trial, and usually require collection of additional data or samples. Additional funds, independent of the ARDSnet contracts, are generally required for ancillary studies. Proposals for ancillary studies should include information regarding support for additional efforts by ARDSnet people, including the Clinical Coordinating Center, if needed. Ideas for ancillary studies must be presented to the full Steering Committee for discussion and approval before submitting a grant proposal to the funding agency. The effect of the ancillary study on the main study and its scientific value and validity will be determined by the Steering Committee. Upon approval of the concept, the ancillary study proposal will be reviewed by Natural History or Pathogenesis as appropriate.

Application Instructions

Note: Natural History and Pathogenesis submission forms are attached below

1. Submit sub-studies at least 2 weeks before regularly scheduled meetings of the Natural History or Pathogenesis Committees (link to view committee meeting schedules: http://www.ardsnet.org/event).
2. Ancillary studies require review by the ARDS Network Steering Committee after review by the Natural History or Pathogenesis Committee. Therefore ancillary studies should be submitted at least 5 weeks before regularly scheduled meetings of the Natural History or Pathogenesis Committee.
3. Biographical Sketches are required for all key personnel who are not ARDS Network members.
4. The research plan (Sections A-D) should be concise and limited to no more than 6 pages. The research plan includes specific aims, background and significance, preliminary studies, and research design and methods.
5. The research plan should describe in detail any assistance requested from the ARDSNet Coordinating Center, i.e., generation of data sets, data analysis, etc.
6. For submissions to the Natural History Committee, the research plan should indicate if the proposed sub-study requires collection of new data. If so, the research plan should describe the resources available to do this and how associated expenses will be paid.
7. For submissions to the Pathogenesis Committee, the research plan must explicitly indicate the amount of patient-derived biological material requested, i.e., mL of plasma or urine or mcg of DNA.
8. All proposals should include a statement confirming that all investigators named on the project have read the proposal and agree to participate.
9. If analyses are to be conducted by investigators independent of the ARDSNet Coordinating Center, the Coordinating Center will verify selected aspects of the analyses during the review process. Therefore, if investigators plan to conduct their own analyses, they are encouraged to discuss the analytical plan with the Clinical Coordinating Center in advance. This will help to avoid delays during the review process.
10. Appendix material is not encouraged.
11. Submit proposals ELECTRONICALLY to Andrea Harabin, Ph.D. (harabina@nhlbi.nih.gov ).

Information Regarding Proposed Sub-studies:

• Institutional Review Board approval will be required for all sub-studies and ancillary studies.
• For sub-studies approved by the Pathogenesis Committee, the ARDSnet Repository cannot release any samples until the investigator obtains and supplies any required IRB approval to the Committee.
• For sub-studies approved by the Pathogenesis Committee, investigators can only perform those measurements specifically approved by the Committee, and they must return unused residual samples to the ARDSnet Repository.
• It is expected that the results (positive or negative) of all approved sub-studies, including those considered non-publishable by the study's investigators, will be presented to the ARDSnet Steering Committee in a timely manner.
• The ARDSnet Publications Committee must review all publications resulting from the sub-study prior to submission for publication in any format (including abstracts).