Verfahren. Formale Vorgaben

Transkript

1 Leitfaden für die Erstellung von Projektskizzen im Rahmen der Fördermaßnahme des Bundesministeriums für Bildung und Forschung (BMBF) Förderung des Strukturaufbaus in der Versorgungsforschung (Modul 2) Dieser Leitfaden stellt einen erläuternden Text zu den Richtlinien zur Förderung des Strukturaufbaus in der Versorgungsforschung dar. Er dient als Hilfestellung zur Gestaltung einer beurteilungsfähigen Projektskizze und soll offene Fragen im Vorfeld der Einreichung klären. Projektskizzen, die den Vorgaben der Förderrichtlinien und des Leitfadens nicht entsprechen, können ohne weitere Prüfung zurückgewiesen werden. Verfahren In dieser Fördermaßnahme sind zwei fachliche Begutachtungsschritte vorgesehen. Die nach diesem Leitfaden erstellten Projektskizzen werden unter Hinzuziehung eines unabhängigen Expertenkreises begutachtet (Punkt der Förderrichtlinien). Im Fall eines positiven Votums zur weiteren Ausarbeitung des Antrages erfolgt die Aufforderung zur Erstellung einer ausführlichen Vorhabenbeschreibung, welche in einem zweiten fachlichen Begutachtungsschritt wiederum unter Hinzuziehung eines unabhängigen Expertenkreises geprüft wird (Punkt der Förderrichtlinien). Erst im Fall einer Empfehlung zur Förderung ist der vollständige Formantrag vorzulegen. Formale Vorgaben Eine vollständige Bewerbung muss die folgenden Teile umfassen: 1. das ausgefüllte und verbindlich eingereichte Internet-Formular (Projektübersicht) und die strukturierte Projektskizze als eine Datei (pdf -Format). 2. die unterschriebene Papierform der vorher online eingereichten Projektübersicht und Projektskizze samt Anlagen in 4-facher Ausfertigung (davon bitte ein Exemplar ohne Bindung). Diese Unterlagen müssen identisch mit der elektronisch eingereichten Version sein. Unter steht Ihnen die elektronische Antragserfassung pt(outline* zur Verfügung. Bitte folgen Sie den Anweisungen des Programms während der Registrierung als Nutzer, des Ausfüllens des Online-Formulars und der verbindlichen Einreichung der Projektskizze. Die Eingaben in das Internet-Formular (Projektübersicht) und die verbindliche Einreichung der Projektskizze müssen bis spätestens zum 15. Mai 2015 elektronisch erfolgt sein. Entscheidend für die Fristwahrung ist die auf elektronischem Wege im Internet-Portal verbindlich eingereichte Projektskizze. Zusendungen per oder Fax werden nicht berücksichtigt. Die Unterlagen in 1

2 Papierform in 4-facher Ausfertigung (davon ein ungebundenes Exemplar als Kopiervorlage, keine Spiralbindung) sollen bis zum 27. Mai 2015 bei dem Projektträger vorliegen. Die Projektskizze ist in englischer Sprache abzufassen, der Umfang sollte 10 Seiten für Modul 2 zzgl. Anhang nicht überschreiten (DIN-A4-Format, Arial 11 Punkt, 1,5-zeilig, 1-seitig, Ränder jeweils 2,0 cm,) Die Projektskizze soll alle Informationen beinhalten, die für ein sachgerechtes Urteil hinsichtlich der wissenschaftlichen und konzeptionellen Planung des Kooperationsnetzwerkes erforderlich sind. Sie muss aus sich heraus, ohne Lektüre der zitierten Literatur, verständlich sein und eine Beurteilung ohne weitere Informationen/Recherche zulassen. Das Vorhaben soll in knapper, aussagekräftiger Form beschrieben werden. Die nachfolgende Gliederung ist verbindlich. Erläuternde Hinweise sind bei dem jeweiligen Gliederungspunkt zu finden. Nicht zutreffende Felder können entsprechend mit n.a. gekennzeichnet werden, eine kurze Begründung hierfür ist einzutragen. Die Projektskizze in Papierform ist einzureichen beim: Projektträger im DLR Gesundheitsforschung z.hd. Dr. Annika Putz Kennwort Nachwuchsgruppen Versorgungsforschung Heinrich-Konen-Straße Bonn Tel: Fax: Gliederungsschema für eine Projektskizze zur Beantragung einer Nachwuchsgruppe in der Versorgungsforschung Alle Informationen zur inhaltlichen Ausrichtung der Förderung, den Voraussetzungen für eine Förderung sowie den Kriterien der Begutachtung finden sich in den Richtlinien zur Förderung des Strukturaufbaus in der Versorgungforschung. Im Folgenden wird ergänzend die Gliederung der Projektskizze erläutert. Die Projektskizze umfasst zwei Teile. Im ersten Teil A werden die Struktur und das Forschungsprofil der Einrichtung für Versorgungsforschung am ausgewählten Standort dargelegt. Im zweiten Teil B sind die Struktur der Nachwuchsgruppe sowie das zu bearbeitende Forschungsprojekt näher zu erläutern. Hinsichtlich der Darstellung der Nachwuchsgruppe ist es wichtig, dass der Beitrag zur Realisierung der strategischen Ziele der Fördermaßnahme konkret beschrieben und damit für einen Expertenkreis beurteilbar ist. Diese verbindliche Gliederung enthält kursive Textpassagen zur Erläuterung der jeweiligen Kapitel. Die Texte zu den Aufzählungszeichen sollen Hinweise auf die Art der geforderten Informationen geben. Hierbei sind vielfach Beispiele aufgeführt, die als Hilfestellung gedacht sind. Keinesfalls wird erwartet, dass alle Beispiele in die Projektskizze integriert werden. Zur Beurteilung soll der Projektskizze bereits ein Finanzierungskonzept zugrunde liegen, aus dem klar das Ausmaß des Engagements der beteiligten Einrichtung in der Versorgungsforschung hervorgeht. Im Hinblick auf die Konzeption der Nachwuchsgruppe und des Projektes werden die 2

