WELLBEING OF WOMEN RESEARCH GRANT APPLICANT GUIDELINES 2018 Amended October 2017 WELLBEING OF WOMEN RESEARCH PROJECT GRANTS 2018 GUIDELINES FOR APPLICANTS TABLE OF CONTENTS About Wellbeing of Women... 1 The Project Grants Scheme... 1 Triage Process... 2 Completing the Application Form... 3 Additional Information... 7 Appendix 1: for Randomised Controlled Trials... 7 Applicants are strongly advised to read these guidelines before they commence writing their application and to note the conditions of acceptance. Failure to follow the format suggested by the guidelines may reduce an applicant's chance of success or result in applications being rejected. The upper limit for this award is 200,000 ABOUT WELLBEING OF WOMEN Wellbeing of Women is the charity dedicated to improving the health of women and babies across the UK. Every year we invest in special research projects and allocate funds towards the training of specialist doctors, nurses and midwives. We fund basic science, clinical and translational research on all aspects of obstetrics, gynaecology, midwifery or with a focus on women s reproductive health. Studies in the area of gynaecology, urology and oncology are all appropriate to our funding. THE PROJECT GRANTS SCHEME Applicability Applications are invited for a Research Project Grant, to be undertaken in the UK or Ireland, relevant to our remit of women s reproductive health and childbirth. Wellbeing of Women is
inviting applications for projects in basic science, clinical or translational research in one of the following three areas: 1. Pregnancy, birth and the postpartum period (including pre-term birth, miscarriage and fertility) 2. Gynaecological Cancers 3. General Wellbeing surrounding women s health issues (such as menopause, incontinence, sexual health, mental health, menstrual disorders and endometriosis) Level of Award Applications may be made for the financial support of a project (up to 200,000), normally for two to three years, to cover direct research costs. The award is intended to support an established, independent researcher leading their own work. The award of a Project Grant is subject to the acceptance of the Wellbeing of Women s Terms and Conditions for Research Grants. Restrictions The following restrictions apply to Research Project Grants: Funds will not be released without evidence of ethical committee support. We do not pay indirect costs or NHS Service and Support Costs. Charges for administration by University or NHS Authorities will not be met. We will not pay the Apprenticeship Levy. Applicants should note that the Research Advisory Committee may deduct items of expenditure contained within the application which they do not consider strictly necessary. Successful Applicants Please be aware that successful applicants will be expected to reasonably aid Wellbeing of Women with publicity and fundraising. This may involve activities such as providing quotes and/or lay write-ups, speaking at our events or hosting visits at your lab. While we would ensure that any requests were not excessive or disruptive, by applying you are agreeing to reasonable assistance in principle. TRIAGE PROCESS Please note that as funding is strictly limited, all applications undergo our triage process which follows AMRC guidance. Each application is sent to two members of our Research Advisory Committee and scored in areas of Significance of Research Question, Research Design, People and Workplace including User Involvement and Value for Money. Scores are collated and looked at by the Chair of the Research Advisory Committee. Systems are in place to ensure the process is as fair as possible e.g. if one score comes above the threshold and one comes below, it will be scored by a third person. Last year we received 42 applications and 16 were sent out for full peer review, meaning 26 were removed at the triage stage. 2 applications were ultimately funded. We endeavor to give brief feedback to all applications removed at this stage but this cannot be guaranteed. 2
COMPLETING THE APPLICATION FORM Please complete the application form for Wellbeing of Women Research Project Grant 2018 using font size 10-12 pt. throughout. Please save two copies of the application one as a Word document and one as a PDF. E-mail both versions to jbarratt@wellbeingofwomen.org.uk, and send one original signed hard copy of the completed form to Jeremy Barratt, Senior Research Manager, Wellbeing of Women, 1st Floor, Fairgate House, 78 New Oxford Street, London WC1A 1HB by the closing date. The closing date applies to all copies so please obtain all signatures as early as possible. The closing date for applications is 1.00 p.m. on Friday 16 th February 2018. LATE APPLICATIONS WILL NOT BE ACCEPTED IN ANY CIRCUMSTANCES. PLEASE OBTAIN ALL NECESSARY SIGNATURES ASAP. The points below relate to specific sections of the application form. Please note that where references are made to UK institutions, applicants from Ireland should complete with reference to relevant equivalents. 