WELLCOME TRUST CLINICAL RESEARCH FACILITY

							    WELLCOME TRUST CLINICAL RESEARCH FACILITY
                    Manchester

                                 Scientific Advisory Board
                                  Guidelines for Members

1.        Remit

1.1       Scientific Advisory Board
The remit of the Scientific Advisory Board (SAB) is to establish and implement an assessment
procedure to ensure that all research projects entering the Clinical Research Facility (CRF) meet
the following basic criteria:

         High quality research
         Use of the CRF would offer ‘added value’ to the study
         Ethical, and compliant with the requirements of full Clinical Governance
         The costings for the various elements of the study are in place
         Research is investigator-led

It is anticipated there will be five categories of projects submitted to the SAB, requiring different
levels of assessment:

Category               Details
1                      Grant funded, subjected to peer-review
2                      Grant funded, not subject to peer-review
3                      Pilot work
4                      Commercially funded, investigator-led
5                      Commercially funded, contract work

Category 1: Applications externally peer-reviewed – applications which have already been
externally peer-reviewed, or those which will be peer-reviewed, as part of an external grant
application, will not be subjected to further peer review by the SAB.

Categories 2, 3, 4 and 5: Applications not peer-reviewed - the SAB have a duty to assess the
scientific merit of any application that is submitted to the CRF without external peer-review. The
co-chairs will select external referees in advance of the SAB meeting for applications in these
categories. The comments of the external referee will be incorporated into the Designated
Members presentation to the SAB (see Section 4 below).

1.2       Member
As a Member of the SAB you are asked to read and evaluate the enclosed applications according
to both the criteria for scientific merit (outlined in section 2 below), and the supplementary
criteria (outlined in section 3 below). Your responsibilities to the Scientific Advisory Board are
detailed in section 4 below.




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2.        Scientific Evaluation

2.1       Peer Review Criteria
Applications should be assessed on the following criteria:

         Significance – is the research original, does it address an important issue in the field?
          What is the potential impact of the research? To what extent will the research extend the
          knowledge base relevant to improving human health? To what extent will it contribute,
          either directly or indirectly, to relieving the burden of disease?

         Timely – How important is it to conduct the research at this time? Will the research
          capitalise on a new advance, does it exploit a specific development or opportunity,
          offering the opportunity to take the international lead? Does it relate to a new or
          developing healthcare need?

         Approach – are the conceptual framework, design, methods and analyses suitably
          developed, well integrated, and appropriate to the aims of the proposed research project?
          Does the PI acknowledge any potential problems of the research, and identify possible
          solutions/alternatives?

         Feasibility – does the application demonstrate the PI and their staff have the necessary
          qualifications, experience, and expertise to successfully conduct the research? Is there
          evidence of past achievements, preliminary data, access to necessary technologies,
          subjects, equipment, etc. to support this?

2.2       Peer Review Banding Criteria
Bearing in mind the assessment criteria outlined above in 2.1 and the overall quality of the
proposal applications should be banded according to the following scale:

Band                   Description                                                Action

Alpha-A                Research which is at the forefront internationally, or     Top Priority
                       nationally where there are no international comparators,
                       and which has the potential to have an important and
                       substantial impact on understanding, practice or policy
Alpha-B                Research which is at the forefront of the UK effort in     High Priority
                       the field, with the potential to make significant
                       contribution to the field
Alpha-C                Research, which is nationally competitive, with the        Medium Priority
                       potential to make a valuable contribution to the field.
Beta-rated             Research judged to be nationally competitive, but at a     If resource permits
                       lower priority.
Delta-rated             Work which would add to understanding but is not         Decline
                         competitive
                        Work judged to be seriously flawed in design
                        Work judged unsuitable to the purposes of the CRF



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3.           Supplementary Evaluation

3.1          Supplementary Assessment Criteria
There are further criteria which fall outside the scope of scientific merit, but which will feed into
the SAB assessment process following the review of scientific merit:

            Added value – to what extent would use of the CRF and its resources add-value to the
             research? For example does the CRF contribute to the probability of success of the
             research; does the research appropriately utilise the unique resources of the CRF?

            Duration – can the research reasonably be conducted within the proposed timeframe?

            Recruitment of Subjects – are there adequate plans for including both genders and
             minorities and their subgroups as appropriate to the scientific goals of the research? Does
             the application sufficiently address issues concerning the successful recruitment and
             retention of subjects?

            Adverse Effects – does the application acknowledge the potential adverse effects on
             humans, animals, or the environment, and identify sufficiently plans for protecting or
             minimizing such effects?

            Dissemination of Research Results – are the proposed plans for disseminating the
             research results appropriate and adequate?




4.           Scientific Advisory Board Assessment

For each application submitted to the CRF one Designated Members of the SAB will be
identified, with responsibility for making a full evaluation of the application according to the
criteria in sections 2 and 3 above.

The Designated Member will be required to make a five minute presentation to the SAB detailing
the following:

      i.         Outline of the application
      ii.        DM’s comments and recommended banding
      iii.       Referee’s comments and recommended banding (where appropriate)

Following this presentation the board will discuss the application to reach a consensus banding
according to the scale detailed in section 2.2 above.

Once all applications have been discussed and banded, the SAB will rank all applications based
on priority.




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