Plan an Ancillary Study

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What Is an Ancillary Study?

An ancillary study (AS) uses HCHS/SOL data or stored biospecimens or collects new data to investigate scientific questions not covered in the parent study. AS require their own funding and must be approved by the Ancillary Studies Committee (ASC), Steering Committee (SC), and when applicable, the NHLBI and OSMB.

Types include:

  • New Data Collection
  • Stored Biospecimens Request
  • Secondary Data Analyses
  • Career Development Awards
  • Consortium Seeking Funding
  • Administrative Supplements

Steps to Submit an Ancillary Study Proposal

  1. Identify Sponsorship and Collaborate - Must be a HCHS/SOL PI or Co-PI.
  2. Submit a Concept Proposal, except for AS doing secondary data analyses only
  3. Submit a Full Proposal
  4. Submit AS proposal via HCHS/SOL Web Portal

Policy Summary

All AS must be sponsored by a HCHS/SOL PI or Co-PI and cover all related costs. When data or materials are requested from other AS, their PIs must also sponsor it. Participant recruitment must be handled by HCHS/SOL field center’s staff. Use of stored biospecimens must follow volume and reserve policies. AS data must be sent to the Coordinating Center and included in NHLBI repositories. Publications require HCHS/SOL review. AS submitting a renewal must submit a new AS proposal.

Timeline for Review

Step Estimated Time
Concept Proposal Approval by ASC and SC:  Up to 4 weeks
Full Proposal Review by ASC and SC: 4 to 8 weeks
NHLBI/OSMB Review: Up to 8 weeks

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