Ancillary Studies

The registry encourages proposals from individual investigators and institutions to carry out secondary or ancillary studies. Investigators who wish to initiate secondary or ancillary studies must submit a written request for approval from the Steering Committee. The Steering Committee will accept secondary and ancillary study concepts on a rolling basis, but will not authorize ancillary, secondary or other abstracts and papers to be submitted for publication/presentation until the primary study products have been accepted for publication.

Written requests should be directed to the co-PIs, Dr. Glass and Dr. Shellhaas, and must contain the following information (maximum 5 pages for parts 1-4):

1.      Project Summary (including hypothesis and specific aims)

2.      Study Design (including statistical analyses and power estimates)

3.      Investigators and Sites

4.      Study and Publication Timeline

5.      Preliminary Budget, if applicable

6.      References

7.      Letters of Support, if applicable

The Steering Committee will review and approve, reject, or request modification of secondary and ancillary study proposals within one month of receipt. The Steering Committee will be responsible for making sure that the study is technically feasible, and does not interfere with the overall operation and resources of the registry. All concept proposals for ancillary and secondary studies must be reviewed and approved by at least 75% of the members of the Steering Committee.

Overlapping proposals. If more than one group of investigators proposes the same or similar studies, the Steering Committee will critically review the overlapping concept proposals. The Steering Committee will consider the proposing site’s success in recruiting subjects as a significant criterion in the evaluation of overlapping concept proposals. The Steering Committee will strongly encourage collaboration among investigators with shared interests. The Steering Committee will not support submission of overlapping manuscripts.

Data & Analysis. The investigators of ancillary and secondary studies will be required to coordinate with the registry co-PIs and biostatistician during data analysis to ensure that all study data are consistent with the data in the main study database. Data collected by ancillary studies shall be subject to access regulations as indicated in the section on Data Management and Access.

Authorship. Ancillary and secondary study manuscripts should be designed to allow inclusion of all participating site investigators. Participating sites and investigators should be offered the opportunity to participate as an author in ancillary and secondary publications. Authorship shall be defined by standard criteria as above. All registry investigators who do not meet the criteria for authorship will be listed as contributors in the acknowledgments section.

Publication. To ensure appropriate authorship, grant and network identification, study methodology description, analysis plans, and interpretation, all final abstracts and manuscripts must be reviewed and approved by the Steering Committee, prior to submission for publication. Selected members of the Steering Committee will formally review the final version of all abstracts and papers prior to submission. Approval from the co-PIs and 75% of the Steering Committee will be required for all manuscripts.