For Clinicians & Researchers

Background:

The ARDSNet Steering Committee, the main governing body of the network, has appointed two sub-committees to manage requests for network data and biospecimens from ARDSNet studies still in the Proprietary Period (up to three years following publication of a trial’s main paper). The Pathogenesis Committee oversees ancillary and sub-study projects utilizing biological material collected as part of network studies. The Natural History Committee reviews proposals utilizing data from ARDSNet clinical trials. Both committees are responsible for evaluating the scientific merit of each proposal, the implications of the research, and soundness of the study design. During the proprietary period, non-ARDSNet investigators are encouraged to obtain an ARDSNet collaborator.

Proposals that involve Open Period studies (completed studies that have been published three or more years ago) are under the purview of The National Heart, Lung and Blood Institute (NHLBI). Requests related to Open Period studies must be directed to the NHLBI Biologic Specimen and Data Repository through their BioLINCC website. This website serves to coordinate searches across data and biospecimen collections from NHLBI sponsored trials and to provide an electronic means for requests for additional information and the submission of requests for collections. Exception: proposals involving DNA for both Proprietary and Open Period studies must go through the Pathogenesis Committee.

Instructions for applying for data/samples from Open Period studies are located on the BioLINCC website.

Study Publications:

All projects using ARDSNet data or samples authored by ARDSNet investigators require manuscript review/approval by the ARDSNet Publications Committee. Such publications should cite “for the ARDS Network” (see guidelines listed on the right). Non-ARDSNet investigators should cite the NHLBI ARDS Network in the acknowledgement section.

How do I know which ARDSNet studies are Open Period and how do I determine what type of proposal I have and whom to submit to?

ARDSNet CCC Assistance

You will need to work with the Clinical Coordinating Center (CCC) at Massachusetts General Hospital to obtain:

• Data and/or samples from Proprietary Period studies
• DNA from either Open or Proprietary Period studies

Requirements to obtain data/samples through the CCC:

• Proposal approved by either Natural History or Pathogenesis Committees (approval letter from the committee Chair)
• IRB approval (or exemption letter)
• Note: significant changes to approved proposals will require approval from the corresponding committee
• Data variables meeting HIPAA definition of Limited Access Data will require a data use agreement (DUA) signed by the ARDSNet Investigator Sponsor of your proposal (or your center PI)