Background

The Research Governance Framework for Health and Social Care (section 2.3.2, DOH 2001) states that all health/social care research must be peer reviewed. There are already many systems in place for externally funded projects to be reviewed. The creation of a Peer Review Committee in BICMS provides the means to extend this process of quality assurance of research to 'own account' projects i.e. staff or undergraduate/ postgraduate researchers' projects which have not had an independent external review or for further review of externally reviewed projects where research governance issues have not been considered.

Research Ethics Committees have undergone major review nationally, driven by the Central Office for Research Ethics Committees, to ensure compliance with the Research Governance Framework. One of the outcomes of this review is that Research Ethics Committees will expect Principal Investigators to provide evidence of peer review.

As part of an initiative to ensure compliance with the new Research Governance Framework, we propose to establish a Peer Review Committee in BICMS. The Committee will comprise a chair (currently Graham Hitman, Diabetes), vice-chair (currently Edel O'Toole, Cutaneous), a paediatric representative (currently Nick Croft, Digestive Diseases) and representatives of the other centres within BICMS (this could ideally be a clinician nominated by the Centre Lead or alternatively the Research Lead). The representative from each Centre will be known as the Centre Research Governance Lead (RGL). Each Centre should also have an alternate RGL. In attendance will be administrative support (currently Kerry Newbury). An arrangement will be required for ad hoc statistical support and this may have a cost implication.

Summary of Process (see flow-chart)

All new projects which require ethical approval need to be submitted to the Committee, including those externally peer reviewed. If the investigator's Centre RGL is happy that there is evidence of independent peer review, he/she performs a small scale review re local issues and recommends that the Chair/Vice-Chair sign off the review pro forma if appropriate. In all other scenarios, researchers are requested to provide the names of 2 internal and 2 external reviewers of which at least one of each pair should be clinical. The majority of project proposals will normally only be reviewed internally. However, a judgment will be made by a Committee member if the project requires external peer review. If there is uncertainty about a project, additional reviewers may be selected by the appropriate committee member.

Applications can be received at any time (peer review application form and copy of protocol or grant proposal, which should include details of proposed use of resources).

Internal reviewers

We request that all applicants provide the names of two internal reviewers who are not involved in the proposed project. The reviewer should not be a current collaborator with the applicant. We ask applicants to contact reviewers to ascertain if they would be willing to perform a peer review on a project, in order to speed up the process. All academic staff within BICMS must show enthusiasm for participation in the Peer Review process for this to work.

External reviewers

We request that all applicants also provide the names of two external reviewers, who may be contacted, if necessary. The reviewers should be external to Queen Mary, University of London (unless there are exceptional circumstances). We require the applicant to stipulate their relationship with the reviewers. We ask applicants to contact reviewers to ascertain if they would be willing to perform a peer review on a project, if necessary, in order to speed up the process. If they agree, their contact details are entered on the peer review application form and forwarded in the usual manner to the Peer Review Committee. The Committee member, who is allocated the project may choose also to send the project to an external reviewer of their own choice. A copy of the application form and a review pro forma is then forwarded to the identified reviewers. The review covers six areas and gives the opportunity for the reviewer to provide detailed comments.

Peer Review

Committee members/ reviewers are asked to assess the proposal in the following areas:-

• The importance or relevance of the problem to be addressed in relation to either or both of:
• The particular field of research as a whole.
• The value of this research for health or social care.
• Validity of the methodology
• If the research presents ethical concerns, does the plan of investigation/scientific background address these concerns?
• The quality of analysis provided (statistical or qualitative, as appropriate).
• The capacity and expertise of the research team in the context of the proposed study.
• Appropriateness of resource requirements.
• General feedback (indicate major areas where changes will be required, indicate whether any weaknesses indicated in any of the above categories are major or minor areas of concern).

Reviewers are asked to perform the review within two weeks with assessment pro formas being returned to the Committee Administrative support (currently Kerry Newbury).

What happens when a review is received?

