Definition of an Ancillary Study:
A COPDGene ancillary study is one that extends research questions or resources beyond that in the original program. These studies require review and approval by the Ancillary Studies and Publications Committee and the COPDGene Executive Committee and include studies such as:
1. Analytical Ancillary Studies: Additional analyses of the main study data, which are not included in the main analyses of the study;
2. Supplemental Ancillary Studies: Use of COPDGene study data from one or more clinical centers in concert with additional data collection at those clinical centers on their study participants;
3. Clinical Trials Involving COPDGene Subjects: Clinical trials (single or multiple site) involving COPDGene subjects and which use COPDGene study data to select subjects [whether the data comes from the COPDGene Data Coordinating Center (DCC) or from clinical center records] will require review and approval by the COPDGene OSMB in addition to review and approval by both the Ancillary Studies and Publications Committee and the COPDGene Executive Committee.
The proposed ancillary study may be done without supplemental funding or may derive funding from other than COPDGene funds. Examples include studies funded by investigator-initiated NIH research awards (R01s), grants from academic institutions, private sources (e.g., pharmaceutical companies), or those performed at no cost (generally because of the special interest of a researcher). Ancillary studies involve the collection of new data, either directly from participants or from previously collected samples, images, or other sources (e.g., medical records).
Philosophy:
Investigators individually and collaboratively are encouraged to propose and conduct ancillary studies. Such studies enhance the value of COPDGene and ensure the continued interest of the diverse group of investigators who are critical to the successes of the study as a whole. They provide an exceptional opportunity for investigators, both within and outside of COPDGene, to conduct additional projects at minimal cost.
At each level of review, highest priority will be given to studies that:
1. Do not interfere with the main COPDGene objectives
2. Have the highest scientific merit
3. Produce the smallest burden on COPDGene participants and the least demand on COPDGene resources, such as blood samples
4. Demonstrate willingness to follow the COPDGene guidelines for data sharing
5. Have the potential to develop new sources of funding to exploit the opportunities created by the COPDGene core program
6. Require the unique characteristics of the COPDGene cohort
7. Demonstrate a feasible plan for funding additional costs of the study.