How It Works

Review of Requests

Research Proposals are checked and reviewed in 3 stages: Stage 1, by the Wellcome Trust which is the secretariat for the Independent Review Panel (IRP) ; Stage 2, by the study Sponsors; Stage 3, by the IRP.

Review of Research Proposals

1. Stage 1 - Wellcome Trust (secretariat for the IRP):

1.1	A qualified statistician is a member of the research team
1.2	All solicited fields are completed
1.3	The researcher plans to publish the analysis results

If one or more of these checks fail, the proposal will be returned to the researcher for further information.

If all of these checks pass, then the proposal will advance to stage 2.

2. Stage 2 - The Study Sponsors check the following:

Sponsors generally review for the criteria below. Note that some Sponsors may opt out of a particular check. See individual Sponsor pages for details of each Sponsors' policies.

2.1	The Research Proposal is compatible with study informed consent
2.2	The data and studies are available to perform the analysis
2.3	The planned analysis can be conducted in the data access system
2.4	The Research Proposal does not compete with Sponsor's publication plan
2.5	Additional information that may be relevant to complete the review This is generally to provide information to the researcher or for the researcher to provide additional information to the Sponsor, if clarification is needed
2.6	Under exceptional circumstance, for some Sponsors only - check for a potential conflict of interest or an actual or potential competitive risk

A conflict of any of these checks could result in a decline of the Research Proposal, or a request for re-work or further information from the researcher.

If declined by the study Sponsor, the rationale will be provided to the researcher and is made available in the Metrics section of this site, which is updated on a regular basis.

If all of these checks pass, the Research Proposal will advance to stage 3.

3. Stage 3 Review - The Independent Review Panel, which is administered by the Wellcome Trust, considers the following:

3.1	The scientific rationale and relevance of the proposed research to medical science or patient care.
3.2	The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives. This is a high-level review.
3.3	The publication plan for the research.
3.4	Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.
3.5	The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).

Before completing its review, the IRP may ask for additional information from the researcher and if needed seek additional expert advice.

Decisions the Independent Review Panel can make

The Independent Review Panel will make one of the following decisions:

Approval to provide access to the requested data.
Declined with advice to re-submit the Research Proposal.
Declined Research Proposal.

The panel chair informs the IRP Secretariat and relevant study Sponsor or Sponsors of the decision and provides any conditions of access and the rationale why a Research Proposal is not approved. For declined IRP Research Proposals, the rationale is communicated to the researcher. There is no appeal process. For approvals, the Data Sharing Agreement will thereafter be sent by the Sponsor(s).

An overview of the number of Research Proposals submitted and the outcome of the IRP's review is made available in the Metrics section of this site and updated on a regular basis.

Researchers must not use approval by the IRP as scientific endorsement for funding or publication.

Researchers are responsible for gaining any other approvals that are required for the research (for example, from Ethics Committees, Institutional Review Boards, relevant research institutions or funding bodies).

The Independent Review Panel is listed here.

When a decision can be expected

If no further information is needed, and depending on the number of requests received, it is anticipated that the decision from the panel will be communicated approximately 90 calendar days of a Research Proposal being submitted. Researchers will be notified when it is anticipated that the data for their research will be made available.

Review of enquiries to access data from studies not listed on this site

If an enquiry facility is provided, enquiries are answered by the relevant Sponsor(s). Where Sponsors are able to provide access to the data, access will be provided if the Independent Review Panel approves a submitted Research Proposal that includes these studies and the relevant Sponsor(s) receives a signed Data Sharing Agreement.

An overview of the number of enquiries to access data from studies not listed on this site and the outcome of Sponsors' reviews is made available in the Metrics section of this site on a regular basis.

Review of enquires to access study documents without patient level data

These enquiries are answered by the relevant Sponsor(s). Further information about Sponsors' policies are provided in Study Sponsors section of this site.

Request Flow Diagram