1. Application Details All applicants names should be shown on the front page, in the space provided. All correspondence regarding the application will be addressed to the Principal Applicant at the address given. At least one applicant must be able to demonstrate continuous employment at the project site(s) for the duration of the grant. It is preferable, but not essential, that this is the principal applicant. Title of Project: This should be as brief as possible and should be relevant to the work undertaken. Proposed Start Date: This may be an estimate. However, it should be as accurate as possible and reflecting the likely award date of June/July 2018. Proposed Duration: This should be in months. Total Funds Requested: This should be the total from Section 5, Summary of Funds Requested. 1.1. Abstract of Research: This should be a maximum of 250 words in length and should clearly state the objective(s) of the study. 2. Lay Description Applicants must give a simple description of the research to be undertaken which will be understandable by an educated lay audience. This should be no more than two pages of A4. The following points should be addressed, in a language clearly understood by nonscientific readers: About the research: what is the research about? What problem(s) will it tackle? How will it impact on the health of women and/or babies? Does it build on previous research? How will the research be carried out? What happens next? What outcomes do you hope to achieve? How will you disseminate the results? Will this lead to further research? What is the long-term goal? 3
About the researchers: what is their relevant experience/track record? Please devote some time to this section it is extremely important and the quality of the lay summary is considered in awarding the grants. The final decision in awarding grants is taken by our Trustee Board which consists predominantly of lay members. 3. Approvals for Research 3.1. Involving Human Participants or Human Tissue: Where projects/clinical trials or investigations involving human subjects and/or samples are intended, the approval of the appropriate ethics committee must be obtained before the study is commenced. Applicants should give details of recruitment methods, recruitment consent and clinical supervision. 3.2. Human Fertilisation and Embryology Authority: Projects involving the use of human gametes or embryos must show the HFEA licence number in the appropriate space on the application form and in addition, documentary evidence of HFEA approval for the project must be enclosed. 3.6. Use of Animals or Animal Tissue: Wellbeing of Women would prefer the use wherever possible of procedures and techniques that avoid the use of animals and, where this is not possible, the minimum number of animals that will give valid results in any experiment should be used. The applicant s Home Office Project Licence number must be entered in the relevant space on the application form. 4. Certificates No application will be accepted without full completion of this section by the applicant, their Head of Department and the relevant Finance Officer. Wellbeing of Women cannot accept direct or indirect clinical responsibility for injuries and illnesses sustained by patients as a result of the applicant's investigations. 4.4. For research involving NHS patients a signature is needed from the R & D Director or Deputy confirming that the project will be carried out within the NHS research governance framework. Details of the sponsorship arrangements for the study must be provided. 5. Summary of Funds Requested This should be as accurate as possible and the advice of the relevant Finance Officer should be sought in preparing the estimate of expenditure. Applicants must give full details of how the money requested is to be spent. Salaries: Please indicate clearly the number of staff requested and their grade. Allowances should be made for employee/er's contributions for superannuation and National Insurance and these figures should be shown separately. When giving costs, applicants should allow for annual increments on the current salary scale and should include any estimated future national pay awards. Stipends for studentships will be at MRC rates. PLEASE NOTE: For research undertaken in the NHS you must be aware of and consider the AcoRD guidance on attributing research costs. Please discuss with relevant NHS Trusts and/or Clinical Research Networks in order to ensure correctly attributed costs. The guidance can be found here: 4
