Ancillary study proposals may be submitted for a subset of de-identified data for research purposes by investigators of participating sites in the VIRUS study. The proposals are submitted via an
online submission portal. Once submitted, the proposal will be received by Discovery VIRUS Publication Review Workgroup & Discovery Steering Committee for approval amd feedback.
Datasets may be made available to outside groups (non-participating sites/investigators) after the initial publication of the data by VIRUS principal investigators. A DUA will need to be in place for this type of request.
The Discovery VIRUS Publication Review Workgroup will define the approvals via a transparent feedback mechanism to the investigators. For similar proposals (which are scored on par with each other), the review workgroup leadership will encourage investigators to collaborate on the topic. If collaboration is not feasible, preference will be given to the investigator who first submitted the idea to the VIRUS ancillary study portal. The VIRUS project manager or study coordinator will reach out to the investigators for the list of data variables requested for the ancillary study.
Approval Process: The feedback on proposals will be shared with the investigators. The proposals that are approved, will have to follow the SCCM Discovery publications policies, that will be shared upon proposal approval. The Discovery VIRUS Publication Review Workgroup will make it a priority for rapid review of proposals based on the timeline given below.
Information for investigators:
- Any conflict of interest with the ancillary study proposal will be disclosed by the reviewers and the investigators.
- The ancillary study proposals have been kept blinded from the VIRUS core investigator group. The first batch of ancillary proposals will be published once the review period closes and notifications are sent to the investigators.
- SCCM, including the VIRUS core investigators group, has the first right upon publication of the dataset for research hypothesis outlined for the VIRUS Study.
- Study participants can serve on the writing group with the VIRUS core investigators team, if their ancillary study ideas overlap or align with the VIRUS overall project aims.
- Collaboration (national & international) on ancillary proposal submissions are encouraged.
- Ancillary proposal approval and data sharing will also depend of data quality and completion of investigator’s own site data for the VIRUS study.
Timeline:
|
Ancillary study proposal portal open |
Ancillary study proposal portal closed |
Review period |
Notification |
First round of reviews |
April 15, 2020 |
May 30, 2020 |
June 1- June 30, 2020 |
By July 15, 2020 |
Second round of reviews |
July 15, 2020 |
September 30, 2020 |
Oct 1 – Oct 30, 2020 |
By Nov 15, 2020 |
Third round of reviews |
December 1, 2020 |
February 15, 2021 |
March 1 – March 30, 2021 |
By April 15, 2021 |
To submit a request for ancillary studies related to VIRUS please
complete this application.