Peer Review guidelines

Please uses these guidelines in conjunction with JRMO Policy and SOP 14 on peer review,

Contents

A.REVIEW TYPES

1.Review of BH and QMUL Sponsored Projects

I.Review of grant applications:

II.Scientific peer review

III.Review of project level protocols (Quality review) *

IV.Review of resource and capacity

2.Review of resource and capacity for BH or QMUL as a site

B.Guidance on Format or constitution of review groups/designee

C.Proportionality of review

A.REVIEW TYPES

Within Barts Health NHS Trust ([BH] and Queen Mary University of London [QMUL] peer review must be divided in to two parts:

  1. Review of BH and QMUL Sponsored Projects

This includes four distinct elements performed at 4 different time point in the projects life cycle:

  1. Review of grant applications ( pre funding agreement)
  2. Scientific peer review ( either as part of Funder review or once funding agreed)
  3. Review of project level protocols (Quality review) ( part of a valid submission for Provisional sponsorship)
  4. Review of resource and capacity( part of a valid submission for Provisional sponsorship)
  1. Review of resource and capacity for BH or QMUL as a site (performed at point of NHS site confirmation).

1.Review of BH and QMUL Sponsored Projects

This includes four distinct elements:

I.Review of grant applications:

QMUL Institute Directors/CAG Directors of Research should review science and any financial impact to Institute / CAG before application authorisation.

II.Scientific peer review

Under the Research Governance Framework 2005 (RGF) all projects (for health and social care research) must be subjected to an ‘independent’ review, by ‘experts’, in the relevant field.

It is the responsibility of the departmental review committee or designee to ensure that suitable scientific review has occurred.

If scientific review has occurred as part of the study funding body review, as part of a funder’s national open completion this should be accepted and does not need to be repeated.

In instances when a drug or device manufacture is also the funder care should be taken to assess how impartial the any review conducted is likely to be. It is advised that IN many cases an independent scientific review should be undertaken.

Where no appropriate funder review has been undertaken: [see proportionality section below],the Researcher or review group must organise the review.

  • If this is the case the researcher such identify two (best practice) independent * scientific review.
  • The reviewer should be asked to comment of the below points (labelled scientific review consideration).
  • It is the responsibility of the researcher to include any comments of suggestion or justify why not.
  • The comments should be submitted to the departmental committed or designee.
  • The review committee or designee must consider the comments and if decided where they comments have been suitably included and if the reviewer support the study.

It is the committee/ QMUL Institute Directors/CAG Directors of Research responsibility to review the scientific reviews comments and decide if the research should be conducted.

*Independent to researcher’s institution (For this purpose BH and QMUL are view as not independent)

The independence of the reviews chosen can be proportionate to the type of study under review. For example any Drug, device or interventional study should be reviewed by two reviewers who are independent to the Institution. But an education or staff project performing questionnaires could be reviewed by the supervisors

Scientific review considerations:

  • Does the research have a stated hypothesis or research question?
  • Are the stated objectives clear?
  • Is there a clear methodology?
  • Has a robust literature review and rationale been provided?
  • Has a case been made for the clinical, service significance?
  • Is there justification for sample size? There should be justification for sample size in both qualitative and quantitative research, and in the case of quantitative research this should be backed up with a statistical calculation with stated power and P value, and/or named expert statistical advice.
  • Is the proposed data analysis described?
  • What are the arrangements for project management, including the forming of a project steering group?
  • Is the sample representative of the target population?
  • Are the outcomes of the study stated and appropriate?
  • Is the time scale realistic and will the project’s objectives likely to be met?

III.Review of project level protocols (Quality review) *

In order to conduct this element a protocol and IRAS from if needed and should be reviewed in full.

Considerations should include but are not limited to:

  • Does the protocol clearly describe scientific justification, risks and benefits, all procedures involved in the study?
  • Does the protocol match the study design?
  • Does the protocol give a clear description of the practical way in which the study will be conducted?
  • Has all template wording been removed?
  • Is the research proposal/protocol clearly described?
  • Is the protocol consistent with the IRAS submission form?
  • Does the protocol comply with GCP (Good Clinical Practice)?

IV.Review of resource and capacity

Departmental Resource & Capacity Review is to consider the following

  • ‘Resource’ to conduct the project within the Department (e.g. staff capacity, equipment, technology)? This included an understanding of the cost and funding arrangements for the Study.
  • ‘Feasibility’ (e.g. meets Departmental objectives, does not over expose participants to research)?
  • Does the project represent ‘value for money’ for the Department?
  • Does the project benefit the NHS/Trust and/or University?
  • Does the research pose any compatibility issues with the Trusts/University objectives and programmes?
  • This is NOT a review of the project’s science (see section A above) nor ethics (this is conducted by the ethics committee)!