https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-ofhealth-and-social-care-research 5.8. Details of Funds Requested: Materials and Consumables: Detailed costs of materials and consumables must be provided, not merely a rounded total. Animal costs should be included in this section. Equipment: Applications for major items of equipment, when supported by an adequate research protocol, will be considered. Charges for servicing to equipment should be included if these are relevant. If similar equipment is available in the department in question, this should be reported and an explanation given as to why it cannot be used for the project. The overriding issue when considering the disposal of substantial items of equipment, on completion of a grant, is the benefit to future research. The disposal of such items is a local matter. However, the Research Advisory Committee consider that, in most cases the equipment should remain in the possession of the original grant holder who should acknowledge Wellbeing of Women s funding of the equipment. In the event of a local dispute regarding the disposal of equipment, evidence should be submitted for consideration by the Research Advisory Committee. Exclusions: It is expected that the cost of heat, lighting and office equipment will normally be met by the host department, Wellbeing of Women does not cover indirect costs. Charges for administration levied by the University or NHS Trust concerned will not be met. We also will not pay the 0.5% Apprenticeship Levy and it must not be included in grant applications. 5.9. Other Funding Requested: Full details should be given as to whether this, or a closely related application, has been submitted to and is currently under review by any other funding body and also the date by which a decision is expected. Applicants should be aware that it is not uncommon for a Wellbeing of Women referee to have already seen an application previously submitted to another grant-giving body. 6. Proposed Investigation Applicants submitting their first research project are strongly advised to seek the guidance of someone with experience in making a grant application. Clinical projects with a scientific component should include a scientist as an applicant and vice versa. If no clinician is mentioned on the application form, applicants should make it clear how they intend to obtain clinical samples. All projects requiring any statistical input, including sample size calculations, should seek the guidance of a statistician in the design stage of the project. All projects requiring substantial statistical input should include a statistician as an applicant. Patient/user involvement at this stage is always encouraged. For clarity, the entire Proposed Investigation section must be typed in double spacing using 10-12 point fonts only. This section must not exceed 2500 words in total and may include up to 3 figures. Where figures are used, their explanatory text will be included in the 2500 word total. Material in excess of these limits will be disregarded. Applicants must submit their proposal under the following headings. 6.1. Aim: This should contain your hypothesis and what the work will achieve. It should not exceed 100 words, and be listed numerically. 5
6.2. Background: The scientific statement should be self-contained so that a referee should not need to refer to journals. References to current literature are important but should be limited to 20. If unpublished papers have been referred to, copies should be attached. 6.3. Plan of Investigation: Applicants should clearly describe details of proposed studies to be undertaken, the methods to be employed (paying particular attention to any technique that is new or not well known), the number of experiments proposed (and validation of this figure) and the availability of patients (if relevant). The level of expertise of the applicant and of colleagues who will be involved in carrying out the proposed methodology should be indicated. If appropriate, sample size and statistical analysis should be given. Applicants should include a timetable of activities and any problems/obstacles to be anticipated. 7. Justification of support requested This should not exceed 250 words. 8. References This should not exceed 20 references. Please give the title or references cited. 9. Suggestions for possible reviewers Please give the names and addresses (including email) of up to 3 people who have suitable expertise to act as independent reviewers. These potential referees should not be in the same institution as, or have current collaborations with any of the applicants. The nomination of potential reviewers does not guarantee that they will be contacted. In addition, applicants may indicate individuals who should not be contacted with regard to the application. The reasons for this must be given clearly. Please note that this section may be seen by reviewers. 10. Curriculum Vitae The CV of each applicant must not exceed one side of A4 (10-12 font). Applicants are asked to include information relevant to the application only. This should include qualifications with date awarded; present employment and previous posts; grants held with their respective titles, sources of funding, duration and sum awarded; and publications (no more than 5 most relevant to the work to be undertaken). 11. Report on Previous Wellbeing of Women Grant(s) Applicants must give the information requested for each Wellbeing of Women grant that they or any co-applicant have held during the past 5 years. Please use a new sheet for each grant. 6
