1. Essential Elements in Preparing a Program Project or an Individual Research Proposal 如何撰寫整合性研究計畫 何英剛 國家衛生研究院 副院長

2. Features of A Program Project  A unifying well-defined goal or problem area of research to which each component project can correlate and contribute.  The primary function of a program project is to conduct high quality interdisciplinary research.  It is an integrated research effort focused on central theme, including relationship of research component to the central theme and effectiveness of core(s) in supporting the program.

3.  Each component project can share the creative strengths of the others.  The component projects must have independent merit and complement other projects.  The number of component projects must be administratively manageable.  The PI of the program must possess recognized scientific and administrative competence. Features of A Program Project (cont’)

4.  The PI must show a substantial commitment of time and effort to the program and exercise leadership in the program direction and maintenance of its quality control.  All investigators must contribute to, and share the responsibilities of, fulfilling the program objective.  The program provides for components such as clinical, laboratory equipment, or animal cores that are shared by more than one component projects. Features of A Program Project (cont’)

5. General Criteria for Reviewing A Program Project 1.Program as an Integrated Effort a.The significance of the overall program goals and the development of a well-defined PPG focus of importance and relevance to an interested health problem. b.The multidisciplinary or multifaceted character of the program, i.e., its coordination, cohesiveness, interrelationship of the components and relationship to the central theme, and synergistic potential among the individual component projects and core(s).

6. c.The scientific stature, leadership capability and commitment of the Principal Investigator and his/her knowledge and familiarity with respect to the overall program, as well as the component projects. d.The justification for, and usefulness of, the core facilities to the research projects. Each core unit must provide essential facilities or services for two or more approved individual projects. General Criteria for Reviewing A Program Project (cont’)

7. e.Administrative arrangements and organizational structure, through the administrative core, to facilitate and monitor the attainment of objectives and internal quality control. For example, these will include plans to enhance communication and cooperation among the investigators involved in the program, long- term planning and periodic evaluation. f.Reasonableness of the overall budget for the proposed work. General Criteria for Reviewing A Program Project (cont’)

8. 2.Individual Projects and Core Units a.The scientific and technical merit of each research project and the merit of (or justification for) each core unit. b.The qualifications, experience, and commitment of the responsible investigators for the research projects or core units, include their ability to devote adequate time and effort to the project/core and to contribute to the overall program goals. General Criteria for Reviewing A Program Project (cont’)

9. c.The accomplishments (for new applications) and progress (for renewal applications) related to the projects and core units. d.The appropriateness of the budget for each of the proposed projects and core units. General Criteria for Reviewing A Program Project (cont’)

10. Component Research Project  Title and investigators  Specific aims  Background  Progress report/Preliminary studies  Research design and methods  Anticipated results  Human subjects  Gene recombination  Animal investigation  Potential hazards

11. Key Elements To Be Addressed In The Proposal  Progress/preliminary studies  Adequacy and relevance of background  Adequacy and feasibility of approach  Hypothesis, study design, and methodology  Sample population and controls  Data collection and analyses  Significance of study

12. Background  Current status of the field  Reasons for proposing the project (rationale)  Succinct hypothesis  Uniqueness and timeliness of the proposal  Importance and relevance to the problems to be solved.

13. Essential Components Rationale Hypothesis Specific aims Experimental design  The hypothesis should be logical and testable.  The specific aims should follow directly from the hypothesis.  The designs should follow the specific aims and test the hypothesis.

14. Specific Aims Experimental Design Methods and Procedures Data Collection and Analysis Background 非預期結果的話如何修正假說 Significance of study Hypothesis Rationale

15. Adequacy and Feasibility of Approach  In view of the overall objectives, is the proposed approach reasonable ？  Is it likely to be carried out and completed without any major complications or hindrances ？  Does the project proposed recognize and present solutions for potential problems which might arise ？

16. Adequacy And Relevance of Background  Is there sufficient background material to understand the reference point from which the project develops rationale for the proposed research ？  Is the reference material relevant and does it justify the direction taken ？

17. Hypotheses, Study Design, and Methodology  Are the hypotheses appropriate and valid in view of the background material presented ？  Are the aims logical ？  Is the study design appropriate to test the hypotheses presented ？  Are the protocols presented in sufficient detail ？  Are expected outcomes discussed ？  Are hypotheses or protocols discussed if alternative unexpected results are obtained ？

18. Significance of Study  The significance of the proposed work, relative to existing knowledge and theory, should be discussed.  What is the potential importance of the proposed work to the field ？  Discuss any novel ideas or contributions which the project offers.

19. Sample Population and Controls  Is the proposed subject population or sample appropriate ？  Are the sampling techniques acceptable ？  Is there an appropriate control or comparison group ？

20. Data Collection And Analysis  Are there any special problems related to either the collection or analysis of data ？  Are standard instruments being used or are new ones being developed ？  Is the general approach to data analysis clearly presented ？  Is the analysis appropriate to both the quality and quantity of data which have been or will be collected ？