Stage 1: Idea Generating and Vetting – Investigator submits a Concept Sheet and/or reaches out to REGARDS investigators/Central Lab to discuss ideas related to potential ancillary study. Investigator will work with REGARDS investigators and Working Group leads to better develop the scope of work and feasibility in REGARDS. REGARDS can provide limited statistical/data management expertise to help with estimating number and characteristics of participants to be included. Discussions about IRB process should begin here. Detailed background information about REGARDS, investigators and Working Groups can be found here.
Stage 2: Submit Proposal for REGARDS Review – Investigator submits Ancillary Study Proposal Form to the REGARDS Steering Committee. All named co-investigators must review and approve proposal prior to submission. If approved, REGARDS will provide a tailored letter of support. Revisions and resubmission may be required. During this stage, investigator(s) will continue working with the REGARDS coordinating center to understand logistics and budgetary implications of the project including data management and IRB support. REGARDS will provide a preliminary estimate of coordinating center and participant burden after reviewing the proposal.
Stage 3: Submit Application for Grant Funding – Investigator will work with REGARDS Investigators to establish sub-contracts (if needed) or other funding/data sharing arrangements to conduct the research and submit the grant for scientific review. The investigator should alert the REGARDS coordinating center after the grant has been reviewed with a funding decision.
Stage 4: Conduct Research – If the ancillary study is funded, investigator will work with the REGARDS coordinating center for research approvals (IRB and Data Use Agreements), sub-contract documentation, and final scope of work. For participant facing materials, additional review and approval from the Steering Committee and the OSMB will be required for the final versions of these materials and proposed timeline. The Steering Committee may request periodic progress reports and connect the investigators with other interested investigators who come to the REGARDS parent study interested in similar topics or potential data sharing. Reminder: Manuscripts for work done through an ancillary study are also required to submit a REGARDS manuscript proposal through the standard Publications and Presentations Policies and Procedures
Stage 5: Close Out Project and Deposit Data – Any new data generated by the ancillary study should be provided to the REGARDS Coordinating Center within 2 years of study completion. This should be considered in planning budget and timeline. This process is not always applicable as new data are not always generated.