Template Terms of Reference for Trust Peer Review Committee

Purpose

Peer review is a process of assessing the quality of a research proposal or protocol. The Research Governance Framework states that all proposals for health and social care research must be subjected to a review by experts in the relevant fields who are able to offer independent advice on its quality.

Barts Health NHS Trust will not indemnify own account research that has not been subject to appropriate peer review.

Frequency of meetings/review

1-3 monthly dependent on the number of projects being tabled.

Terms of reference:

  • To assess the scientific quality of proposed research projects focusing on:
  • The appropriateness of the study design in relation to the objectives of the study, the statistical methodology (including sample size calculation where appropriate), and the potential for reaching sound conclusions with the smallest number of research participants.
  • The justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants, other present and future patients, and the concerned communities.
  • The justification for use of control arms in trials, (whether placebo or active comparator), and the randomisation process to be used.
  • Criteria for prematurely withdrawing research participants.
  • Criteria for suspending or terminating the research as a whole.
  • The adequacy of provisions made for monitoring and auditing the conduct of the research, including the constitution of a data safety monitoring committee (DSMC).
  • The adequacy of the research site, including the supporting staff, available facilities, and emergency procedures. For multi-centre research, these locality issues will be considered separately from the ethical review of the research proposal itself.
  • The manner in which the results of the research will be reported and published.
  • To recommend and review any issues or clarifications to the Investigator for project amendment and action.
  • To assess and agree any subsequent amendments.
  • To obtain confidentiality agreements with external reviewers to protect the interests of the investigator and Sponsor.
  • To provide a detailed, signed and dated report of the peer review of individual projects to the Investigator for submission to the applicable ethics committee in accordance with section A45 of the COREC form, and the Research and Development Department.
  • Act as a resource to update the department of on-going and future research.
  • To support an environment of best practice in research conduct in compliance with any applicable regulation or guidelines.
  • To ensure the Investigator is aware of his or her responsibilities as defined by the Research Governance Framework for Health and Social Care.

NOTE: The Departmental Peer Review Committee may also act as a Data Safety Monitoring Committee (DSMC) if the members include the appropriate clinical, managerial and statistical expertise. Conflicts of interest may occur and should be stated so that individuals can exclude themselves from the process as necessary.

Confidentiality of data should be at the heart of any data safety monitoring process and it is recommended that interim reports are only utilised by the DSMC and not externalised unless there are no data protection issues.

SOP 14 AD 1 Template Terms Of Reference for Trust Peer Review Committee V2.0 24/8/16Page 1 of 2