3 durch nationale und internationale Standards gegebenen Maßstäbe guter wissenschaftlicher Praxis zugrunde gelegt. 3

4 II: Module 2: Junior research group in health care research Please prepare your application according to the the guidelines outlined below. Explanatory notes are mentioned for each respective item. They should not appear in the application. Outline for junior research group in health care research (Module 2) Project description Synopsis Applicant Organization Name, address. (name, employment status, telephone, ) Health care research institution (Location of junior research group) Leader of the junior research group Title of the research project Aim of the project Institution / department Head of the institution / department postal address Name, employment status, address, telephone, fax, Not exceeding 140 characters. Acronym is optional. Explanation of main aims of the project. Study type Methods Target and study population, sample size Outcome variables E.g. analysis of secondary data, prospective or retrospective study, controlled study Description of methodological approaches (data collection, statistical analysis, ) Describe the population which will be in focus of the study, selection of study population, comment on estimated sample size. Primary and secondary patient-relevant outcomes of the study Collaboration partners Enumeration of collaboration partners and their tasks (e.g. recruitment, allocation of data / methods) Project duration Funding applied for Duration of the project: up to 5 years, indicated in months (whole numbers only) Total amount of funding applied for including lump sum/overhead costs, if applicable. 4

5 A. Local health care research situation: structures, research and training programs 1. Local existing structures for health care research Describe the health care research institution which will accomodate the junior research group. If other working groups in the field of health care research exist at the faculty, please name them. Overview of interconnectedness on-site (e.g. established collaborations). Comment on the perspectives for health care research at the site. 2. Health care research profile and scientific expertise of the institute Comment on the scientific expertise on-site, where the junior research group will be set up (e.g. qualifications of the scientific team). Overview of research profile and research activities at the institution, also regarding the promotion of young scientists. Please also comment on the future development. 3. Integration in existing structures and sustainability Describe integration of the junior research group into existing structures at the institution. Comment on accompanying support from the institution or faculty for the junior research group, especially with regard to allocation of basic equipment / infrastructure. An appropriate signed letter of intent (LOI) has to be provided (see Attachments III.3). Statement of the faculty regarding sustainability of the junior research group after BMBF funding, either by further financing the junior research group (e.g. by transferring the position of the junior research group leader in a permanent position with adequate personnel and material resources) (at least 70% of BMBF funding), or by establishing a new junior research group with a comparable environment (in accordance to the funding provided by BMBF for the existing junior research group) once for five years. An appropriate legally signed letter of intent has to be provided (see Attachments III.4). 5

6 B. Junior research group and research project 1. Description of junior research group Comment on qualification and expertise of the junior research group leader. (Curriculum vitae, third party funding and list of relevant publications, seeattachments III.1, III.2 and III.5). Comment on number, qualification and expertise of further group members (e.g. Phd student, technical assistant, student research assistant). Indicate which of them are financed from other sources apart from this application. 2. Summary of the research project Describe briefly the research project (not exceeding characters) including concise and understandable information concerning topic, research aims, research questions, study design and expected outcomes and their benefits (abbreviations should be avoided). 3. Research question 3.1 Aim and research question Describe the addressed problem in German health care. Explain briefly the existing situation, the relevance of the research question and the expected results. Which principal research questions will be addressed? Bring them into order indicating major and minor starting hypotheses. What is the novel aspect of the proposed study? 3.2 State of the art Explicitly outline the scientific innovation of the proposed project. Which studies have been conducted either by you or by others? What is the relevance of their results? State on the existence of international studies regarding the topic to be investigated, discuss the applicability of the international study results for the German health care system. If you believe that no relevant previous studies have been performed, give details of your research strategy with respect to existing information. This should both detail the background of the major research question and the feasibility of the study. 6