When peer reviews are received for a project, the Peer Review Committee members review and ratify all recommendations using e-mail. A final decision is agreed upon and the applicant is informed of the outcome. If only one review is received within the two week deadline, this is sufficient for the Research Governance Framework, but 2 reviews will be requested for all projects. If a project is given approval by both internal reviewers, it can proceed without any revision. The project may be submitted for appropriate NHS/University approval and then to either the Local or the Multi-Centre Research Ethics Committee. Rarely, the project will be acceptable to one internal reviewer but not to the second and an external reviewer's opinion will then be sought. If a project is initially not approved, the following process will commence:-

Minor amendments

Minor amendments or further information required. Revise project according to reviewer's recommendations. The Chair/Vice-Chair will give approval for the ethics application/grant application to proceed but researchers are asked to specify clearly in a covering letter what amendments they have made in response to the reviewer's comments, as well as to submit a revised protocol. If there are any disagreements with the outcome of the process, the project should be referred to the Chair/Vice-Chair.

Major amendments

Complete major revision required. Principal Investigator to discuss outcome with Centre Lead and agree plan to complete substantive revision of the project (with support as agreed). In submitting their revised application to the peer review committee, researchers are asked to specify clearly in a covering letter what amendments they have made in response to the reviewer's comments, as well as to submit a revised protocol. The internal reviewer for the project will decide if all the recommendations have been addressed. If they agree that they have, the Chair/Vice-Chair will give approval for the project to proceed.

Reject

Reject on the basis that the project has major scientific flaws. If the investigator and the appropriate centre lead disagree with the decision then they can request for the decision to be re-assessed by an independent, external expert in their field, chosen by the Chair of the BICMS Peer Review Committee. The subsequent decision will be final.

When researchers submit their project to the ethics committee, they are expected to provide BICMS Peer Review Committee feedback as evidence that the scientific review has been undertaken, along with a brief note of the specific changes that have been made to the protocol as appropriate, in response to reviewers' comments, as well as the final amended version of the protocol. The application can then be submitted to the Local Research Ethics Committee.

Committee

The Committee will be formally accountable to the Director of the Joint R and D office and the Director of BICMS. The Committee will submit a brief quarterly report outlining volume of work undertaken (numbers of projects submitted, reviewed, approved) and summarising key issues that have been raised, any problems and any proposed changes in procedures required. The Chair and Committee members will review and make recommendation on projects on an ongoing basis, using e-mail. The Committee will communicate electronically, however, it is envisaged that the Committee will need to meet periodically to review difficult submissions and to formally ratify decisions made over email and Chair's actions. Quorum will be 50% of the membership. If any queries pertaining to a specific project arise, and an appropriate specialist in the research area is not present, the Chair may seek their additional advice in order to finally approve the project if there are conflicting comments from the independent reviewers.

Secretariat

It is essential that the peer review committee has administrative support (currently Kerry Newbury (k.newbury@qmul.ac.uk).

Tenure

For the Chair: 2 years

Members: rolling programme of 12 months

Edel O'Toole Centre for Cutaneous Research, BICMS

(with contributions from GAH and MC)

Appendix 1: BICMS Clinical Governance Committee 2005 -2006

Chair:	Graham Hitman	g.a.hitman@qmul.ac.uk
Vice Chair and Cutaneous :	Edel O'Toole	edelann@doctors.org.uk
Members:
Diabetes:	David Leslie	r.d.g.leslie@qmul.ac.uk
Digestive Diseases:	Nick Croft	n.m.croft@qmul.ac.uk
Pathology:	Sam Agrawal	s.g.agrawal@qmul.ac.uk
Neurosciences :	Silvia Marino	s.marino@qmul.ac.uk
Infection & Immunity:	Armine Sefton	a.m.sefton@qmul.ac.uk
Surgery:	Steve Bustin	s.a.bustin@qmul.ac.uk
Administrator:	Kerry Newbury	k.newbury@qmul.ac.uk