4/10/2012

1

Carol Haussler

Lynda Olin

Joan Rankin Shapiro

Research Administration

UA College of Medicine, Phoenix

Developing, writing and submitting a research proposal is complex and time-consuming.

We don’t expect you to do everything on your own.

It takes a whole village…

2

What Does it Take?

Your Village…

3

Internal and External Colleagues

Interdisciplinary Collaboration

Networking

Departmental Admin Support

Research Admin at UA COM-PHX

Navigating the administrative details

Interface with Tucson

Compliance issues

4/10/2012

2

Role of Research Administration

4

There are many moving parts, we will help you make all of them come

together properly

Today’s Topics

Developing a Research Proposal

What is the Question?

Writing a Plan to Answer the Question

5

University of ArizonaCollege of Medicine

Phoenix

How to Begin?

Map out your research question!

6

4/10/2012

3

The Research Question

A research question is a statement that identifies the phenomenon to be studied

7

Developing a Research Question Things you need to ask yourself

Do I know the field and its literature well?

What important research questions remain in the field that need further exploration?

Can my study fill a gap in that field?

Will my study lead to a greaterunderstanding of the mechanism(s)involved?

8

Developing a Research Question More things you need to ask yourself

What research has been done in my area of interest?

Is the timing right for this question to be answered?

Is it a hot topic or becoming obsolete?

Would funding sources be interested inthis research question?

Will my study have a significant impacton the field?

9

4/10/2012

4

The “So What” FactorWhat is the potential impact of the

research you are proposing?

What is the benefit of answering your research question?

Who will it help (and how)?

If you can’t make a definitive statement about the purpose of your research it is unlikely to be viewed by others in a positive light.

10

Narrow Your Focus

The field of interest is often very encompassing.

However, an investigator’s research should be narrowly focused, not broad-based.

11

Narrow Your Focus For example, “What can be done to

prevent drug abuse?”

This is too large a question to answer.

It would be better to begin with a more focused question.

“What is the relationship between specific early childhood experiences and subsequent substance-abusing behaviors?”

12

4/10/2012

5

Develop Your Hypotheses

A well-thought-out and focused research question leads directly into your hypotheses.

What predictions would you make about the phenomenon you are examining?

13

Hypotheses

Hypotheses are more specific predictions about the nature and direction of the relationship between two variables.

14

Hypotheses

Central Hypothesis:

Specific genetic changes are required to cause cellular resistance to radiation and chemotherapy.

Focused Hypothesis:

We hypothesize that the specific mutation involving the loss of gene x leads to cellular resistance to the chemotherapeutic drug BCNU.

15

4/10/2012

6

Developing Strong Hypotheses Strong hypotheses:

Give insight into a research question;

Are testable and measurable by the proposed experiments;

Spring logically from the experience of the investigator;

Normally no more than three primary hypotheses should be proposed for a research study.

16

Developing Strong Hypotheses

Make sure you:

Provide a rationale for your hypotheses –where did they come from, and why are they strong?

Are there alternative possibilities for the hypotheses that could be tested?

Why did you choose the one(s) you did over the others that you might have proposed?

17

Developing Specific Aims

Specific Aims are steps you are going to take to test your hypotheses.

The specific aims section should serve as a succinct description of what you plan.

The Specific Aims are the goals you propose to accomplish in the course of the grant period you are requesting.

18

4/10/2012

7

Specific Aims (continued)

19

Make sure:

Your objectives are measurable and highly focused;

Each hypothesis is matched with one or more specific aims;

The technology proposed should be within your expertise;

The aims are feasible, given the time and money you are requesting in the grant.

Concept Paper

Once you have developed the research question, hypothesis and specific aim(s) you are ready to write a concept paper.

This is an important tool to help you organize your thoughts regarding your research strategy as well as to promote, disseminate or get feedback on your ideas.

20

Concept Paper

A concept paper is a succinct description of your research plan (3-5 pages) and can be particularly useful when trying to recruit collaborators for a specific technology that you wish to employ or develop in your laboratory.

Concept papers can also be important in soliciting letters of support.

21

4/10/2012

8

Basic Proposal Elements Project Summary/Abstract

Hypothesis/Specific Aims

Research Strategy/Plan

Bibliography

Biosketches

Facilities and Other Resources

Equipment

Budgets and Budget Justifications

Contractual and Compliance

Letters of Support

22

Project Summary/Abstract An abstract succinctly describes all major

aspects of the proposed project

It should contain the following information:

A statement of the purpose of the research;

A statement of the importance of the research;

A summary of the background and feasibility of your project;

A brief description of the relevant data;

The target population;23

Project Summary/Abstract And…

Hypotheses and methodology;

A brief description of evaluation methods and expected results;

A brief description of the contributions of your research to the field of knowledge and health outcomes.