It should be note that this is taken means any costs documented by the study to be meet by the department or underwriting of a study will be taken as agreed through this signature.

2.Review of resource and capacity for BH or QMUL as a site

The process for this review varies if the project is:

  • NIHR portfolio studies: North Thames CRN procedures will be followed to obtain Pharmacy review, Imaging review, costing and contracting review and CAG agreement.

Any individual or committee requested to perform this function for the NT network should consider points below labelled resource and capacity review considerations.

  • Non NIHR portfolio studies

Individual PIs will be responsible for obtaining Pharmacy review, Imaging review, costing and contracting review and CAG agreement. These should be obtained in writing and sent to for the Team Leaders review

Any individual or committee requested to perform this function for the NT network should consider points below labelled Resource and capacity review considerations.

Resource and capacity review considerations.

This review is place to appropriately respond to the question:

Can this research project be deliver successfully [recruiting to target and Protocol compliance] at this site?

Considerations should include but are not limited to:

  • Is the Team appropriate to lead/ run this project?
  • Is the team appropriately resources?
  • Does the Principal investigator have sufficient time to lead this project ( consider Work plan and existing committeemen’s)
  • Does the team have capacity to run this project (staff and facilities) IS the team overcommitted?
  • Are the existing project that would directly clash with this project (are there competing projects)?
  • Is the financing appreciate and sufficient?
  • Is the CAG / Institute is being asked to underwrite any cost? Has this been agreed?
  • Does this project fit with the CAG/ Institute research strategy?

B.GUIDANCE ON FORMAT AND CONSTITUTION OF REVIEW GROUPS

It is important that the committee has a sufficient range of expertise to address all the relevant criteria. Committees are often well placed to judge scientific quality but do not always involve people able to assess the impact on routine clinical work and related services such as Pathology, Pharmacy or Imaging. Failure to address these issues at the outset may lead to problems when the research is underway. An important part of the decision making process will be the affordability of unfunded or part funded research.

A Department (the Clinical Academic Group (CAG) or Institute) lead should identify a process suitable to the Departments – suitability should consider:

  • Amount of research performed within their department
  • Type of research
  • Drug trials, Student projects
  • hosted and sponsored
  • Commercially sponsored vs non Commercially sponsored

Based on this assessment the department can decide if they will:

  • Form a committee, to meet and discuss proposed studies
  • Designate one or more individuals to carry out review

There are benefits and problems with both system and both should be considered fully. Please contact the JRMO for further specific advice.

A procedure/ terms of reference should be created for which ever system is chosen. See associated documents 1 for a template.

These should outline:

  • Chair or lead
  • List of members ( either of a committee or of hose delegated to perform review)
  • Submission process
  • Documents required
  • What will be reviewed
  • Time lines of meetings or turnaround times of reviewers**
  • Decision options
  • How review outcome will be disseminated, and/ or escalated
  • Details of how reviews and outcome details should be logged.

Once created the procedure /Terms of reference should be submit to the JRMO Governance Operations Manager, who will review to ensure this meets with JRMO policy and SOP.

Once agreed the Procedure/Terms of reference should be passed to all member of the review committee.

Departmentsshould conduct annual assessment of its reviews.

C.PROPORTIONALITY OF REVIEW

Externally funded research - Research that is externally funded through open competition normally has external scientific peer review conducted by the funders built into the application process. However, these research projects still require a resource and capacity review (as described above). Copies of all review approval documentation (internal and external) must be sent to the JRMO for their records.

This includes commercial and non-commercially funded research.

Own account/internally funded research - It is important that own account and internally funded research is subject to a thorough review, including independent peer review in order to make sure the Trust and QMUL can demonstrate that all its research meets the required standards of quality, probity, financial transparency and that the School/ Institute/ CAG/ Trust site (as applicable) has the required funds to cover all the costs associated with the project.

Student research - Student research and other projects that are short-term and have minimal resource implications should be treated proportionately, with the emphasis on general appropriateness and the impact the research could have on the institution, service delivery and on patients. CAGs, Institute and Schools may wish to consider a fast track form of review for these studies to ensure there is no unnecessary delay in commencement and inform JRMO of any relevant deadlines.

Research in small sub-specialties or small departments - Researchers working in small sub-specialties or small departments where there are limited numbers of people able to provide independent expertise, may need to send their research for external review. However, if researchers choose this route they must:

  • Make sure that their ideas are adequately protected;
  • Make the findings of the external reviewer available to the local peer review committee and JRMO.

SOP 14 Associated Document 2 Peer review guidance V2.0 25/8/16Page 1 of 4