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Wellcome

Review of requests

The Wellcome Trust has taken responsibility for managing the review of research proposals and the operation of the IRP.  The Trust will also administer the IRP secretariat and appoint new panel members. www.wellcome.ac.uk

Review of research proposals

Research proposals are checked by the Wellcome Trust and the relevant sponsors to make sure the information is complete and that they meet the requirements of this initiative and the sponsor’s requirements for informed consent. They are then sent to the Independent Review Panel. The panel considers the following:

  • The scientific rationale and relevance of the proposed research to medical science or patient care.
  • The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives. This is a high-level review.
  • The publication plan for the research.
  • 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.
  • 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 panel may ask for additional information from the researcher and may also seek the views of other non-study sponsor experts. Where views of other non-study sponsor experts are required, the researcher will be asked to provide names of three independent experts who could be consulted.

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.
  • Approval to provide access to the requested data subject to conditions.
  • Rejection with advice to re-submit the research proposal.
  • Rejection of the research proposal.

The panel Chairman informs the IRP secretariat and relevant study sponsor or sponsors of the decision and provides any conditions of access and the rationale and reasons why a research proposal is not approved or why conditions are required. This rationale and reason is communicated to the researcher and any conditions are added to the Data Sharing Agreement. There is no appeal process.

An overview of the number of research proposals submitted and the outcome of the Independent Review Panel’s review is made available in the Metrics section of this site on a regular basis.

Researchers should not use approval by the Independent Review Panel 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 Charter is provided here.

When a decision can be expected

Where no further information is needed, and depending on the number of requests received, it is anticipated that the decision from the panel will usually be communicated within 60 working 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

Where an enquiry facility is provided, enquiries are answered by the relevant study sponsor or sponsors. 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 will be 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 study sponsor or sponsors. Further information about sponsors’ policies are provided in Study Sponsors section of this site.