Although the abstract comes first in most application formats, it is best to be written LAST.

24

4/10/2012

9

Specific Aims The elements within a specific aim should

contain the following information:

Tissues or animals used

Measurable terms

Time-phased objectives

Dosing and reagents

One can number or bullet each specific aim.25

Specific Aim Example

An Example:

To test the hypothesis that freshly resected brain tumor cells (tissue) will die when exposed to physiological doses of drug we plan to determine the number of cells undergoing apoptosis … (measurable terms) at 48 hours (time-phased objectives) following doses of 1, 5 and 7 micrograms exposure to the chemotherapeutic agent BCNU (reagent).

26

Specific Aims

And…

Specific aims should be in a logical progression;

If each specific aim is to deal with a hypothesis–state the hypothesis as illustrated in the previous example;

Be mindful of the page limitations. Generally, specific aims are limited to a single page.

27

4/10/2012

10

The NIH Research Strategy Significance of Project

Innovation of Project

Approach

Preliminary Studies or Progress Report

Strategy, Methodology & Analyses

Overall Impact & Future Directions

28

Significance

Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.

Explain how the proposed project will improve scientific knowledge,technical capability, and/or clinicalpractice in one or more broad fields.

29

SignificanceDescribe how the concepts, methods,

technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Explain why you are doing the study.

This section is your opportunity to convince reviewers that your research has impact and significance.

30

4/10/2012

11

Innovation Explain how the application challenges and

seeks to shift current research or clinical practice paradigms.

Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and

Describe any advantage over existing methodologies, instrumentation, or interventions.

31

Approach Preliminary Studies or Progress Report

For new applications, include preliminary data.

Reviewers will place less emphasis on preliminary data for applications from Early Stage Investigators.

Renewal and revision applicationsrequire a progress report.

32

Approach

Develop a defense as to why your hypotheses and objectives need to be done and why it is relevant to the target population you are proposing;

Use statistics and prevalence rates to emphasize the need;

33

4/10/2012

12

Approach Strategy, Methodology & Analyses

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.

If these are techniques for which you do not have publications or expertise be sure you have a collaborator or consultant for this part of the experiment.

If you have collaborators you mustdefine their role as well as their training and expertise to conduct their part of the study;

34

Approach Discuss potential problems, alternative

strategies, and benchmarks for success anticipated to achieve the aims.

If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

35

Approach This section will detail how you plan to conduct

the study and should contain the following information:

State the specific aims and the hypothesis you will be testing;

State the rationale for the design of the specific aims you have chosen to use rather than alternative methods;

If the objective is to work with patients or patient records provide the numbers thatare needed (if it is a pilot study or an expansion of a pilot study) to achievethe objective;

36

4/10/2012

13

Approach

It is important to cite any manuscripts you have published in peer-reviewed journals to further prove your abilities to conduct the proposed study.

The subject matter can be different but if the methods to be employed are the same it can be used in this section.

37

Approach The literature you cite must show the

reviewers that you understand your field and possess the knowledge to perform the tasks you propose.

Make sure you cite all the current papers concerning this subject leaving only a few older than ten years as part of the historical picture.

38

Approach What information will you collect and how will

it be recorded;

Fully explain inclusion and exclusion criteria that are associated with the study;

Describe any instruments, data processes or data collection forms that you will be using;

Data analysis and evaluation must include the statistical procedures and methods used for each hypothesis;

39

4/10/2012

14

Approach In addition…

You must discuss the gender and minority representation and the basis of any exclusions;

Lastly, the goal of the research design and methods section is to minimize the number of assumptions the reviewers must make about your project by showing them that you are using sound scientific techniques.

40

Approach Expected Outcomes

Discuss the long-term applications of this research and how this will contribute to the existing pool of knowledge.

Sum up this section with a few bullets explaining why your proposed research is important, innovative, timely andworthwhile.

41

Basic Proposal Elements Project Summary/Abstract

Hypothesis/Specific Aims

Research Strategy/Plan

Bibliography

Biosketches

Facilities and Other Resources

Equipment

Budgets and Budget Justifications

Contractual and Compliance

Letters of Support

42

4/10/2012

15

Last, But Not Least

Please contact us early in the process

We will help you navigate through the administrative maze

Carol Hausslerchaussle@email.arizona.edu602.827.2101

Lynda Olinlolin@arizona.edu602.827.2323

43