7 4. Study design 4.1 Overview of study design and target population Give an overview of the study design and explain why you have chosen this design. Give a schematic diagram (flow chart) of design, procedures, and stages. Describe the target population and justify the population to be studied (inclusion and exclusion criteria). Make sure that inclusion and exclusion criteria are comparable to usual care situation (external validity). What is the proposed sample size and what is the justification for that calculation? Include reflections on possibilities regarding generalisation. 4.2 Feasibility Describe and justify your approach to achieve necessary sample sizes and data. Please give details how to overcome access barriers. Justify that the analysed situation is comparable to the situation in usual health care. 4.3 Methodological approach Describe your methods of data collection. Give a short explanation for the chosen methods. What is the impact of the chosen method for your data? Which instruments will be used to record the data? Are the instruments validated and reliable? If you plan to use existing data: Give detailed information on datasets to be used. Specify the type of dataset, e.g. routine data from sickness funds, or scientific use files. Comment on the quality of the existing data. Which characteristics / items that are enclosed in the existing data will be used for this study? How generalizable are the expected results derived from this dataset? Describe the methods against bias that will be implemented. Please do comment on anticipated non-response and missing data. Illustrate your method of data analysis. Explain why this method is chosen and describe the planned steps of data analysis. What is the proposed strategy of statistical analysis? Which data items and variables will be included in the analysis? Which are the independent and dependent variables? Which additional information will be documented to adjust for confounding? Please provide examples of statistical models and assumptions that will be used. Justify clearly the sample size necessary for this analysis. 7

8 5. Work plan, time schedule, milestones Describe intended working operations and time frame (give an overview in a Gantt- Chart). Milestones indicating the working progress have to be defined (include in Gantt- Chart). 6. Dissemination and implementation Beyond regular research publication, please outline intended measures to disseminate and implement the results within the health care system (e.g. patient information, information for health care providers, changing of health care practise) and the actors involved (e.g. sickness funds, professional societies, general practitioners). 7. Financial plan Total costs for the junior research group have to be assigned in the table below. Costs for basic equipment as well as service deliveries are not applicable for funding. Applied funds have to be justified according to the work plan. Position PM Year 1 max. 5 (sum) Personnel x Scientific Non-scientific Other Subcontracts x Consumables X Equipment X Travel costs X Overhead / lump sum X Total amount x PM: Persons Months Please state shortly what is included in the position and comment if necessary on: - Subcontracts (why are they necessary? For which work packages?) - Consumables (statement regarding the items needed, including case payment) - Travel costs (list of intended journeys) - Equipment (can only be funded when it is not included in the basic equipment, or when existing equipment is not available for the project). 8

9 8. Other funding In case you have already submitted the same request for financial support or parts hereof to other institutions, please mention this here. Indicate those parties which will provide funds, free services, or consumables such as drugs or medical products. If this is not the case please declare: A request for funding this project has not been submitted to any other addressee. In case I submit such a request, I will inform the Federal Ministry of Education and Research immediately. 9

10 III: Attachments Please prepare your application for each module with the following documents: 1 References Please list publications you have quoted within your application. References should be listed according to their numerical appearance in the text. 2 Third party funding Please list third party funding for the last 5 years of the institution or faculty with relevance for health care research. 3 Support Statement of the facultiy or institution regarding accompanying support for the junior research group, especially with regard to allocation of basic equipment / infrastructure. An appropriate signed letter of intent (LOI) has to be provided. 4 Sustainability Statement of the faculty regarding sustainability of the funding measure after BMBF funding. An appropriate signed letter of intent (LOI) has to be provided with this application. 5 Curriculum vitae Include tabular scientific CVs (not exceeding 1 page per person) for academic staff members playing a leading role (e.g. junior research group leader, study statistician, not all collaborating partners at all trial sites). The junior research group leader has to list all his relevant publications and third party funding (if applicable) on a second page of the CV. 6 Declaration of commitments 6.1 Declaration of commitment of participating centres Participating/recruiting centres must declare their commitment on a separate sheet including their signatures (if an umbrella organisation or a network of several recruiting centres is involved, it is sufficient when the authorised representative of the organisation or the network, signs the sheet) and giving the following details, if applicable: 10

11 a) Name of investigator b) Institution c) Trial name d) Trial duration e) Inclusion/exclusion criteria f) Strategy for the determination of recruitment figures at the recruiting centre g) Number of patients expected to be recruited for the trial under the above mentioned criteria h) Detailed description of the working package conducted by each/the participating centre(s) i) Conflict of interest j) Signature 6.2 Declaration of commitment of sickness funds or other institutions providing data (e.g. German Pension Fund) If data from sickness funds or other institutions are used for the study, the access to data needs to be clarified and documented. a) Contact person b) Institution c) Study name d) Data provided (inclusion/ exclusion criteria, number of patients) e) Data protection f) Conflict of interest g) Signature 11