RANDOMISED CONTROL TRIALS ADDITIONAL INFORMATION For additional guidance for grant applicants regarding the supporting documentation required for randomised controlled trials see Appendix 1. TRAVEL Grant holders can claim for expenses (as part of the financial support) to present their work, either as an oral or poster presentation, at relevant scientific meetings within the UK or overseas. Full details should be included and these claims will be scrutinised by our Committee. Wellbeing of Women support must be acknowledged in all presentations and publications and copies should be sent to us. OPEN ACCESS Applicants are encouraged to cost for open access publication and include this expense. REQUESTS FOR EXTENSIONS Extensions are not normally considered but applicants may put in a new proposal for consideration if they wish to continue the work. This proposal would be considered in competition with other applications and should include a report on the work undertaken to date. The application should be in the form of a new application using the guidelines in this document. Please note that in the event of an award being made, additional funding will not be granted under any circumstances other than a new application. FUNDRAISING All grant awardees consent to: a) Promptly complete a fundraising questionnaire once notified of the grant award. b) Keep Wellbeing of Women informed of any publications and/or publicity arising from the grant project, preferably in advance. c) Reasonably aid Wellbeing of Women with fundraising activities, for example speaking at our events or hosting a visit to your laboratory. IMPORTANT The Terms and Conditions for a Wellbeing of Women grant are available on our website https://www.wellbeingofwomen.org.uk/apply-for-funding/. APPENDIX 1 Additional guidance for grant applicants regarding the supporting documentation required for randomised controlled trials For proposals which include a randomised controlled trial (as part of a project grant or as part of a fellowship), the following additional guidance is given. Wellbeing of Women requires a succinct summary of your proposed research. The following headings should be considered, as appropriate: 7
Target population: Define the population from which the trial sample will be recruited. Intervention(s) being evaluated: Give a clear definition of the intervention to be evaluated. Measurement of outcomes and duration of follow up: Details should include the justification of the use of the proposed outcome measures, the proposed duration of the treatment period and the frequency and duration of follow-up. Sample size: State the required sample size, giving details of the estimated effect size, power and/or precision employed in the calculation. Planned analyses: Please give details of the planned method(s) of analyses. Project timetables including recruitment rate: Indicate the anticipated duration of the study, paying particular attention to the expected recruitment rate and a justification for your estimate. Required expertise Randomised controlled trials almost always require multidisciplinary expertise. They usually need to draw on the expertise and knowledge of clinicians and of those trained in health service research methodologies such as health economics, medical statistics, study design and qualitative approaches. Wellbeing of Women will usually expect teams proposing multicentre randomised controlled trials to include input from a registered clinical trials unit, or one with equivalent experience. Applicants will also be expected to engage a qualified Trial Manager for appropriate projects. Public involvement Wellbeing of Women recognises the increasing active involvement of members of the public in research and would usually expect to see evidence of public involvement in the development, running or oversight of randomised controlled trial proposals. Governance and regulation Applicants are asked to: 1. Follow the Medical Research Council s Good Clinical Practice guidelines (http://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/) when planning how RCTs will be supervised. 2. Note that trials involving medicinal products must comply with "The Medicines for Human Use (Clinical Trials) Regulations 2004". In the case of such trials, Wellbeing of Women expects the employing institution of the chief investigator to be nominated as the sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. Wellbeing of Women is prepared to accept the nomination of multiple sponsors. Applicants who are provisionally awarded funding will need to obtain confirmation of a sponsor(s) prior to receiving funds. Wellbeing of Women reserve the right to withdraw from funding the project if they are not satisfied with the arrangements put in place to conduct the trial. Clinical Trial Authorisation (CTA): Please indicate if a CTA is required. The MRHA have published information, and an algorithm, to help in identifying whether a trial should be managed within The Medicines for Human Use Regulations 2004. Please see www.mhra.gov.uk for further information. The DH/MRC website (http://www.ct-toolkit.ac.uk/) contains additional information about Clinical Trials regulations and a helpful FAQ page. 8